WO2017149468A1 - Système et procédé permettant l'association de résultats d'une analyse réalisée sur des échantillons biologiques, en particulier des échantillons biologiques soumis à des recherches cliniques, avec des variables pré-analytiques auxquelles lesdits échantillons sont exposés - Google Patents

Système et procédé permettant l'association de résultats d'une analyse réalisée sur des échantillons biologiques, en particulier des échantillons biologiques soumis à des recherches cliniques, avec des variables pré-analytiques auxquelles lesdits échantillons sont exposés Download PDF

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Publication number
WO2017149468A1
WO2017149468A1 PCT/IB2017/051189 IB2017051189W WO2017149468A1 WO 2017149468 A1 WO2017149468 A1 WO 2017149468A1 IB 2017051189 W IB2017051189 W IB 2017051189W WO 2017149468 A1 WO2017149468 A1 WO 2017149468A1
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WO
WIPO (PCT)
Prior art keywords
biological samples
population
station
analysis
transport
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Application number
PCT/IB2017/051189
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English (en)
Inventor
Maurizio CHELI
Bruno CAVIGIOLI
Original Assignee
D. P. Medical S.R.L.
Themis S.R.L.
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Filing date
Publication date
Application filed by D. P. Medical S.R.L., Themis S.R.L. filed Critical D. P. Medical S.R.L.
Publication of WO2017149468A1 publication Critical patent/WO2017149468A1/fr

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/40—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/54—Labware with identification means
    • B01L3/545—Labware with identification means for laboratory containers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D79/00—Kinds or details of packages, not otherwise provided for
    • B65D79/02—Arrangements or devices for indicating incorrect storage or transport
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00722—Communications; Identification
    • G01N35/00871—Communications between instruments or with remote terminals
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H15/00—ICT specially adapted for medical reports, e.g. generation or transmission thereof
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/20—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/14—Process control and prevention of errors
    • B01L2200/143—Quality control, feedback systems
    • B01L2200/147—Employing temperature sensors
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/18—Transport of container or devices
    • B01L2200/185—Long distance transport, e.g. mailing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/02—Identification, exchange or storage of information
    • B01L2300/021—Identification, e.g. bar codes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/02—Identification, exchange or storage of information
    • B01L2300/021—Identification, e.g. bar codes
    • B01L2300/022—Transponder chips
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/02—Identification, exchange or storage of information
    • B01L2300/023—Sending and receiving of information, e.g. using bluetooth
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/02—Identification, exchange or storage of information
    • B01L2300/024—Storing results with means integrated into the container
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/0627—Sensor or part of a sensor is integrated
    • B01L2300/0663—Whole sensors
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L9/00—Supporting devices; Holding devices
    • B01L9/06—Test-tube stands; Test-tube holders
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N2001/002—Devices for supplying or distributing samples to an analysing apparatus
    • G01N2001/007—Devices specially adapted for forensic samples, e.g. tamper-proofing, sample tracking

