NZ752677B2 - Analysis system and method for testing a sample - Google Patents
Analysis system and method for testing a sample Download PDFInfo
- Publication number
- NZ752677B2 NZ752677B2 NZ752677A NZ75267717A NZ752677B2 NZ 752677 B2 NZ752677 B2 NZ 752677B2 NZ 752677 A NZ752677 A NZ 752677A NZ 75267717 A NZ75267717 A NZ 75267717A NZ 752677 B2 NZ752677 B2 NZ 752677B2
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- New Zealand
- Prior art keywords
- cartridge
- analysis device
- operating instrument
- test
- analysis
- Prior art date
Links
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Classifications
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Abstract
The present disclosure is concerned with the field of bioanalytics. Described systems and methods concern, in particular, testing a sample by means of an analysis system. The prob-lem addressed by the present embodiments is to provide a system for testing a sample, such as a biological sample, in a more efficient, individual and/or flexible manner. The claimed solution involves using an analysis system for testing a sample. The analysis sys-tem comprises a cartridge for receiving the sample, an analysis device for receiving the cartridge and subsequently carrying out the test using the received cartridge, and an oper-ating instrument which is separable from the analysis device with respect to a data connec-tion and/or which is wirelessly connectable to the analysis device. The operating instru-ment is designed to determine or read out a cartridge identifier corresponding to the car-tridge and, using this cartridge identifier, to retrieve from a database control information for carrying out the test and to transmit the control information to the analysis device. The analysis device is configured for carrying out the testing using the control information transmitted independently, disconnectedly, and/or separately from the operating instru-ment. more efficient, individual and/or flexible manner. The claimed solution involves using an analysis system for testing a sample. The analysis sys-tem comprises a cartridge for receiving the sample, an analysis device for receiving the cartridge and subsequently carrying out the test using the received cartridge, and an oper-ating instrument which is separable from the analysis device with respect to a data connec-tion and/or which is wirelessly connectable to the analysis device. The operating instru-ment is designed to determine or read out a cartridge identifier corresponding to the car-tridge and, using this cartridge identifier, to retrieve from a database control information for carrying out the test and to transmit the control information to the analysis device. The analysis device is configured for carrying out the testing using the control information transmitted independently, disconnectedly, and/or separately from the operating instru-ment.
Description
Analysis system and method for testing a sample
The present disclosure relates to an analysis system according to the preamble of claims
1, 9, 16, and 25, to a method according to the preamble of claims 41, 43, 45 and 47, and
to a computer program product.
Preferably, the present disclosure deals with analysing and testing a sample, in
particular from a human or animal, particularly preferably for analytics and diagnostics,
for example with regard to the presence of diseases and/or pathogens and/or for
determining blood counts, antibodies, hormones, steroids or the like. Therefore, the
present disclosure is in particular within the field of bioanalytics. A food sample,
environmental sample or another sample may optionally also be tested, in particular for
environmental analytics or food safety and/or for detecting other substances.
Preferably, by means of the present disclosure, at least one analyte (target analyte) of a
sample can be determined, identified or detected. In particular, the sample can be tested
for qualitatively or quantitatively determining at least one analyte, for example in order
for it to be possible to detect or identify a disease and/or pathogen.
Within the meaning of the present disclosure, analytes are in particular nucleic-acid
sequences, in particular DNA sequences and/or RNA sequences, and/or proteins, in
particular antigens and/or antibodies. In particular, by means of the present disclosure,
nucleic-acid sequences can be determined, identified or detected as analytes of a
sample, and/or proteins can be determined, identified or detected as analytes of the
sample. More particularly preferably, the present disclosure deals with systems, devices
and other apparatuses for carrying out a nucleic-acid assay for detecting or identifying a
nucleic-acid sequence and/or a protein assay for detecting or identifying a protein.
The present disclosure deals in particular with what are known as point-of-care systems,
i.e. in particular with mobile systems, devices and other apparatuses, and deals with
methods for carrying out tests on a sample at the sampling site and/or independently
and/or away from a central laboratory or the like. Preferably, point-of-care systems can
be operated autonomously of and/or independently from a mains network for supplying
electrical power.
US 5,096,669 discloses a point-of-care system for testing a biological sample, in
particular a blood sample. The system comprises a single-use cartridge and an analysis
device. Once the sample has been received, the cartridge is inserted into the analysis
device in order to carry out the test. The cartridge comprises a microfluidic system and a
sensor apparatus comprising electrodes, which apparatus is calibrated by means of a
40 calibration liquid and is then used to test the sample.
Furthermore, A1 discloses a point-of-care system for integrated and
automated DNA or protein analysis, comprising a single-use cartridge and an analysis
device for fully automatically processing and evaluating molecular-diagnostic analyses
using the single-use cartridge. The cartridge is designed to receive a sample, in
particular blood, and in particular allows cell disruption, PCR and detection of PCR
amplification products, which are bonded to capture molecules and provided with a
label enzyme, in order for it to be possible to detect bonded PCR amplification products
or nucleic sequences as target analytes in what is known as a redox cycling process.
DE 100 58 394 C1 discloses a method for testing a sample using a reaction array
comprising at least two reaction compartments for receiving substances that react with
one another, the reaction compartments being interconnected by means of a supply
space. In order to measure the substances, an exchange of substances and thus chemical
crosstalk between the individual reaction compartments is prevented by lowering a
sensor cover. In this way, the detection sensitivity of the method is increased.
EP 2 305 383 B1 discloses an instrument for carrying out and analysing microarray
experiments. In particular, this document discloses carrying out microarray experiments
in parallel in order to detect specific interactions between probe molecules and target
molecules in a microtiter plate. In this case, probes in the form of a substance library are
provided on carriers, and therefore a sample can be simultaneously analysed on a
plurality of probes in parallel. In the context of microarray experiments of this kind, it is
also disclosed that a desired operating mode can be specified for a processing apparatus
externally, in particular by a user.
US 2011/0253224 A1 discloses a feedback control in microfluidic systems. The control
of fluids involves the use of feedback from one or more processes or events taking place
in the microfluidic system. For instance, a detector may detect one or more fluids at a
measurement zone and, using this data, a control system may determine whether to
modulate subsequent fluid flow in the microfluidic system.
US 2015/0148705 A1 discloses systems and devices for sampling and profiling
microbiota of skin. A microbe profiling device includes a handheld housing with an
elongated flexible strip including a microbe-capture region and a location information
storage component. The strip is configured to capture microbes from one or more
regions of a skin surface of an individual, and the location information storage
component is configured to store information associated with the location of said one or
more regions.
40 US 2014/0296089 A1 discloses systems and methods for multi-analysis and sample
processing. A device may be provided, capable of receiving the sample, and performing
one or more of a sample preparation, sample assay, and detection step. The device may
be capable of performing multiple assays.
DE 20 2010 007 208 U1 discloses a device for testing of body fluids applied to carrier
materials. The device comprises at least two apparatuses for determining different
substances present in the body fluid, wherein the carrier materials to be inserted into the
device are provided with a coding specific to the relevant body fluid and substance to be
determined. The relevant apparatus can be activated via the corresponding coding.
Furthermore, an additional external device can be provided to evaluate and to present
measurement results.
US 2002/0060247 A1 discloses an analyte test instrument system including data
management system and a method of managing data for a plurality of analyte test
instruments connect to a data communication network. The method comprises the steps
of: Detecting via a host computer, the connection of each instrument to the data
communication network; uploading data received from each instrument to the host
computer; processing the uploaded data on the host computer for operator review; and
downloading configuration data from the host computer to each test instrument, the
downloaded data comprising instruments specific setup and control data.
AU 2013 201509 B2 discloses Point-of-Care fluidic systems and uses thereof.
Specifically, the invention provides portable medical devices that allow real-time
detection of analytes from a biological fluid. A system for detecting an analyte in a
bodily fluid comprises a fluidic device in which a sample of bodily fluid can react with
reactants contained within the device, based on a protocol transmitted from an external
device, to yield a detectable signal indicative of the presence of said analyte. The system
further comprises a reader assembly for detecting said detectable signal. The external
device is external to the reader assembly and stores a plurality of protocols, wherein the
reader assembly is configured to download a fluidic device-specific protocol selected
from the plurality of protocols on the external device to run on the fluidic device based
on an identity of the fluidic device.
US 5,961,451 A discloses a non-invasive apparatus having a retaining member to retain
a removable biosensor. The apparatus includes a non-invasive extraction device to non-
invasively extract a biological sample from an end-user, preferably through the skin by
transdermal permeation. The apparatus further comprises a biosensor to sense a
characteristic, property, or parameter of the biological sample.
US 2006/0292039 A1 discloses a measuring system making it possible for a user to
check his/her own health state at a desired place without visiting inspection agencies.
First, a user collects body fluid which is introduced to a chip as a sample. The sample is
40 made to act on a detection reagent which acts on a specific component in the sample to
generate a predetermined detection reaction. The chip is set to a mobile terminal, which
measures an amount of a specific component in the sample. The mobile terminal
transmits the measurement value to an analysis centre.
US 2015/0244852 A1 discloses an apparatus and method for Point-of-Collection
measurement of a biomolecular reaction. A biological sample is collected on a modular
diagnostic test platform, which is inserted into a smartphone accessory. Optical,
electrical, mechanical, or other means are used to transduce a biomolecular binding
event and communicate the results with the smartphone. The result can then be
presented quantitatively, displayed to the user, stored for later comparison, and
communicated to a central hub location where medical professionals can provide
additional review.
The problem addressed by the present disclosure is to provide an analysis system, a
method and a computer program product for evaluating a sample, it being possible to
test the sample and/or to test measurement results in a more efficient, individual and/or
flexible manner.
The above problem is solved by an analysis system according to claim 1, 2, 3 or 4, by a
method according to claim 32, 33, 34 and 35, or by a computer program product
according to claim 36. Advantageous developments are the subject of the dependent
claims.
A proposed analysis system is provided for testing an in particular biological sample.
Some embodiments relate to an analysis system for testing a sample,
the analysis system comprising a cartridge for receiving the sample, and
the analysis system comprising an analysis device for receiving the cartridge and
subsequently carrying out the test using the received cartridge,
wherein the cartridge comprises a sensor apparatus for detecting analytes of the
sample during the test and a memory means, the memory means being provided in
the sensor apparatus,
wherein a cartridge identifier corresponding to the cartridge is stored in the
memory means as data,
wherein the analysis device comprises an electrical connection apparatus with
electrical contact elements for establishing an electronic connection to the sensor
apparatus, wherein the cartridge identifier can be read out via the electronic
connection between the cartridge and the analysis device created by means of the
contact elements, and wherein measurement results obtained by the sensor
apparatus from testing the sample can be electrically transmitted to the analysis
device by means of the same electronic connection,
wherein the analysis system comprises an operating instrument which is
40 separable from the analysis device with respect to a data connection and/or which
is wirelessly connectable to the analysis device,
the operating instrument being designed to receive the cartridge identifier
corresponding to the cartridge and, using this cartridge identifier, to retrieve from
a database control information for carrying out the test and to transmit said
control information to the analysis device.
Some embodiments relate to an analysis system for testing a sample,
the analysis system comprising a cartridge for receiving the sample, and
the analysis system comprising an analysis device for receiving the cartridge and
subsequently carrying out the test using the received cartridge,
wherein the cartridge comprises a sensor apparatus for detecting analytes of the
sample during the test and a memory means, the memory means being provided in
the sensor apparatus,
wherein a cartridge identifier corresponding to the cartridge is stored in the
memory means as data,
wherein the analysis device comprises an electrical connection apparatus with
electrical contact elements for establishing an electronic connection to the sensor
apparatus, wherein the cartridge identifier can be read out via the electronic
connection between the cartridge and the analysis device created by means of the
contact elements, and wherein measurement results obtained by the sensor
apparatus from testing the sample can be electrically transmitted to the analysis
device by means of the same electronic connection,
wherein the analysis system comprises an operating instrument which is
separable from the analysis device with respect to a data connection and/or
wirelessly connectable to the analysis device,
the operating instrument being configured to retrieve from a database control
information for controlling actuators of the analysis device for carrying out the test
supported by the cartridge and to transmit to the analysis device said control
information, and the analysis device being configured to carry out the test using
the transmitted control information independently, disconnected and/or
separately from the operating instrument.
Some embodiments relate to an analysis system for testing a sample,
the analysis system comprising a cartridge for receiving the sample, and
the analysis system comprising an analysis device for receiving the cartridge and
subsequently carrying out the test using the received cartridge,
wherein the cartridge comprises a sensor apparatus for detecting analytes of the
sample during the test and a memory means, the memory means being provided in
the sensor apparatus,
wherein a cartridge identifier corresponding to the cartridge is stored in the
40 memory means as data,
wherein the analysis device comprises an electrical apparatus with electrical
contact elements for establishing an electronic connection to the sensor apparatus,
wherein the cartridge identifier can be read out via the electronic connection
between the cartridge and the analysis device created by means of the contact
elements, and wherein measurement results obtained by the sensor apparatus
from testing the sample can be electrically transmitted to the analysis device by
means of the same electronic connection,
wherein the analysis system comprises an operating instrument which is
separable from the analysis device with respect to a data connection and/or
wirelessly connected to the analysis device,
the analysis device being configured to receive control information from the
operating instrument, to control the test of the sample in the cartridge using said
control information, and to transmit measurement results determined during the
test to the operating instrument without any prior evaluation.
Some embodiments relate to an analysis system for testing a sample,
the analysis system comprising a cartridge for receiving the sample, and
the analysis system comprising an analysis device for receiving the cartridge and
subsequently carrying out the test using the received cartridge,
wherein the cartridge comprises a sensor apparatus for detecting analytes of the
sample during the test and a memory means, the memory means being provided in
the sensor apparatus,
wherein a cartridge identifier corresponding to the cartridge is stored in the
memory means as data,
wherein the analysis device comprises an electrical connection apparatus with
electrical contact elements for establishing an electronic connection to the sensor
apparatus, wherein the cartridge identifier can be read out via the electronic
connection between the cartridge and the analysis device created by means of the
contact elements, and wherein measurement results obtained by the sensor
apparatus from testing the sample can be electrically transmitted to the analysis
device by means of the same electronic connection,
wherein the analysis system comprises a portable operating instrument, the
operating instrument being configured to receive the cartridge identifier
corresponding to the cartridge and, using the cartridge identifier, to retrieve from
a database evaluation information for evaluating measurement results determined
during the test that originate from the sensor apparatus, and to evaluate the
measurement results using the evaluation information independently,
disconnected and/or separately from the analysis device.
40 Some embodiments relate to a method for testing a sample by means of an analysis
system,
the analysis system comprising a cartridge for receiving the sample,
the analysis system comprising an analysis device for receiving the cartridge and
subsequently carrying out the test using the received cartridge,
wherein the analysis system comprises an operating instrument which is
separable from the analysis device with respect to a data connection and/or
wirelessly connectable to the analysis device,
wherein the cartridge comprises a sensor apparatus for detecting analytes of the
sample during the test and a memory means, the memory means being provided in
the sensor apparatus,
wherein the analysis device comprises an electrical connection apparatus with
electrical contact elements for establishing an electronic connection to the sensor
apparatus for electrically transmitting measurement results obtained by the
sensor apparatus from testing the sample to the analysis device,
the analysis device establishing an electronic connection to the sensor apparatus
by means of the electrical contact elements and reading out the cartridge identifier
corresponding to the cartridge from the memory means via the electronic
connection between the cartridge and the analysis device created by means of the
contact elements,
the operating instrument receiving the cartridge identifier and, using the cartridge
identifier, retrieving from a database control information for carrying out the test
and transmitting said control information to the analysis device.
Some embodiments relate to a method for testing a sample by means of an analysis
system,
the analysis system comprising a cartridge for receiving the sample,
the analysis system comprising an analysis device for receiving the cartridge and
subsequently carrying out the test using the received cartridge,
wherein the analysis system comprises an operating instrument which is
separable from the analysis device with respect to a data connection and/or
wirelessly connectable to the analysis device,
wherein the cartridge comprises a sensor apparatus for detecting analytes of the
sample during the test and a memory means, the memory means being provided in
the sensor apparatus,
wherein the analysis device comprises an electrical connection apparatus with
electrical contact elements for establishing an electronic connection to the sensor
apparatus for electrically transmitting measurement results obtained by the
sensor apparatus from testing the sample to the analysis device,
the analysis device establishing an electronic connection to the sensor apparatus
by means of the electrical contact elements and reading out the cartridge identifier
40 corresponding to the cartridge from the memory means via the electronic
connection between the cartridge and the analysis device created by means of the
contact elements,
the operating instrument retrieving from a database control information for
controlling actuators of the analysis device for carrying out the test supported by
the cartridge and transmitting to the analysis device said control information, and
the analysis device carrying out the test using the transmitted control information
independently, disconnected and/or separately from the operating instrument.
Some embodiments relate to a method for testing a sample by means of an analysis
system,
the analysis system comprising a cartridge for receiving the sample,
the analysis system comprising an analysis device for receiving the cartridge and
subsequently carrying out the test using the received cartridge,
wherein the analysis system comprises an operating instrument which is
separable from the analysis device with respect to a data connection and/or
wirelessly connectable to the analysis device,
wherein the cartridge comprises a sensor apparatus for detecting analytes of the
sample during the test and a memory means, the memory means being provided in
the sensor apparatus,
wherein the analysis device comprises an electrical connection apparatus with
electrical contact elements for establishing an electronic connection to the sensor
apparatus for electrically transmitting measurement results obtained by the
sensor apparatus from testing the sample to the analysis device,
the analysis device establishing an electronic connection to the sensor apparatus
by means of the electrical contact elements and reading out the cartridge identifier
corresponding to the cartridge from the memory means via the electronic
connection between the cartridge and the analysis device created by means of the
contact elements,
the analysis device receiving control information from the operating instrument,
controlling the test of the sample in the cartridge using the control information and
transmitting measurement results determined during the test to the operating
instrument without any prior evaluation.
Some embodiments relate to a method for testing a sample by means of an analysis
system,
the analysis system comprising a cartridge for receiving the sample,
the analysis system comprising an analysis device for receiving the cartridge and
subsequently carrying out the test using the received cartridge,
wherein the analysis system comprises a portable operating instrument,
wherein the cartridge comprises a sensor apparatus for detecting analytes of the
sample during the test and a memory means, the memory means being provided in
the sensor apparatus,
wherein the analysis device comprises an electrical connection apparatus with
electrical contact elements for establishing an electronic connection to the sensor
apparatus for electrically transmitting measurement results obtained by the
sensor apparatus from testing the sample to the analysis device,
the analysis device establishing an electronic connection to the sensor apparatus
by means of the electrical contact elements and reading out the cartridge identifier
corresponding to the cartridge from the memory means via the electronic
connection between the cartridge and the analysis device created by means of the
contact elements,
the operating instrument receiving the cartridge identifier corresponding to the
cartridge and, using the cartridge identifier, retrieving from a database evaluation
information for evaluating measurement results determined during the test that
originate from the sensor apparatus, and evaluating the measurement results
using the evaluation information independently, disconnected and/or separately
from the analysis device.
Some embodiments relate to a computer program product comprising program code
means which, when executed, cause the method steps of any one of the aforementioned
methods to be carried out.
The analysis system is in particular portable, mobile and/or is a point-of-care system
and/or is or can be operated autonomously, in particular independently from a power
network, in particular at the sampling site and/or away from a central laboratory and/or
by means of a power storage unit.
The analysis system preferably comprises an analysis device and a cartridge for testing
the sample, the cartridge preferably being designed for receiving the sample.
Particularly preferably, the analysis device is designed to receive the cartridge or to
connect said cartridge electrically, thermally and/or pneumatically. The analysis device
is preferably designed to subsequently carry out the test using the received cartridge.
For this purpose, the cartridge can be inserted or loaded into the analysis device,
whereupon the analysis device can act on the cartridge in order to carry out the test.
Channels in which the sample can be conveyed are preferably provided in said
cartridge. This makes it possible for the sample to be pretreated or processed on the card
and/or for the sample to be evaluated or analysed by means of a sensor apparatus, which
40 is preferably also located on the card.
Particularly preferably, the analysis system comprises an operating instrument. This
operating instrument may be or comprise a smartphone, tablet or the like. Therefore, the
operating instrument is in particular a portable and/or mobile (terminal) device.
It is preferable for the operating instrument to be separable or separated from the
analysis device physically and/or with respect to a data connection. This can be
achieved, for example, by disconnecting or terminating or breaking a data connection
between the analysis device and the operating instrument, in particular manually or by
removing the operating instrument from the analysis device.
Alternatively or additionally, it is provided for the operating instrument to be
connectable or connected to the analysis device wirelessly and/or via a radio connection
or air interface. Particularly preferably, the operating instrument can be or is
automatically connected to and/or disconnected and/or separated from the analysis
device with respect to a data connection, in particular via what is known as an ad-hoc
data connection or an ad-hoc network, such as a Bluetooth connection, which is
established and/or configured automatically. In addition to the Bluetooth standard, other
conventional short-range transmission methods, NFC, WPAN or WLAN are also
suitable.
