EP4670174A1 - METHOD AND INSTRUMENT FOR TESTING A VOLUME OF A BIOLOGICAL SAMPLE - Google Patents
METHOD AND INSTRUMENT FOR TESTING A VOLUME OF A BIOLOGICAL SAMPLEInfo
- Publication number
- EP4670174A1 EP4670174A1 EP24714085.8A EP24714085A EP4670174A1 EP 4670174 A1 EP4670174 A1 EP 4670174A1 EP 24714085 A EP24714085 A EP 24714085A EP 4670174 A1 EP4670174 A1 EP 4670174A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- test
- computing device
- sample container
- clinical
- conditions
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
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Classifications
-
- 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
Definitions
- the following description relates to field of biological samples testing.
- Analytic and clinical laboratories typically comprise laboratory instruments that are configured to automatically carry out one or more clinical tests (e.g. clinical chemistry and/or immunoassay tests) on biological samples (such as blood samples) by means of one or more analysers.
- clinical tests e.g. clinical chemistry and/or immunoassay tests
- biological samples such as blood samples
- the laboratory instrument reads the barcode on the tube and queries for a test order based on the barcode (either in the connected laboratory information system or in the local instrument console software) and at least one analyser in the laboratory instrument carries out the test(s) in the test order. In some cases, a rerun of the test(s) or reflex test(s) may have to be additionally carried out.
- a method e.g. a computer-implemented method.
- the method comprises: accessing, by a computing device, test order data, wherein the test order data comprise information specifying a set of clinical tests to be carried out by a laboratory instrument on a biological sample contained in a sample container, wherein each clinical test of the set of clinical tests is associated with a set of retain conditions so that the sample container is associated with one or more sets of retain conditions; determining, by the computing device, whether at least one set of retain conditions associated with the sample container is met; and if at least one set of retain conditions associated with the sample container is met, causing, by the computing device, the sample container to be retained in the laboratory instrument; wherein each set of retain conditions associated with a respective clinical test comprises a condition that one or more rules require that one or more supplementary tests shall be carried out whenever one or more supplementary test conditions on the respective clinical test are met.
- a computing device may comprise at least one memory and at least one processor.
- a computing device may also comprise one or more input/output units.
- a computing device e.g. the computing device carrying out the method according to the present invention, may comprise a plurality of processors and/or a plurality of memories.
- the computing device according to the present invention may comprise one or more computing devices integrated with the laboratory instrument.
- a computing device may be a distributed computing system, e.g. a computing network.
- the computing device may comprise a computing device integrated with the laboratory instrument and another computing device remote from the computing device integrated with the laboratory instrument.
- the computing device accesses test order data, the test order data comprising information specifying a set of clinical tests to be performed by the laboratory instrument on the biological sample, wherein the biological sample is contained in a sample container.
- the biological sample may be a sample of a bodily fluid of a human or animal subject.
- the bodily fluid may be a physiological fluid, such as blood, saliva, urine, sweat, amniotic fluid, cerebrospinal fluid, ascites fluid, or the like.
- the biological sample may be put into a sample container after collection and it may be held in the container while being processed.
- the sample container may be a sample tube.
- sample tubes comprise a closed tube end and an end opposite thereto. The latter end defines an opening for inserting the sample in the sample tube.
- the opening may be closed, e.g. sealed, by a cap.
- Sample containers may be accommodated in a sample container rack (or “rack”).
- a sample container rack is configured to receive and to hold at least one sample container, in particular a plurality of sample containers.
- the rack may comprise a plurality of receptacles, wherein each receptacle is configured to hold a respective sample container, specifically in a substantially upright position.
- a set may comprise one or more elements.
- the set of clinical tests may comprise one or more clinical tests.
- a clinical test may comprise one or more procedures that, when carried out on the biological sample, allow for estimating the value of a parameter, e.g. a clinical parameter.
- a clinical test may comprise physical, biological, optical, mechanical, immunological, and/or chemical procedures.
- a clinical test may be an immunoassay test or a chemical test.
- the test order data may comprise further clinical tests, e.g. tests that are not to be carried out by the laboratory instrument.
- the test order data may comprise a set of test identifiers, comprising one or more test identifiers. Each test identifiers of the set is associated with and at least one identifier uniquely identifies a respective clinical test of the set of clinical tests. A test identifier contains information specifying the respective clinical test.
- the test identifiers may be alphanumeric strings. For instance, the alphanumeric string “TSH” uniquely identifies the thyroid-stimulating hormone test and the string “Lp-PLA2” uniquely identifies the Lipoprotein-Associated Phospholipase A2 test.
- accessing data may comprise retrieving the data e.g. from the at least one memory of the computing device that carries out the method of the present invention, from the memory of another computing device, or from another remote data storage (a database, a secondary memory, a cloud storage or the like). Accordingly, in some cases, retrieving data may comprise downloading data. Additionally or alternatively, “accessing data” may comprise receiving the data, e.g. from a user or a computing device different from the computing device accessing the data. The two options are not mutually exclusive. For instance, accessing, data may comprise receiving the data, storing the data in the memory of the computer device and retrieving the data by accessing said memory.
- the sample container may comprise an indicium, e.g. a barcode, which may for example be securely affixed, e.g. by means of adhesive, to the sample container, for instance to its wall or its cap.
- the test order data may be retrieved by the computing device by reading indicium data from the indicium on the sample container.
- a data reading unit may be comprised in the computing device or functionally connected to the computing device.
- the data reading unit may comprise an optical scanner configured to decode a barcode or a QR code.
- the indicium may be an RFID tag and the data reading unit may comprise an RFID reader.
- the test order data may be fully comprised in or coincide with the indicium data.
- the test order data are “directly” read from the sample container, meaning that the information content of the test order data is fully present on the sample container, more precisely in the indicium.
- the test order data may be “indirectly” read from the sample container, meaning that the sample container only acts as an intermediary between the source of the test order data (e.g. a remote database) and the computing device.
- the data reading unit may obtain from the indicium a link (the indicium data) for retrieving the test order data from a source. For instance, a QR code on the sample tube may be scanned by the data reading unit to obtain such a link.
- test order data and the indicium data are distinct.
- a portion of the test order data may be directly read and another portion may be indirectly read.
- the test order data may partially overlap with the indicium data.
- the indicium data may comprise the identifier identifying the clinical test, wherein the identifier is also part of the test order data.
- the computing device may retrieve the rest of the test order data from another source, e.g. its own memory or a remote data storage.
- the set of clinical tests is to be carried out by the laboratory instrument.
- the laboratory instrument may comprise at least one analyser (i.e. one or more analysers) configured to carry out the set of clinical tests.
- Each analyser may comprise an aspiration unit configured to aspirate a volume of sample from the sample container and then dispense it, as well as an analytical unit configured to carry out one or more clinical tests on said volume.
- the test order comprises information specifying a plurality of clinical tests
- all these clinical tests are to be carried out by a single analyser.
- a first subset of the clinical tests is to be carried out by a first analyser of the laboratory instrument and a second subset of the clinical tests is to be carried out by a second analyser of the laboratory instrument.
- the laboratory instrument may comprise a plurality of areas, e.g. physically delimited portions of space, wherein each area is configured to receive and support sample containers, e.g. to receive and support racks holding sample containers.
- the laboratory instrument may comprise a moving component configured to move sample containers among the plurality of areas, e.g. from a first area to a second area. Each area may comprise a (region of a) horizontal plate onto which a rack may be placed.
- the moving component may be configured to move at least in two dimensions e.g. which may be mutually orthogonal.
- the plurality of areas may comprise a loading/unloading area, a buffer area (or “waiting area”) and at least one queue area, in particular a queue area for each analyser comprised in the laboratory instrument.
- the loading/unloading area is an area accessible to a user and/or a machine to load sample containers in the laboratory instrument and unload sample containers from the laboratory instrument.
- the buffer area is an area where the sample containers can be located while awaiting further processing. In particular, the buffer area may be located in the laboratory instrument so that the samples cannot be altered while at the buffer area.
- the queue area for a given analyser is an area accessible to the given analyser, e.g. to the aspiration unit of the analyser. Typically, the queue area is located in the vicinity of the analyser associated thereto, so that the aspiration unit of the analyser may aspirate a portion of the biological sample contained in a sample container located in the queue area.
- the computing device may be comprised in the laboratory instrument and may be configured to control the operations of the (other components of the) laboratory instrument, and, in particular, of its analyser(s) and of the moving component.
- the computing device may be external to (e.g. remote from) the laboratory instrument and configured to communicate with another computing device within the laboratory instrument, which is configured to control the laboratory instrument.
- the computing device may be a distributed computing system comprising a computing device integrated with the laboratory instrument and another computing device remote from the computing device integrated with the laboratory instrument.
- the method comprises causing, by the computing device, the set of clinical tests to be carried out by the laboratory instrument, in particular by one or more analyser(s) in it.
- the laboratory instrument may be configured to process the sample according to one or more rules.
- a rule specifies one or more actions that the laboratory instrument is required to carry out, if one or more conditions are met. More particularly, the laboratory instrument is configured, when carrying out clinical tests, to abide by each rule of the one or more rules, i.e. to carry out, if the one or more conditions associated with said rule are met, the one or more actions required by said rule.