Definitions

  • the present invention relates to the analysis of biological samples such as biological samples subjected to clinical investigations and in particular to a system and a method according to the preamble of claim 1 and claim 11 respectively, in order to verify the effects of pre-analytical variables on the results of the analysis performed on biological samples.
  • a plurality of biological samples acquired at a retrieval station is stored in respective collection units (for example, test tubes for blood samples), generally combined in certified containers for the safe transport of biological material relative to any risk of spreading, and transported from the retrieval station to an analysis station.
  • respective collection units for example, test tubes for blood samples
  • the transport of samples is an important pre-analytical step, wherein the samples may be exposed to pre-analytical conditions defined by various transport parameters, including environmental parameters such as temperature, humidity and light conditions, and dynamic parameters, including handling and shocks, which can cause changes in certain physical, chemical or biological properties, which to some extent affect the results of the clinical analysis to which samples are finally subjected.
  • transport parameters including environmental parameters such as temperature, humidity and light conditions, and dynamic parameters, including handling and shocks, which can cause changes in certain physical, chemical or biological properties, which to some extent affect the results of the clinical analysis to which samples are finally subjected.
  • Hemolysis affects tests on potassium, glucose, LDH and in general all the tests affected by the rupture of red blood cells
  • Vibrations involve the rupture of the cell wall and chemical bonds
  • Centrifugation speed is a stage of processing the samples that occurs in the laboratory and during which cytolysis and sample heating take place;
  • Heat involves the activation of coagulation, agglutinins, and a change in state of protein molecules
  • - Location of the collecting vessel influences the amplitude of the surface of the biological material in contact with the air, which causes the activation of coagulation factors;
  • WO 2004/108968 describes the execution of quality control on biological samples and a system for monitoring such pre-analytical variables.
  • the document describes a quality evaluation step for the samples taken that may take place before or at the same time as the clinical essay.
  • the quality of a sample may be assessed before running a clinical test on the sample so that one may decide not to run the clinical test if the quality of the sample is not acceptable.
  • This approach may provide significant savings of resources, and - with an independent quality evaluation step for each sample - a laboratory is able to monitor samples that usually do not have sufficient quality, and take remedial measures to obtain and preserve the sample in such cases.
  • pre-analytical conditions typically the transport conditions in a pre-analytical step
  • results of the clinical analysis of the biological samples are desirable also to be able to correlate the pre-analytical conditions, typically the transport conditions in a pre-analytical step, with the results of the clinical analysis of the biological samples.
  • One object of the present invention is therefore to propose a system and a method during the pre-analytical step for quality control of biological samples intended for clinical investigations.
  • a further object of the invention is to propose a system and a method to evaluate the effects of the pre-analytical conditions that occur during the transport step of the biological samples.
  • the sensor means for the acquisition of transport parameters are placed in the probe collection unit in an internal space corresponding to the inner space of a collection unit intended to receive a biological sample.
  • the sensor means for the acquisition of transport parameters include at least one among the following transport parameter sensors:
  • At least one gas sensor for particular types of samples, at least one gas sensor.
  • the probe collection unit has a hole adapted to put the inner space of said probe collection unit in communication with the external environment.
  • the identification data of at least one population of biological samples include at least one among the following data:
  • an associated identification datum of an operator and preferably of a retrieval operator and a transport operator.
  • the measurement data of transport parameters comprise at least one of:
  • the system's probe collection unit is provided with an identification code and has a radio communication means adapted to transmit the measurement data of transport parameters remotely to the database system either directly or indirectly via an intermediate repeater device, together with the respective identification code.
  • the radio communication means of the probe collection unit are adapted to transmit remotely the measurement data of transport parameters at the retrieval station, at least at one intermediate station between the retrieval station and the analysis station, and at the analysis station.
  • an intermediate station is a station wherein the means and conditions of transport are changed, or it is a predetermined intermediate point on the route, identified by its position along the route, for example marked by GPS coordinates or a cell tower or a wi-fi hotspot.
  • the database system is arranged to make available through a remote communications link the identification data of at least one population of biological samples, the measurement data of the transport parameters, and the result data from clinical analysis.
  • the population of biological samples is arranged in a transport container and an additional humidity sensor is coupled to said transport container to detect any spreading of the biological samples due to evaporation or rupture of the collection unit.
  • Another object of the invention is a method for controlling biological samples to be subjected to clinical analysis, as claimed.
  • the aforementioned method is furthermore characterized in that it comprises, in a first step, at the retrieval station, the transmission to the database system of the identification data together with an identification code of the probe collection unit associated with at least one population of biological samples; in a second step, at the analysis station or an intermediate station between the retrieval station and the analysis station, the transmission of the measurement data to the database system; and in a third step, at the analysis station, the transmission of the result data from clinical analysis.
  • the acquisition of the measurement data of the transport parameters comprises at least one of:
  • the set of measurement data of the acquired transport parameters, relative to a population of biological samples defines a pre-analytical condition of the population of biological samples.
  • the pre-analytical condition is a parameter vector, each parameter being a time- dependent parameter, or a parameter vector with constant values, e.g. representative of the averages of the parameters over time, or the maximum values of parameters or the summations of the relative maximum/minimum values of the parameters, or a vector of mixed parameters including time-dependent parameters and corresponding to derived constant values.
  • the method comprises generating a report indicative of at least one predetermined relationship between the identification data, the measurement data and the result data from clinical analysis.