By means of the operating instrument, it is preferably possible to achieve the
configurations of the analysis device required for the test, and therefore it is not
necessary for the analysis device to comprise any complex user interfaces, but rather the
analysis device preferably comprises, at most, an on-off switch and a rudimentary status
display (not comprising a screen or the like). This advantageously makes it possible to
use standard hardware that can be configured in a flexible manner, such as smartphones
or tablets, in order for a user-friendly configuration to be achieved, enabling or
facilitating a flexibility with regard to the embodiment of the operating instrument and
for corresponding data and interfaces to be updated in a simple and software-based
manner.
In this respect, one aspect of the present disclosure is that the operating instrument is
preferably designed to determine, read out or receive a cartridge identifier
corresponding to the cartridge and, using the cartridge identifier, to retrieve from a
database control information for carrying out the test, which information is in particular
specific to the cartridge or a batch to which the cartridge is assigned, and/or to transmit
said information to the analysis device.
This aspect is advantageous in that it is thus possible to use control information that is
40 individual, unique and/or specific to the specific cartridge. This control information can
incorporate characteristic features of the specific cartridge or a batch of cartridges,
relating for example to the substances therein, to the suitability for a certain test, to the
use of certain sensor arrangements, or to specific information for carrying out the test,
wherein the information is adapted to the cartridge, the batch or the like, and contains,
for example, adapted times, temperatures or the like.
In this regard, the use of the operating instrument that can be separated and/or
disconnected from the analysis device and/or wirelessly connected to the analysis
device is particularly advantageous in that the cartridge or the cartridge batch can be
identified in a simple manner and independently from the analysis device, and
corresponding control information can, separately and/or disconnected from the analysis
device, also be retrieved and/or stored temporarily, for example in advance. The control
information can then be transmitted to the analysis device at a later stage, also
independently from a link between the operating instrument and the Internet and/or the
database.
According to another aspect of the present disclosure, which can also be implemented
independently, the operating instrument is preferably designed to transmit to the
analysis device control information for carrying out the test supported by the cartridge,
which information is in particular specific to the cartridge or a batch to which the
cartridge is assigned, the analysis device being designed to carry out the test using the
transmitted control information independently from and/or separately and/or
disconnected from the operating instrument.
It is therefore preferable for the analysis system to be configured by the operating
instrument to such an extent that the test of the in particular biological sample using the
cartridge can be started or has been started by the analysis device. It is then not
necessary for the operating instrument to remain permanently connected to the analysis
device, and therefore the operating instrument can be used in a manner in which it is
separated and/or disconnected from the analysis device with respect to a data
connection.
This makes it possible to handle and use the operating instrument in a flexible manner
and independently from the analysis device, in particular in cases where the sample is
tested for a prolonged period of time. Another advantage is that the analysis device can
operate autonomously following corresponding configuration, and therefore the proper
testing of the sample is not dependent on the maintenance of the radio connection
between the operating instrument and the analysis device, which may be subject to
disturbance, but rather the test can advantageously be carried out in a very robust,
reliable and disturbance-resistant manner as a result of the test not being dependent on
the maintenance of the radio connection.
40 According to another aspect of the present disclosure, which can also be implemented
independently, the analysis device is designed to receive control information from the
operating instrument, which information is in particular specific to the cartridge or a
batch to which the cartridge is assigned, to control the testing of the sample in the
cartridge using the control information, and to transmit measurement results determined
during the test to the operating instrument without any prior evaluation.
It is therefore preferable for the measurement results to be interpreted outside the
analysis device, particularly preferably by the operating instrument. Alternatively,
evaluation can, however, also take place externally, for which purpose the operating
instrument can send the measurement results to a server for example. The analysis
device is preferably not set up to directly interpret the measurement results from the test
of the sample.
Advantageously, interpreting the measurement results outside the analysis device, in
particular by means of the operating instrument, is advantageous in that the evaluation
methods can be dynamically adapted without having to make any changes to the
analysis device. This is particularly advantageous in the context of the present analysis
system based on cartridges which are separated from the analysis device in an initial
state and are inserted into the analysis device for carrying out the tests.
In this regard, the present system provides the flexibility of using different cartridges in
order to carry out different tests on different samples. Different measurement results can
then in turn be interpreted in different ways. Adapting an analysis device to variable
conditions of this kind is complex and may require that the hardware, after some time,
be replaced because the processing capacity is too low or because of some other
adaptation requirement, even though the mechanical components of the analysis device
might not actually need to be replaced.
Consequently, it has been found to be particularly advantageous for the analysis device
to be physically separated from the operating instrument and for the measurement
results to be evaluated outside the analysis device by means of the operating instrument
or via the operating instrument, in particular since the operating instrument can be
replaced in a simpler and more cost-effective manner and also at more frequent intervals
without the complex mechanical system of the analysis device for carrying out the test
using the cartridge also having to be exchanged.
Another aspect of the present disclosure, which can also be implemented independently,
likewise relates to the evaluation of the measurement results. In this respect, it is
preferable for the operating instrument to be designed to determine, read out or receive
a cartridge identifier corresponding to the cartridge and, using the cartridge identifier, to
retrieve from a database evaluation information designed for evaluating measurement
results determined during the test, which information is in particular specific to the
40 cartridge or a batch to which the cartridge is assigned, and to evaluate the measurement
results using the evaluation information independently and/or separately and/or
disconnected from the analysis device.
In this regard, it is advantageous that, by identifying the cartridge using the cartridge
identifier, it is possible to use evaluation information which is individual or unique to
the cartridge or the cartridge batch. In this respect, it is possible to take into account
properties of the sample preparation, the cartridge, the environmental conditions and/or
the sensor arrangement or other information that is specific to the cartridge and
conducive to rapid and/or reliable evaluation of the measurement results.
Further advantages have already been explained in the context of the measurement
results being evaluated externally outside the analysis device, to which reference is
made.
Another advantage is that the measurement results can be evaluated in the operating
instrument in an individual and correspondingly accurate manner. If the evaluation
information is retrieved from the database in advance and initially stored temporarily in
the operating instrument, as is the case in a preferred embodiment, despite the flexible
hardware there is thus no need for a connection to the Internet or other servers and/or
databases for the purpose of evaluating the measurement results.
This is particularly advantageous in connection with the fact that the proposed analysis
system is preferably a point-of-care system for use on site, i.e. in the surroundings of the
sampling site. In case of doubt, the proposed analysis system is used for example in the
countryside in a pigsty or on a mountainous pasture where infrastructural weak points
can typically lead to mobile communication connections or the like not being reliably
available. In this case, it is particularly advantageous for the measurement results to be
evaluated in the operating instrument outside of and separately and/or disconnected
from the analysis device.
The present disclosure also relates to a method for testing an in particular biological
sample by means of the analysis system comprising the cartridge, the analysis device
for receiving the cartridge and the operating instrument, which is preferably separable
and/or disconnectable from the analysis device with respect to a data connection and/or
wirelessly connectable to the analysis device with respect to a data connection.
According to one aspect of the proposed method, which can also be implemented
independently, a cartridge identifier corresponding to the cartridge is determined, read
out or received by the operating instrument. Using the cartridge identifier, control
information is retrieved from a database and/or transmitted to the analysis device. In
this case, the control information is preferably specific to the cartridge or a batch with
which the cartridge is associated, the cartridge or batch corresponding to the cartridge
40 identifier. Furthermore, the control information is designed to control the analysis
device in order to carry out the test using the cartridge. As a result, the advantages that
have already been explained at the outset can be achieved.
In another aspect of the proposed method, which can also be implemented
independently, the operating instrument transmits control information to the analysis
device, the control information preferably being specific to the cartridge or a batch with
which the cartridge is associated and/or being suitable for carrying out the test
supported by the cartridge. Furthermore, the analysis device carries out the test using
the transmitted control information independently and/or separately and/or disconnected
from the operating instrument. As a result, the advantages that have already been
explained at the outset can be achieved.
According to another aspect of the proposed method, which can also be implemented
independently, the analysis device receives the control information from the operating
instrument, which information is preferably specific to the cartridge and/or batch. The
analysis device controls the testing of the sample in the cartridge using the control
information. The measurement results determined during the test are transmitted to the
operating instrument without any prior evaluation. As a result, the advantages that have
already been explained at the outset can be achieved.
According to another aspect of the proposed method, which can also be implemented
independently, the operating instrument determines, reads out or receives a cartridge
identifier corresponding to the cartridge or batch. Using the cartridge identifier,
evaluation information, which is preferably specific to the cartridge or batch, is
retrieved from a database, which evaluation information is suitable or designed for
evaluating measurement results determined during the test. Using the evaluation
information, the measurement results are evaluated independently and/or separately
and/or disconnected from the analysis device. As a result, the advantages that have
already been explained at the outset can be achieved.
As a result, a data connection between the operating instrument and the analysis device
may be provided initially. Subsequently, control information is preferably transmitted to
the analysis device. In this case, the control information preferably corresponds to a
cartridge, which can be or is loaded into the analysis device, or to a batch with which
the cartridge is associated. Using the control information, testing of a sample received in
the cartridge is preferably started. After the test has begun, the operating instrument can
be separated and/or disconnected from the analysis device or the operating instrument is
separated and/or disconnected from the analysis device and the test is continued,
preferably brought to an end, by means of the analysis device comprising the cartridge
and independently from the operating instrument. Subsequently, a measurement result,
as the result of the test, can be transmitted to the operating instrument. If the operating
instrument has previously been separated and/or disconnected from the analysis device,
40 the measurement results are preferably transmitted automatically once the operating
instrument has been reconnected to the analysis device and/or a data connection
between the operating instrument and the analysis device has been re-established.
According to another aspect of the present disclosure, which can also be implemented
independently, the analysis device receives from the operating instrument the control
information specific to the cartridge. The analysis device controls the testing of the
sample in the cartridge using the control information. The measurement results
determined during the test are transmitted to the operating instrument without any prior
evaluation.
According to another aspect of the present disclosure, which can also be implemented
independently, the operating instrument determines, reads out or receives an identifier
corresponding to the cartridge. Using the identifier, evaluation information specific to
the cartridge is retrieved from a database, which evaluation information is suitable or
designed for evaluating measurement results determined during the test. Using the
evaluation information, the measurement results are evaluated independently and/or
separately and/or disconnected from the analysis device.
Another aspect of the present disclosure, which can also be implemented independently,
relates to a computer program product comprising program code means which, when
executed, for example by a processor, computer, microcontroller or one or more other
data processing apparatuses for executing the program code means, in particular of the
operating instrument and/or the analysis device, cause the method steps or the method
according to the present disclosure to be carried out.
The term "analysis device" is preferably understood to mean an instrument which is in
particular mobile and/or can be used on site, and/or which is designed to chemically,
biologically and/or physically test and/or analyse a sample or a component thereof,
preferably in and/or by means of a cartridge. In particular, the analysis device controls
the pretreatment and/or testing of the sample in the cartridge. For this purpose, the
analysis device can act on the cartridge, in particular such that the sample is conveyed,
temperature-controlled and/or measured in the cartridge.
The term "cartridge" is preferably understood to mean a structural apparatus or unit
designed to receive, to store, to physically, chemically and/or biologically treat and/or
prepare and/or to measure a sample, preferably in order to make it possible to detect,
identify or determine at least one analyte, in particular a protein and/or a nucleic-acid
sequence, of the sample.
A cartridge within the meaning of the present disclosure preferably comprises a fluid
system having a plurality of channels, cavities and/or valves for controlling the flow
through the channels and/or cavities.
In particular, within the meaning of the present disclosure, a cartridge is designed to be
at least substantially planar, flat and/or card-like, in particular is designed as a
(micro)fluidic card and/or is designed as a main body or container that can preferably be
closed and/or said cartridge can be inserted and/or plugged into a proposed analysis
device when it contains the sample.
The term "operating instrument" is preferably understood to mean an apparatus by
means of which the analysis device can be controlled, control information can be
transmitted to the analysis device, and/or measurement results can be received from the
analysis device and/or measurement results can be evaluated. Preferably, the operating
instrument is or forms a user interface for controlling the test and/or the evaluation or
outputting of measurement results.
The operating instrument can alternatively be called operator control instrument. The
operating instrument preferably is configured to be operated by an operator (user) for
controlling, in particular of the analysis device, the test and/or the evaluation. Thus, the
operating instrument is or comprises a user interface for input of commands and transfer
of pieces of control information to the analysis device.
The operating instrument preferably comprises an input apparatus for controlling the
analysis device, for controlling data transmission and/or for controlling the evaluation
of measurement results. Alternatively or additionally, the operating instrument
comprises an output apparatus for outputting, in particular displaying, information, in
particular status information, operating elements and/or results. The operating
instrument preferably comprises a processor, microcontroller and/or memory for
executing a computer program product for data transmission, for control and/or for
evaluating measurement results.
Particularly preferably, the operating instrument is a mobile terminal device, in
particular for a radio and/or mobile network, such as a smartphone, tablet computer,
mobile telephone or the like. The operating instrument can preferably be operated
independently from a power network, using a power storage means, in particular a
(rechargeable) battery, and in a mobile manner, autonomously of and/or independently
from further components of the analysis system, in particular the analysis device. The
operating instrument preferably comprises one or more interfaces for wireless data
communications, in particular a WPAN communication interface, a WLAN
communication interface, a near-field communication interface, an optical
communication interface such as a camera, and/or a mobile radio interface.
The term "test" as used herein preferably means a test procedure/sequence and/or
performing an assay, in particular one, several or all steps for performing an assay to
determine one or more analytes of a sample. The steps are preferably realized by or
40 within the analysis system, analysis device and/or cartridge.
An "assay" according to the present disclosure is preferably an investigative procedure
for qualitatively and/or quantitatively measuring, detecting and/or identifying the
presence, amount, and/or functional activity of a target entity or analyte of the sample.
The analyte can, e.g., be a drug, a biological, chemical and/or biochemical substance,
and/or a cell in an organism or organic sample. In particular, the analyte can be a
molecule, a nucleic-acid sequence, a DNA, an RNA and/or a protein.
Preferably, the assay according to the present disclosure is a nucleic-acid assay for
detecting or identifying a nucleic-acid sequence and/or a protein assay for detecting or
identifying a protein.
An assay, test or test procedure according to the present disclosure accordingly
preferably covers at least one of: controlling actuators of the analysis device like a pump
drive, temperature control apparatus, and valve actuators; acting on the cartridge or
sample; treating the sample; preparing the sample; performing one or more mixing
processes and/or reactions with the sample; conveying the sample; and measuring one
or more properties of the sample, particularly with the sensor apparatus of the cartridge.
The sensor apparatus or a sensor array thereof preferably comprises multiple sensor
fields and/or electrodes for specifically bonding and/or detecting one or more analytes
to be detected or measured. Further, the sensor apparatus preferably is configured for
electrical or electrochemical detection of analytes of the sample.
Alternatively or additionally, the sensor apparatus and/or the sensor device can be
configured for detecting or measuring other or further analytes compounds, material
characteristics, or the like without specific bonding and/or by means of optical
measurement, impedance measurement, capacitance measurement, spectrometric
measurement, mass spectrometric measurement, or tomography like MRT. In this
regard, the sensor apparatus, thus, can be formed by an arrangement enabling such
measurement. In particular, the sensor apparatus or cartridge or any other sample carrier
of the analysis device or system can comprise or form a cavity having a window for said
optical measurement. The optical sensor or the sensor apparatus, such as a spectrometer,
can be realized independently of the cartridge and/or can form part of the analysis
device.
In the following, the present disclosure is explained based primarily on the sensor
apparatus having multiple sensor fields and/or being or comprising a chip having
electrodes for electrochemical detection. However, unless stated or conductible
unambiguously to the contrary, it is to be understood that measurement results
alternatively or additionally can be achieved by or can be the outcome of one or more of
the above mentioned measurement techniques even if not mentioned explicitly.
An assay, test or test procedure according to the present disclosure preferably starts or
begins with the analysis device acting on and/or controlling processes on the cartridge
and/or the sample. In particular, a test starts or begins with actuators acting on the
cartridge. For example, a test can start with conveying the sample within the cartridge.
Methods and/or steps performed before insertion or receiving of the cartridge into/by
the analysis device and/or before conveying, treating and/or preparing the sample within
said cartridge are preferably not part of an assay, test or test procedure according to the
present disclosure.
The "control information", thus, preferably is configured to carry out such an assay, test
or test procedure or to enable the analysis system or the analysis device to carry out
such an assay, test or test procedure. Preferably, said control information is configured
to control or to define a control sequence or to be used by the analysis device to carry
out said assay, test or test procedure. A "control information", thus, preferably has
instructions being configured for controlling the assay, test or test procedure. In
particular, the control information is configured to control an assay, test or test
procedure by defining steps or parameters of steps including controlling and/or
feedback controlling actuators like the pump drive, the temperature control apparatuses
and valve actuators.
The above-mentioned aspects and features of the present disclosure and the aspects and
features of the present disclosure that will become apparent from the claims and the
following description can in principle be implemented independently from one another,
but also in any combination or order.
Other aspects, advantages, features and properties of the present disclosure will become
apparent from the claims and the following description of a preferred embodiment with
reference to the drawings, in which:
Fig. 1 is a schematic view of a proposed analysis system and/or analysis device
comprising a proposed cartridge received therein;
Fig. 2 is a schematic view of the cartridge;
Fig. 3 is a schematic view of the analysis system; and
Fig. 4 shows a schematic sequence using the analysis system.
In the Figures, which are only schematic and sometimes not to scale, the same reference
signs are used for the same or similar parts and components, corresponding or
comparable properties and advantages being achieved even if these are not repeatedly
described.
Fig. 1 is a highly schematic view of a proposed analysis system 1 and analysis device
200 for testing an in particular biological sample P, preferably by means of or in an
apparatus or cartridge 100.
Fig. 2 is a schematic view of a preferred embodiment of the proposed apparatus or
cartridge 100 for testing the sample P. The apparatus or cartridge 100 in particular
forms a handheld unit, and in the following is merely referred to as a cartridge.
The term "sample" is preferably understood to mean the sample material to be tested,
which is in particular taken from a human or animal. In particular, within the meaning
of the present disclosure, a sample is a fluid, such as saliva, blood, urine or another
liquid, preferably from a human or animal, or a component thereof. Within the meaning
of the present disclosure, a sample may be pretreated or prepared if necessary, or may
come directly from a human or animal or the like, for example. A food sample,
environmental sample or another sample may optionally also be tested, in particular for
environmental analytics, food safety and/or for detecting other substances, preferably
natural substances, but also biological or chemical warfare agents, poisons or the like.
Preferably, the analysis system 1 and/or analysis device 200 controls the testing of the
sample P in particular in or on the cartridge 100 and/or is used to evaluate the testing
and/or to collect, to process and/or to store measurement results from the test.
The analysis system 1 preferably comprises one or more cartridges 100 for receiving the
sample P. The analysis system 1 preferably comprises the analysis device 200 for
receiving the cartridge 100 and subsequently carrying out the test using the received
cartridge 100.
By means of the proposed analysis system 1, analysis device 200 and/or cartridge 100
and/or using the proposed method for testing the sample P, preferably an analyte A of
the sample P, in particular a (certain) nucleic-acid sequence and/or a (certain) protein, or
particularly preferably a plurality of analytes A of the sample P, can be determined,
identified or detected. Said analytes A are in particular detected, identified and/or
measured not only qualitatively, but particularly preferably also quantitatively.
Therefore, the sample P can in particular be tested for qualitatively or quantitatively
determining at least one analyte A, for example in order for it to be possible to detect a
40 disease and/or pathogen or to determine other values, which are important for
diagnostics, for example.
Particularly preferably, a molecular-biological test is made possible by means of the
analysis system 1 and/or analysis device 200 and/or by means of the cartridge 100.
Particularly preferably, a nucleic-acid assay for detecting a nucleic-acid sequence, in
particular a DNA sequence and/or RNA sequence, and/or a protein assay for detecting a
protein, in particular an antigen and/or antibody, are made possible or are carried out.
Preferably, the sample P or individual components of the sample P or analyte A can be
amplified if necessary, in particular by means of PCR, and tested, identified or detected
in the analysis system 1, analysis device 200 and/or in the cartridge 100, and/or for the
purpose of carrying out the nucleic-acid assay. Preferably, amplification products of the
analyte A or analytes A are thus produced.
In the following, further details are first given on a preferred construction of the
cartridge 100, with features of the cartridge 100 preferably also directly representing
features of the analysis system 1, in particular even without any further explicit
explanation.
The cartridge 100 is preferably at least substantially planar, flat, plate-shaped and/or
card-like.
The cartridge 100 preferably comprises an in particular at least substantially planar, flat,
plate-shaped and/or card-like main body or support 101, the main body or support 101
in particular being made of and/or injection-moulded from plastics material, particularly
preferably polypropylene.
The cartridge 100 preferably comprises at least one film or cover 102 for covering the
main body 101 and/or cavities and/or channels formed therein at least in part, in
particular on the front, and/or for forming valves or the like, as shown by dashed lines
in Fig. 2.
The analysis system 1 or cartridge 100 or the main body 101 thereof, in particular
together with the cover 102, preferably forms and/or comprises a fluidic system 103,
referred to in the following as the fluid system 103.
The cartridge 100, the main body 101 and/or the fluid system 103 are preferably at least
substantially vertically oriented in the operating position and/or during the test, in
particular in the analysis device 200, as shown schematically in Fig. 1. In particular, the
main plane or surface extension of the cartridge 100 thus extends at least substantially
vertically in the operating position.