- a rule may be defined by statements including strings and variables, e.g. in a specific data format or following a specific syntax, such as the syntax of a programming language.
- the rules for a laboratory instrument may be stored as rule data in the memory of computing device, or in the memory of another computing device, or any other remote data storage.
- the rule refers to a clinical test
- the rule and the respective clinical test are associated with one another.
- the rule specifies one or more actions that the laboratory instrument is required to carry out if one or more conditions on the clinical test, e.g. on the result of the clinical test, are met.
- a clinical test may have zero, one or a plurality of rules associated with it.
- a rule associated to a clinical test may comprise the identifier associated with the clinical test.
- a rule may require that a supplementary test shall be carried out by the laboratory instrument if a respective supplementary test condition is met.
- the supplementary test is carried out if the supplementary test condition is met, while the supplementary test is not carried out if the supplementary test condition is not met.
- a rule may require that a plurality of supplementary tests shall be carried out if one supplementary test condition is met.
- a rule may require that a plurality of supplementary tests shall be carried out if a plurality of respective supplementary test conditions are met.
- a rule may comprise information specifying (i) the respective clinical test associated thereto, (ii) the one or more supplementary tests, and (iii) the one or more supplementary tests conditions that, if met, prompt the laboratory instrument to carry out the one or more supplementary tests.
- the computing device may be configured to: (a) assess the presence of one or more rules associated with said test, (b) check whether the one or more supplementary tests conditions are met and (c) if the one or more supplementary tests conditions are met, cause the laboratory instrument to carry out the one or more supplementary tests.
- the test order data may comprise information specifying one or more primary tests.
- a rule may require that the one or more supplementary test are carried out by the laboratory instrument after the primary test to which they are associated has been carried out.
- a supplementary test is also a clinical test, however its execution is contingent on the supplementary test condition(s) being met, while the primary test, if present in the test order, is always to be performed.
- the execution of one supplementary test may be contingent on one supplementary test condition, while in other examples the execution may be contingent on a plurality of supplementary test conditions.
- One or more supplementary tests may be associated with each clinical test of the set of clinical tests.
- the one or more supplementary test conditions are conditions that, when met, trigger the execution of one or more supplementary tests.
- the one or more supplementary test conditions are met if the clinical test satisfies certain criteria.
- the one or more supplementary test conditions may consist of the condition that the clinical test is a predetermined clinical test. In this case, every time the primary test is run, the supplementary test is also run.
- the one or more supplementary test condition may consist of a result condition on a result of the clinical test. In other words, if the result of the clinical test meets the result condition, the supplementary test is performed. Accordingly, a rule may require that a supplementary test shall be carried out by the laboratory instrument if a result condition on the result of the clinical test is met.
- the execution of a clinical test may lead to one or more results, wherein each result may be a numerical value or an alphanumeric string.
- the result condition may be a match condition, according to which the result has to be identical to a predetermined value or string.
- the result of a primary clinical test may be either the string “acceptable” or the string “unacceptable”. If this is the case, the match condition may be the condition that the result of the primary test is equal to “unacceptable”.
- the result condition may be a threshold condition, according to which the result has to be less than or greater than a predetermined value, or the result has to be within a predetermined range, i.e. between two predetermined values.
- the supplementary test may be a rerun test, i.e. the supplementary test may coincide with the primary test. If this is the case, the primary test may be performed two or more times, e.g. if a result indicates an anomaly (e.g. the result is outside a predetermined range). Accordingly, if the clinical test meets the one or more supplementary test condition, one or more reruns of the clinical test are performed, that is, the clinical test is repeated one or more times.
- the supplementary test may be a reflex test, i.e. the supplementary test may be different from the primary test, and it may be a clinical test carried out e.g. to confirm a result of the primary test by different means or to disambiguate a result of the primary test.
- a rule of the one or more rules may require to carry out the same reflex test a plurality of times.
- the reflex test may also be referred to as “replicate reflex test”. Accordingly, a rule may specify that a given supplementary test may be carried out more than once.
- the one or more rules may be generated by a user of the laboratory instrument, e.g. to implement the workflow of the laboratory comprising the laboratory instrument.
- the one or more rules may be generated by the user with the aim of improving the reliability of the test results.
- the one or more rules may require to run a secondary test if the result of the first test falls within a range of values that renders this result inconclusive and/or, according to some reliability requirements, not reliable enough.
- each clinical test in the set of clinical tests is associated with a respective set of retain conditions, i.e. one set of retain conditions for one clinical test.
- the retain conditions are conditions that determine, depending on whether they are met or not, whether the sample container shall be further retained within the laboratory instrument while and/or after the one or more clinical tests of the set of clinical tests are being/have been performed.
- the test order data specify a set of clinical tests to be carried out on a sample in a sample container.
- a sample (and its container) is associated with the set of clinical tests. Consequently, there are one or more sets of retain conditions associated with the sample container containing the sample on which the set of clinical tests is to be performed.
- a set of retain conditions may comprise one or more retain conditions.
- a set of retain conditions associated with a clinical test is met if each and every retain condition in the set is met.
- a set of retain conditions associated with a clinical test is not met if at least one of the retain conditions in the set is not met.
- a set of retain conditions associated with a clinical test may be implemented by one or more computer instructions that, when executed by the computing device, cause the computing device to check whether the retain conditions associated to the clinical tests are met or not.
- the one or more computer instructions may cause the computing device to parse the one or more rules to determine whether at least a rule of the one or more rules is associated with the clinical test.
- the computer instructions may be defined by statements including strings and variables, e.g. in a specific data format or following a specific syntax, such as the syntax of a programming language.
- a retain condition associated with a given clinical test may be specifically defined for the given clinical test.
- the retain condition for the specific clinical may be implemented by computer instructions defined by a portion of software specific to the given clinical test.
- the set of retain conditions associated with any clinical tests may be implemented by using a general function, e.g. a subroutine, that depends on one or more arguments.
- the set of retain conditions associated with each clinical test may be implemented by the computer instructions that are executed by the processor when the general function is invoked with an argument associated with said each clinical test.
- the function may carry out a regular expression search on the one or more rules to find a string that depends on an argument of the function.
- the set of retain conditions associated with each clinical test may be implemented by the computer instructions that are executed by the processor when the general function is invoked with the test identifier of said clinical test as argument.
- the set of retain conditions for a given clinical test comprises at least a condition that one or more rules require that one or more supplementary tests shall be carried out if their respective supplementary test conditions (associated with the given clinical test) are met.
- this retain condition may also be referred to as “rule condition”.
- the rule condition associated with a clinical test is the existence of at least one rule of the one or more rules that: (i) is associated with the clinical test and (ii) introduces the possibility of having to run one or more supplementary tests.
- a clinical test may or may not be associated with a rule encompassing potential supplementary test(s).
- each set of retain conditions comprises a respective rule condition.
- the method further comprises determining whether at least one set of retain conditions of the one or more sets of retain conditions associated with the sample container is met, namely determining whether all retain conditions of at least one set are met.
- the sets may be checked sequentially or in parallel or partially sequentially and partially in parallel. In the case of a sequential determination, the determination may stop as soon as one met set of retain conditions is found.
- the method comprises causing the sample container to be retained in the laboratory instrument, e.g. even after each test of the set of clinical tests has been at least initiated.
- causing the sample container to be retained in the laboratory instrument may comprise causing the sample container to remain within the laboratory instrument after the sample container is no longer needed for carrying out the set of clinical tests.
- causing the sample container to be retained in the laboratory instrument may comprise causing the sample container to be retained in the laboratory instrument after the set of clinical tests has been at least initiated by the laboratory instrument, e.g. by one or more analysers of the laboratory instrument. Specifically, each clinical test of the set of clinical tests may have been initiated.
- a clinical test may be considered initiated if the volume of sample needed for the clinical test has been aspirated from the sample container containing the sample.
- the computing device may cause the sample container to be retained in the laboratory instrument at least until it has been assessed, e.g. by the computing device, whether one or more second release conditions (discussed below) are met.
- causing the sample container to be retained in the laboratory instrument may comprise causing the sample container to be placed at the waiting area of the laboratory instrument.
- the sample container may be moved from the queue area of the analyser that has carried out the last clinical test of the set of clinical tests to the waiting area of the laboratory instrument and may be held at the waiting area, e.g. until supplementary test(s) shall be carried out or until it may be released (as discussed below).
- test order data specify only one clinical test, e.g. clinical test A, and clinical test A is associated with a set of retain conditions comprising only one retain condition, a1 (which is the rule condition for test A). Whenever a1 is met, the sample container is retained.
- test order data specify only clinical test A and clinical test A is associated with a set of retain conditions comprising retain condition a1 (which is the rule condition for test A) and retain condition a2 (e.g. a probability condition, discussed below). Whenever both a1 and a2 are met, the sample container is retained.
- retain condition a1 which is the rule condition for test A
- retain condition a2 e.g. a probability condition, discussed below.