  • Figures 2a and 2b are perspective views of a probe collection unit used by the system for the control of biological samples according to the present invention
  • - Figure 3 is a flowchart that shows the steps of the method for the control of biological samples according to the present invention.
  • Figure 1 schematically shows a system object of the invention for the control of biological samples acquired at least at one retrieval site 10 and intended to be subject to clinical analysis at an analysis site 12.
  • a population of said biological samples is placed in respective collection units PI, P2, Pn, in this embodiment described by way of example, represented in the form of test tubes, such as test tubes for the collection of blood samples marked with a respective identifier code, and transported from a retrieval station 20 to an analysis station 22.
  • the transport takes place preferably by aggregating the collection units PI, P2, Pn in a transport container 24, possibly provided with environmental parameter sensors, and preferably a humidity sensor (not shown) adapted to detect any spreading of the biological samples, due to evaporation or rupture of the collection unit, and having safety functions to notify an operator at the time of the opening of the container.
  • the population of biological samples means at least one biological sample and preferably a plurality of biological samples transferred simultaneously from the retrieval station to the analysis station and substantially subject to the same conditions of transport.
  • At least one probe collection unit S is associated with the collection units PI, P2, Pn in the transport from the retrieval station 20 to the analysis station 22, so as to be exposed substantially to the transport conditions to which the population of biological samples contained in the collecting unit PI, P2, Pn is subjected.
  • the probe collection unit 52 is arranged to acquire the measurement data of transport parameters.
  • a database system 30, residing on a remote server accessible in the cloud, includes at least one data memory module 32 and a first data processing unit 34 of the system for the control of biological samples object of the invention.
  • the data memory module 32 includes:
  • a first submodule 32a adapted to store identification data of the population of biological samples associated with at least one retrieval site 10 of said samples and at least one respective retrieval time;
  • a second submodule 32b adapted to store the measurement data of transport parameters of the population of biological samples taken during transport from the retrieval station 20 to the analysis station 22;
  • the data processing unit 34 is linked to the submodules 32a, 32b and 32c of the data memory module 32 and comprises a processor 40, adapted to read from and write to the memory submodules, as well as to determine at least one associative relationship between the identification data of the population of biological samples, the measurement data of the transport parameters, and the result data from clinical analysis.
  • the data processing unit 34 also comprises a data transmission/reception module 42, adapted to link bidirectionally the data processing unit 34 with the communication terminals T available from one or more operators, which are arranged to communicate with the probe collection unit S at the retrieval station 20, the analysis station 22, and possibly one or more intermediate stations.
  • the intermediate stations may be sorting sites for the collection units and the associated probe collection unit or simply the locations of the collection units and the associated probe collection unit intermediate between the retrieval station and the analysis station, illustrated in the figure by the association of a terminal T to the transport vehicle.
  • the terminals T represented in the figure may be the same terminal in possession of an operator who follows the retrieval, transport and analysis operations, in which case, these are mobile terminals such as tablets or smartphones; or different terminals in possession of different operators dedicated to each operation, in which case these may be a mobile terminal (tablet or smartphone) or a fixed terminal (PC) located at the relative station.
  • these are mobile terminals such as tablets or smartphones; or different terminals in possession of different operators dedicated to each operation, in which case these may be a mobile terminal (tablet or smartphone) or a fixed terminal (PC) located at the relative station.
  • the link between the data processing unit 34 and the communication terminals T is a radio 1 communications link, such as a link through a public communications network.
  • the probe collection unit S shown in figures 2a and 2b, is identical to the collection units used for the storage of biological samples and comprises a body 50 of a generally cylindrical shape, open at one end, which is closed by a cap 52.
  • the probe collection unit S may be advantageously provided with a hole 54 to allow the reduction of the moments of inertia between the surrounding environment and the inside of the test tube in the detection of environmental parameters.
  • the probe collection unit S Inside the probe collection unit S is arranged a printed circuit board 56 with a processor 58, a power supply battery (not shown) and a plurality of transport parameter acquisition sensors, including transport environmental conditions, arrangement and dynamics, i.e. the parameters necessary for the detection and logging of events that occur during the transport of biological samples from the retrieval station 20 to the analysis station 22.
  • the probe collection unit includes:
  • a temperature sensor 60 adapted to detect the internal temperature of the probe collection unit, that for the purposes of the invention is considered to be approximately equal to the internal temperature of the collection unit PI, P2, Pn;
  • a device for measuring the time 62 such as a clock or a stopwatch, adapted to measure the transport time between the retrieval station 20, any intermediate stations and the analysis station 22;
  • a light sensor 64 advantageously positioned at the height of the dead space of the collection unit, namely the space immediately below the cap and above the surface of the biological sample, and adapted to detect the light condition to which the population of biological samples associated with the probe collection unit S is subject.
  • an accelerometer sensor 66 preferably a triaxial accelerometric sensor, adapted to detect accelerations and/or decelerations experienced by the probe collection unit, and therefore by the collection units PI, P2, Pn associated to it during transport, for example due to the handling and shocks experienced by the container 24;
  • a humidity sensor 68 adapted to detect the internal humidity of the probe collection unit, that for the purposes of the invention is considered to be approximately equal to the internal humidity of the collection unit PI, P2, Pn;
  • a location sensor 70 adapted to detect the geographical position of the probe collection unit
  • an alignment sensor 72 adapted to detect the spatial arrangement of the probe collection unit in order to determine, for example, the condition of verticality, closely related to the surface of the biological sample that will be exposed to the air inside the collection unit;
  • the processor 58 forms a second data processing unit of the system for the control of biological samples object of the invention and is arranged to acquire the measurement data detected by the sensors and store it, at least temporarily, before transmitting it.