The cartridge 100 and/or the fluid system 103 preferably comprises a plurality of
cavities, in particular at least one receiving cavity 104, at least one metering cavity 105,
at least one intermediate cavity 106A-G, at least one mixing cavity 107, at least one
storage cavity 108, at least one reaction cavity 109A-C, at least one intermediate
temperature-control cavity 110 and/or at least one collection cavity 111, as shown in
Fig. 1 and Fig. 2.
The cartridge 100 and/or the fluid system 103 also preferably comprises at least one
pump apparatus 112 and/or at least one sensor arrangement or sensor apparatus 113.
Some, most or all of the cavities are preferably formed by chambers and/or channels or
other depressions in the cartridge 100 and/or the main body 101, and particularly
preferably are covered or closed by the cover 102. However, other structural solutions
are also possible.
In the example shown, the cartridge 100 or the fluid system 103 preferably comprises
two metering cavities 105, a plurality of intermediate cavities 106A to 106G, a plurality
of storage cavities 108A to 108E and/or a plurality of reaction cavities 109A-C, which
can preferably be loaded separately from one another, in particular a first reaction cavity
109A, a second reaction cavity 109B and an optional third reaction cavity 109C, as can
be seen in Fig. 2.
The reaction cavity/cavities 109A-C is/are used in particular to carry out an
amplification reaction, in particular PCR, or several, preferably different, amplification
reactions, in particular PCRs. It is preferable to carry out several, preferably different,
PCRs, i.e. PCRs having different primer combinations or primer pairs, in parallel and/or
independently and/or in different reaction cavities 109A-C.
To carry out the nucleic-acid assay, preferably nucleic-acid sequences, as analytes A of
the sample P, are amplified in the reaction cavity/cavities 109A-C by means of an
amplification reaction, in particular in order to produce amplification products for the
subsequent detection in the sensor arrangement or sensor apparatus 113.
Within the meaning of the present disclosure, amplification reactions are in particular
molecular-biological reactions in which an analyte A, in particular a nucleic-acid
sequence, is amplified/copied and/or in which amplification products, in particular
40 nucleic-acid products, of an analyte A are produced. Particularly preferably, PCRs are
amplification reactions within the meaning of the present disclosure.
"PCR" stands for polymerase chain reaction and is a molecular-biological method by
means of which certain analytes A, in particular portions of RNA or RNA sequences or
DNA or DNA sequences, of a sample P are amplified, preferably in several cycles,
using polymerases or enzymes, in particular in order to then test and/or detect the
amplification products or nucleic-acid products. If RNA is intended to be tested and/or
amplified, before the PCR is carried out, a cDNA is produced starting from the RNA, in
particular using reverse transcriptase. The cDNA is used as a template for the
subsequent PCR.
Preferably, during a PCR, a sample P is first denatured by the addition of heat in order
to separate the strands of DNA or cDNA. Preferably, primers or nucleotides are then
deposited on the separated single strands of DNA or cDNA, and a desired DNA or
cDNA sequence is replicated by means of polymerase and/or the missing strand is
replaced by means of polymerase. This process is preferably repeated in a plurality of
cycles until the desired quantity of the DNA or cDNA sequence is available.
For the PCR, marker primers are preferably used, i.e. primers which (additionally)
produce a marker or a label, in particular biotin, on the amplified analyte A or
amplification product. This allows or facilitates detection. Preferably, the primers used
are biotinylated and/or comprise or form in particular covalently bonded biotin as the
label.
The amplification products and/or other portions of the sample P produced in the one or
more reaction cavities 109A-C can be conducted or fed to the connected sensor
arrangement or sensor apparatus 113, in particular by means of the pump apparatus 112.
The sensor apparatus 113 is used in particular for detecting, particularly preferably
qualitatively and/or quantitatively determining, the analyte A or analytes A of the
sample P, in this case particularly preferably the nucleic-acid sequences and/or proteins
as the analytes A. Alternatively or additionally, however, other values may also be
collected or determined.
As already explained at the outset, in particular nucleic-acid sequences, preferably DNA
sequences and/or RNA sequences, and/or proteins, in particular antigens and/or
antibodies, are preferably qualitatively and/or quantitatively determined as analytes A of
the sample P. In the following, however, a distinction is not made between nucleic-acid
sequences and proteins, or between the nucleic-acid assay for detecting nucleic-acid
sequences and the protein assay for detecting proteins.
In particular, the pump apparatus 112 comprises or forms a tube-like or bead-like raised
portion, in particular by means of the film or cover 102, particularly preferably on the
back of the cartridge 100, as shown schematically in Fig. 1.
The cartridge 100, the main body 101 and/or the fluid system 103 preferably comprise a
plurality of channels 114 and/or valves 115A, 115B, as shown in Fig. 2.
By means of the channels 114 and/or valves 115A, 115B, the cavities 104 to 111, the
pump apparatus 112 and/or the sensor arrangement and/or sensor apparatus 113 can be
temporarily and/or permanently fluidically interconnected and/or fluidically separated
from one another, as required and/or optionally or selectively, in particular such that
they are controlled by the analysis system 1 or the analysis device 200.
The cavities 104 to 111 are preferably each fluidically linked or interconnected by a
plurality of channels 114. Particularly preferably, each cavity is linked or connected by
at least two associated channels 114, in order to make it possible for fluid to fill, flow
through and/or drain from the respective cavities as required.
The fluid transport or the fluid system 103 is preferably not based on capillary forces, or
is not exclusively based on said forces, but in particular is essentially based on the
effects of gravity and/or pumping forces and/or compressive forces and/or suction
forces that arise, which are particularly preferably generated by the pump or pump
apparatus 112. In this case, the flows of fluid or the fluid transport and the metering are
controlled by accordingly opening and closing the valves 115A, 115B and/or by
accordingly operating the pump or pump apparatus 112, in particular by means of a
pump drive 202 of the analysis device 200.
Preferably, each of the cavities 104 to 110 has an inlet at the top and an outlet at the
bottom in the operating position. Therefore, if required, only liquid from the respective
cavities can be removed via the outlet.
In the operating position, the liquids from the respective cavities are preferably
removed, in particular drawn out, via the outlet that is at the bottom in each case, it
preferably being possible for gas or air to flow and/or be pumped into the respective
cavities via the inlet that is in particular at the top. In particular, relevant vacuums in the
cavities can thus be prevented or at least minimised when conveying the liquids.
In particular, the cavities, particularly preferably the storage cavity/cavities 108, the
mixing cavity 107 and/or the receiving cavity 104, are each dimensioned and/or
40 oriented in the normal operating position such that, when said cavities are filled with
liquid, bubbles of gas or air that may potentially form rise upwards in the operating
position, such that the liquid collects above the outlet without bubbles. However, other
solutions are also possible here.
The receiving cavity 104 preferably comprises a connection 104A for introducing the
sample P. In particular, the sample P may for example be introduced into the receiving
cavity 104 and/or cartridge 100 via the connection 104A by means of a pipette, syringe
or other instrument.
The receiving cavity 104 preferably comprises an inlet 104B, an outlet 104C and an
optional intermediate connection 104D, it preferably being possible for the sample P or
a portion thereof to be removed and/or conveyed further via the outlet 104C and/or the
optional intermediate connection 104D. Gas, air or another fluid can flow in and/or be
pumped in via the inlet 104B, as already explained.
Preferably, the sample P or a portion thereof can be removed, optionally and/or
depending on the assay to be carried out, via the outlet 104C or the optional
intermediate connection 104D of the receiving cavity 104. In particular, a supernatant of
the sample P, such as blood plasma or blood serum, can be conducted away or removed
via the optional intermediate connection 104D, in particular for carrying out the protein
assay.
Preferably, at least one valve 115A, 115B is assigned to each cavity, the pump
apparatus 112 and/or the sensor apparatus 113 and/or is arranged upstream of the
respective inlets and/or downstream of the respective outlets.
Preferably, the cavities 104 to 111 or sequences of cavities 104 to 111, through which
fluid flows in series or in succession for example, can be selectively released and/or
fluid can selectively flow therethrough by the assigned valves 115A, 115B being
actuated, and/or said cavities can be fluidically connected to the fluid system 103 and/or
to other cavities.
In particular, the valves 115A, 115B are formed by the main body 101 and the film or
cover 102 and/or are formed in another manner, for example by additional layers,
depressions or the like.
Particularly preferably, one or more valves 115A are provided which are preferably
tightly closed initially or in the storage state, particularly preferably in order to seal
liquids or liquid reagents F, located in the storage cavities 108, and/or the fluid system
103 from the open receiving cavity 104 in a storage-stable manner.
Preferably, an initially closed valve 115A is arranged upstream and downstream of each
storage cavity 108. Said valves are preferably only opened, in particular automatically,
when the cartridge 100 is actually being used and/or while inserting the cartridge 100
into the analysis device 200 and/or for carrying out the assay.
A plurality of valves 115A, in particular three valves in this case, are preferably
assigned to the receiving cavity 104, in particular if the intermediate connection 104D is
provided in addition to the inlet 104B and the outlet 104C. Depending on the use, in
addition to the valve 115A on the inlet 104B, then preferably only the valve 115A either
at the outlet 104C or at the intermediate connection 104D is opened.
The valves 115A assigned to the receiving cavity 104 seal the fluid system 103 and/or
the cartridge 100 in particular fluidically and/or in a gas-tight manner until the sample P
is inserted and the receiving cavity 104 or a connection 104A of the receiving cavity
104 is closed.
As an alternative or in addition to the valves 115A (which are initially closed), one or
more valves 115B are preferably provided which are not closed in a storage-stable
manner and/or which are open initially and/or which can be closed by actuation. These
valves are used in particular to control the flows of fluid during the test.
The cartridge 100 is preferably designed as a microfluidic card and/or the fluid system
103 is preferably designed as a microfluidic system. In the present disclosure, the term
"microfluidic" is preferably understood to mean that the respective volumes of
individual cavities, some of the cavities or all of the cavities 104 to 111 and/or channels
114 are, separately or cumulatively, less than 5 ml or 2 ml, particularly preferably less
than 1 ml or 800 µl, in particular less than 600 µl or 300 µl, more particularly preferably
less than 200 µl or 100 µl.
Particularly preferably, a sample P having a maximum volume of 5 ml, 2 ml or 1 ml can
be introduced into the cartridge 100 and/or the fluid system 103, in particular the
receiving cavity 104.
Reagents and liquids which are preferably introduced or provided before the test in
liquid form as liquids or liquid reagents F and/or in dry form as dry reagents S are
required for testing the sample P, as shown in the schematic view according to Fig. 2 by
reference signs F1 to F5 and S1 to S10.
Furthermore, other liquids F, in particular in the form of a wash buffer, solvent for dry
40 reagents S and/or a substrate, for example in order to form detection molecules and/or a
redox system, are also preferably required for the test, the detection process and/or for
other purposes, and are in particular provided in the cartridge 100, i.e. are likewise
introduced before use, in particular before delivery. At some points in the following, a
distinction is not made between liquid reagents and other liquids, and therefore the
respective explanations are accordingly also mutually applicable.
The analysis system 1 or the cartridge 100 preferably contains all the reagents and
liquids required for pretreating the sample P and/or for carrying out the test or assay, in
particular for carrying out one or more amplification reactions or PCRs, and therefore,
particularly preferably, it is only necessary to receive the optionally pretreated sample P.
The cartridge 100 or the fluid system 103 preferably comprises a bypass 114A that can
optionally be used, in order for it to be possible, if necessary, to conduct or convey the
sample P or components thereof past the reaction cavities 109A-C and/or, by bypassing
the optional intermediate temperature-control cavity 110, also directly to the sensor
apparatus 113.
The cartridge 100, the fluid system 103 and/or the channels 114 preferably comprise
sensor portions 116 or other apparatuses for detecting liquid fronts and/or flows of fluid.
It is noted that various components, such as the channels 114, the valves 115A, 115B, in
particular the valves 115A that are initially closed and the valves 115B that are initially
open, and the sensor portions 116 in Fig. 2 are, for reasons of clarity, only labelled in
some cases, but the same symbols are used in Fig. 2 for each of these components.
The collection cavity 111 is preferably used for receiving excess or used reagents and
liquids and volumes of the sample, and/or for providing gas or air in order to empty
individual cavities and/or channels.
In particular, the collection cavity 111 can optionally be connected to individual cavities
and channels or other apparatuses fluidically in order to remove reagents and liquids
from said cavities, channels or other apparatuses and/or to replace said reagents and
liquids with gas or air. The collection cavity 111 is preferably given appropriate large
dimensions.
Once the sample P has been introduced into the receiving cavity 104 and the connection
104A has been closed, the cartridge 100 can be inserted into and/or received in the
proposed analysis device 200 in order to test the sample P, as shown in Fig. 1.
Alternatively, the sample P could also be fed in later.
Fig. 1 shows the analysis system 1 in a ready-to-use state for carrying out a test or assay
40 on the sample P received in the cartridge 100, and/or in the operating position. In this
state, the cartridge 100 is therefore linked to, received by and/or inserted into the
analysis device 200.
In the following, some features and aspects of the analysis device 200 are first explained
in greater detail, in particular on the basis of Fig. 1. The features and aspects relating to
said device are preferably also directly features and aspects of the proposed analysis
system 1, in particular even without any further explicit explanation.
The analysis system 1 or analysis device 200 preferably comprises a mount or
receptacle 201 for mounting and/or receiving the cartridge 100.
Preferably, the cartridge 100 is fluidically, in particular hydraulically, separated or
isolated from the analysis device 200. In particular, the cartridge 100 forms a preferably
independent and in particular closed or sealed fluidic or hydraulic system 103 for the
sample P and the reagents and other liquids. In this way, the analysis device 200 does
not come into direct contact with the sample P and can in particular be reused for
another test without being disinfected and/or cleaned first.
It is however provided that the analysis device 200 can be connected or coupled
mechanically, electrically, thermally and/or pneumatically to the cartridge 100.
In particular, the analysis device 200 is designed to have a mechanical effect, in
particular for actuating the pump apparatus 112 and/or the valves 115A, 115B, and/or to
have a thermal effect, in particular for temperature-controlling the reaction
cavity/cavities 109A-C and/or the intermediate temperature-control cavity 110.
In addition, the analysis device 200 can preferably be pneumatically connected to the
cartridge 100, in particular in order to actuate individual apparatuses, and/or can be
electrically connected to the cartridge 100, in particular in order to collect and/or
transmit measured values or measurement results 713, for example from the sensor
apparatus 113 and/or sensor portions 116.
The analysis system 1 or analysis device 200 preferably comprises a pump drive 202,
the pump drive 202 in particular being designed for mechanically actuating the pump
apparatus 112.
Preferably, a head of the pump drive 202 can be rotated in order to rotationally axially
depress the preferably bead-like raised portion of the pump apparatus 112. Particularly
preferably, the pump drive 202 and pump apparatus 112 together form a pump, in
40 particular in the manner of a hose pump or peristaltic pump and/or a metering pump, for
the fluid system 103 and/or the cartridge 100.
Particularly preferably, the pump is constructed as described in DE 10 2011 015 184
B4. However, other structural solutions are also possible.
Preferably, the capacity and/or discharge rate of the pump can be controlled and/or the
conveying direction of the pump and/or pump drive 202 can be switched. Preferably,
fluid can thus be pumped forwards or backwards as desired.
The analysis system 1 or analysis device 200 preferably comprises a connection
apparatus 203 for in particular electrically and/or thermally connecting the cartridge 100
and/or the sensor arrangement or sensor apparatus 113.
As shown in Fig. 1, the connection apparatus 203 preferably comprises a plurality of
electrical contact elements 203A, the cartridge 100, in particular the sensor arrangement
or sensor apparatus 113, preferably being electrically connected or connectable to the
analysis device 200 by the contact elements 203A.
The analysis system 1 or analysis device 200 preferably comprises one or more
temperature-control apparatuses for temperature-controlling the cartridge 100 and/or
having a thermal effect on the cartridge 100, in particular for heating and/or cooling, the
temperature-control apparatus(es) (each) preferably comprising or being formed by a
heating resistor or a Peltier element.
Individual temperature-control apparatuses, some of these apparatuses or all of these
apparatuses can preferably be positioned against or abutted on the cartridge 100, the
main body 101, the cover 102, the sensor arrangement, sensor apparatus 113 and/or
individual cavities and/or can be thermally coupled thereto and/or can be integrated
therein and/or in particular can be operated or controlled electrically by the analysis
device 200. In the example shown, in particular the temperature-control apparatuses
204A-C are provided.
Preferably, the temperature-control apparatus, referred to in the following as the
reaction temperature-control apparatus 204A, is assigned to one of the reaction cavities
109A-C or to a plurality of reaction cavities 109A-C, in particular in order for it to be
possible to carry out one or more amplification reactions therein.
The reaction cavities 109A-C are preferably temperature-controlled simultaneously
and/or uniformly, in particular by means of one common reaction temperature-control
apparatus 204A or two reaction temperature-control apparatuses 204A.
More particularly preferably, the reaction cavity/cavities 109A-C can be temperature-
controlled from two different sides and/or by means of two or the reaction temperature-
control apparatuses 204A that are preferably arranged on opposite sides.
Alternatively, each reaction cavity 109A-C can be temperature-controlled independently
and/or individually.
The temperature-control apparatus, referred to in the following as the intermediate
temperature-control apparatus 204B, is preferably assigned to the intermediate
temperature-control cavity 110 and/or is designed to (actively) temperature-control or
heat the intermediate temperature-control cavity 110 and/or a fluid located therein, in
particular the amplification products, preferably to a preheat temperature.
The intermediate temperature-control cavity 110 and/or intermediate temperature-
control apparatus 204B is preferably arranged upstream of or (immediately) before the
sensor arrangement or sensor apparatus 113, in particular in order for it to be possible to
temperature-control or preheat, in a desired manner, fluids to be fed to the sensor
arrangement or sensor apparatus 113, in particular analytes A and/or amplification
products, particularly preferably immediately before said fluids are fed.
Particularly preferably, the intermediate temperature-control cavity 110 or intermediate
temperature-control apparatus 204B is designed or provided to denature the sample P or
analytes A and/or the amplification products produced, and/or to divide any double-
stranded analytes A or amplification products into single strands and/or to counteract
premature bonding or hybridising of the amplification products, in particular by the
addition of heat.
Preferably, the analysis system 1, analysis device 200 and/or the cartridge 100 and/or
one or each temperature-control apparatus comprise/comprises a temperature detector
and/or temperature sensor (not shown), in particular in order to make it possible to
control and/or feedback control temperature.
One or more temperature sensors may for example be assigned to the sensor portions
116 and/or to individual channel portions or cavities, i.e. may be thermally coupled
thereto.
The temperature-control apparatus 204C, referred to in the following as the sensor
temperature-control apparatus 204C, is in particular assigned to the sensor apparatus
113 and/or is designed to (actively) temperature-control or heat fluids located in or on
40 the sensor arrangement or sensor apparatus 113, in particular analytes A and/or
amplification products, reagents or the like, in a desired manner, preferably to a
hybridisation temperature.
The sensor temperature-control apparatus 204C is preferably planar and/or has a contact
surface which is preferably rectangular and/or corresponds to the dimensions of the
sensor arrangement or sensor apparatus 113, the contact surface allowing for heat
transfer between the sensor temperature-control apparatus 204C and the sensor
apparatus 113.
Preferably, the analysis device 200 comprises the sensor temperature-control apparatus
204C. However, other structural solutions are also possible in which the sensor
temperature-control apparatus 204C is integrated in the cartridge 100, in particular the
sensor arrangement or sensor apparatus 113.
Particularly preferably, the connection apparatus 203 comprises the sensor temperature-
control apparatus 204C, and/or the connection apparatus 203 together with the sensor
temperature-control apparatus 204C can be linked to, in particular pressed against, the
cartridge 100, in particular the sensor arrangement or sensor apparatus 113.
More particularly preferably, the connection apparatus 203 and the sensor temperature-
control apparatus 204C (together) can be moved towards and/or relative to the cartridge
100, in particular the sensor arrangement or sensor apparatus 113, and/or can be
positioned against said cartridge, preferably in order to both electrically and thermally
couple the analysis device 200 to the cartridge 100, in particular the sensor arrangement
or sensor apparatus 113 or the support thereof.
Preferably, the sensor temperature-control apparatus 204C is arranged centrally on the
connection apparatus 203 or a support thereof and/or is arranged between the contact
elements 203A.
In particular, the contact elements 203A are arranged in an edge region of the
connection apparatus 203 or a support thereof or are arranged around the sensor
temperature-control apparatus 204C, preferably such that the connection apparatus 203
is connected or connectable to the sensor apparatus 113 thermally in the centre and
electrically on the outside or in the edge region. However, other solutions are also
possible here.
The analysis system 1 or analysis device 200 preferably comprises one or more valve
actuators 205A, B for actuating the valves 115A, 115B. Particularly preferably,
different (types or groups of) valve actuators 205A and 205B are provided which are
assigned to the different (types or groups of) valves 115A and 115B for actuating each
40 of said valves, respectively.
The analysis system 1 or analysis device 200 preferably comprises a control apparatus
207 for controlling the sequence of a test or assay and/or for collecting, evaluating
and/or outputting or providing measured values or measurement results 713, in
particular from the sensor apparatus 113, and/or from test results and/or other data or
values.