- Clinical test A is associated with a set of retain conditions comprising retain condition a1 and retain condition a2
- clinical test B is associated with a set of retain conditions comprising only one retain condition, b1 (which is the rule condition for test B). If both a1 and a2 are met or if b1 is met, the sample container is retained.
- the computing device causes the sample container to be retained in any case in which there is a possibility of having to carry out one or more supplementary tests as followup to a clinical test in the test order data. It should be noted that, for the sample container to be retained, it is sufficient that one clinical test has the potential to trigger one or more supplementary tests on the sample.
- the sample container is caused to be retained in the laboratory instrument (e.g. at the waiting area), so that, if a supplementary test must indeed be carried out, the sample container is promptly available to the analyser. Accordingly, there is no delay in processing the sample, which may be otherwise caused e.g. by having to reroute the sample container to the laboratory instrument. Therefore, the method leads to an increase in the efficiency of sample testing.
- the sample container may be accommodated in a rack and the rack may further accommodate one or more additional sample containers.
- the racks may be the units that are moved.
- the moving component may be configured to move racks.
- a rack accommodating a plurality of sample container may be retained if at least one sample container is to be retained, i.e. if at least one sample container has at least one associated set of retain conditions that is met.
- a sample container in a rack comprising additional sample container(s) may be retained if at least one of its associated set of retain conditions is met but also if at least one set of retain conditions associated to at least one of the additional sample containers is met.
- the method may be considered as comprising: accessing, by a computing device, test order data for each sample container of a plurality of sample containers accommodated in a rack, wherein the test order data comprise information specifying a set of clinical tests to be carried out by a laboratory instrument on a biological sample contained in said each sample container, wherein each clinical test is associated with a set of retain conditions so that said each sample container is associated with one or more sets of retain conditions; determining, by the computing device, whether at least one set of retain conditions associated with at least one sample container of the plurality of sample containers accommodated in the rack is met; and if at least one set of retain conditions associated with at least one sample container of the plurality of sample containers accommodated in the rack is met, causing, by the computing device, the rack to be retained in the laboratory instrument; wherein each set of retain conditions associated with a respective clinical test comprises a condition that one or more rules require that one or more supplementary tests shall be carried out whenever one or more supplementary test conditions on the respective clinical test are met.
- the laboratory instrument may comprise one or more analysers and the set of clinical test may be carried out by a single analyser or by a plurality of analysers of the laboratory instrument.
- a plurality of analysers e.g. P analysers
- each analyser may be configured to carry out a respective subset of the set of clinical tests.
- the workflow for processing the sample container may be as follows: the sample container may be moved to a first queue area of a first analyser configured to carry out ti clinical tests, then to a second queue area of a second analyser configured to carry out t2 clinical tests and so on until the sample container is moved to a P-th queue area of a P-th analyser configured to carry out t p clinical tests. Afterwards, if at least one set of retain conditions associated with the sample container is met, the computing device causes the sample to be retained in the laboratory instrument, e.g. at the waiting area. The met set of retain conditions may be associated with a clinical test carried out at any of the P analysers.
- the sample container may pass through the waiting area every time it is moved from a queue area to another queue area.
- moving the sample container from a first queue area to a second queue area may comprise moving the sample container from the first queue area to the waiting area and moving the sample container from the waiting area to the second queue area.
- causing the sample container to be retained in the laboratory instrument may comprise instructing, by the computing device, the laboratory instrument to retain the sample container.
- the computing device may be external to the laboratory instrument.
- the computing device may instruct the laboratory instrument to retain the sample container and/or the rack in which the sample container is accommodated.
- the computing device may communicate with a second computing device within the laboratory instrument and transmit the instruction to retain the sample container, wherein the second computing device may control the moving component to retain the sample container.
- causing the sample container to be retained in the laboratory instrument may comprise controlling, by the computing device, one or more components of the laboratory instrument to retain the sample container.
- the computing device may be a component of the laboratory instrument and may control other components of the laboratory instrument so that the sample container is retained.
- the computing device may control the moving component to place the sample container in the waiting area.
- the method may further comprise retaining, e.g. by the laboratory instrument, the sample container in the laboratory instrument.
- the laboratory instrument retains the sample container, e.g. by placing it in the waiting area.
- the moving component of the laboratory instrument may move the sample container to the waiting area, e.g. from a queue area.
- the method may further comprise determining, by the computing device, whether one or more first release conditions are met, and, if the one or more first release conditions are met, causing, by the computing device, a release of the sample container to be initiated; wherein the one or more first release conditions comprise the condition that all sets of retain conditions associated with the sample container are not met.
- causing the release of the sample container from the laboratory instrument to be initiated may comprise causing the sample container to be moved to the loading/unloading area of the laboratory instrument, e.g. so that the sample container may be unloaded by an operator or a robot.
- the one or more first release conditions comprise the first release condition that each and every set of retain conditions associated with the sample container is not met. In general, all of the one or more first release conditions have to be met for the release of the sample to be initiated. In one instance, the one or more first release conditions may consist of the first release condition that each and every set of retain conditions associated with the sample container is not met.
- the computing device causes the laboratory instrument to initiate the release of the sample container.
- the circumstances for initiating the release of the sample container may be as follows:
- Scenario III Whenever b1 is not met and, at the same time, at least one of a1 and a2 is not met, release of the sample container is initiated.
- the sample container is not retained in the laboratory instrument and is put into condition to be released from the laboratory instrument. This way, the sample container is freed, e.g. for further processing by another laboratory instrument within the laboratory, and it does not occupy space within the laboratory instrument unnecessarily. Therefore, the method leads to an increase in the efficiency of sample testing.
- causing the release of the sample container to be initiated may comprise instructing, by the computing device, the laboratory instrument to initiate the release of the sample container.
- the computing device may be external to the laboratory instrument.
- the computing device may instruct the laboratory instrument to initiate the release of the sample container and/or the rack in which the sample container is accommodated.
- causing the release of the sample container to be initiated may comprise controlling, by the computing device, one or more components of the laboratory instrument to initiate the release of the sample container.
- the computing device may be internal to the laboratory instrument and may control other components of the laboratory instrument so that the release is initiated.
- the computing device may control the moving component to place the sample container in the loading/unloading area.
- the method may further comprise initiating, e.g. by the laboratory instrument, the release of the sample container from the laboratory instrument.
- the laboratory instrument initiates the release of the sample container, e.g. by placing it in the loading/unloading area.
- the moving component of the laboratory instrument may move the sample container to the loading/unloading area, e.g. from a queue area.
- the method may also further comprise releasing the sample container from the laboratory instrument, e.g. unloading the sample container from the loading/unloading area, e.g. by an operator or a machine.
- the one or more first release conditions may further comprise additional first release conditions besides the one that all sets of retain conditions associated with the sample container are not met.
- the sample container may be accommodated in a rack and the rack may further accommodate one or more additional sample containers.
- the one or more first release conditions may further comprise, for each additional sample container, the condition that all sets of retain conditions associated with said each additional sample container are not met.
- the release of a sample container in a rack may be initiated only if all sample containers in the rack can be released. Indeed, if sample containers are in a rack and the sample containers may not be moved singularly in and out of racks within the laboratory instrument, the racks may be the units that are moved. Thus, exemplarily, the moving component may be configured to move racks.
- the computing device causes the laboratory instrument to initiate the release of the sample container if, for each and every sample container, all the respective associated sets of retain conditions are not met.
- the release of the sample container implies the release of the whole rack, namely of all additional sample containers.
- the one or more first release conditions may comprise A/ first release conditions, each first release condition being associated with a respective sample container and requiring that all sets of retain conditions associated with the respective sample container are not met.
- the method may further comprise accessing test order data for each of the additional sample containers.
- Illustrative scenarios with two sample containers X and Y accommodated in a rack may be as follows:
- the test order data specify only clinical test A for sample container X and only clinical test C for sample container Y.
- Clinical test A is associated with a set of retain conditions comprising retain condition a1 (which is the rule condition for test A) and retain condition a2 (e.g. a probability condition, discussed below).
- Clinical test C is associated with a set of retain conditions comprising retain condition d (which is the rule condition for test C) and retain condition c2 (e.g. a probability condition, discussed below). If (I) at least one of a1 and a2 is not met and (ii) at least one of c1 or c2 is not met, the release of the rack and, thus, of the sample containers X and Y, is initiated.
- Scenario V The test order data specify for sample container X two clinical tests, clinical test A and clinical test B, and for sample container Y two clinical tests, clinical test C and clinical test D.
- Clinical test A is associated with a set of retain conditions comprising only retain condition a1
- clinical test B is associated with a set of retain conditions comprising only retain condition b1 .
- Clinical test C is associated with a set of retain conditions comprising only retain condition c1
- clinical test D is associated with a set of retain conditions comprising only retain condition d1 (which is the rule condition for test D). If none of a1 , b1 , c1 and d1 is met, the release of the rack and, thus, of the sample containers X and Y, is initiated.
- a supplementary test condition may be a result condition.
- the one or more supplementary test conditions on one clinical test (referred to as “first clinical test”) of the set of clinical tests comprise at least a result condition on a result of the first clinical test.