  • the printed circuit board 56 is stably fixed so as not to experience spurious vibrations to which it would be subjected during centrifugation or due to sudden movements.
  • a transceiver module 76 is provided which allows, by means of a dedicated wireless link L, the transmission of the measurement data of transport parameters acquired by the sensors to a communication terminal T, for example according to an RFID communication protocol, and possibly the reception of data storage activation signals or data storage interruption signals, the programming of the activity and the download of stored data.
  • the transceiver module 76 is positioned within the cap 52 in such a way that a relative antenna is oriented towards the outside.
  • On the probe collection unit S is attached a label 80 on which an identification code 82 is provided, which allows, inter alia, to easily distinguish the probe collection unit S from the collection units PI, P2, Pn containing biological samples.
  • the system allows the pre-analytical conditions of a population of biological samples to be detected with predetermined and possibly configurable periodicity.
  • the method comprises, in sequence, a step 100 of storing biological samples in respective collection units PI, P2, Pn, a step 200 of associating a probe collection unit S with the collection units PI, P2, Pn, a step 300 of activating the probe collection unit (activating the processor 58 and the sensors 60-74) and launching the monitoring of the pre-analytical conditions to which the biological samples are subjected.
  • step 300 the transmission from the communication terminal T, associated with the retrieval site 10, to the database system 30 occurs for the identification data of the population of biological samples, including at least one identifier code of the collection units PI, P2,. .., Pn, an identification code of the probe collection unit S associated therewith, an identification datum of the retrieval station 20, an identification datum of a retrieval and/or transport operator, a retrieval time, and a transport start time from the retrieval station 20. These data can possibly also be stored in the probe unit.
  • the association between the collection unit (biological samples) and the probe collection unit can take place manually, e.g. by reading the identifier codes via printed bar code reader devices, or automatically, via query of the collection units and of the probe collection unit from the communication terminal T associated with the retrieval site 10, if the collection units and the probe collection unit are equipped with electronic identification devices, for example RFID labels.
  • Step 300 is initiated by an operator who transmits to the probe collection unit, via the communication terminal T, the identification datum of the retrieval station and synchronizes the date and time.
  • the transport parameters are acquired (detection and storage), identified by step 400.
  • intermediate stations may be provided, e.g. dispatch stations, from which transmit, to the database system 30, the measurement data of the transport parameters in association with the location information of the intermediate station.
  • the collection units PI, P2, Pn and the associated probe collection unit S arrive at the analysis station 22, at step 500, the storage of the transport parameters from the sensors 60-74 of the probe collection unit S is stopped, and therefore the monitoring of the pre- analytical conditions to which the biological samples have been subjected is completed.
  • the pre-analytical step must be understood as the step that precedes the clinical analysis, regardless of the place or places where it takes place.
  • the pre-analytical step concerns the transport conditions of the biological samples, i.e. the environmental and dynamic conditions to which the samples are exposed in the transport step between a retrieval station and an analysis station and possibly in the step of handling the samples at an analysis site before reaching the analysis station.
  • step 600 the measurement data of the transport parameters are sent from the probe collection unit to the communication terminal T associated with the analysis site
  • step 700 the result data are obtained from the clinical analysis conducted on the biological samples of the collection units PI, P2, Pn, and these data are transmitted from the communication terminal T to the database system 30.
  • the database system 30 is arranged to generate one or more reports indicative of predetermined relationships between the identification data, the measurement data and the result data from clinical analysis.
  • the report is a comparison report between the result data from clinical analysis of a single analysis station and all the result data from clinical analysis for each pre-analytical condition stored in the database system.
  • the report is a comparison report between the result data from clinical analysis of a single analysis station and all the result data from clinical analysis for homogeneous pre-analytical conditions, i.e. which present measurement values between pairs of maximum and minimum thresholds, stored in the database system.
  • the report is a comparison report between the result data from clinical analysis from a single analysis station and all the result data from clinical analysis for at least one predetermined pre-analytical condition, for example, a selected pre-analytical condition wherein one or more parameters exceed a predetermined threshold, stored in the database system.
  • the report is a comparison report between result data from clinical analysis of a single analysis station over time for each pre-analytical condition stored in the database system.
  • the report is a comparison report between the result data from clinical analysis of a single analysis station over time, for homogeneous pre-analytical conditions, stored in the database system.
  • the report is a comparison report between result data from clinical analysis of a single analysis station over time for at least one predetermined pre-analytic condition stored in the database system.
  • the method further comprises, at step 900, the generation of a quality control report indicative of at least one predetermined relationship between the measurement data and respective predetermined thresholds.
  • the system object of the invention allows the identification data, the measurement data and the result data from clinical analysis to be processed with mathematical statistical methods to produce reports on the quality of the pre-analytical conditions related to the analyses performed on the samples.
  • the system makes available an on-line consultation service for the traceability of the transport conditions and evaluation of the transport parameters based on the type of clinical analysis requested both in interactive format and for communication to the analysis site management software.
  • the system and method described above allow the effects of physical stress to which the organic materials are subjected to be assessed.
  • the data collected make possible the evaluation of the quality of the pre-analytical step, both as a whole and in a finer detail: for example, being able to assess particularly critical steps in the preparation of the samples, such as centrifugation characteristics.
  • the intermediate stations and the analysis station do not require any intervention by the operators for the transmission of data to the database system.
  • the use of the system and the method according to the invention described above, allow the following results to be obtained.