The control apparatus 207 preferably comprises an internal clock or time base by means
of which the sequence of the test is or can be controlled and/or by means of which test
steps that follow temporally one another or that extend over time are controlled or can
be controlled by the control apparatus 207.
The control apparatus 207 preferably controls or is designed to control actuators of the
analysis device 200 for acting on the cartridge 100 in order to carry out the test. The
actuators are in particular the pump drive 202, the temperature-control apparatuses
and/or the valve actuators 205A, B.
The analysis system 1 or analysis device 200 preferably comprises one or more sensors
206A-H. In particular, fluid sensors 206A are designed or provided to detect liquid
fronts and/or flows of fluid in the fluid system 103. Particularly preferably, the fluid
sensors 206A are designed to measure or detect, for example optically and/or
capacitively, a liquid front and/or the presence, the speed, the mass flow rate/volume
flow rate, the temperature and/or another value of a fluid in a channel and/or a cavity, in
particular in a respectively assigned sensor portion 116, which is in particular formed by
a planar and/or widened channel portion of the fluid system 103.
The fluid sensor 206A preferably measures a fluid entering or leaving the sensor portion
116 and/or a content change or fluid change in the sensor portion 116, and in the
process generates a measurement result 706A that corresponds to the fluid entering, the
fluid leaving, the content change and/or the fluid change in the sensor portion 116. This
measurement result 706A from the fluid sensor 206A can be retrieved by the control
apparatus 207 and/or transmitted to the control apparatus 207. The control apparatus
207 controls or is designed to control the test and/or the actuators, preferably using or
taking into account the measurement result 706A from the fluid sensor 206A. In
particular, when a content change, an entering fluid, a leaving fluid and/or a fluid
change is detected in the sensor portion 116, in particular when a liquid front is
detected, the control apparatus 207 influences a program sequence. In this case, for
example a check can be carried out or a subsequent step of the test can be controlled, in
particular by activating the actuators in a particular and/or differing manner.
40 Particularly preferably, the sensor portions 116 are each oriented and/or incorporated in
the fluid system 103 and/or fluid flows against or through the sensor portions 116 such
that, in the operating position of the cartridge 100, fluid flows through the sensor
portions 116 in the vertical direction and/or from the bottom to the top, or vice versa, in
particular in order to make it possible or easier to accurately detect liquid.
Alternatively or additionally, the analysis device 200 preferably comprises one or more
(different, other and/or further) sensors 206B.
Preferably, the other sensor 206B is or comprises a pressure sensor for determining the
(relative) air pressure. The other sensor 206B can generate a measurement result 706B,
which corresponds in particular to the air pressure. This measurement result 706B can
be retrieved by the control apparatus 207 and/or transmitted to the control apparatus
207. The control apparatus 207 controls or is designed to control the test and/or the
actuators, preferably using or taking into account the measurement result 706B from the
other sensor 206B.
Alternatively or additionally, one or more temperature sensors 206C are provided for
detecting the internal temperature and/or the temperature in the interior space 212A of
the analysis device 200, in particular the temperature of an atmosphere in the interior
space 212A. Alternatively or additionally, one or more temperature sensors 206C are
provided for detecting the ambient temperature and/or the temperature of an atmosphere
surrounding the analysis device 200 and/or the temperature of one or more of the
temperature apparatuses.
The temperature sensor 206C preferably measures a temperature, in particular of the
interior space 212A of the analysis device 200, and in the process generates a
measurement result 706C that corresponds to the temperature, in particular of the
interior space 212A and/or atmosphere of or parts of the interior space 212A. This
measurement result 706C from the temperature sensor 206C can be retrieved by the
control apparatus 207 and/or transmitted to the control apparatus 207. The control
apparatus 207 controls or is designed to control the test and/or the actuators, preferably
using or taking into account the measurement result 706C from the temperature sensor
206C.
The analysis device 200 preferably comprises a tilt sensor 206D for detecting the
inclination and/or orientation of the analysis device 200 and/or of the cartridge 100. The
tilt sensor 206D is in particular designed and set up to determine the inclination of the
analysis device 200 and/or of the cartridge 100 that differs from that in an operating
position.
The tilt sensor 206D preferably measures the inclination, and in the process generates a
40 measurement result 706D that corresponds to the inclination of the analysis device 200
and/or of the cartridge 100. This measurement result 706D from the tilt sensor 206D can
be retrieved by the control apparatus 207 and/or transmitted to the control apparatus
207. The control apparatus 207 controls or is designed to control the test and/or the
actuators, preferably using or taking into account the measurement result 706D from the
tilt sensor 206D. In particular, if the inclination is too great, the test is prevented,
blocked or interrupted, and/or an error is identified, processed, transmitted and/or
signalled.
The analysis device 200 may comprise an acceleration sensor 206E. The acceleration
sensor 206E is preferably designed to determine an acceleration of the analysis device
200, in particular an acceleration in the vertical and/or horizontal direction with respect
to the operating position.
The acceleration sensor 206E preferably measures the acceleration, and in the process
generates a measurement result 706E that corresponds to the acceleration of the analysis
device 200 and/or of the cartridge 100. This measurement result 706E from the
acceleration sensor 206E can be retrieved by the control apparatus 207 and/or
transmitted to the control apparatus 207. The control apparatus 207 controls or is
designed to control the test and/or the actuators, preferably using or taking into account
the measurement result 706E from the acceleration sensor 206E. In particular, if the
acceleration is too great, the test is prevented, blocked or interrupted, and/or an error is
identified, processed, transmitted and/or signalled.
The analysis device 200 may comprise a humidity sensor 206F for determining the
(relative) atmospheric humidity and/or the dew point of the atmosphere inside or in the
interior space 212A and/or outside the analysis device 200.
The humidity sensor 206F preferably measures the (relative) atmospheric humidity
and/or the dew point, and in the process generates a measurement result 706F that
corresponds to the (relative) atmospheric humidity and/or the dew point of the
atmosphere in the analysis device 200 and/or the surroundings of the analysis device
200. This measurement result 706F from the humidity sensor 206F can be retrieved by
the control apparatus 207 and/or transmitted to the control apparatus 207. The control
apparatus 207 controls or is designed to control the test and/or the actuators, preferably
using or taking into account the measurement result 706F from the humidity sensor
206F. In particular, if the (relative) atmospheric humidity is too high and/or if the dew
point is approached or reached, the test is prevented, blocked or interrupted, and/or an
error is identified, processed, transmitted and/or signalled.
The analysis device 200 may comprise a position sensor 206G for determining the
position or location, for example by means of a GPS sensor. The position sensor 206G
is preferably designed to determine the location of the analysis device 200 in space, in
40 particular on the Earth's surface, and/or to output the geographical position, the location
and/or the coordinates of the analysis device 200.
The position sensor 206G preferably measures the position, in particular the
geographical position, of the analysis device 200, and in the process generates a
measurement result 706G that corresponds to the position or geographical position. This
measurement result 706G from the position sensor 206G can be retrieved by the control
apparatus 207 and/or transmitted to the control apparatus 207. The control apparatus
207 controls or is designed to control the test and/or the actuators, preferably using or
taking into account the measurement result 706G from the position sensor 206G.
The analysis device 200 may comprise a cartridge sensor 206H for determining or
checking the position or alignment of the cartridge 100 in or with respect to the analysis
device 200. In particular, the cartridge sensor 206H is designed to detect an incorrect
position of the cartridge 100 in the analysis device 200. Alternatively or additionally,
the cartridge sensor 206H is designed to detect and/or verify the correct and/or
operating position of the cartridge 100 in the analysis device 200.
The cartridge sensor 206H preferably measures the position of the cartridge 100 in the
analysis device 200, and in the process generates a measurement result 706H that
corresponds to the position or alignment of the cartridge 100 in the analysis device 200.
This measurement result 706H from the cartridge sensor 206H can be retrieved by the
control apparatus 207 and/or transmitted to the control apparatus 207. The control
apparatus 207 controls or is designed to control the test and/or the actuators, preferably
using or taking into account the measurement result 706H from the cartridge sensor
206H. In particular, if the cartridge 100 is incorrectly positioned in the analysis device
200, the test is prevented or blocked and/or the cartridge 100 is automatically ejected
from the analysis device 200 or the like. Alternatively or additionally, the test is enabled
if it is detected that the cartridge 100 is in the correct operating position in the analysis
device 200.
The control apparatus 207 preferably controls or feedback controls the pump drive 202,
the temperature-control apparatuses 204 and/or the valve actuators 205, in particular
taking into account or depending on the desired test and/or measured values from the
sensor arrangement or sensor apparatus 113 and/or sensors 206A-H.
The flows of fluid are controlled in particular by accordingly activating the pump or
pump apparatus 112 and actuating the valves 115A, 115B.
Particularly preferably, the pump drive 202 comprises a stepper motor, or a drive
calibrated in another way, such that desired metering can be achieved, at least in
principle, by means of appropriate activation.
Additionally or alternatively, the fluid sensors 206A are used to detect liquid fronts or
flows of fluid, in particular in cooperation with the assigned sensor portions 116, in
order to achieve the desired fluidic sequence and the desired metering by accordingly
controlling the pump or pump apparatus 112 and accordingly activating the valves
115A, 115B.
Optionally, the analysis system 1 or analysis device 200 comprises an input apparatus
208, such as a keyboard, a touch screen or the like, and/or a display apparatus 209, such
as a screen.
The analysis system 1 or analysis device 200 preferably comprises at least one interface
210, for example for controlling, for communicating and/or for outputting measured
data or test results and/or for linking to other devices, such as a printer, an external
power supply or the like. This may in particular be a wired or wireless interface 210.
The analysis system 1 or analysis device 200 preferably comprises a power supply 211,
preferably a battery or an accumulator, which is in particular integrated and/or
externally connected or connectable.
Preferably, an integrated accumulator is provided as a power supply 211 and can be
(re)charged by an external charging device (not shown) via a connection 211A and/or is
interchangeable.
The analysis system 1 or analysis device 200 preferably comprises a housing 212, all
the components and/or some or all of the apparatuses preferably being integrated in the
housing 212. Particularly preferably, the cartridge 100 can be inserted or slid into the
housing 212, and/or can be received by the analysis device 200, through an opening 213
which can in particular be closed, such as a slot or the like.
The analysis system 1 or analysis device 200 is preferably portable or mobile.
Particularly preferably, the analysis device 200 weighs less than 25 kg or 20 kg,
particularly preferably less than 15 kg or 10 kg, in particular less than 9 kg or 6 kg.
The fluidic, in particular pneumatic, coupling between the cartridge 100 and the analysis
device 200 will be explained in greater detail in the following, it being possible for the
following aspects to be implemented independently from the preceding aspects.
As already explained, the analysis device 200 can preferably be pneumatically linked to
the cartridge 100, in particular to the sensor arrangement or sensor apparatus 113 and/or
to the pump apparatus 112.
Particularly preferably, the analysis device 200 is designed to supply the cartridge 100,
in particular the sensor arrangement or sensor apparatus 113 and/or the pump apparatus
112, with a working medium, in particular gas or air.
Preferably, the working medium can be compressed and/or pressurised in the analysis
device 200 or by means of the analysis device 200.
Preferably, the analysis device 200 comprises a pressurised gas supply 214 for this
purpose, in particular a pressure generator or compressor, preferably in order to
compress and/or pressurise the working medium.
The pressurised gas supply 214 is preferably integrated in the analysis device 200 or the
housing 212 and/or can be controlled or feedback controlled by means of the control
apparatus 207. The pressurised gas supply 214 can also, at least in part, be formed on or
by the cartridge 100.
Preferably, the pressurised gas supply 214 is electrically operated or can be operated by
electrical power. In particular, the pressurised gas supply 214 can be supplied with
electrical power by means of the power supply 211.
The analysis device 200 or pressurised gas supply 214 is preferably designed to
compress the working medium to a pressure of more than 100 kPa, particularly
preferably more than 150 kPa or 250 kPa, in particular more than 300 kPa or 350 kPa,
and/or of less than 1 MPa, particularly preferably less than 900 kPa or 800 kPa, in
particular less than 700 kPa and/or to feed said medium to the cartridge 100 at said
pressure.
Preferably, air can be drawn in, in particular from the surroundings, as the working
medium by means of the analysis device 200 or pressurised gas supply 214. In
particular, the analysis device 200 or pressurised gas supply 214 is designed to use the
surroundings as a reservoir for the working medium or the air. However, other solutions
are also possible here, in particular those in which the analysis device 200 or pressurised
gas supply 214 comprises a preferably closed or delimited reservoir, such as a tank or
container, comprising the working medium, and/or is connected or connectable thereto.
Preferably, the analysis device 200 or pressurised gas supply 214 comprises an inlet, the
working medium in particular being able to be drawn in and/or conducted in the
pressurised gas supply 214 via the inlet.
40 Preferably, the analysis device 200 or pressurised gas supply 214 comprises a filter, the
filter preferably being integrated in the inlet and/or it preferably being possible for the
working medium to be filtered by means of the filter and/or it preferably being possible
for particles to be separated from the working medium by means of the filter.
The filter is preferably designed as a micro filter or as a fine particulate air filter.
Preferably, particles having a particle diameter of more than 10 µm, particularly
preferably more than 8 µm or 9 µm, in particular more than 6 µm or 7 µm, more
particularly preferably more than 4 µm or 5 µm, can be separated by means of the filter,
the particle diameter preferably being the maximum or average diameter of the
respective particles. This ensures that the channels or lines in the cartridge that convey
the working medium do not become contaminated or clogged and/or that no undesired
pressure loss occurs.
The analysis device 200 or pressurised gas supply 214 preferably comprises a
connection element 214A, in particular in order to pneumatically connect the analysis
device 200 and/or pressurised gas supply 214 to the cartridge 100.
Fig. 3 is a schematic view of the proposed analysis system 1 for testing an in particular
biological sample P, comprising the analysis device 200 for receiving the cartridge 100
and subsequently carrying out the test using the received cartridge 100, and an operating
instrument 400 for the analysis device 200.
The operating instrument 400 is preferably designed to control the analysis device 200.
Alternatively or additionally, the operating instrument 400 can receive or retrieve
information, in particular (measurement) results such as measured values, from the
analysis device 200. In particular, the operating instrument 400 is a mobile terminal
device such as a smartphone, a tablet or the like.
The operating instrument 400 is preferably implemented or provided so as to be
physically separated from the analysis device 200. The operating instrument 400 can
preferably be separated and/or disconnected from the analysis device 200 physically
and/or with respect to a data connection.
The operating instrument 400 can preferably be wirelessly connected to the analysis
device 200. A data connection DVA can thus be established between the analysis device
200 and the operating instrument 400. However, the data connection DVA can in
principle also be established in another manner, for example wired.
It is preferable for the operating instrument 400 to also be operational when separated or
disconnected from the analysis device 200, in particular for carrying out evaluations or
40 for other purposes. Alternatively or additionally, the analysis device 200 is also
operational when separated or disconnected from the operating instrument 400, in
particular for continuing a test.
Particularly preferably, the operating instrument 400 comprises an interface 430 for
establishing data connections DVA, DVB, DVD. The interface 430 and/or the operating
instrument 400 in particular comprises what is referred to as an analysis device interface
431 that is designed to establish the preferably wireless data connection DVA to the
analysis device 200. This can, for example, be a radio interface, WPAN interface,
Bluetooth interface and/or a Bluetooth module or the like.
The interface 210 of the analysis device 200 preferably corresponds to the interface 430
and/or the analysis device interface 431 of the operating instrument 400, in particular
such that the data connection DVA between the operating instrument 400 and the
analysis device 200 can be established. The interface 210 of the analysis device 200 and
the analysis device interface 431 preferably support the same data transmission method
and/or radio transmission method or radio standard, in particular WLAN or WPAN
methods such as Bluetooth, NFC, Zigbee or the like.
Particularly preferably, the interface 210 of the analysis device 200 and the analysis
device interface 431 make possible or facilitate what is known as an ad-hoc connection.
In this case, the data connection DVA is established preferably automatically when the
devices, i.e. the operating instrument 400 and the analysis device 200, are within range
of one another. In other words, the operating instrument 400 and the analysis device 200
each comprise a wireless data interface 430, 210, respectively, which are designed to
jointly establish an ad-hoc data connection between the operating instrument 400 and
the analysis device 200, preferably such that, when the operating instrument 400 and the
analysis device 200 approach one another in space, the data connection DVA
therebetween is automatically established and is preferably displayed by means of the
operating instrument 400.
The data connection DVA is preferably a point-to-point connection. The data
connection DVA connects the analysis device 200 to the operating instrument 400
preferably directly and/or without any interposed networks. It is possible for the
operating instrument 400 to establish data connections DVA to different analysis
devices 200 simultaneously or in succession. Alternatively or additionally, it is possible
for one analysis device 200 to establish data connections DVA to a plurality of
operating instruments 400 simultaneously or in succession.
In order to control the test, it is preferable for precisely one data connection DVA to be
provided between the analysis device 200 to be controlled and the operating instrument
400 controlling the analysis device 200, and/or for control information 510 to be
40 received and/or accepted or to be acceptable and/or receivable and/or for measurement
results 713 to be transmitted or to be transmittable only via precisely one data
connection DVA between the analysis device 200 to be controlled and the operating
instrument 400 controlling the analysis device 200.
The analysis device 200 preferably comprises a receiver 210A for, preferably
wirelessly, receiving the control information 510 from the operating instrument 400.
Preferably, the interface 210 comprises the receiver 210A, via which signals, in
particular control information 510, are or can be received from the operating instrument
400.
Alternatively or additionally, the analysis device 200 and/or the interface 210 comprises
a transmitter 210B, via which data, in particular results such as measurement results 713
from the sensor apparatus 113, are or can be sent, particularly preferably to the
operating instrument 400.
The interfaces 210, 431 preferably correspond to one another such that they support the
same data transmission standard and/or radio standard, in particular Bluetooth, WLAN
or the like. These interfaces are particularly preferably interfaces 210, 431 which make
possible what is known as an ad-hoc connection, the data connection DVA preferably
being established automatically when the devices, i.e. the operating instrument 400 and
the analysis device 200, are within range of one another.
The analysis system 1 preferably further comprises a database 500 or the database 500
is assigned to the analysis system 1. The database 500 is preferably an external database
500 that is implemented or provided so as to be physically separated from the operating
instrument 400 and/or from the analysis device 200. In principle, however, it is not
impossible for the database 500 to be provided or implemented such that it can be
directly linked, in particular to the operating instrument 400, or to be provided or
implemented by the operating instrument 400.
The operating instrument 400 can access the database 500 via a data connection DVD.
For this purpose, the operating instrument 400 and/or the interface 430 can comprise a
database interface 432 by means of which the database 500 can be accessed, in
particular via a network N. The network N may be the Internet or another data network.
It is also preferable for the operating instrument 400 to be able to establish the data
connection DVD to the database 500 via a wireless interface, in particular WLAN,
WPAN, mobile communications or the like. However, in principle, other solutions are
also possible here.
Particularly preferably, the operating instrument 400 comprises different interfaces 430
that are independent of one another for establishing data connections DVA, DVD to the
analysis device 200 and to the database 500, the analysis device 200 (as a peripheral
40 device of the operating instrument 400) being designed to communicate exclusively
with or via the operating instrument 400.
The analysis system 1, in particular the database 500, preferably comprises control
information 510 by means of which the analysis device 200 can be controlled in order to
carry out a test.
The control information 510 preferably defines the actuation of the actuators of the
analysis device 200 in a particular manner, such that the sample P is tested in the
cartridge 100. In particular, actuators for carrying out the test can be or are controlled
using the control information 510 such that said actuators act on the cartridge 100
and/or the sample P. These actuators are in particular the pump drive 202 and/or one or
more temperature-control apparatuses 204 and/or one or more valve actuators 205. The
control information 510 preferably comprises parameters and/or instructions for
carrying out one or more steps of the method for testing the sample P explained above.
Preferably, the analysis system 1 comprises calibration information 520 that can be
stored in the database 500 and/or can be retrieved from the database 500. The
calibration information 520 is preferably capable of influencing the test of the sample P,
in particular depending on the specific cartridge 100, on a cartridge batch of the specific
cartridge 100 and/or on the specific test.
The calibration information 520 is in particular default or basic settings, parameters
and/or threshold values for sensors such as the sensor apparatus 113 of the cartridge
100, for one or more of the sensor(s) 206A-H of the analysis device 200 and/or for one
or more of the actuators.
Calibration information 520 can be used in addition to control information 510 for
carrying out the test, the calibration information 520 preferably influencing or
specifying the control information 510. The calibration information 520 can be or can
form the control information 510 or a part of the control information 510, even if this is
not explicitly mentioned in the following.
The analysis device 200 can be calibrated and/or configured by calibration information
520 that can form part of the control information 510 or can be provided separately. For
this purpose, the calibration information 520 can be determined, retrieved and/or
transmitted to the analysis device 200 by means of the operating instrument 400.
In one example, fluid sensor calibration information 521 is provided which influences
setting and/or evaluation of the fluid sensor 206A. The fluid sensor calibration
information 521 is preferably dependent on the test to be carried out, the phase of the
test and/or expected effects of a content change in a sensor portion 116 during the test
40 sequence, and/or contains various specifications which are dependent thereon.