- the method may further comprise: obtaining, by the computing device, probability data, wherein the probability data comprise information specifying a probability that a result of the first clinical test meets the result condition; and determining, by the computing device, by using the probability data, whether the probability that the result of the first clinical test satisfies the result condition exceeds a probability threshold; wherein the set of retain conditions associated with the first clinical test further comprises the condition - hereinafter referred to as “probability condition” - that the probability that the result of the first clinical test satisfies the result condition exceeds the probability threshold.
- “obtaining data” may comprise accessing the data as discussed above.
- “obtaining data” may comprise generating the data, e.g. creating the data based on one or more inputs.
- “obtaining data” may comprise accessing a first portion of the data and generating a second portion of the data e.g. from the first portion of the data.
- the probability data may comprise a probability value, expressed e.g. as a percentage or as a real number between 0 and 1 , that indicates the probability that a result of a clinical test meets the result condition.
- the probability value quantifies the likelihood that the one or more supplementary tests will actually be carried out.
- the step of obtaining the probability data and the step of determining whether the probability that the result of the first clinical test satisfies the respective result condition exceeds a probability threshold may be carried out if the rule condition is met, i.e. if one or more rules require that the one or more supplementary tests shall be carried out if the one or more supplementary test conditions on the first clinical test are met.
- the probability data may be obtained based on the specific result condition, e.g. by using a value in the result condition as input for a probability distribution function.
- determining whether the probability exceeds a probability threshold is equivalent to checking whether the probability condition is met.
- the probability threshold is a numerical value which, like the probability, may be expressed as a percentage or as a real number between 0 and 1 .
- the probability threshold may be a fixed value, e.g. a hardcoded value, that is always the same for the related result condition.
- the probability threshold may be stored in the memory of computing device, or in the memory of another computing device, or any other remote data storage.
- the computing device may determine, by using the probability data, whether the probability that the result of the first clinical test satisfies the result condition exceeds a probability threshold. In other words, the probability is evaluated against the probability threshold and it is assessed whether the probability is greater than the probability threshold. Thus, a comparison between two numerical values is carried out.
- the set of retain conditions for the first clinical test comprises at least two conditions, namely the rule condition and the probability condition.
- the likelihood of it happening is also factored in.
- the approach is more fine-tuned and, in particular, it may reduce a waste of time by avoiding that the sample container is retained when supplementary tests will only be performed in very few cases.
- the set of clinical tests may have more than one clinical test in the set of clinical tests whose set of retain conditions comprise the probability condition.
- all sets of retain conditions may comprise the probability condition.
- the one or more supplementary test conditions may comprise at least a result condition on a result of said each clinical test.
- the method may further comprise, for each clinical test of the set of clinical tests: obtaining, by the computing device, probability data, wherein the probability data comprise information specifying a probability that a result of said each clinical test meets the result condition; and determining, by the computing device, by using the probability data, whether the probability that the result of said each clinical test satisfies the result condition exceeds a probability threshold; wherein each set of retain conditions further comprises the condition that the probability that the result of said each clinical test satisfies the result condition exceeds the probability threshold.
- the computing may determine whether a set or retain conditions is met by checking the conditions in the following order: (i) the rule condition; and (ii) (if present) the probability condition.
- the probability that a result of the given clinical test meets the result condition may be set to a default value, e.g. 0 or 1 .
- obtaining the probability data may comprise: accessing history data, the history data comprising information specifying how often the result condition is met; and generating the probability data using the history data.
- the probability data may be data derived e.g. from medical literature and/or from history data, wherein the history data comprise information specifying how often the result condition is met by the result of the first clinical test, namely how often the result of the first clinical test has satisfied the result condition in past executions of the clinical test.
- the history data may comprise a record of all the times the first clinical test was carried out and a record of the results of the first clinical test in all these instances.
- the history data may comprise statistics about the results in relation to the result condition, e.g. a flag for each execution of the first clinical test indicating whether the result in that occurrence met the result condition.
- the history data may be data collected from previous executions of the clinical test and stored e.g. in a database, such as a local database or a cloud database.
- the history data may relate to the laboratory instrument that is to carry out the set of clinical tests.
- the history data may be collected from a plurality of laboratory instruments of the same type of the laboratory instrument that is to carry out the set of clinical tests.
- the plurality of laboratory instruments may include instruments within the same laboratory or instruments across different laboratories, e.g. within the same geographical region as defined by national or other administrative borders.
- the computing device may determine a number indicating how many times the result condition was met, e.g. by looking at the results themselves or by looking at the flags, and compute the probability value by dividing this number by the total number of times the clinical test was carried out.
- the probability data may have been previously derived from the medical literature and/or from history data and the computing device may simply access the probability data. The use of history data for generating the probability data makes the estimation of the probability more accurate. In particular, it can be more accurately determined in which cases it is unlikely that the supplementary test(s) would be carried out, and, thus, retaining the sample container is more likely to lead to a waste of time than not.
- the probability threshold may be dynamically selected, e.g. based on circumstances of the first clinical test.
- the probability threshold may be selected among a plurality of predetermined probability thresholds based on one or more selection criteria, the one or more selection criteria comprising information specifying any or any combination of: the laboratory instrument, a laboratory configured to carry out the first clinical test, a priority of the biological sample.
- the method may comprise the step of selecting, by the computing device, the probability threshold among a plurality of predetermined probability thresholds based on one or more selection criteria.
- each predetermined probability threshold may be associated with one or more selection criteria, in that, whenever the one or more selection criteria apply to the specific conditions under which the first clinical test is carried out by the laboratory instrument, the probability threshold will be selected to be said predetermined probability threshold.
- the probability threshold may take on different values depending on which criteria apply to the specific case.
- a selection criterium may comprise information about the laboratory instrument, such as a model or a manufacturer of the instrument. For instance, when the model is an older model that takes a longer time to receive/release the sample container, when compared to a newer model, the probability threshold for the older model may be lower than the probability threshold for the newer model, for the sake of processing efficiency.
- Another selection criterium may comprise information about a laboratory in which the clinical test will be carried out, e.g. a size of the laboratory, which may be expressed by means of various quantities, such as physical size, number of instruments, throughput. For instance, in a laboratory with a bigger size, the transport of sample containers may take considerably more time than in a laboratory of a smaller size, so that rerouting a sample container may be rather undesirable. Accordingly, the probability threshold for the bigger laboratory may be lower than the probability threshold for the smaller laboratory, for the sake of processing efficiency.
- Another selection criterium may comprise information about a priority of the sample.
- a sample with priority (such as a STAT sample) may have a lower probability threshold with respect to a sample without priority, such as about 0 or 0%.
- the plurality of probability thresholds with their associated criteria may be stored in a database.
- the computing device may determine whether a selection criterium applies by accessing biological sample data, wherein the biological sample data may comprise information specifying features of the biological sample (e.g. priority), and/or equipment data comprising information about the instrument and the laboratory.
- the biological sample data and the test order data may form a single data set.
- the determination of whether to retain the sample container may be adapted case by case.
- the probability data may comprise a plurality of probability values, each probability value indicating the probability that the result of the first clinical test meets a respective result condition. For example, this may be the case whenever the first clinical test is associated to a plurality of rules, each rule of the plurality of rules specifying a respective result condition.
- the one or more supplementary tests consist of a plurality of supplementary tests. If the one or more rules require that the plurality of supplementary tests shall be carried out if the one or more supplementary test conditions on the first clinical test are met, the method may further comprise: obtaining, by the computing device, probability data, wherein the probability data comprise information specifying, for each supplementary test of the plurality of supplementary tests, a respective probability that a result of the first clinical test meets the respective result condition; and determining, by the computing device by using the probability data and for each supplementary test of the plurality of supplementary tests, whether the probability that the result of the first clinical test satisfies the respective result condition exceeds a respective probability threshold.
- the set of retain conditions for the first clinical test further comprise the condition that, for at least one supplementary test of the plurality of supplementary tests, the probability that the result of the first clinical test satisfies the respective result condition exceeds a respective probability threshold.
- each threshold applicable to a respective probability may be a single threshold applicable to each probability associated with a respective supplementary test associated with the first clinical test, e.g. all the respective probability thresholds are equal with one another, or they may be a plurality of thresholds, each threshold applicable to a respective probability.
- the method may further comprise: determining, whether, for at least one clinical test, according to the one or more rules associated with said at least one clinical test, at least one supplementary test of the one or more supplementary tests shall be carried out; and if the at least one supplementary test of the one or more supplementary clinical tests shall be carried out, causing, by the computing device, the at least one supplementary test of the one or more supplementary tests to be carried out.
- supplementary test(s) it may be determined whether supplementary test(s) shall indeed be carried out and, if so, the computing device may cause such supplementary test(s) to be carried out.
- causing the at least one supplementary test to be carried out may comprise causing the retained sample container to be moved from the waiting area to the queue area of the analyser configured to carry out the at least one supplementary test and causing the analyser to perform the at least one supplementary test.
- causing the at least one supplementary test to be carried out may comprise instructing, by the computing device, the laboratory instrument to carry out the at least one supplementary test.