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  • Investigating Or Analysing Biological Materials (AREA)

Abstract

L'invention concerne un procédé et un système pour conditionner des échantillons biologiques acquis au moins au niveau d'un site d'extraction et destinés à être soumis à une analyse clinique au niveau d'un site d'analyse, au moins une population desdits échantillons biologiques étant placée dans des unités de collecte respectives dans une phase pré-analytique et transportée d'une station d'extraction à une station d'analyse. Une unité de collecte de sonde comprend des moyens de capteur pour l'acquisition de paramètres de transport, et est associée à la population d'échantillons biologiques pendant le transport de la station d'extraction à ladite station d'analyse, de façon à être sensiblement exposée aux conditions de transport auxquelles ladite population d'échantillons biologiques est soumise. Un système de base de données traite une relation associative entre les données d'identification d'au moins une population d'échantillons biologiques associée à au moins un site d'extraction d'échantillons et au moins un moment d'échantillonnage respectif, des données de mesure des paramètres de transport de la population d'échantillons biologiques détectés par les capteurs d'acquisition des paramètres de transport de l'unité de collecte de sonde pendant le transport de la station d'extraction à la station d'analyse, et les données de résultat d'une analyse clinique réalisée sur la population d'échantillons biologiques au niveau d'un site d'analyse.
PCT/IB2017/051189 2016-03-01 2017-03-01 Système et procédé permettant l'association de résultats d'une analyse réalisée sur des échantillons biologiques, en particulier des échantillons biologiques soumis à des recherches cliniques, avec des variables pré-analytiques auxquelles lesdits échantillons sont exposés WO2017149468A1 (fr)

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IT102016000021558 2016-03-01
ITUB2016A001187A ITUB20161187A1 (it) 2016-03-01 2016-03-01 Sistema e procedimento per l’associazione dei risultati di analisi eseguite su campioni biologici, in particolare campioni biologici sottoposti ad indagini cliniche, con variabili pre-analitiche a cui detti campioni sono esposti.