Alternatively or additionally, tilt sensor calibration information 524 can be provided,
preferably comprising one or more threshold values 525, in particular a start threshold
value 526 for blocking the start of a test if said threshold value is exceeded, and/or an
interruption threshold value 527 for interrupting the test and/or for processing errors if
said threshold is exceeded.
Alternatively or additionally, sensor arrangement calibration information 528 can be
provided, by means of which properties of the sensor arrangement or sensor apparatus
113 are or can be set. In particular, it is provided that the sensor arrangement calibration
information 528 is transmitted or can be transmitted to the sensor arrangement or sensor
apparatus 113 by the analysis device 200, and that the sensor arrangement or sensor
apparatus 113 carries out or is designed to carry out a measurement taking into account
the sensor arrangement calibration information 528.
The proposed analysis system 1 preferably comprises evaluation information 530 which
is stored in the database 500 and/or is retrievable or can be retrieved from the database
500. The evaluation information 530 is preferably designed to be able to interpret
measurement results 713 that originate from the cartridge 100, in particular from the
sensor apparatus 113.
The control information 510 and/or the evaluation information 530 particularly
preferably comprises instructions, preferably in the form of an algorithm and/or for
controlling a process on or using a processor or controller. The instructions preferably
form a module that can be or is implemented by the analysis device 200 and/or the
operating instrument 400, as a result of which the behaviour of the analysis device 200
and/or the operating instrument 400 can be or is changed.
The instructions are in particular commands, machine code, pre-compiled source code
or source code. The instructions preferably form a module-like software component, in
particular a plugin. The instructions can be designed to form and/or to replace a module
of the operating instrument 400 and/or of the analysis device 200. For this purpose, the
control information 510 and/or the evaluation information 530 can comprise a
(software) interface for coupling or implementation by the control apparatus 207 and/or
an evaluation module 440 of the operating instrument 400.
The control information 510 particularly preferably comprises or forms a module of the
control apparatus 207 that can be exchanged, preferably in terms of software. This
module preferably contains instructions such as logic commands, loops and the like for
controlling the test, in particular in the form of a computer program or computer
40 program product to be executed by the analysis device 200 and/or the control apparatus
207. The control information 510 can be or form, in particular as a plugin, an
exchangeable part of the control apparatus 207.
An evaluation module 440 is preferably formed by the operating instrument 400 or the
operating instrument 400 comprises the evaluation module 440. By means of the
evaluation module 440, measurement results 713 read out from the sensor apparatus 113
are evaluated preferably using the evaluation information 530 retrieved from the
database 500 and/or the evaluation module 440 is designed for this purpose.
The evaluation information 530 particularly preferably comprises or forms a module of
the evaluation apparatus 440 that can be exchanged, preferably in terms of software.
This module preferably contains instructions such as logic commands, loops and the
like for controlling the evaluation of measurement results 713, in particular in the form
of a computer program or computer program product to be executed by the operating
instrument 400 and/or the evaluation module 440. The evaluation information 530 can
be or form, in particular as a plugin, an exchangeable part of the evaluation module 440.
The computer program product preferably is a non-transitory computer-readable media.
Alternatively or additionally, the instructions can comprise parameters for configuring
the control apparatus 207 and/or the evaluation module 440. These parameters are
preferably provided in addition to the instructions, for example for the analysis device
200 in the form of or comprising the calibration information 520. Alternatively, the
control information 510 and/or evaluation information 530 can however also merely
comprise parameters and/or other information for the control and/or evaluation.
The database 500 preferably comprises a results memory 550 in which results can be
stored and/or saved.
Within the meaning of the present disclosure, the term "database" should preferably be
understood in a broad sense and also incorporates multi-part databases in particular.
Therefore, in principle, the database 500 can be provided in different physical units or at
different locations and/or can be composed of a plurality of subdatabases.
The operating instrument 400 can preferably be separated and/or disconnected from the
analysis device 200 with respect to a data connection and/or physically. For this
purpose, the analysis device 200 can initially be connected to the operating instrument
400 by the data connection DVA being established.
In order to control the test and/or the analysis device 200, the operating instrument 400
can retrieve control information 510 from the database 500 and transmit said
information to the analysis device 200 in unaltered or altered form.
40 The operating instrument 400 is preferably designed to evaluate measurement results
713 which can preferably be generated by the sensor apparatus 113 of the cartridge 100
while the sample P is being tested. For this purpose, it is provided that measurement
results 713, which can originate from a sensor apparatus 113 of the cartridge 100 and/or
which can be transmitted from the analysis device 200 to the operating instrument 400,
are or can be evaluated in the operating instrument 400. For this purpose, the operating
instrument 400 can retrieve or receive the evaluation information 530 from the database
500 and, using this evaluation information 530, evaluate the measurement results 713,
in particular in the evaluation module 440 of the operating instrument 400.
The operating instrument 400 preferably comprises a memory 450. The memory 450
can be used to store, at least temporarily, control information 510, calibration
information 520 and/or evaluation information 530, or the operating instrument 400 and
the memory 450 can be designed for this purpose. Alternatively or additionally,
evaluation results 740, that have been or can be generated from the measurement results
713 by means of the operating instrument 400, can be stored in the memory 450.
In one example, the operating instrument 400 comprises an output apparatus 410,
preferably an in particular touch-sensitive screen or display 411 and/or a speaker 412.
Alternatively or additionally, the operating instrument 400 comprises an input apparatus
420, in particular a camera 421, a touchpad 422, a microphone 423 and/or a keyboard
424.
The operating instrument 400 is preferably designed to display an operating interface or
a user interface via the output apparatus 410, in particular the screen or display 411, or
to provide in another way operating elements for controlling the test and/or the analysis
device 200, and/or to output a status or other information relating to the test.
Alternatively or additionally, commands can be received via the input apparatus 420, by
means of which the operating instrument 400 starts, configures and/or controls the test
of the sample P in a manner corresponding to the commands.
Preferably, the transmission of commands and/or information to the analysis device 200
is triggered via the input apparatus 420 or can be triggered by the input apparatus 420.
In particular, transmission of the control information 510 from the operating instrument
400 to the analysis device 200 can be initiated or controlled via the input apparatus 420.
Alternatively or additionally, the analysis device 200 can be controlled in order to
receive the cartridge 100 and/or to start the test, preferably using the control information
510 and/or a command received via the input apparatus 420. The operating instrument
400 is therefore preferably designed to transmit to the analysis device 200 control
information 510 for receiving or ejecting the cartridge 100. In this case, a cartridge 100
can in particular be inserted only when the operating instrument 400 is connected to the
40 analysis device 200, whereupon the operating instrument 400 can verify the cartridge
100 and can eject said cartridge or block a test if an error, such as incompatibility, is
detected.
Alternatively or additionally, the operating instrument 400 is designed to transmit
control information 510 for starting the test to the analysis device 200. The test is thus
preferably started only by a command originating from the operating instrument 400.
The analysis device 200 itself preferably does not comprise a user interface for
generating a start command or for causing the test to start. This task is preferably
reserved for the operating instrument 400.
The cartridge 100 preferably comprises at least one cartridge identifier 100C which
corresponds to the cartridge 100 and/or to a batch with which the cartridge 100 is
associated.
The cartridge identifier 100C is in particular a piece of information that is specific to the
relevant cartridge 100, is in particular unique and/or is designed to uniquely identify the
cartridge 100, such as an identification code which is assigned to the relevant cartridge
100 and makes it possible for said cartridge to be identified in a preferably unique
manner.
Alternatively or additionally, the cartridge identifier 100C makes it possible to assign
the cartridge 100 to a production cycle and/or to a batch of particular cartridges 100. A
batch is preferably characterised in that cartridges 100 are produced in the same
continuous production cycle and/or are produced having the same components, in
particular having the same sensor apparatuses 113 and/or the same reagents and the like.
There is preferably a plurality of batches which can differ from one another with regard
to production periods, batches of starting materials used and the like, for example.
The cartridge identifier 100C can be stored and/or saved in a memory means 100D of
the cartridge 100. The memory means 100D can be a barcode 124, an NFC tag and/or a
memory which is provided in the sensor apparatus 113, is connected to the sensor
apparatus 113 or is assigned to the sensor apparatus 113, or another apparatus for
storing code or the like.
The cartridge identifiers 100C are preferably assigned to the respective cartridges 100.
In particular, the cartridge identifier 100C is formed by the cartridge 100, connected
thereto and/or arranged thereon.
The analysis system 1 can comprise one or a plurality of cartridges 100 which can each
preferably be distinguished from one another by means of at least one cartridge
identifier 100C and/or which are assigned to a batch.
Another aspect of the present disclosure, which can also be implemented independently,
relates to a cartridge 100 having at least two cartridge identifiers 100C that each
correspond to the cartridge 100. The cartridge identifiers 100C can preferably be read
out by different read-out methods, in particular optically, by radio, by a wired
connection or the like.
The respective cartridges 100 can comprise two different memory means 100D having
the same or corresponding cartridge identifiers 100C. The memory means 100D are
preferably independent of one another and/or separated from one another physically.
The memory means 100D can preferably be read out in different ways, in particular
electronically and/or by an electronic connection on the one hand, and wirelessly, in
particular optically and/or by radio on the other hand.
In the example shown, corresponding cartridge identifiers 100C are stored, saved or
recorded both in a memory that can be read out electronically, in particular of the sensor
apparatus 113, and in a memory that can be read out wirelessly, by radio or optically, in
particular the barcode 124. This makes it possible for the cartridge identifier 100C or
the cartridge identifiers 100C corresponding to the same cartridge 100 to be read out in
different ways.
This advantageously makes it possible to retrieve control information 510, calibration
information 520 and/or evaluation information 530 from the database 500
independently, disconnected or separately from the analysis device 200, preferably by
optically reading out the cartridge identifier 100C from the cartridge 100. Alternatively
or additionally, a memory means 100D of the cartridge 100 that can be read out
electronically makes it possible for the cartridge identifier 100C to be read out without
there being an optical connection to or visual contact with the cartridge 100, for
example when said cartridge is inserted into the analysis device 200.
The at least two cartridge identifiers 100C can be the same or, in one aspect of the
present disclosure, which can also be implemented independently, said cartridge
identifiers 100C can be different. In particular, it is possible and preferable for a (first)
cartridge identifier 100C to be individual or unique to the cartridge 100, i.e. designed to
uniquely identify the cartridge 100. A (different or second) cartridge identifier 100C is
preferably designed to assign the cartridge 100 to a batch of cartridges 100. The at least
two cartridge identifiers 100C preferably correspond to one another. In particular, the
cartridge identifier 100C corresponding to the batch and/or the batch can be identified
using the cartridge identifier 100C that uniquely identifies the cartridge 100. Preferably,
both cartridge identifiers 100C are read out and used, in particular in order to determine
40 and/or retrieve control information 510 and/or evaluation information 530 on the one
hand and in order to verify said information on the other hand.
The respective cartridges 100 are preferably identified at least twice or a cartridge
identifier 100C is read out and used at least twice, namely preferably once directly by
the operating instrument 400 in order to retrieve control information 510 and/or
calibration information 520 and/or evaluation information 530 and a second time by
means of or via the analysis device 200 in order to ensure that the test is carried out
using control information 510, calibration information 520 and/or evaluation
information 530 that corresponds to the cartridge 100 and/or in order to ensure and/or
verify that the control information 510, calibration information 520 and/or evaluation
information 530 corresponds to the cartridge 100.
Fig. 4 shows a schematic sequence of a preferred method for testing and/or evaluating
by means of the proposed analysis system 1, in particular in a manner which is
dependent on the individual cartridge 100. The following aspects and/or method steps
can also be implemented and can be advantageous individually or in different
combinations, the described order being preferred, but not obligatory, and it being
possible for steps to be omitted or added or carried out independently.
As explained above, at least one cartridge identifier 100C corresponds to the
(respective) cartridge 100. This cartridge identifier 100C is preferably stored in a
memory means 100D, in particular the barcode 124 and/or a memory cell of the sensor
apparatus 113, on the cartridge 100. However, in principle, other storage options are
possible here or there is the option of providing other memory means 100D. For
example, a memory means 100D assigned to the cartridge 100 can be arranged on the
packaging of the cartridge 100 or can form part of said packaging.
Preferably, the cartridge 100, in particular the sensor apparatus 113, is electrically
contacted by the analysis device 200. This is preferably achieved by one or more
contact elements 203A, as shown in Fig. 1 by way of example.
If the cartridge identifier 100C is stored in the sensor apparatus 113 or is assigned
thereto, said cartridge identifier 100C can be read out by the analysis device 200 via a
data connection DVC between the cartridge 100 and the analysis device 200 that can be
created by means of the contact elements 203A. This is symbolised by the arrow 601,
which represents the data transmission from the cartridge 100 to the analysis device
200. The cartridge identifier 100C stored in the sensor apparatus 113 and/or assigned to
the sensor apparatus 113 identifies the cartridge 100 preferably uniquely or on a one-to-
one basis.
The cartridge identifier 100C read out from the cartridge 100 by the analysis device 200
40 can be transmitted to the operating instrument 400 via the data connection DVA
between the analysis device 200 and the operating instrument 400, as indicated in Fig. 4
by the arrow 602, which represents the data transmission between the analysis device
200 and the operating instrument 400. In addition to the cartridge identifier 100C, a
device identifier 200C can optionally also be transmitted from the analysis device 200
to the operating instrument 400. The device identifier 200C preferably corresponds to
the specific analysis device 200 and/or makes it possible for said analysis device 200 to
be identified.
In an alternative, which can also be carried out additionally, the cartridge identifier
100C is or can be determined directly by the operating instrument 400. Particularly
preferably, this is achieved optically and/or using the camera 421 of the operating
instrument 400, preferably by reading in a code, in particular the barcode 124. It is
however also possible for the cartridge identifier 100C to be directly and/or wirelessly
determined from the relevant cartridge 100 by the operating instrument 400 in some
other way, for example by radio, in particular by reading out an RFID tag which is
optionally assigned to the cartridge 100 or arranged on the cartridge 100, or an NFC
memory apparatus or the like which is assigned to the cartridge 100, is arranged on the
cartridge 100 or forms part of the cartridge 100 in some other way.
As a result, the cartridge identifier 100C is therefore particularly preferably transmitted
to the operating instrument 400 either directly by the operating instrument 400 reading
out the memory means 100D of the cartridge 100, or indirectly by data being
correspondingly transferred via the analysis device 200, and the operating instrument
400 thereby receives or determines the cartridge identifier 100C.
In one aspect of the present disclosure, which can also be implemented independently,
the operating instrument 400 receives or determines information, which is preferably
cartridge-specific and/or cartridge-batch-specific, by means of the cartridge identifier
100C, or the operating instrument 400 is designed for this purpose.
The operating instrument 400 retrieves or is designed to retrieve, preferably
automatically, the control information 510 for controlling the analysis device 200 in
order to carry out the test supported by the cartridge 100 and/or analysis information
530 for evaluating measurement results 713 determined during the test, by reading out
the cartridge identifier 100C of the cartridge 100 or after said cartridge identifier 100C
has been read out.
In particular, it is provided that the operating instrument 400 receives or retrieves
control information 510 on the basis of the cartridge identifier 100C, which information
is specific to the cartridge 100, the batch thereof and/or specific for carrying out the test
using the cartridge 100. Particularly preferably, the control information 510 is retrieved
from the database 500 or can be retrieved from the database 500.
Preferably, the cartridge identifier 100C is transmitted to the database 500, as indicated
in Fig. 4 by the arrow 603, which corresponds to the data transmission from the
operating instrument 400 to the database 500.
The database 500 can send back control information 510 corresponding to the cartridge
100 and/or to the cartridge identifier 100C, i.e. transmit said information to the
operating instrument 400, as indicated in Fig. 4 by the arrow 604, which represents the
data transmission between the database 500 and the operating instrument 400.
Alternatively or additionally, calibration information 520 and/or evaluation information
530 can also be transmitted to the operating instrument 400 in a corresponding manner
from the database 500 to the operating instrument 400 or is or can be retrieved from the
database 500 by the operating instrument 400.
In one variant, the information can also be retrieved without the cartridge identifier
100C being transmitted to the database 500. In a variant of this kind, control
information 510, calibration information 520 and/or evaluation information 530 which
is available to the operating instrument 400 and, for example, has been previously
retrieved and/or temporarily stored in the operating instrument 400, can be identified by
means of the operating instrument 400 on the basis of the cartridge identifier 100C and
can be selected for subsequent use.
In another variant, which can be combined with the two previous methods for
determining and/or retrieving the control information 510, calibration information 520
and/or evaluation information 530, the information is selected and/or retrieved in
addition by using and/or transmitting a device identifier 200C for identifying the
analysis device 200 and/or an operating instrument identifier 400C for identifying the
operating instrument 400. This makes it possible for the control information 510,
calibration information 520 and/or evaluation information 530 to be specific to or
compatible with the analysis device 200 and/or the operating instrument 400 and for
said information to be selected, transmitted, retrieved and/or sent back in a manner in
which it is specific to or compatible with the analysis device 200 and/or the operating
instrument 400.
Preferably, control information 510 is retrieved or determined that corresponds to both
the cartridge 100 and the analysis device 200, particularly preferably to the combination
of the cartridge 100 and the analysis device 200. As a result, the test can be carried out
in a manner which is specific to both the cartridge 100 and the analysis device 200, and
this contributes to making tests highly reproducible and reliable.
In one aspect of the present disclosure, which can also be implemented independently,
the cartridge identifier 100C, which preferably corresponds only to the batch with which
40 the cartridge 100 is associated, is first determined by the operating instrument 400, in
particular is or can be read out from the cartridge 100 directly by the operating
instrument 400.
Using the cartridge identifier 100C, the control information 510 and/or evaluation
information 530 is retrieved, in particular by means of the operating instrument 400.
The retrieved control information 510 and/or evaluation information 530 is preferably
stored temporarily in the operating instrument 400.
The control information 510 is transmitted by the operating instrument 400 preferably
to the analysis device 200 or the operating instrument 400 is designed for this purpose.
This is indicated in Fig. 4 by the arrow 605, which corresponds to data transmission
from the operating instrument 400 to the analysis device 200.
Optionally, calibration information 520 can also be transmitted from the operating
instrument 400 to the analysis device 200. Alternatively or additionally, the operating
instrument 400 can modify the control information 510, in particular taking into account
the calibration information 520. The control information 510 can however also already
comprise or incorporate the calibration information 520. It is therefore not obligatory
for the calibration information 520 to be transmitted to the analysis device 200.
Preferably, transmission only takes place if the cartridge 100, the control information
510, and the assignment, association and/or compatibility thereof have been verified.
This ensures that the control information 510 to be transmitted corresponds to the
cartridge 100 which is intended to be used to carry out the test. This is provided for in
particular if the control information 510 and/or evaluation information 530 has been
previously retrieved by the operating instrument 400 and/or stored temporarily in the
operating instrument 400.
Verification is achieved particularly preferably by a/the cartridge identifier 100C. In
particular, for verification, a cartridge identifier 100C different from the cartridge
identifier for retrieving the control information 510 and/or evaluation information 530 is
used, and/or a cartridge identifier 100C that is read out from another memory means
100D of the cartridge 100 is used.
The cartridge identifier 100D provided for verification is preferably read out by means
of or via the analysis device 200 and/or transmitted to the operating instrument 400.
This takes place if the cartridge 100 is in direct contact with the analysis device 200 for
carrying out the test, i.e. if the cartridge 100 is in particular loaded or inserted into the
analysis device 200. This ensures that the cartridge 100 which is intended to be used to
carry out the test is determined. Verification by means of the cartridge identifier 100C
of the cartridge 100 therefore makes it possible to ensure that the test is carried out
using the control information 510 that corresponds to the cartridge 100.
Verification can be achieved by checking that the cartridge identifier 100D provided for
verification is assigned to the control information 510 and/or by checking that the
cartridge identifier 100C provided for verification is assigned to the cartridge identifier
100C used for determining the control information 510. In this respect, it can be
checked whether the cartridge identifier 100C provided for verification corresponds to
the batch of cartridges 100 to which the control information 510 corresponds. This can
be achieved by an assignment, allocation or mapping, such as a table or database, and/or
by verification means which are assigned to or form part of the control information 510.
For this purpose, the control information 510 can comprise corresponding assignment
means, for example information relating to cartridge identifier groups. Verification can
be carried out by these assignment means.
Other retrieved information, in particular the evaluation information 530, can be
verified in a corresponding manner.
The control information 510 can be received by the analysis device 200 and used for
controlling the test. Alternatively or additionally, the control information 510 can also
be verified in the analysis device 200.
After the control information 510 has been transmitted, the test is started, preferably in a
manner controlled by the operating instrument 400.
In Fig. 4, the testing process on the cartridge 100 by means of the analysis device 200 is
indicated by the arrow 606.
According to one aspect of the present disclosure, which can also be implemented
independently, the analysis device 200 is designed to carry out the test using the
transmitted control information 510 and independently and/or separately and/or
disconnected from the operating instrument 400 and/or the test is carried out
independently and/or separately and/or disconnected from the operating instrument 400.
Particularly preferably, the test is carried out independently and/or separately from the
operating instrument 400. For this purpose, the analysis device 200 is preferably
designed to carry out or continue the test using the transmitted control information 510
and independently and/or separately and/or disconnected from the operating instrument
400 and/or when the data connection DVA is disconnected, terminated or broken.