- the computing device may be external to the laboratory instrument.
- causing the at least one supplementary test to be carried out may comprise controlling, by the computing device, one or more components of the laboratory instrument to carry out the at least one supplementary test.
- the computing device may be internal to the laboratory instrument and may control other components of the laboratory instrument so that the at least one supplementary test is carried out.
- the computing device may control the moving component to place the sample container in the queue area and the analyser to carry out the at least one supplementary test.
- the method may also further comprise carrying out, by the laboratory instrument (in particular by an analyser), the at least one supplementary test.
- Determining, whether, according to the one or more rules associated to a given clinical test, at least one supplementary test of the one or more supplementary tests shall be carried out may comprise determining whether the one or more supplementary test conditions on said given clinical test are met.
- the execution of one supplementary test may be contingent on one supplementary test condition or on a plurality of supplementary test conditions.
- a supplementary test may be carried out, if only one supplementary test condition is met.
- a supplementary test may be carried out if a plurality of supplementary test conditions is met. Accordingly, it may be determined that at least one supplementary test shall be carried out if at least a subset of the one or more supplementary test conditions is met, wherein the subset may be proper or may coincide with the whole set of supplementary test conditions.
- the one or more supplementary test conditions may comprise at least a result condition on a result of said at least one clinical test.
- the method may further comprise, for the at least one clinical test of the set of clinical tests, accessing, by the computing device, test result data, wherein the test result data comprise information specifying a test result of said at least one clinical test; wherein determining, whether, according to the one or more rules, at least one supplementary test of the one or more supplementary tests shall be carried out comprises determining whether the result condition on the test result of said at least one clinical test is met.
- the method may further comprise, for each clinical test of the set of clinical tests: determining whether according to the one or more rules associated with said each clinical test, at least one supplementary test of the one or more supplementary tests shall be carried out; and if the at least one supplementary test of the one or more supplementary clinical tests shall be carried out, causing, by the computing device, the at least one supplementary test of the one or more supplementary tests to be carried out.
- At least one supplementary test shall be carried out and causing the at least one supplementary test to be carried out there may be a delay, e.g. in case the analyser is not promptly available or in case the moving component is busy with other operations.
- the method may further comprise: causing, by the computing device, a release of the biological sample to be initiated; wherein the one or more second release conditions comprise the condition that, according to the one or more rules, none of the one or more supplementary tests shall be carried out for any clinical test of the set of clinical tests.
- the one or more second release conditions may comprise the condition that the one or more supplementary test conditions are not met for any clinical test of the set of clinical tests.
- it may be determined for each clinical test of the set of clinical tests whether, according to the one or more rules associated with said each clinical test, at least one supplementary test of the one or more supplementary tests shall be carried out.
- causing a release of the sample container to be initiated may comprise causing the sample container to be moved to the loading/unloading area of the laboratory instrument, e.g. so that the sample container may be unloaded by an operator or a robot.
- the one or more second release conditions comprise the second release condition that all supplementary test conditions collectively associated with the set of clinical tests are not met. In other words, no supplementary test condition is met. This means that none of the (primary) clinical tests has actually triggered a supplementary test.
- the sample container is no longer retained in the laboratory instrument and is put into condition to be released from the laboratory instrument. This way, the sample container is freed, e.g. for further processing by another laboratory instrument within the laboratory, and it does not occupy space within the laboratory instrument unnecessarily. Therefore, the method leads to an increase in the efficiency of sample testing.
- the one or more second release conditions may further comprise additional second release conditions besides the one that all supplementary test conditions collectively associated with the set of clinical tests (that were carried out on the sample in the sample container) are not met.
- the sample container may be accommodated in a rack and the rack may further accommodate one or more additional sample containers, wherein each additional sample container contains a sample on which a respective set of clinical test is carried out.
- the one or more second release conditions may further comprise, for each additional sample container, the condition that the one or more supplementary test conditions are not met for any clinical test of the set of clinical tests associated with said each additional sample container. Accordingly, the release of a sample container in a rack may be initiated only if all sample containers in the rack can be released. Indeed, if sample containers are in a rack and the sample containers may not be moved singularly in and out of racks within the laboratory instrument, the racks may be the units that are moved.
- the moving component may be configured to move racks.
- the computing device causes the laboratory instrument to initiate the release of the sample container if, for each and every sample container, all the respective associated supplementary test conditions are not met.
- the release of the sample container implies the release of the whole rack, namely of all additional sample containers.
- the one or more second release conditions may comprise N second release conditions, each second release condition being associated with a respective sample container and requiring that all supplementary test conditions associated with the respective sample container are not met.
- a second aspect of the present invention relates to a computing device comprising a processor configured to perform the method described herein.
- the computing device according to the second aspect of the present invention is configured to:
- the laboratory instrument comprises the computing device according to the previous aspect.
- the laboratory instrument is the laboratory instrument described herein when discussing the first aspect of the present invention.
- the laboratory instrument according to the present invention comprises a buffer area, a loading/unloading area and a moving component.
- the moving component is configured to move the sample container, e.g. the rack in which the sample container is accommodated, to the buffer area and to the loading/unloading area, thereby (i) causing the sample container to be retained in the laboratory instrument and (ii) initiating the release of the sample container, respectively.
- a computer program product comprises instructions which, when the program is executed by a computer, cause the computer to carry out the method described herein.
- the computer may be the computing device according to the second aspect of the present invention.
- a further aspect of the present invention refers to a computer-readable medium, e.g. a transitory computer readable medium comprising instructions which, when executed by a computer, cause the computer to carry out the method described herein.
- the computer may be the computing device according to the second aspect of the present invention.
- Figure 1 a shows a schematic representation of a laboratory instrument comprising one analyser and of a computing device external to the laboratory instrument.
- Figure 1 b shows a schematic representation of a laboratory instrument comprising one analyser and of a computing device comprised in the laboratory instrument.
- Figure 2 shows a schematic representation of a laboratory instrument comprising two analysers and of a computing device external to the laboratory instrument.
- Figure 3 shows a flow chart of an exemplary method for determining the processing of a sample container within a laboratory instrument comprising one analyser.
- Figures 4a to 4d show examples of rules.
- Figure 5 shows a flow chart of an exemplary method for determining the processing of a rack holding a plurality of sample containers within a laboratory instrument comprising one analyser.
- Figures 6a to 6d show a flow chart of an exemplary method for determining the processing of a rack holding a plurality of sample containers within a laboratory instrument comprising two analysers.
- Figure 1a shows a schematic representation of a laboratory instrument 400 comprising one analyser 230 and of a computing device 100 external to the laboratory instrument 400.
- the computing device 100 is physically distinct from the laboratory instrument 400 and may be e.g. located remotely from the laboratory instrument 400.
- the computing device 100 comprises a processor 11 1 (e.g. a CPU, a GPU, or the like), and a memory 1 12.
- the memory 112 may comprise a primary memory and a secondary memory (not shown).
- the computing device 100 may also comprise a input output (I/O) interface 1 10 for communicating with input/output units, such as a screen, a keyboard, a touch screen, a printer, or the like.
- I/O input output
- the computing device 100 may comprise a Network Interface Controller (NIC) 1 14 configured to connect said device with one or more networks (e.g. an intranet, the internet, a cellular network, or the like).
- NIC Network Interface Controller
- the computing device may comprise a plurality of NICs.
- the computing device 100 is in data communication 12 with the laboratory instrument 400 (e.g. with the computing device 231 discussed below), for example by means of the NIC 1 14 or by other means.
- the laboratory instrument 400 is configured to receive sample containers, such as sample tubes, containing respective biological samples, and to analyse such biological samples.
- sample containers such as sample tubes
- the sample containers may be accommodated within racks 320a-320f.
- a rack may hold a plurality of sample containers arranged in a line.
- the figure shows three sample containers in each rack, however this example is not limiting.
- each rack may accommodate seven sample containers.
- the laboratory instrument 400 comprises an analyser 230 as well as a plurality of areas, namely the loading/unloading area 220, the buffer area (or “waiting area”) 260 and the queue area 210 for the analyser 230. Furthermore, the laboratory instrument 400 comprises a moving component (or “carrier”) 270 configured to move sample containers among the plurality of areas, e.g. from a first area to a second area. Each area may comprise a (region of a) horizontal plate onto which a rack may be placed.
- the carrier 270 is configured to move along two mutually orthogonal directions A1 and A2. In particular, the carrier 270 picks up a rack positioned in the loading/unloading area 220 or in the buffer area 260 and moves that rack to the queue area 210 for the analyser 230.
- the analyser 230 comprises a computing device 231 and a pipettor 232.
- the computing device 231 may be referred to as “second computing device”, while the computing device 100 may be referred to as “first computing device”.
- the second computing device 231 may comprise a processor and memory as well as the other components discussed for the first computing device 100.
- the second computing device 231 is configured to control the analyser 230, in particular the pipettor 232.
- the carrier is controlled by the second computing device 231 , while in other examples the carrier is controlled by the first computing device 100.
- the pipettor 232 is configured to draw a portion of biological sample from a sample container.