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WO2018005129A1 (fr) * 2016-06-27 2018-01-04 Beckman Coulter, Inc. Enregistrement d'historique pour échantillons de matériau biologique
IT201700116227A1 (it) * 2017-10-16 2019-04-16 Inpeco Holding Ltd Metodo di tracciabilità del trasporto di contenitori di campioni biologici
WO2019158733A1 (fr) * 2018-02-15 2019-08-22 DX-Labtrack GmbH Procédé intelligent de génération de rétroaction pendant la commande et la surveillance d'échantillons
WO2019198028A1 (fr) * 2018-04-11 2019-10-17 Isens - Electrónica Lda Boîte pour le conditionnement et la surveillance d'échantillons biologiques et ses utilisations
WO2020072945A1 (fr) 2018-10-05 2020-04-09 TMRW Life Sciences, Inc. Appareil de conservation et d'identification d'échantillons biologiques dans des conditions cryogéniques
CN113945418A (zh) * 2021-10-19 2022-01-18 杭州臻稀生物科技有限公司 全程可追溯的污水采样方法及系统
WO2022023481A1 (fr) * 2020-07-29 2022-02-03 Smart4Diagnostics Gmbh Gestion préanalytique de paramètres de récipient d'échantillon
GB2597686A (en) * 2020-07-29 2022-02-09 Smart4Diagnostics Gmbh Pre-analytic management of sample container parameters
EP3938789A4 (fr) * 2019-03-13 2022-11-16 Motryx Inc. Dispositif détecteur permettant de détecter des paramètres de transport et procédé de fabrication associé
USD1002868S1 (en) 2020-12-09 2023-10-24 TMRW Life Sciences, Inc. Cryogenic vial carrier
US12017227B2 (en) 2020-12-10 2024-06-25 TMRW Life Sciences, Inc. Specimen holder with wireless transponder for attachment to specimen collection body

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US20090075367A1 (en) * 2007-04-20 2009-03-19 Bennett Liss Systems and methods for storing and monitoring, and for evaluating and ensuring the quality of cord blood
EP2273250A1 (fr) * 2008-04-28 2011-01-12 Hitachi Ltd. Boîtier de stockage d échantillon basse température et système de support pour transport d organismes
US20140171829A1 (en) * 2012-12-05 2014-06-19 Theranos, Inc. Systems, devices, and methods for bodily fluid sample transport

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018005129A1 (fr) * 2016-06-27 2018-01-04 Beckman Coulter, Inc. Enregistrement d'historique pour échantillons de matériau biologique
US11977088B2 (en) 2016-06-27 2024-05-07 Beckman Coulter, Inc. History logging for samples of biological material
IT201700116227A1 (it) * 2017-10-16 2019-04-16 Inpeco Holding Ltd Metodo di tracciabilità del trasporto di contenitori di campioni biologici
WO2019158733A1 (fr) * 2018-02-15 2019-08-22 DX-Labtrack GmbH Procédé intelligent de génération de rétroaction pendant la commande et la surveillance d'échantillons
WO2019198028A1 (fr) * 2018-04-11 2019-10-17 Isens - Electrónica Lda Boîte pour le conditionnement et la surveillance d'échantillons biologiques et ses utilisations
EP3778025B1 (fr) * 2018-04-11 2024-05-08 Isens - Electrónica, Lda. Étui d'emballage et de surveillance d'échantillons biologiques
EP3860343A4 (fr) * 2018-10-05 2022-08-03 TMRW Life Sciences, Inc. Appareil de conservation et d'identification d'échantillons biologiques dans des conditions cryogéniques
WO2020072945A1 (fr) 2018-10-05 2020-04-09 TMRW Life Sciences, Inc. Appareil de conservation et d'identification d'échantillons biologiques dans des conditions cryogéniques
EP3938789A4 (fr) * 2019-03-13 2022-11-16 Motryx Inc. Dispositif détecteur permettant de détecter des paramètres de transport et procédé de fabrication associé
GB2597686A (en) * 2020-07-29 2022-02-09 Smart4Diagnostics Gmbh Pre-analytic management of sample container parameters
WO2022023481A1 (fr) * 2020-07-29 2022-02-03 Smart4Diagnostics Gmbh Gestion préanalytique de paramètres de récipient d'échantillon
USD1002868S1 (en) 2020-12-09 2023-10-24 TMRW Life Sciences, Inc. Cryogenic vial carrier
US12017227B2 (en) 2020-12-10 2024-06-25 TMRW Life Sciences, Inc. Specimen holder with wireless transponder for attachment to specimen collection body
CN113945418B (zh) * 2021-10-19 2022-06-24 杭州臻稀生物科技有限公司 全程可追溯的污水采样方法及系统
CN113945418A (zh) * 2021-10-19 2022-01-18 杭州臻稀生物科技有限公司 全程可追溯的污水采样方法及系统

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