This makes it possible for example to transmit the control information 510 to the
analysis device 200 by means of the operating instrument 400, to start the test process,
and to subsequently disconnect, terminate or break the data connection DVA between
the analysis device 200 and the operating instrument 400, such that the analysis device
200 carries out or can carry out the test self-actingly, automatically and/or
40 autonomously of and independently from the operating instrument 400. Therefore,
while the test is underway, a user together with the operating instrument 400 can move
away from the analysis device 200 and/or can use the operating instrument 400 for other
purposes.
In order to carry out the test, the analysis device 200 preferably acts on the cartridge 100
such that the sample P is prepared, conveyed and/or analysed inside the cartridge 100,
or the analysis device 200 is designed for this purpose. Preferably, the test is or can be
controlled by the control apparatus 207 of the analysis device 200.
In order to carry out the test, the analysis device 200 preferably receives the control
information 510 and, preferably, the calibration information 520, particularly preferably
via the operating instrument 400 in each case. For this purpose, the operating instrument
400 is preferably designed to transmit, and the analysis device 200 is designed to
receive, the control information 510 and, preferably, the calibration information 520.
Using the control information 510, the control apparatus 207 controls apparatuses
and/or actuators of the analysis device 200 such that said apparatuses and/or actuators
act on the cartridge 100, or the control apparatus 207 is designed for this purpose.
The actuators are in particular the pump drive 202, the temperature-control
apparatus(es) 204 and/or the (valve) actuators 205. By means of the actuators, the
sample P can be conveyed within the fluid system 103 of the cartridge 100 and/or the
temperature of the sample P can be changed and/or the sample P can be mixed with
reagents and/or prepared and/or fed to the sensor apparatus 113 in order to ultimately
determine, by means of the sensor apparatus 113, measurement results 713 that
correspond to the sample P.
The sample P is preferably conveyed inside the cartridge 100 to the sensor apparatus
113 in a manner specified by the control information 510 and/or the analysis device 200
is designed to do this, preferably together with the cartridge 100.
Valves 115A, 115B of the cartridge 100 are preferably opened or closed in a manner
specified by the control information 510 and/or the analysis device 200 is designed to
do this, preferably together with the cartridge 100.
One or more temperature-control apparatuses 204 of the analysis device 200 are
preferably controlled such that the sample P and/or sensor apparatus 113 are
temperature-controlled in a manner specified by the control information 510 and/or the
analysis device 200 is designed to do this, preferably together with the cartridge 100.
40 Control on the basis of the control information 510 and, preferably, of the calibration
information 520 is preferably carried out, as explained in connection with Fig. 1 and 2,
in particular so as to carry out a nucleic-acid assay for detecting a nucleic-acid sequence
and/or a protein assay for detecting a protein. The control information 510 is therefore
preferably designed to, the control information 510 in particular comprising instructions
and/or parameters, in order to carry out a nucleic-acid assay for detecting a nucleic-acid
sequence and/or a protein assay for detecting a protein. However, other assays are also
possible.
The control information 510 preferably comprises valve control information 510A for
actuating one or more valve actuators 205 in order to open and/or close valves on the
cartridge 100.
Alternatively or additionally, the control information 510 comprises pump drive control
information 510B for controlling the pump drive 202, which can act, mechanically or
otherwise, on the pump apparatus 112 of the cartridge 100 in order to convey fluid, in
particular the sample P, through the fluid system 103 of the cartridge 100.
Alternatively or additionally, the control information 510 comprises temperature-control
apparatus control information 510C which specifies a temperature or a temperature
curve or temperature profile of or for one or more temperature-control apparatuses 204
of the analysis device 200, as a result of which the sample P or another substance
contained in the fluid system 103 of the cartridge 100 can be temperature-controlled, in
particular in order to carry out a PCR and/or hybridisation.
Alternatively or additionally, the control information 510 comprises execution
information 511 for executing the test, in particular the sequence for controlling
different actuators. The execution information 511 can also be separate from the control
information 510, can be stored in the database 500 and/or can be transmitted to the
analysis device 200 and/or the operating instrument 400.
Execution information 511 includes in particular delay information 511A, looping
information 511B for repeating certain steps and/or condition information 511C for
defining conditions, in particular threshold values, for triggering further steps or events.
The control information 510 can be in the form of a control file. The control
information 510 preferably contains or can be represented as a command sequence
which defines the execution of the test, in particular in a sequential or procedural
manner. The analysis device 200 preferably comprises an interpreter for the control
information 510.
40 The analysis device 200 and/or the control apparatus 207 preferably comprises a
memory 207A in which the control information 510 is stored and/or temporarily stored
or in which said information can be stored. In particular, it is provided that the analysis
device 200 receives the control information 510 and, optionally, calibration information
520 and saves said information in the memory 207A. This makes it possible for the
control apparatus 207 to control the analysis device 200 and/or actuators of the analysis
device 200 independently and/or separately and/or disconnected from the operating
instrument 400 in order to carry out or continue the test of the sample P.
The control apparatus 207 preferably controls and/or feedback controls and/or is
designed to control and/or feedback control apparatuses of the analysis device 200 in
order to carry out the test.
The control apparatus 207 preferably comprises an actuator interface 207B by means of
which one or more of the actuators can be controlled. In particular, the actuator interface
207B makes it possible to supply power to and/or to specify a target value for one or
more of the actuators. This makes it possible to specify a target temperature value
and/or a target temperature profile or curve for one or more of the temperature-control
apparatuses 204 by means of the actuator interface 207B. Alternatively or additionally,
the pump drive 202 can be controlled.
The pump drive 202 preferably comprises a stepper motor, as a drive element, and the
actuator interface 207B preferably comprises a corresponding stepper motor controller.
Owing to this combination, fluid can be conveyed in the fluid system 103 of the
cartridge 100 in a very accurate manner. In addition, via the actuator interface 207B, the
analysis device 200 and/or the control apparatus 207 can activate and/or supply power
to one or more of the valve actuators 205, such that valves 115A, 115B located on the
cartridge 100 can be opened and/or closed.
Alternatively or additionally, the analysis device 200, in particular the control apparatus
207, comprises a read-out module 207C for reading out measurement results 713 from
the sensor apparatus 113. The read-out module 207C can be designed to digitalise
measurement results 713 determined in the sensor apparatus 113 and to store and/or
transmit said results in the form of a code or data set. In some cases, at least with regard
to the digitalisation of the measurement results, the read-out module 207C can also be
located in the cartridge 100 or in the sensor apparatus 113, and/or the read-out module
207C can read out measurement results 713 digitalised by the sensor apparatus 113.
Alternatively or additionally, the analysis device 200 and/or the control apparatus 207
can comprise an error module 207D for identifying errors. In particular, the error
module 207D is designed to detect errors in the execution of the test. Alternatively or
additionally, the error module 207D can detect and document errors in boundary
40 conditions, for example a temperature, inclination or the like, and/or control the analysis
device 200 according to and/or taking into account the error detection.
The analysis system 1, the cartridge 100 and/or the analysis device 200 is/are preferably
designed to carry out the proposed method and/or the method is preferably controlled by
means of the control information 510, taking into account the control information 510
or in a manner specified by the control information 510. However, the method described
below can also be modified and the disclosure can also be used and be advantageous for
other methods for testing an in particular biological sample.
Within the context of the method, a sample P having at least one analyte A on the basis
of a fluid or a liquid from the human or animal body, in particular blood, saliva or urine,
is usually first introduced into the receiving cavity 104 via the connection 104A, in
order to detect diseases and/or pathogens, it being possible for the sample P to be
pretreated, in particular filtered.
Once the sample P has been received, the receiving cavity 104 and/or the connection
104A thereof is fluidically closed, in particular in a liquid-tight and/or gas-tight manner.
Preferably, the cartridge 100 together with the sample P is then linked or connected to
the analysis device 200, in particular is inserted or slid into the analysis device 200.
The method sequence, in particular the flow and conveying of the fluids, the mixing and
the like, is controlled by the analysis device 200 or the control apparatus 207, in
particular by accordingly activating and actuating the pump drive 202 or the pump
apparatus 112 and/or the valve actuators 205 or valves 115A, 115B.
During the nucleic-acid assay, a desired volume of the sample P that is mixed and/or
pretreated in the mixing cavity 107 is subsequently preferably fed to one or more
reaction cavities 109A-C, particularly preferably via (respectively) one of the upstream,
optional intermediate cavities 106A to 106C and/or with different reagents or primers,
in this case dry reagents S4 to S6, being added or dissolved.
In the reaction cavities 109A-C, the amplification reactions or PCRs are carried out to
copy/amplify the analytes A. This is carried out in particular by means of the assigned,
preferably common, reaction temperature-control apparatus(es) 204A and/or preferably
simultaneously for all the reaction cavities 109A-C, i.e. in particular using the same
cycles and/or temperature (curves/profiles).
During the nucleic-acid assay, a label is in particular produced directly and/or during the
amplification reaction(s) (in each case) and/or is attached to the analytes A and/or
amplification products. This is in particular achieved by using corresponding, preferably
40 biotinylated, primers. However, the label can also be produced and/or bonded to the
analytes A and/or amplification products separately or later, optionally also only in a
sensor compartment of the sensor apparatus 113 and/or after hybridisation. In particular,
during the protein assay, a label is only bonded to analytes A after hybridisation of the
analytes A to the capture molecules.
The label is used in particular for detecting bonded analytes A and/or amplification
products. In particular, the label can be detected or the label can be identified in a
detection process, as explained in greater detail in the following.
After carrying out the amplification reaction(s), corresponding fluid volumes and/or
amplification products are conducted out of the reaction cavities 109A-C in succession
to the sensor arrangement, in particular the sensor apparatus 113 and/or the sensor
compartment, in particular via a group-specific and/or separate intermediate cavity
106E, 106F or 106G (respectively) and/or via the optional (common) intermediate
temperature-control cavity 110.
After the sample P and/or the analytes A and/or amplification products are fed to the
sensor apparatus 113, the analytes A and/or amplification products are hybridised to the
capture molecules, preferably by (actively) temperature-controlling, in particular
heating, the sensor arrangement or sensor apparatus 113, in particular by means of the
sensor temperature-control apparatus 204C.
When carrying out the protein assay, the sample P or the analytes A is/are preferably fed
directly from the mixing cavity 107 to the sensor arrangement or sensor apparatus 113
and/or is/are guided past the intermediate cavity/cavities 106A-G, reaction
cavity/cavities 109A-C and/or the intermediate temperature-control cavity 110 via the
bypass 114A.
Once the sample P, analytes A and/or amplification products are hybridised and/or
bonded to the capture molecules, detection follows, in particular by means of the
preferably provided label, or in another manner.
In the following, a particularly preferred variant of the detection is described in greater
detail, specifically electrochemical detection, but other types of detection, for example
optical detection, capacitive detection or the like, may also be carried out.
Following the (respective) bondings/hybridisations, preferably an optional washing
process takes place and/or additional reagents or liquids, in particular from the storage
cavities 108B to 108E, are optionally fed in.
Subsequently and/or after the washing process, in accordance with a preferred variant of
40 the method, detection of the analytes A and/or amplification products bonded to the
capture molecules takes place.
If the bonded analytes A or amplification products are still not marked or provided with
a label, in particular during the protein assay, the labels are then fed to the sensor
arrangement or the sensor compartment, preferably from the storage cavity 108E.
Optionally, there is then another washing process.
In order to detect the analytes A or amplification products bonded to the capture
molecules, a reagent F4 and/or detector molecules, in particular alkaline
phosphatase/streptavidin, is/are fed to the sensor apparatus 113, preferably from the
storage cavity 108D.
Within the meaning of the present disclosure, the term "detector molecules" is
preferably understood to mean molecules that bond specifically to the marker or label of
the (bonded) analytes A or amplification products and thus allow the detection thereof.
In particular, the detector molecules may be enzyme conjugates and/or
immunoconjugates, which bond specifically to the marker or label, in particular biotin,
and comprise a reporter enzyme for converting a substrate.
In the context of the present disclosure, the detector molecules are preferably based on
streptavidin, which has a high affinity for biotin, and/or alkaline phosphatase, which can
convert non-reactive phosphate monoesters to electrochemically active molecules and
phosphate.
Preferably, a detection system is used, where the label is based on biotin and where the
detector molecules are based on streptavidin/alkaline phosphatase. However, other
detector molecules can also be used.
The reagents F4 or detector molecules can bond to the bonded analytes or amplification
products, in particular to the label of the bonded analytes A or amplification products,
particularly preferably to the biotin marker.
Optionally, subsequently or after the reagents F4 and/or detector molecules have
bonded to the analytes A and/or amplification products and/or the labels, an (additional)
washing process and/or flushing takes place, preferably by means of the fluid or reagent
F3 or wash buffer, in particular in order to remove unbonded reagents F4 and/or
detector molecules from the sensor apparatus 113.
Preferably, a reagent S8 and/or substrate for the detection, in particular from the storage
40 cavity 106D, is lastly fed to the sensor arrangement or sensor apparatus 113, preferably
together with a fluid or reagent F2 (in particular a buffer), which is suitable for the
substrate, particularly preferably for dissolving the reagent S8 and/or substrate, the fluid
or reagent in particular taken from the storage cavity 108B.
Preferably, p-aminophenyl phosphate (pAPP) is used as the substrate.
The substrate preferably reacts on and/or with the bonded analytes A or amplification
products and/or detector molecules and/or allows these to be electrochemically
measured.
Preferably, a first or electrochemically active substance is detected in the sensor
apparatus 113 by electrochemical measurement and/or redox cycling.
The measurement is preferably taken just once and/or for the entire sensor array 113A
of the sensor apparatus 113 and/or for all the sensor fields 113B of said sensor array, in
particular simultaneously or in parallel. In particular, the bonded analytes A or
amplification products are detected, identified or determined simultaneously or in
parallel in a single or common detection process.
However, in principle, it is also possible to measure a plurality of sample portions in the
sensor apparatus 113 or in a plurality of sensor apparatuses 113 in succession or
separately.
The test results or measurement results 713 are in particular electrically transmitted to
the analysis device 200 or the control apparatus 207 thereof, preferably by means of the
electrical connection apparatus 203, and are accordingly prepared, analysed, evaluated,
stored, displayed and/or output, in particular by the display apparatus 209 and/or
interface 210.
After the test has been carried out, the cartridge 100 is disconnected from the analysis
device 200 and/or is released or ejected therefrom, and is in particular disposed of.
The test results or measurement results 713 that have been determined by means of the
testing method described above or by means of another testing method are transmitted,
in particular electrically, to the analysis device 200 and/or the control apparatus 207
thereof, preferably by means of the electrical connection apparatus 203. The
measurement results 713 are transmitted from or via the analysis device 200 preferably
to the operating instrument 400, and are prepared, analysed, evaluated, stored, displayed
and/or output by the operating instrument 400.
The measurement result(s) 713 of the sensor apparatus 113 is/are preferably transmitted
from the cartridge 100 to the analysis device 200 and/or retrieved by the analysis device
200 from the cartridge 100 and/or the sensor apparatus 113. For this purpose, the
analysis system 1 is preferably designed to transmit the measurement result 713 from
the sensor apparatus 113 of the cartridge 100, from the analysis device 200 and/or via
the analysis device 200 to the operating instrument 400. This is indicated in Fig. 4 by
the arrow 607, which corresponds to the results retrieval from the cartridge 100 by the
analysis device 200.
In one aspect of the present disclosure, which can also be implemented independently,
the measurement result(s) 713, i.e. in particular the result for the test of the sample P
using the analysis device 200, is/are preferably transmitted to the operating instrument
400 without any prior evaluation or can be transmitted without any prior evaluation.
This is indicated in Fig. 4 by the arrow 608, which corresponds to the data transmission
from the analysis device 200 to the operating instrument 400.
Transmitting the measurement results 713 without any prior evaluation in the analysis
device 200 makes possible an individual and/or easily adaptable evaluation outside of
the analysis device 200.
Transmission of the measurement result 713 without any prior evaluation can also be
referred to as the transmission of unprocessed measurement results 713. This should be
understood to mean that, although it is possible to carry out processing in terms of data
transmission, as provided for by transmission protocols, in order to address transmission
errors or the like, it is not provided that the measurement results 713 are interpreted
prior to transmission, i.e. the significance of measurement results is not determined or
established and, if applicable, conclusions are not made with regard to properties of the
sample P. In the present case of a biological sample P, this means in particular that
measurement results 713 are assigned to the presence of certain substances/analytes
and/or concentrations and/or diseases or the like not in the analysis device 200, but
rather externally.
The measurement results 713 are preferably evaluated in the operating instrument 400
after the operating instrument 400 has received the measurement results 713 from the
analysis device 200 and/or the cartridge 100. In Fig. 4, the evaluation process by means
of the operating instrument 400 is indicated by the arrow 609.
The evaluation of the measurement results 713 by means of the operating instrument
400 can also be carried out independently and/or separately and/or disconnected from
40 the analysis device 200.
As mentioned previously, the operating instrument 400 can determine and/or retrieve, in
particular from the database 500, evaluation information 530 on the basis of the
cartridge identifier 100C and/or the device identifier 200C. The evaluation information
530 is designed or used to evaluate measurement results 713 determined during the test.
The measurement results 713 can be evaluated by the operating instrument 400 on the
basis of or using said evaluation information 530. For this purpose, the operating
instrument 400 is preferably designed to retrieve and/or receive measurement results
713 from the analysis device 200.
In one aspect of the present disclosure, which can also be implemented independently,
the operating instrument 400 evaluates or is designed to evaluate the measurement
results 713 using the evaluation information 530 and independently and/or separately
and/or disconnected from the analysis device 200. It is also possible for the data
connection DVA between the analysis device 200 and the operating instrument 400 to
be disconnected, terminated or broken after the measurement results 713 have been
retrieved, and for the evaluation to also be carried out separately and/or disconnected
from the analysis device 200.
In particular, the evaluation information 530 comprises instructions, in particular an
algorithm, in order to compute or calculate with the measurement results 713 and to
assign said measurement results 713 to a physical variable, value or property. As a
result, the measurement results 713 can be interpreted.
The evaluation information 530 is preferably individual, unique and/or specific to a
specific cartridge 100 or batch of cartridges 100 and/or to a specific analysis device 200
and/or the combination of a specific cartridge 100 and an analysis device 200.
Alternatively or additionally, the evaluation information 530 is individual, unique
and/or specific to a/the operating instrument 400, in particular an operating system of
the operating instrument 400.
The evaluation information 530 is particularly preferably dependent on the specific
sensor apparatus 113 of the respective cartridges 100 and can be specific to a specific
type of cartridge or a specific batch of cartridges and/or a specific test or evaluation that
can be carried out using a type of cartridge or a batch of cartridges.
The measurement results 713 can be evaluated by means of the operating instrument
400 on the basis of or using said evaluation information 530.
The evaluation information 530 preferably comprises (field) assignment information
531 which, in the case of a sensor apparatus 113 having a plurality of sensor fields
113B, assigns functions and/or properties to the measurement results 713 that
40 correspond to the respective sensor fields 113B.
Alternatively or additionally, the evaluation information 530 comprises interpretation
information 532 which assigns certain properties of the sample P to measurement
results 713. This interpretation information may be threshold values, or the
interpretation information 532 comprises threshold values or the like.
Preferably, interpretation information 532 is available that relates to the respective
sensor fields 113B and/or to the measurement results 713 corresponding thereto, and
therefore the interpretation information 532 comprises the (field) assignment
information 531 or vice versa.
The (field) assignment information 531 is particularly preferably dependent on the
specific sensor apparatus 113 of the respective cartridges 100 and can be specific to a
specific type of cartridge and/or a specific analysis that can be carried out using a type
of cartridge. Alternatively or additionally, the same also applies to the interpretation
information 532.
Different control information 510 and/or calibration information 520 and/or evaluation
information 530 can be provided for the same cartridge 100, in particular when different
tests can be carried out using the same cartridge 100, and the information corresponds to
one of the tests that can be carried out, respectively.
The evaluation information 530 preferably comprises an assignment of the measurement
results 713, which are preferably in the form of a value, a number, a code or the like, to
a physical variable. As a result, the measurement results 713 can be interpreted.
The (field) assignment information 531 is preferably designed to assign each of the
measurement results 713 from the respective sensor fields 113B to a property or a
sensor type of the respective sensor fields 113B.
As mentioned at the outset, the evaluation information 530 preferably comprises
instructions, which preferably form an algorithm and/or a plugin or module. This
evaluation information 530 can form all or part of the evaluation module 440 of the
operating instrument 400. For this purpose, the evaluation information 530 is integrated
in the operating instrument 400 as a component or a module which defines the
behaviour of the evaluation module 440 and/or of the operating instrument 400.
The operating instrument 400 implements the evaluation information 530 preferably by
interpreting the instructions using a processor or controller of the operating instrument
400. The instructions are in particular source code, pre-compiled code or machine code
40 for being executed on the operating instrument 400.
The evaluation information 510 is preferably specific to a certain group of operating
instruments 400, in particular specific to a certain operating system or a group of
operating systems.
Depending on the operating instrument identifier 400C for identifying an operating
instrument 400 or group, class or kind of operating instruments 400, in particular having
the same operating system, it is possible to provide, make available and/or retrieve
different forms of the same or different evaluation information 510. In particular, when
transmitting the operating instrument identifier 400C, the database 500 sends evaluation
information 510 of such kind back to the operating instrument 400, that can be
processed, compiled, used and/or executed by the operating instrument 400.