- the pipettor 232 may include a pipette for aspirating/dispensing the biological sample and a motor for moving the pipette inside the sample container and retracting it.
- the motor may further move the pipettor 232 along a circular trajectory from a position over the queue area 232 (and specifically over a sample container at the queue area 232), where a portion of the sample is aspirated, to a position within the body of the analyser 230, where the portion of the sample is dispensed, and back.
- the first computing device 100 may be configured to carry out the method according to the first aspect of the present invention alone.
- the processor 11 1 may be configured to carry out the method.
- the secondary memory may store a computer program comprising instructions which, when executed by the processor 1 1 1 , cause the computing device 100 to carry out the method according to the first aspect of the present invention.
- the first computing device 100 and the second computing device 231 may be configured to carry out the method according to the first aspect of the present invention together.
- the first computing device 100 and the second computing device 231 may be considered parts of a distributed computing device. Some steps of the method may be carried out by the first computing device 100 and other steps of the method may be carried out by the second computing device 231 .
- Figure 1 b shows a schematic representation of a laboratory instrument 400 comprising one analyser 230 and of a computing device 100 comprised in the laboratory instrument 400.
- the system of Figure 1 b is identical to the system of Figure 1 a except for the fact that, in this example, the computing device 100 is physically part of the laboratory instrument 400 and may be e.g. located within the laboratory instrument 400.
- the data communication between the computing device 100 and the other components of the laboratory instrument 400 may occur via a bus or via an internal network.
- Figure 2 shows a schematic representation of a laboratory instrument 400 comprising two analysers 230a, 230b and of a computing device 100 external to the laboratory instrument 400.
- the laboratory instrument 400 of Figure 2 is similar to the laboratory instrument 400 of Figure 1 a, wherein the only difference is that there are two analysers 230a, 230b instead of only one.
- the laboratory instrument 400 comprises a first analyser 230a and a second analyser 230b as well as respective first queue area 210a and second queue area 210b.
- Figure 2 shows rack 320f at the second queue area 210b.
- the first analyser 230a comprises a computing device 231 a and a pipettor 232a
- the second analyser comprises a computing device 231 b and a pipettor 232b.
- the computing device 100 may be referred to as “first computing device” and the computing device 231 a may be referred to as “second computing device”, while the computing device 231 b may be referred to as “third computing device”.
- the third computing device 231 b may comprise a processor and memory as well as the other components discussed for the first computing device 100.
- the method may be performed by the first computing device 100 alone or by the first computing device 100 and the second computing device 231 a together.
- the second computing device 231a may be configured to control the carrier 270, while the third computing device 231 b may not.
- the method may be performed by the first computing device 100 together with the second computing device 231 a and/or the third computing device 231 b.
- the second computing device 231 a is configured to control the first analyser 230a, in particular its pipettor 232a, while the third computing device 231 b is configured to control the second analyser 230b, in particular its pipettor 232b.
- the first analyser 230a and the second analyser 230b may be different from each other in that they may be configured to carry out different clinical tests.
- the first analyser 230a may be a chemistry analyser and the second analyser 230b may be an immunoassay analyser.
- the laboratory instrument 400 comprising two analysers 230a, 230b may also comprise the computing device 100, similarly to what shown in Figure 1 b.
- Figure 3 shows a flow chart of an exemplary method 500a for determining the processing of a sample container within a laboratory instrument 400 comprising one analyser 230.
- the first computing device 100 accesses test order data at step 510, wherein the test order data comprise information specifying a plurality of clinical tests to be carried out on a biological sample contained in the sample container.
- the test order data comprise a list of test identifiers in the form of alphanumeric strings.
- the first computing device 100 may read a barcode on the sample container and retrieve the test order data from a remote computer by using the information contained in the barcode.
- the remote computer is located where the biological sample was taken from the subject.
- the first computing device 100 may access biological sample data at step 510.
- the first computing device 100 and/or the second computing device 231 cause the analyser 230 to carry out the plurality of clinical tests.
- Each clinical test is associated with a set of retain conditions and, thus, the sample container is associated with a plurality of sets of retain conditions.
- Each set of retain conditions associated with a respective clinical test comprises a condition that one or more rules require that one or more supplementary tests shall be carried out whenever one or more supplementary test conditions on the respective clinical test are met.
- the first computing device 100 accesses rule data at step 515, wherein the rule data comprise one or more rules for the laboratory instrument 400.
- the rule data may or may not comprise rules associated with the clinical tests specified in the test order data.
- Figures 4a to 4d show examples of rules.
- the rule shown in Figure 4a whenever the result of the primary clinical test identified as T 1 has flags “HH” and “LL”, a supplementary test should be carried out.
- the supplementary test is the clinical test identified as T1 , which, if the result has flags “HH” and “LL”, shall be carried out a second time.
- this rule requires a rerun of the primary clinical test.
- a supplementary test should be carried out, namely the reflex test identified as T3.
- the reflex test identified as T4 has a value greater than 150
- two supplementary tests should be carried out, namely the reflex test identified as T5 and the reflex test identified as T6.
- the supplementary test identified as T8 should be performed three times.
- the first computing device 100 determines, at step 520, whether at least one set of retain conditions among the plurality of sets of retain conditions associated with the sample container is met.
- the plurality of clinical tests specified by the test order data may be T1 , T4 and T9 and the rule data may comprise the rules of Figures 4a to 4d.
- each set of retain conditions comprises only the rule condition.
- each set of retain conditions consists of the condition that there exists a rule is associated with the clinical test that introduces the possibility of having to run one or more supplementary tests.
- the set of retain conditions associated with test T1 is met because there is a rule that prescribes that the test T1 should be rerun if a given condition on the result of T1 is met.
- the set of retain conditions associated with test T4 is also met because there is a rule that prescribes that reflex tests T5 and T6 should be run if a given condition on the result of T4 is met.
- the set of retain conditions associated with test T9 is not met because there is no rule associated with T9.
- step 520 Since at least one set of retain conditions is met (specifically, two sets), the determination of step 520 is affirmative. It should be noted that, if the first computing device 100 makes the determination for one set at the time, it may stop after finding the first set of retain conditions that is met.
- each set of retain conditions comprises the rule condition and a probability condition.
- the rules of Figures 4a-4d comprise result conditions (i.e. conditions on the result of the primary clinical test) that, when met, trigger the execution of one or more supplementary tests.
- the probability condition is the condition that the probability that the result of the clinical test satisfies the result condition exceeds a probability threshold.
- the probability threshold may be the same for all clinical tests, such as 60% (or 0.6).
- the first computing device 100 first determines whether the rule condition in each set of retain conditions is met and, if so, determines whether the corresponding probability condition is met.
- the first computing device 100 obtains probability data, wherein the probability data comprise information specifying a probability that a result of a clinical test meets the result condition.
- the first computing device 100 obtains the probability data for those tests for which the rule condition is met, in this case T1 and T4.
- the probability data for test T 1 may state that there is a probability of 40% that the result of T 1 has the flag HH, LL, while the probability data for test T4 may state that there is a probability of 70% that the result of T4 has value greater than 150.
- the first computing device 100 uses the probability data to determine whether the probability conditions in the sets of retain conditions are met.
- the probability condition for test T1 is not met (because 40% ⁇ 60%), while the probability condition for test T4 is met (since 70%>60%). Therefore, the set of retain conditions for T1 is not met (rule condition is met, but probability condition is not met), the set of retain conditions for T4 is met (both rule condition and probability condition are met) and the set of retain conditions for T9 is not met (rule condition is not met, probability condition is not even checked). Since at least one set of retain conditions is met (specifically, one set), the determination of step 520 is affirmative.
- a third exemplary case may be identical to the second exemplary case, except that the probability data for test T4 state that there is a probability of 30% that the result of T4 has value greater than 150. In this case, no set of retain conditions associated with the sample container is met, so that the determination of step 520 is negative.
- the sample container may be released or retained after the pipettor 232 of the analyser 230 has drawn a volume of the biological sample.
- the determination of step 520 may be done upstream, e.g. before or as soon as the sample container is loaded in the laboratory instrument 400, or may be done right after the pipettor 232 has completed its operation.
- a negative determination at step 520 corresponds to a determination that a first release condition is met, wherein the first release condition is the condition that all sets of retain conditions associated with the sample container are not met.
- the first computing device 100 causes the release of the sample container to be initiated at step 570 by causing the sample container to be moved to the loading/unloading area 220.
- the first computing device 100 is comprised in the laboratory instrument 400, it may directly control the carrier 270 to move the sample container to the loading/unloading area 220.
- the first computing device 100 is external to the laboratory instrument 400, it may instruct the second computing device 231 to control the carrier 270 to move the sample container to the loading/unloading area 220.
- the sample container may be moved from the queue area 210 to the loading/unloading area 220.
- the first computing device 100 causes the sample container to be retained within the laboratory instrument 400 at step 530 by causing the sample container to be moved to the buffer area 260. If the first computing device 100 is comprised in the laboratory instrument 400, it may directly control the carrier 270 to move the sample container to the buffer area 260. If the first computing device 100 is external to the laboratory instrument 400, it may instruct the second computing device 231 to control the carrier 270 to move the sample container to the buffer area 260.