The analysis system 1, in particular the database 500, therefore preferably comprises
different items of evaluation information 530 or is designed to generate and/or provide
different items of evaluation information 530, the different items of evaluation
information 530 generating or making possible the same or similar functionality on
different operating instruments 400. Nevertheless, the evaluation information 530 is
preferably specific to a cartridge 100 or a batch of cartridges 100.
As a result, different items of evaluation information 530 are preferably provided and/or
can be retrieved for different cartridges 100 or batches of cartridges 100, and said
different items of evaluation information 530 are each provided and/or can each be
retrieved in different versions for different operating instruments 400.
The operating instrument 400 preferably outputs or is designed to output, by means of
the output apparatus 410, the evaluation results 740 that are determined, in particular
calculated, by evaluating the measurement results 713 using the evaluation information
530. For this purpose, the operating instrument 400 can display the evaluation results
740 graphically or otherwise, in particular by means of the screen or display 411.
Alternatively or additionally, the operating instrument 400 sends or is designed to send
the evaluation results 740 to the database 500.
The operating instrument 400 is preferably designed to transmit, to the analysis device
200, control information 510 for receiving or ejecting the cartridge 100. Alternatively or
additionally, the operating instrument 400 is designed to transmit control information
510 for starting the test to the analysis device 200. Alternatively or additionally, the
operating instrument 400 is designed to retrieve and/or receive measurement results 713
from the analysis device 200.
40 The operating instrument 400 is preferably designed to receive and/or display an
operating status of the analysis device 200.
In particular, the operating instrument 400 comprises a graphical user interface which is
displayed on the screen or display 411. The graphical user interface preferably
comprises an interface which graphically symbolises the possible controls and/or states
of the analysis device 200. Alternatively or additionally, the user interface is designed to
control interaction with the database 500 and/or with the analysis device 200. For this
purpose, the operating instrument 400 can be designed so as to be touch-sensitive, in
particular via a touch-sensitive screen or display 411. Alternatively or additionally, the
user interface can however also be controlled via the touchpad 422, the microphone
423, the keyboard 424 or some other input apparatus 420.
In one aspect of the present disclosure, the analysis system 1 comprises a plurality of
cartridges 100 which support the same or different tests. It is therefore possible for there
to be a plurality of different types of cartridge for carrying out different tests and/or for
the analysis system 1 to comprise or support said types of cartridge. It is preferable for
these cartridges 100 to be inserted into the same analysis device 200 and/or for the test
using the cartridges 100 to be carried out or be able to be carried out by means of the
same analysis device 200.
In another aspect, the proposed analysis system 1 comprises a plurality of analysis
devices 200. It is preferable that the analysis devices 200 can each be coupled to the
same operating instrument 400. The same operating instrument 400 can thus be
connected to different analysis devices 200, the data connection DVA preferably
connecting to or being established to just one of the analysis devices 200 at any one
time. Alternatively, the same operating instrument 400 can however also be connected
to a plurality of analysis devices 200 simultaneously. In this case, it is preferable for the
operating instrument 400 to assist in selecting an analysis device 200 for configuration
and/or control. In particular, an analysis device 200 can be selected by the operating
instrument 400 via the input apparatus 420, such that (only) the selected analysis device
200 is subsequently controlled.
The analysis system 1 can comprise or support a plurality of operating instruments 400.
In particular, a plurality of operating instruments 400 can be coupled to the same
analysis device 200 alternately, but preferably not simultaneously. By coupling the
analysis device 200 to an operating instrument 400, the data connection DVA between
the analysis device 200 and the operating instrument 400 is preferably established, such
that control information 510 can be transmitted to the analysis device 200 and/or results
can be transmitted to the operating instrument 400.
The database 500 preferably comprises a plurality of different items of control
40 information 510 for carrying out tests using the different cartridges 100 and/or different
analysis devices 200. The control information 510 can also be formed in multiple parts.
In particular, the control information 510 can comprise parts specific to the cartridge
100 and parts specific to the analysis device 200.
The analysis device 200 can preferably be calibrated and/or configured by calibration
information 520 that can form part of the control information 510 or can be provided
separately. For this purpose, the calibration information 520 can be determined,
retrieved and/or transmitted to the analysis device 200 by means of the operating
instrument 400.
In one example, fluid sensor calibration information 521 is provided which influences
setting and/or evaluation of the fluid sensor 206A. The fluid sensor calibration
information 521 is preferably dependent on the test to be carried out.
In another aspect of the present disclosure, which can also be implemented
independently, a computer program product is provided that comprises program code
means for carrying out the proposed method. The computer program product is in
particular an instruction stored on a storage medium, in particular in the form of a
smartphone app or the like, which is set up to determine and/or receive the cartridge
identifier 100C. Alternatively or additionally, said instruction is designed to transmit the
cartridge identifier 100C to the database 500 and to subsequently receive control
information 510 from the database 500. Alternatively or additionally, said instruction is
designed to transmit or forward control information 510 to the analysis device 200.
Alternatively or additionally, said instruction is designed to receive, evaluate and/or
interpret measurement results 713, in particular using retrieved and/or received
evaluation information 530.
Evaluating the measurement results 713 preferably comprises assigning measurement
results 713 corresponding to particular sensor fields 113B to functions of the respective
sensor fields 113B. This can be achieved by using different evaluation methods,
threshold values or the like for different sensor fields 113B.
It is possible for sensor fields 113B of the same kind to be evaluated together. In this
case, it is preferable that measurement results 713 corresponding to sensor fields 113B
of the same kind are tested for considerable deviations, that measurement results 713
having considerable deviations with respect to other measurement results 713 for sensor
fields 113B of the same kind are rejected, and that only similar measurement results 713
for sensor fields 113B of the same kind are evaluated.
During evaluation, it is possible to determine measurement results 713 for sensor fields
113B of the same kind. Alternatively or additionally, the measurement results 713,
jointly or in a calculated manner, for example the average value thereof, can be
compared with a threshold value or with a plurality of threshold values, or evaluated in
40 some other way. In this case, the one or more threshold values may be values or,
alternatively or additionally, specified profile or curve progressions, specified gradients,
maximum values thereof or the like.
By evaluating the measurement results 713, the evaluation result 740 is generated,
which preferably corresponds to a physical value, variable or property of the sample P,
preferably directly. For example, the evaluation result 740 represents the presence of
certain DNA sequences and/or RNA sequences and/or proteins, in particular antigens
and/or antibodies.
Alternatively or additionally, the evaluation result 740 can however also be or comprise
an interpretation derived from the presence of the DNA sequences and/or RNA
sequences and/or proteins, in particular antigens and/or antibodies, in particular
information on whether or how likely it is that a certain disease and/or pathogen, such
as a virus, bacterium or the like, is present in the sample P.
The evaluation result 740 is preferably output by the output apparatus 410 of the
operating instrument 400, or can be output, in particular displayed, by the output
apparatus 410.
If a disease and/or a pathogen is detected, it can be provided that the operating
instrument 400 automatically outputs or sends a warning and/or message.
Measurement results 713 and/or evaluation results 740 are preferably archived.
Particularly preferably, these results are saved, or saved temporarily, in the operating
instrument 400. Alternatively or additionally, these results are saved and/or archived in
the database 500, in particular in the results memory 550 of the database 500. For this
purpose, the evaluation results 740 can be transmitted from the operating instrument
400 to the database 500 via data transmission 610.
Archiving in the database 500 can be temporally offset with respect to the evaluation
results 740 being generated and/or the measurement results 713 being retrieved or
received. This is in particular the case when the test or evaluation is carried out without
there being a data connection DVD between the database 500 and the operating
instrument 400. In this case, the measurement results 713 and/or evaluation results 740
can be transmitted to the database 500 in a temporally offset manner and/or at a later
point in time, as soon the data connection DVD is restored or can be re-established.
Control information 510 and/or calibration information 520 and/or evaluation
information 530 can be retrieved from the database 500 separately, disconnected and/or
independently from the analysis device 200. For this purpose, a data connection DVB
between the cartridge 100 and the operating instrument 400 is preferably used, for
example by the operating instrument 400 reading in the barcode 124 and determining
40 the cartridge identifier 100C by evaluation. This is also possible when the data
connection DVA between the analysis device 200 and the operating instrument 400 is
disconnected, terminated or broken.
Furthermore, the operating instrument 400 can also retrieve control information 510,
calibration information 520 and/or evaluation information 530 from the database 500
independently, disconnected and/or separately from the cartridge 100 and/or the
analysis device 200. It is therefore possible for example for the operating instrument
400 to firstly determine, read out or receive the cartridge identifier 100C. Retrieval from
the database 500 can take place subsequently, also independently from the cartridge 100
and/or the analysis device 200. For this purpose, in particular only the data connection
DVD between the operating instrument 400 and the database 500 is required. The
retrieved data can be stored temporarily in the memory 450.
It is preferable for the analysis device 200 to determine or read out the cartridge
identifier 100C and send it to the operating instrument 400 before the test is carried out
using a specific cartridge 100, even if the operating instrument 400 has already
previously retrieved or received control information 510, calibration information 520
and/or evaluation information 530. The cartridge identifier 100C transmitted from the
analysis device 200 to the operating instrument 400 before the test has begun can then
be checked by the operating instrument 400 in order to determine whether control
information 510, calibration information 520 and/or evaluation information 530 that
corresponds to the cartridge 100 and/or the cartridge identifier 100C is provided, in
particular already stored or temporarily stored in the memory 450.
If the operating instrument 400 identifies control information 510 and/or calibration
information 520 that already corresponds to the cartridge 100 or the cartridge identifier
100C, this information can be transmitted to the analysis device 200 and the test using
the cartridge 100 inserted into the analysis device 200 can be started.
Alternatively, required control information 510 and/or calibration information 520 is
retrieved from the database 500.
In a preferred development of the disclosure, the analysis system 1 comprises a plurality
of different cartridges 100 for carrying out preferably different tests, to which different
control information 510 and evaluation information 530 corresponds.
For the same cartridge 100, different control information 510 and/or evaluation
information 530 can be provided, selected, selectable, retrieved, retrievable, used and/or
usable, in particular when different tests can be carried out using the same cartridge 100,
and the control information 510 corresponds in each case to one of the tests that can be
carried out.
In another aspect of the present disclosure, which can also be implemented
independently, a computer program product is provided that comprises program code
means for carrying out the proposed method. This computer program product is in
particular an instruction stored on a storage medium, in particular in the form of a
smartphone app or the like.
The instruction is preferably set up to control the operating instrument 400, and/or to
determine and/or receive the cartridge identifier 100C.
Alternatively or additionally, the instruction is set up to control the operating instrument
400, to transmit the cartridge identifier 100C to the database 500, and to subsequently
receive control information 510 from the database 500.
Alternatively or additionally, the instruction is designed to control the operating
instrument 400 and/or to transmit or forward control information 510 to the analysis
device 200.
Alternatively or additionally, the instruction is designed to control the operating
instrument 400, and/or to receive, evaluate and/or interpret measurement results 713, in
particular using retrieved and/or received evaluation information 530.
In general, the analysis device 200, the cartridge 100 or in particular the sensor
apparatus 113 may measure, detect or identify the one or more analytes A by means of
specific bonding, in particular by means of capture molecules and/or of means of
electrochemical detection such as redox cycling, or the like, preferably performed on the
cartridge 100 and/or in the sensor apparatus 113. Preferably, the capture molecules are
arranged or immobilized on a sensor array or on sensor fields or electrodes of the sensor
apparatus 113. In particular, an immuno-assay or a protein assay for detecting or
identifying a protein and/or a nucleic-assay for detecting or identifying a nucleic-acid
sequence can be or is realized.
Alternatively or additionally, measurements without specific bonding and/or without
electrochemical detection can be used or performed, preferably in or by the analysis
device 200 and/or cartridge 100. Such measurements can include an optical
measurement, impedance measurement, capacitance measurement, spectrometric
measurement, mass spectrometric measurement, or the like. For this purpose, the
analysis device 200 or cartridge 100 may comprise an optical spectrometer and/or allow
optical measurements of the treated or untreated sample P. Thus, it is possible to
measure, detect or identify other or further analytes A, compounds, material
characteristics, or the like of the sample P, e.g. within the cartridge 100 or any other
sample carrier. These alternative or additional measurements can be used or processed
40 and/or evaluated in a similar manner as described or differently.
In particular, the present disclosure relates also to any one of the following aspects
which can be realized independently or in any combination, also in combination with
any aspects described above or in the claims:
1. Analysis system 1 for testing an in particular biological sample P,
the analysis system 1 comprising a cartridge 100 for receiving the sample P, and
the analysis system 1 comprising an analysis device 200 for receiving the cartridge 100
and subsequently carrying out the test using the received cartridge 100,
characterised
in that the analysis system 1 comprises an operating instrument 400 which preferably
can be separated from the analysis device 200 with respect to a data connection and/or
wirelessly connected to the analysis device 200,
- the operating instrument 400 being designed to determine or receive a cartridge
identifier 100C corresponding to the cartridge 100 and, using this cartridge identifier
100C, to retrieve from a database 500 control information 510 for carrying out the
test and/or to transmit said control information 510 to the analysis device 200; and/or
- the operating instrument 400 being designed to transmit to the analysis device 200
control information 510 for carrying out the test supported by the cartridge 100, and
the analysis device 200 being designed to carry out the test using the transmitted
control information 510 independently and/or separately from the operating
instrument 400; and/or
- the analysis device 200 being designed to receive control information 510 from the
operating instrument 400, to control the test of the sample P in the cartridge 100
using the control information 510 and to transmit measurement results 713
determined during the test to the operating instrument 400 without any prior
evaluation; and/or
- the operating instrument 400 being designed to determine or receive a cartridge
identifier 100C corresponding to the cartridge 100 and, using the cartridge identifier
100C, to retrieve from a database 500 evaluation information 530 for evaluating
measurement results 713 determined during the test, and to evaluate the
measurement results 713 using the evaluation information 530 independently and/or
separately from the analysis device 200.
2. Analysis system according to aspect 1, characterised in that the cartridge 100
comprises a memory means 100D from which the cartridge identifier 100C can be read
out, preferably electronically, in particular by means of the analysis device 200, and/or
40 optically, preferably by means of a camera 421 of the operating instrument 400, the
operating instrument 400 preferably being designed to automatically retrieve from the
database 500 the control information 510 for controlling the analysis device 200 in
order to carry out the test supported by the cartridge 100 and/or analysis information
530 for evaluating measurement results 713 determined by the test, by the cartridge
identifier 100C of the cartridge 100 being read out or after the cartridge identifier 100C
has been read out.
3. Analysis system according to aspect 1 or 2, characterised in that the control
information 510 and/or the evaluation information 530 comprises instructions,
preferably in the form of an algorithm, and/or the instructions forming a module which
can be implemented by the analysis device 200 and/or the operating instrument 400, as
a result of which the behaviour of the analysis device 200 and/or of the operating
instrument 400 can be changed.
4. Analysis system according to any one of the preceding aspects, characterised in
that the analysis device 200 is designed to control apparatuses of the analysis device
200 using the control information 510
- such that the sample P is conveyed inside the cartridge 100 to a sensor apparatus
113 in a manner specified by the control information 510, and/or
- such that valves 115 of the cartridge 100 are opened or closed in a manner
specified by the control information 510, and/or
- such that one or more temperature-control apparatuses 204 of the analysis device
200 are controlled such that the sample P and/or a sensor apparatus 113 is
temperature-controlled in a manner specified by the control information 510.
. Analysis system according to any one of the preceding aspects, characterised in
that the analysis device 200 comprises:
- a receiver 210A for, preferably wirelessly, receiving the control information 510
from the operating instrument 400, and/or
- a memory 207A for storing the control information 510, and/or
- a control apparatus 207 for controlling and/or feedback controlling apparatuses
of the analysis device 200 in order to carry out the test, and/or
- a connection apparatus 203 for establishing an electronic connection to a sensor
apparatus 113 of the cartridge 100, and/or
- a read-out module 207C for reading out measurement results 713 from the
sensor apparatus 113 of the cartridge 100, and/or
- a transmitter 210B for transmitting measurement results 713 read out from the
sensor apparatus 113 to the operating instrument.
6. Analysis system according to any one of the preceding aspects, characterised in
that the operating instrument 400 comprises an evaluation module 440 which is
designed to evaluate measurement results 713 read out from the sensor apparatus 113,
preferably by means of the evaluation information 530 retrieved from the database 500.
7. Analysis system according to any one of the preceding aspects, characterised in
that the evaluation information 530 comprises interpretation information 532 which
assigns the measurement results 713 to physical variables such that the measurement
results 713 can be interpreted.
8. Analysis system according to any of the preceding aspects, characterised in that the
sensor apparatus 113 comprises a plurality of sensor fields 113B and the evaluation
information 530 comprises assignment information 531 for assigning each of the
measurement results 713 from the respective sensor fields 113B to a property of the or a
sensor type of the respective sensor fields 113B.
9. Analysis system according to any one of the preceding aspects, characterised in
that the operating instrument 400 comprises an output apparatus 410, preferably a
display apparatus, in particular a display 411, and is designed to output evaluation
results 740 that are determined, in particular calculated, by evaluating the measurement
results 713 using the evaluation information 530.
10. Analysis system according to any one of the preceding aspects, characterised in
that the operating instrument 400 is designed to
- transmit, to the analysis device 200, control information 510 for receiving or
ejecting the cartridge 100, and/or
- transmit control information 510 to the analysis device 200 for starting the test,
and/or
- retrieve and/or receive measurement results 713 from the analysis device 200,
and/or
- send evaluation results 740 to a database 500.
11. Analysis system according to any one of the preceding aspects, characterised in
that the operating instrument 400 comprises an input apparatus 420, in particular a
touch-sensitive screen, by means of which the transmission of commands and/or
information to the analysis device 200 can be triggered; and/or
in that the operating instrument 400 and the analysis device 200 each comprise a
wireless data interface 430, 210 which are designed to jointly establish an ad-hoc data
connection between the operating instrument 400 and the analysis device 200,
preferably such that, when the operating instrument 400 and the analysis device 200
approach one another in space, the data connection (DVA) therebetween is
automatically established and is preferably displayed by means of the operating
instrument 400.
12. Analysis system according to any one of the preceding aspects, characterised in
that the operating instrument 400 comprises different interfaces 430 that are
independent of one another for establishing data connections (DVA, DVD) to the
analysis device 200 and to the database 500, the analysis device 200, as a peripheral
device of the operating instrument 400, being designed to communicate exclusively
with or via the operating instrument 400.
13. Analysis system according to any one of the preceding aspects, characterised in
that the analysis system 1 comprises a plurality of different cartridges 100 for carrying
out preferably different tests to which different control information 510 and evaluation
information 530 corresponds.
14. Method for testing an in particular biological sample P by means of an analysis
system 1,
the analysis system 1 comprising a cartridge 100 for receiving the sample P, the
cartridge 100 comprising a sensor apparatus 113 for measuring sample-specific
measurement results and a fluid system for conveying the sample P to the sensor
apparatus 113,
the analysis system 1 comprising an analysis device 200 for receiving the cartridge 100
and subsequently carrying out the test using the received cartridge 100,
characterised
40 in that the analysis system 1 comprises an operating instrument 400 which preferably
can be separated from the analysis device 200 with respect to a data connection and/or
wirelessly connected to the analysis device 200,
- the operating instrument 400 determining or receiving a cartridge identifier 100C
corresponding to the cartridge 100 and, using the cartridge identifier 100C, retrieving
from a database 500 control information 510 for carrying out the test and/or
transmitting said control information 510 to the analysis device 200; and/or
- the operating instrument 400 transmitting to the analysis device 200 control
information 510 for carrying out the test supported by the cartridge 100, and the
analysis device 200 carrying out the test using the transmitted control information
510 independently and/or separately from the operating instrument 400; and/or
- the analysis device 200 receiving control information 510 from the operating
instrument 400, controlling the test of the sample P in the cartridge 100 using the
control information 510 and transmitting measurement results 713 determined during
the test to the operating instrument 400 without any prior evaluation; and/or
- the operating instrument 400 determining or receiving a cartridge identifier 100C
corresponding to the cartridge 100 and, using the cartridge identifier 100C,
retrieving from a database 500 evaluation information 530 for evaluating
measurement results 713 determined during the test, and evaluating the
measurement results 713 using the evaluation information 530 independently and/or
separately from the analysis device 200.
. Computer program product comprising program code means which, when
executed, cause the method steps of the method according to claim 14 to be carried out.
Individual aspects and features of the present disclosure and individual method steps
and/or method variants may be implemented independently from one another, but also
in any desired combination and/or order.
‐ 72 ‐
List of reference signs:
1 a nalysis system 11 4A bypass
100 c ar tridge 115A initially clos e d val v e
100C c artridge identifier 115B initially open valve
0D mem ory me ans 116 sensor portion
101 main body 35 124 barcode
102 cover
103 f luid system 200 a nalysis device
10 4 r eceivin g cavity 20 0C d evice identi fier
104A c onnectio n 20 1 r eceptacle
4B i nlet 202 p ump drive
4C outlet 203 c onnectio n apparatus
104D i ntermedi ate conn ection 20 3A c ontact elem ent
10 5 m eterin g c a v i ty 204A r eaction temperature‐control
apparatus
6A‐G i ntermedi ate cavity
4B i ntermedi ate temp eratur e‐
107 m ixing c a vity
control apparatus
8A‐E s torage ca v it y
4C s ensor te mp er ature‐control
apparatus
109 r eaction cavity
5A ( valve) actu a tor for 1 15A
10 9A f irst reactio n cavity
5B ( valve) actu a tor for 1 15B
109B s econd react ion cavity
6A f luid sensor
109C third reaction cavity
6B other se nsor
11 0 i ntermedi ate temp eratur e‐
control cavity
6C t emper a ture sensor
111 c ollection cavity
6D t ilt sensor
112 pump appar a tus
206E a cceleration sensor
113 s ensor apparatus
6F humidity se nsor
113A s ensor array
206G p osition sen s or
11 3B s ensor fi eld
6H c artridge se n sor
114 c hannel
207 c ontrol apparatus
‐ 73 ‐
7A mem ory 440 e valuation module
7B a ctuator inte rface 450 mem ory
7C r ead‐out mo dule
207D e rror modul e 50 0 d atab ase
208 input app aratus 20 510 control infor m ation
209 d isplay apparatus 51 0A v alve control infor m ati on
210 inter face 510B pump drive control infor m ation
21 0A r eceiver 510C temper a ture‐control apparatus
c ontrol infor m ation
21 0B t ransmitter
511 ex ecution information
2 11 p ower supply
51 1A d elay in f or m a tion
211A c onnectio n
511B l ooping information
212 housing
511C c ondition information
21 2A i nterior spac e
520 c alibration i nformatio n
213 opening
521 f luid sensor calibration
214 pressurised gas supply
information
214A c onnectio n elemen t
524 c alibration i nformatio n
(tilt sensor)
52 5 threshold va l ue (tilt sens o r)
400 operating i nstrument
526 s tart threshold value
400C o perating i nstrument identifier
(tilt sensor)
410 output apparatus
527 interruption threshold value
411 display
(tilt sensor)
412 s peaker
528 calibration in formation (sensor
arrangement)
420 input app aratus
530 e valuation information
421 camer a
531 (field) assign ment information
422 touchpad
532 interpretati o n informatio n
423 microphone
550 r esults memory
424 keyboard
430 inter face
601 data transmission cartridge –
431 a nalysis device inter face
analysis de v i c e
43 2 d atab ase int e rfac e
‐ 74 ‐
602 data transmission analysis device
– operatin g i n strument
A a nalyte
603 data transmi ssion operating i n s‐
DVA data co nnect ion analysis device –
trument – database
operatin g i n strument
604 data transmi ssion database –
DVB data co nnect ion cartridge – oper‐
operatin g i n strument
ating instrument
605 d ata transmission operating ins‐
DVC data co nnect ion cartridge – anal‐
trument – an alysis device
ysis device
606 testing pr ocess
DVD data co nnect ion dat a b a se – oper‐
607 results retrieva l cartridge – ana‐
ating instrument
lysis device
F(1‐5) l iquid rea g e n t(s)
608 data transmi ssion an alysi s device
P s ample
– operatin g i n strument
N (data) network
609 evaluation process
S(1‐10) d ry rea gent( s )
610 d ata transmission operating in‐
strument – datab ase
70 6A m easur e m e n t result fro m t he flu‐
id sensor
70 6B m easur e m e n t result fro m t he
other sensor
70 6C m easur e m e n t result fro m t he
temper ature sensor
70 6D m easur e m e n t result fro m t he tilt
sensor
70 6E m easur e m e n t result fro m t he ac‐
celeration sensor
70 6F m easur e m e n t result fro m t he
humidity sensor
70 6G m easur e m e n t result fro m t he po‐
sition sensor
70 6H m easur e m e n t result fro m t he car‐
tridge sensor
713 measur ement result from the
sensor app ar atus
740 e valuation r e sult
Claims (51)
1. Analysis system for testing a sample, 5 the analysis system comprising a cartridge for receiving the sample, and the analysis system comprising an analysis device for receiving the cartridge and subsequently carrying out the test using the received cartridge, 10 wherein the cartridge comprises a sensor apparatus for detecting analytes of the sample during the test and a memory means, the memory means being provided in the sensor apparatus, wherein a cartridge identifier corresponding to the cartridge is stored in the 15 memory means as data, wherein the analysis device comprises an electrical connection apparatus with electrical contact elements for establishing an electronic connection to the sensor apparatus, wherein the cartridge identifier can be read out via the electronic 20 connection between the cartridge and the analysis device created by means of the contact elements, and wherein measurement results obtained by the sensor apparatus from testing the sample can be electrically transmitted to the analysis device by means of the same electronic connection, 25 wherein the analysis system comprises an operating instrument which is separable from the analysis device with respect to a data connection and/or which is wirelessly connectable to the analysis device, the operating instrument being designed to receive the cartridge identifier 30 corresponding to the cartridge and, using this cartridge identifier, to retrieve from a database control information for carrying out the test and to transmit said control information to the analysis device.
2. Analysis system according to claim 1, wherein the analysis device is 35 configured for carrying out the testing using the control information transmitted independently, disconnectedly, and/or separately from the operating instrument.
3. Analysis system according to any one of the preceding claims, wherein the cartridge comprises a second memory means from which a second cartridge 40 identifier can be read out by the operating instrument.
4. Analysis system according to any one of the preceding claims, wherein the control information comprises instructions that form a module which can be implemented by the analysis device, as a result of which the behaviour of the 45 analysis device is changeable or changed.
5. Analysis system according to any one of the preceding claims, wherein the analysis device comprises a receiver for wirelessly receiving the control information from the operating instrument.
6. Analysis system according to any one of the preceding claims, wherein the operating instrument comprises an input apparatus by means of which the transmission of commands and/or information to the analysis device can be triggered.
7. Analysis system according to any one of the preceding claims, wherein the operating instrument comprises different interfaces that are independent of one another for establishing data connections to the analysis device and to the database, the analysis device, as a peripheral device of the operating instrument, 10 being configured to communicate exclusively with or via the operating instrument.
8. Analysis system according to any one of the preceding claims, wherein the analysis system comprises at least one cartridge for carrying out different tests to which different pieces of control information correspond or a plurality of different 15 cartridges for carrying out different tests to which different pieces of control information correspond.
9. Analysis system for testing a sample, 20 the analysis system comprising a cartridge for receiving the sample, and the analysis system comprising an analysis device for receiving the cartridge and subsequently carrying out the test using the received cartridge, 25 wherein the cartridge comprises a sensor apparatus for detecting analytes of the sample during the test and a memory means, the memory means being provided in the sensor apparatus, wherein a cartridge identifier corresponding to the cartridge is stored in the 30 memory means as data, wherein the analysis device comprises an electrical connection apparatus with electrical contact elements for establishing an electronic connection to the sensor apparatus, wherein the cartridge identifier can be read out via the electronic 35 connection between the cartridge and the analysis device created by means of the contact elements, and wherein measurement results obtained by the sensor apparatus from testing the sample can be electrically transmitted to the analysis device by means of the same electronic connection, 40 wherein the analysis system comprises an operating instrument which is separable from the analysis device with respect to a data connection and/or wirelessly connectable to the analysis device, the operating instrument being configured to retrieve from a database control 45 information for controlling actuators of the analysis device for carrying out the test supported by the cartridge and to transmit to the analysis device said control information, and the analysis device being configured to carry out the test using the transmitted control information independently, disconnected and/or separately from the operating instrument.
10. Analysis system according to claim 9, wherein the operating instrument is designed to receive the cartridge identifier corresponding to the cartridge and, using this cartridge identifier, to retrieve from the database the control information for carrying out the test..
11. Analysis system according to claim 9 or 10, wherein the control information comprises instructions that form a module which can be implemented by the analysis device, as a result of which the behaviour of the analysis device is changeable or changed.
12. Analysis system according to any one of claims 9 to 11, wherein the analysis device is configured to control apparatuses of the analysis device using the control information such that at least one of: 15 the sample is conveyed inside the cartridge to the sensor apparatus in a manner specified by the control information, valves of the cartridge are opened or closed in a manner specified by the control information, and one or more temperature-control apparatuses of the analysis device are controlled such that the sample and/or the sensor apparatus is temperature-controlled in a manner specified by the control information. 25
13. Analysis system according to any one of claim 9 to 12, wherein the analysis device comprises a receiver for wirelessly receiving the control information from the operating instrument.
14. Analysis system according to any one of claim 9 to 13, wherein the operating 30 instrument comprises an input apparatus by means of which the transmission of commands and/or information to the analysis device is triggerable.
15. Analysis system according to any one of claim 9 to 14, wherein the operating instrument comprises different interfaces that are independent of one another for 35 establishing data connections, the analysis device, as a peripheral device of the operating instrument, being configured to communicate exclusively with or via the operating instrument.
16. Analysis system for testing a sample, the analysis system comprising a cartridge for receiving the sample, and the analysis system comprising an analysis device for receiving the cartridge and subsequently carrying out the test using the received cartridge, wherein the cartridge comprises a sensor apparatus for detecting analytes of the sample during the test and a memory means, the memory means being provided in the sensor apparatus, wherein a cartridge identifier corresponding to the cartridge is stored in the memory means as data, wherein the analysis device comprises an electrical apparatus with electrical 5 contact elements for establishing an electronic connection to the sensor apparatus, wherein the cartridge identifier can be read out via the electronic connection between the cartridge and the analysis device created by means of the contact elements, and wherein measurement results obtained by the sensor apparatus from testing the sample can be electrically transmitted to the analysis device by 10 means of the same electronic connection, wherein the analysis system comprises an operating instrument which is separable from the analysis device with respect to a data connection and/or wirelessly connected to the analysis device, the analysis device being configured to receive control information from the operating instrument, to control the test of the sample in the cartridge using said control information, and to transmit measurement results determined during the test to the operating instrument without any prior evaluation.
17. Analysis system according to claim 16, wherein the operating instrument is designed to receive the cartridge identifier corresponding to the cartridge and, using this cartridge identifier, to retrieve from a database control information for carrying out the test and to transmit said control information to the analysis 25 device.
18. Analysis system according to claim 16 or 17, wherein the analysis device is configured to carry out the test using the transmitted control information independently, disconnected and/or separately from the operating instrument.
19. Analysis system according to any one of claims 16 to 18, wherein the operating instrument is configured to retrieve from a database evaluation information for evaluating measurement results determined by the test. 35
20. Analysis system according to claim 19, wherein the evaluation information comprises instructions that form a module which is implementable by the operating instrument, as a result of which the behaviour of the operating instrument is changeable. 40
21. Analysis system according to any one of claims 16 to 20, wherein the analysis device is configured to control apparatuses of the analysis device using the control information such that at least one of: the sample is conveyed inside the cartridge to the sensor apparatus in a manner 45 specified by the control information, valves of the cartridge are opened or closed in a manner specified by the control information, and that one or more temperature-control apparatuses of the analysis device are controlled such that the sample and/or the sensor apparatus is temperature- controlled in a manner specified by the control information. 5
22. Analysis system according to any one of claim 16 to 21, wherein the analysis device comprises a read-out module for reading out measurement results from the sensor apparatus of the cartridge.
23. Analysis system according to any one of claim 16 to 22, wherein the analysis 10 device comprises a transmitter for transmitting measurement results read out from the sensor apparatus to the operating instrument.
24. Analysis system according to any one of claims 19 to 23, wherein the operating instrument comprises different interfaces that are independent of one 15 another for establishing data connections to the analysis device and to the database, the analysis device, as a peripheral device of the operating instrument, being configured to communicate exclusively with or via the operating instrument.
25. Analysis system for testing a sample, the analysis system comprising a cartridge for receiving the sample, and the analysis system comprising an analysis device for receiving the cartridge and subsequently carrying out the test using the received cartridge, wherein the cartridge comprises a sensor apparatus for detecting analytes of the sample during the test and a memory means, the memory means being provided in the sensor apparatus,, 30 wherein a cartridge identifier corresponding to the cartridge is stored in the memory means as data, wherein the analysis device comprises an electrical connection apparatus with electrical contact elements for establishing an electronic connection to the sensor 35 apparatus, wherein the cartridge identifier can be read out via the electronic connection between the cartridge and the analysis device created by means of the contact elements, and wherein measurement results obtained by the sensor apparatus from testing the sample can be electrically transmitted to the analysis device by means of the same electronic connection, wherein the analysis system comprises a portable operating instrument, the operating instrument being configured to receive the cartridge identifier corresponding to the cartridge and, using the cartridge identifier, to retrieve from a database evaluation information for evaluating measurement results determined 45 during the test that originate from the sensor apparatus, and to evaluate the measurement results using the evaluation information independently, disconnected and/or separately from the analysis device.
26. Analysis system according to claim 25, wherein the analysis device is configured to transmit the measurement results determined during the test to the operating instrument without any prior evaluation . 5
27. Analysis system according to claim 25 or 26, wherein the operating instrument forms a user interface for controlling the test and/or the evaluation or outputting of the measurement results.
28. Analysis system according to any one of claims 25 to 27, wherein the cartridge 10 identifier is unique and/or is designed to uniquely identify the cartridge.
29. Analysis system according to any one of claims 25 to 28, wherein the cartridge comprises a second memory means from which a second cartridge identifier can be read out by the operating instrument.
30. Analysis system according to any one of claims 25 to 29, wherein the analysis device comprises a transmitter for transmitting measurement results read out from the sensor apparatus of the cartridge to the operating instrument. 20
31. Analysis system according to any one of claims 25 to 30, wherein the operating instrument comprises an evaluation module which is configured to evaluate measurement results read out from the sensor apparatus of the cartridge, by means of the evaluation information. 25
32. Analysis system according to any one of claims 25 to 31, wherein the operating instrument comprises an output apparatus and is configured to output, in particular display, evaluation results that are determined by evaluating the measurement results using the evaluation information. 30
33. Analysis system according to any one of claims 25 to 32, wherein the operating instrument comprises an input apparatus by means of which the transmission of commands and/or information to the analysis device can be triggered. 35
34. Analysis system according to any one of claims 25 to 33, wherein the operating instrument comprises different interfaces that are independent of one another for establishing data connections to the analysis device and to the database, the analysis device, as a peripheral device of the operating instrument, being designed to communicate exclusively with or via the operating instrument.
35. Analysis system according to any one of claims 25 to 34, wherein the operating instrument is configured to send evaluation results to a database.
36. Analysis system according to any one of claims 25 to 35, wherein said 45 operating instrument is separable from the analysis device with respect to a data connection and/or wirelessly connectable to the analysis device.
37. Analysis system according to any one of claims 25 to 36, wherein the analysis system comprises at least one cartridge for carrying out different tests or a plurality of different cartridges for carrying out different tests, wherein different pieces of evaluation information correspond to one or more of said different tests 5 or to measurement results resulting therefrom.
38. Analysis system according to any one of claims 25 to 37, wherein the operating instrument is further designed to retrieve, using the cartridge identifier, from a database control information for carrying out the test and to transmit said 10 control information to the analysis device.
39. Analysis system according to claim 38, wherein the analysis device is configured to carry out the test using the transmitted control information independently, disconnected and/or separately from the operating instrument.
40. Analysis system according to any one of claims 25 to 39, wherein the evaluation information comprises instructions that form a module which can be implemented by the operating instrument, as a result of which the behaviour of the operating instrument is changed or changeable.
41. Method for testing a sample by means of an analysis system, the analysis system comprising a cartridge for receiving the sample, 25 the analysis system comprising an analysis device for receiving the cartridge and subsequently carrying out the test using the received cartridge, wherein the analysis system comprises an operating instrument which is separable from the analysis device with respect to a data connection and/or 30 wirelessly connectable to the analysis device, wherein the cartridge comprises a sensor apparatus for detecting analytes of the sample during the test and a memory means, the memory means being provided in the sensor apparatus, , wherein the analysis device comprises an electrical connection apparatus with electrical contact elements for establishing an electronic connection to the sensor apparatus for electrically transmitting measurement results obtained by the sensor apparatus from testing the sample to the analysis device, the analysis device establishing an electronic connection to the sensor apparatus by means of the electrical contact elements and reading out the cartridge identifier corresponding to the cartridge from the memory means via the electronic connection between the cartridge and the analysis device created by means of the 45 contact elements, the operating instrument receiving the cartridge identifier and, using the cartridge identifier, retrieving from a database control information for carrying out the test and transmitting said control information to the analysis device.
42. Method according to claim 41, wherein the analysis device carries out the test using the transmitted control information independently, disconnected and/or separately from the operating instrument. 5
43. Method for testing a sample by means of an analysis system, the analysis system comprising a cartridge for receiving the sample, the analysis system comprising an analysis device for receiving the cartridge and 10 subsequently carrying out the test using the received cartridge, wherein the analysis system comprises an operating instrument which is separable from the analysis device with respect to a data connection and/or wirelessly connectable to the analysis device, wherein the cartridge comprises a sensor apparatus for detecting analytes of the sample during the test and a memory means, the memory means being provided in the sensor apparatus, 20 wherein the analysis device comprises an electrical connection apparatus with electrical contact elements for establishing an electronic connection to the sensor apparatus for electrically transmitting measurement results obtained by the sensor apparatus from testing the sample to the analysis device, 25 the analysis device establishing an electronic connection to the sensor apparatus by means of the electrical contact elements and reading out the cartridge identifier corresponding to the cartridge from the memory means via the electronic connection between the cartridge and the analysis device created by means of the contact elements, the operating instrument retrieving from a database control information for controlling actuators of the analysis device for carrying out the test supported by the cartridge and transmitting to the analysis device said control information, and the analysis device carrying out the test using the transmitted control information 35 independently, disconnected and/or separately from the operating instrument.
44. Method according to claim 43, wherein the operating instrument receives the cartridge identifier and retrieves from the database the control information using the cartridge identifier.
45. Method for testing a sample by means of an analysis system, the analysis system comprising a cartridge for receiving the sample, 45 the analysis system comprising an analysis device for receiving the cartridge and subsequently carrying out the test using the received cartridge, wherein the analysis system comprises an operating instrument which is separable from the analysis device with respect to a data connection and/or 50 wirelessly connectable to the analysis device, wherein the cartridge comprises a sensor apparatus for detecting analytes of the sample during the test and a memory means, the memory means being provided in the sensor apparatus, 5 wherein the analysis device comprises an electrical connection apparatus with electrical contact elements for establishing an electronic connection to the sensor apparatus for electrically transmitting measurement results obtained by the sensor apparatus from testing the sample to the analysis device, 10 the analysis device establishing an electronic connection to the sensor apparatus by means of the electrical contact elements and reading out the cartridge identifier corresponding to the cartridge from the memory means via the electronic connection between the cartridge and the analysis device created by means of the contact elements, the analysis device receiving control information from the operating instrument, controlling the test of the sample in the cartridge using the control information and transmitting measurement results determined during the test to the operating instrument without any prior evaluation.
46. Method according to claim 45, wherein the operating instrument receives the cartridge identifier and, using the cartridge identifier, retrieves from a database control information for carrying out the test and transmits said control information to the analysis device, and/or wherein the analysis device carries out 25 the test using the transmitted control information independently, disconnected and/or separately from the operating instrument.
47. Method for testing a sample by means of an analysis system, 30 the analysis system comprising a cartridge for receiving the sample, the analysis system comprising an analysis device for receiving the cartridge and subsequently carrying out the test using the received cartridge, 35 wherein the analysis system comprises a portable operating instrument, wherein the cartridge comprises a sensor apparatus for detecting analytes of the sample during the test and a memory means, the memory means being provided in the sensor apparatus, wherein the analysis device comprises an electrical connection apparatus with electrical contact elements for establishing an electronic connection to the sensor apparatus for electrically transmitting measurement results obtained by the sensor apparatus from testing the sample to the analysis device, the analysis device establishing an electronic connection to the sensor apparatus by means of the electrical contact elements and reading out the cartridge identifier corresponding to the cartridge from the memory means via the electronic connection between the cartridge and the analysis device created by means of the 50 contact elements, the operating instrument receiving the cartridge identifier corresponding to the cartridge and, using the cartridge identifier, retrieving from a database evaluation information for evaluating measurement results determined during the test that originate from the sensor apparatus, and evaluating the measurement results 5 using the evaluation information independently, disconnected and/or separately from the analysis device.
48. Method according to claim 47, wherein the analysis device transmits the measurement results determined during the test to the operating instrument 10 without any prior evaluation, and/or wherein the operating instrument retrieves, using the cartridge identifier, from a database control information for carrying out the test and transmits said control information to the analysis device.
49. Method according to claim 48, wherein the analysis device carries out the test 15 using the transmitted control information independently, disconnected and/or separately from the operating instrument.
50. Computer program product comprising program code means which, when executed, cause the method steps of the method according to any one of claims 41 20 to 49 to be carried out.
51. A system or method according to any one of the preceding claims, substantially as herein described with reference to the figures and/or examples.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP16020383 | 2016-10-07 | ||
EP16020383.2 | 2016-10-07 | ||
PCT/EP2017/025291 WO2018065114A1 (en) | 2016-10-07 | 2017-10-05 | Analysis system and method for testing a sample |
Publications (2)
Publication Number | Publication Date |
---|---|
NZ752677A NZ752677A (en) | 2021-10-29 |
NZ752677B2 true NZ752677B2 (en) | 2022-02-01 |
Family
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