- the first computing device 100 accesses at step 535 test result data containing the results of the plurality of clinical tests carried out by the analyser 230, e.g. tests T1 , T4 and T9. Then, at step 540, the first computing device 100 determines whether according to the one or more rules, at least one supplementary test shall be carried out. In particular, the first computing device 100 verifies whether the results of the clinical tests satisfy the respective result conditions.
- the test result data may contain the following results: for test T1 , the result is 1000 and has the flag HH associated with it; for test T4, the result is 200; and for test T9, the result is 10.
- test T1 shall be rerun and based on the rule in Figure 4c, reflex tests T5 and T6 shall be run. Thus, three supplementary tests shall be carried out. Accordingly, the determination at step 540 is affirmative.
- the test result data may contain the following results: for test T1 , the result is 1000 and has the flag HH associated with it; for test T4, the result is 100; and for test T9, the result is 10.
- test T1 shall be rerun and based on the rule in Figure 4c, no reflex tests shall be run. Thus, one supplementary test shall be carried out. Accordingly, the determination at step 540 is affirmative.
- the test result data may contain the following results: for test T1 , the result is 300 and does not have the flag HH associated with it; for test T4, the result is 100; and for test T9, the result is 10.
- test T1 shall not be rerun and based on the rule in Figure 4c, no reflex tests shall be run. Thus, no supplementary test shall be carried out. Accordingly, the determination at step 540 is negative. Depending on whether the determination at step 540 is affirmative or not, the sample container may be released or further processed after having been held at the buffer area 260.
- a negative determination at step 540 corresponds to a determination that a second release condition is met, wherein the second release condition is the condition that according to the one or more rules, none of the one or more supplementary tests shall be carried out for any clinical test of the plurality of clinical tests.
- the first computing device 100 causes the release of the sample container to be initiated at step 570 by causing the sample container to be moved to the loading/unloading area 220, as explained above.
- the sample container may be moved from the buffer area 260 to the loading/unloading area 220.
- the first computing device 100 causes at step 550 the one or more supplementary tests that shall be carried out to be actually carried out by the laboratory instrument 400.
- the first computing device 100 may cause the sample container to be moved from the buffer area 260 to the queue area 210 and the analyser 230 to perform the one or more supplementary tests.
- the first computing device 100 may instruct the second computing device 231 to control the analyser 230 to perform the one or more supplementary tests.
- the analyser 230 performs the one or more supplementary tests.
- the first computing device 100 may directly control the carrier 270 to move the sample container to the queue area 210 from the buffer area 260. If the first computing device 100 is external to the laboratory instrument 400, it may instruct the second computing device 231 to control the carrier 270 to move the sample container to the queue area 210 from the buffer area 260.
- Figure 5 shows a flow chart of an exemplary method 500b for determining the processing of a rack holding a plurality of sample containers within a laboratory instrument 400 comprising one analyser 230.
- the method 500b is substantially the same as the method 500a discussed above, with the difference that the plurality of sample containers, since they are in the same rack, can only be handled together, as a whole. Accordingly, a decision on whether to retain or release the rack has to take into account the circumstances of all sample containers.
- the method 500b will be briefly discussed below focussing on the differences with method 500a.
- the first computing device 100 accesses test order data at step 510 and rule data at step 515, as discussed. In this case, the first computing device 100 accesses test order data for each sample container in the rack.
- the first computing device 100 determined whether at least one set of retain conditions associated with at least one sample container in the rack is met. In other words, the check of the sets of retain conditions discussed above is performed for each sample container in the rack, or at least for each sample container until a sample container having at least one met set of retain conditions is found.
- the rack may be released or retained after the pipettor 232 of the analyser 230 has drawn a volume of biological samples from each sample container in the rack.
- a negative determination at step 555 corresponds to a determination that the first release conditions for the rack are met, namely that, for each sample container, all sets of retain conditions associated with said each sample container are not met. Specifically, if the determination at step 560 is negative, the first computing device 100 causes the release of the rack to be initiated at step 560 by causing the rack to be moved to the loading/unloading area 220, similarly to step 570 but with the rack instead of a single sample container.
- the first computing device 100 causes the rack to be retained within the laboratory instrument 400 at step 585 by causing the rack to be moved to the buffer area 260. In the case of the rack, it is sufficient for one sample container in the rack to have at least one set of retain conditions met for the whole rack to be retained. Whenever the rack is retained, i.e. after step 585, the first computing device 100 accesses, at step 535, test result data containing the results of the plurality of clinical tests carried out by the analyser 230 on the biological samples contained in the rack. Then, at step 540, the first computing device 100 determines whether, according to the one or more rules, at least one supplementary test shall be carried out. In particular, the check of the result conditions comprised in the rules discussed above is performed for each sample container in the rack.
- the rack may be released or further processed after having been held at the buffer area 260.
- a negative determination at step 540 corresponds to a determination that the second release conditions for the rack are met, i.e. none of the one or more supplementary tests shall be carried out for any clinical test of any sample container. Specifically, if the determination at step 540 is negative, the first computing device 100 causes the release of the rack to be initiated at step 560 by causing the rack to be moved to the loading/unloading area 220, as explained above. In particular, the rack may be moved from the buffer area 260 to the loading/unloading area 220.
- the first computing device 100 causes the one or more supplementary tests that shall be carried out to be actually carried out by the laboratory instrument 400, as explained above.
- the whole rack is retained within the laboratory instrument 400 and is moved from the buffer area 260 to the queue area 210, if at least one sample container in the rack holds a sample on which at least one supplementary test shall be carried out.
- Figures 6a to 6d show a flow chart of an exemplary method for determining the processing of a rack holding a plurality of sample containers within a laboratory instrument 400 comprising two analysers 230a, 230b.
- the same principles of the methods 500a and 500b apply, with the difference that the clinical tests to be carried out on the biological samples contained in the sample containers may be carried out by two analysers 230a, 230b of the laboratory instrument 400. This implies that the rack may be transported between the analysers 230a and 230b, more specifically between their respective queue areas 210a and 210b.
- the first computing device 100 accesses test order data at step 610 and rule data at step 615, as done in steps 510 and 515 of the method 500b, respectively.
- the first computing device 100 determines whether the clinical tests to be carried out on the plurality of biological samples contained in the respective plurality of sample containers are to be carried out by the first analyser 230a, or the second analyser 230b, or both analysers 230a and 230b.
- condition A is the condition that the test order data of at least one sample container in the rack comprise one or more tests to be carried out by the first analyser 230a
- condition B is the conditions that the test order data of at least one sample container in the rack comprise one or more tests to be carried out by the second analyser 230b.
- the first computing device 100 checks whether at least one clinical test of the Z tests is meant to be carried out by the first analyser 230a and whether at least one clinical test of the Z tests is meant to be carried out by the second analyser 230b.
- the first computing device 100 determines whether condition C is met, i.e. whether at least a set of retain conditions associated with a test to be carried out by the first analyser 230a is met.
- condition C corresponds to the determination of step 555 of the method 500b; it is, thus, determined whether, for at least a sample container in the rack, there is at least one set of retain conditions associated with a test to be carried out by the first analyser 230a that is met.
- the first computing device 100 determines whether condition D is met, i.e. whether at least a set of retain conditions associated with a test to be carried out by the second analyser 230a is met.
- condition D corresponds to the determination of step 555 of the method 500b; it is, thus, determined whether, for at least a sample container in the rack, there is at least one set of retain conditions associated with a test to be carried out by the second analyser 230a that is met.
- the first computing device 100 causes at step 625 the first analyser 230a to carry out the one or more tests it is configured to carry out.
- the first computing device 100 may cause the rack to be moved to the first queue area 210a and the analyser 230a to perform the one or more tests.
- the first computing device 100 may instruct the second computing device 231 a to control the first analyser 230a to perform the one or more clinical tests.
- the first analyser 230a performs the one or more clinical tests.
- the first computing device 100 may directly control the carrier 270 to move the rack to the first queue area 210a, e.g. from the loading/unloading area 220. If the first computing device 100 is external to the laboratory instrument 400, it may instruct the second computing device 231 a to control the carrier 270 to move the rack to the first queue area 210a from the loading/unloading area 220.
- condition C the first computing device 100 causes at step 640 the release of the rack to be initiated, as in step 560 discussed above. If condition C is met, the method proceeds to step 650 of Figure 6b. At step 650, the first computing device 100 causes the rack to be retained within the laboratory instrument 400 by causing the rack to be moved to the buffer area 260, as in step 585. Steps 651 to 654 of Figure 6b correspond to steps 535, 540, 560 and 550 of Figure 5, respectively, wherein the analyser in question is the first analyser 230a.
- the first computing device 100 causes at step 635 the second analyser 230b to carry out the one or more tests it is configured to carry out.
- the first computing device 100 may cause the rack to be moved to the second queue area 210b and the analyser 230b to perform the one or more tests.
- the first computing device 100 may instruct the third computing device 231 b to control the analyser 230b to perform the one or more clinical tests.
- the analyser 230b performs the one or more clinical tests.
- the first computing device 100 may directly control the carrier 270 to move the rack to the second queue area 210b, e.g. from the loading/unloading area 220. If the first computing device 100 is external to the laboratory instrument 400, it may instruct the second computing device 231 a to control the carrier 270 to move the rack to the second queue area 210b from the loading/unloading area 220. If condition D is not met, the first computing device 100 causes at step 640 the release of the rack to be initiated, as in step 560 discussed above. If condition D is met, the method proceeds to step 660 of Figure 6c.
- the first computing device 100 causes the rack to be retained within the laboratory instrument 400 by causing the rack to be moved to the buffer area 260, as in step 585.
- Steps 661 to 664 of Figure 6b correspond to steps 535, 540, 560 and 550 of Figure 5, respectively, wherein the analyser in question is the second analyser 230b.
- the first computing device 100 causes at step 630 the first analyser 230a to carry out the one or more tests it is configured to carry out and the second analyser 230b to carry out the one or more tests it is configured to carry out.
- the first computing device 100 may cause:
- the first computing device 100 may directly control the carrier 270 or indirectly via the second computing device 231 a.
- Step 630 may comprise a combination of steps 625 and 635. If neither condition C nor condition D is met, the first computing device 100 proceeds to step 640, causing the release of the rack to be initiated. If condition C is met and condition D is not met, the method proceeds to step 650 of Figure 6b and continues as described above. If condition C is not met and condition D is met, the method proceeds to step 650 of Figure 6c and continues as described above.
- step 670 the first computing device 100 causes the rack to be retained within the laboratory instrument 400 by causing the rack to be moved to the buffer area 260, as in step 585. Then the first computing device 100 accesses at step 671 test result data containing the results of the one or more clinical tests carried out by the first analyser 230a as well as the results of the one or more clinical tests carried out by the second analyser 230b.
- the first computing device 100 determines whether, according to the one or more rules, at least one supplementary test shall be carried out by the first analyser 230a and and/or at least one supplementary test shall be carried out by the second analyser 230b, similarly to step 540.
- the first computing device 100 causes at step 674 the release of the rack to be initiated, as in step 640.
- the first computing device 100 proceeds to step 673, causing the first analyser 230a to carry out said at least one supplementary test.
- the first computing device 100 may cause the rack to be moved to the first queue area 210a e.g. from the buffer area 260 and the first analyser 230a to perform the at least one supplementary test.
- the first computing device 100 causes at step 675 the second analyser 230b to carry out said at least one supplementary test.
- the first computing device 100 may cause the rack to be moved to the second queue area 21 Ob (e.g. from the first queue area 21 Oa via the buffer area 260) and the second analyser 230b to perform the at least one supplementary test.
- step 672 the first computing device 100 proceeds directly to step 675.
- the first computing device 100 determines whether the test order data of at least one sample container in the rack comprise one or more tests to be carried out by the first analyser 230a and whether the test order data of at least one sample container in the rack comprise one or more tests to be carried out by the second analyser 230b.
- condition A If condition A is met and condition B is not, the determination of whether condition C is met may be carried out at the same time or after step 625;
- condition A and condition B are met, the determination of whether condition C and condition D are met may be carried out at the same time or after step 630;
- condition A is not met and condition B is met, the determination of whether condition D is met may be carried out at the same time or after step 635.
- the first computing device 100 may, after the supplementary tests have been carried out (namely after step 550 or 654 or 664 or 675), cause the release of the rack/sample container to be initiated.
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Abstract
Summarizing the invention, a method is provided. The method comprises: accessing, by a computing device, test order data, wherein the test order data comprise information specifying a set of clinical tests to be carried out by a laboratory instrument on a biological sample contained in a sample container, wherein each clinical test is associated with a set of retain conditions so that the sample container is associated with one or more sets of retain conditions; determining, by the computing device, whether at least one set of retain conditions associated with the sample container is met; and if at least one set of retain conditions associated with the sample container is met, causing, by the computing device, the sample container to be retained in the laboratory instrument; wherein each set of retain conditions associated with a respective clinical test comprises a condition that one or more rules require that one or more supplementary tests shall be carried out whenever one or more supplementary test conditions on the respective clinical test are met.
Description
METHOD AND INSTRUMENT FOR TESTING A VOLUME OF A BIOLOGICAL
SAMPLE
Description
Technical Field
The following description relates to field of biological samples testing.
Analytic and clinical laboratories typically comprise laboratory instruments that are configured to automatically carry out one or more clinical tests (e.g. clinical chemistry and/or immunoassay tests) on biological samples (such as blood samples) by means of one or more analysers.
Typically, when a tube containing a biological sample is introduced into a laboratory instrument, the laboratory instrument reads the barcode on the tube and queries for a test order based on the barcode (either in the connected laboratory information system or in the local instrument console software) and at least one analyser in the laboratory instrument carries out the test(s) in the test order. In some cases, a rerun of the test(s) or reflex test(s) may have to be additionally carried out.
It is an object of the invention to increase the efficiency of sample testing by laboratory instruments, in particular time-wise.
The achievement of this object in accordance with the invention is set out in the independent claims. Further developments of the invention are the subject matter of the dependent claims.
According to a first aspect, a method, e.g. a computer-implemented method, is provided. The method comprises: accessing, by a computing device, test order data, wherein the test order data comprise information specifying a set of clinical tests to be carried out by a laboratory
instrument on a biological sample contained in a sample container, wherein each clinical test of the set of clinical tests is associated with a set of retain conditions so that the sample container is associated with one or more sets of retain conditions; determining, by the computing device, whether at least one set of retain conditions associated with the sample container is met; and if at least one set of retain conditions associated with the sample container is met, causing, by the computing device, the sample container to be retained in the laboratory instrument; wherein each set of retain conditions associated with a respective clinical test comprises a condition that one or more rules require that one or more supplementary tests shall be carried out whenever one or more supplementary test conditions on the respective clinical test are met.
According to the present invention, a computing device may comprise at least one memory and at least one processor. A computing device may also comprise one or more input/output units. A computing device, e.g. the computing device carrying out the method according to the present invention, may comprise a plurality of processors and/or a plurality of memories. In particular, the computing device according to the present invention may comprise one or more computing devices integrated with the laboratory instrument. According to the present invention, a computing device may be a distributed computing system, e.g. a computing network. For example, the computing device may comprise a computing device integrated with the laboratory instrument and another computing device remote from the computing device integrated with the laboratory instrument.
In particular, the computing device accesses test order data, the test order data comprising information specifying a set of clinical tests to be performed by the laboratory instrument on the biological sample, wherein the biological sample is contained in a sample container.
The biological sample (or simply “sample”) may be a sample of a bodily fluid of a human or animal subject. For example, the bodily fluid may be a physiological fluid, such as blood, saliva, urine, sweat, amniotic fluid, cerebrospinal fluid, ascites fluid, or
the like. The biological sample may be put into a sample container after collection and it may be held in the container while being processed.
The sample container may be a sample tube. Typically, sample tubes comprise a closed tube end and an end opposite thereto. The latter end defines an opening for inserting the sample in the sample tube. The opening may be closed, e.g. sealed, by a cap.
Sample containers may be accommodated in a sample container rack (or “rack”). A sample container rack is configured to receive and to hold at least one sample container, in particular a plurality of sample containers. Accordingly, the rack may comprise a plurality of receptacles, wherein each receptacle is configured to hold a respective sample container, specifically in a substantially upright position.
Generally, a set may comprise one or more elements. Thus, the set of clinical tests may comprise one or more clinical tests. A clinical test may comprise one or more procedures that, when carried out on the biological sample, allow for estimating the value of a parameter, e.g. a clinical parameter. In particular, a clinical test may comprise physical, biological, optical, mechanical, immunological, and/or chemical procedures. Exemplarily, a clinical test may be an immunoassay test or a chemical test. The test order data may comprise further clinical tests, e.g. tests that are not to be carried out by the laboratory instrument.
The test order data may comprise a set of test identifiers, comprising one or more test identifiers. Each test identifiers of the set is associated with and at least one identifier uniquely identifies a respective clinical test of the set of clinical tests. A test identifier contains information specifying the respective clinical test. The test identifiers may be alphanumeric strings. For instance, the alphanumeric string “TSH” uniquely identifies the thyroid-stimulating hormone test and the string “Lp-PLA2” uniquely identifies the Lipoprotein-Associated Phospholipase A2 test.
In the present disclosure, “accessing data” may comprise retrieving the data e.g. from the at least one memory of the computing device that carries out the method of the
present invention, from the memory of another computing device, or from another remote data storage (a database, a secondary memory, a cloud storage or the like). Accordingly, in some cases, retrieving data may comprise downloading data. Additionally or alternatively, “accessing data” may comprise receiving the data, e.g. from a user or a computing device different from the computing device accessing the data. The two options are not mutually exclusive. For instance, accessing, data may comprise receiving the data, storing the data in the memory of the computer device and retrieving the data by accessing said memory.
Exemplarily, the sample container may comprise an indicium, e.g. a barcode, which may for example be securely affixed, e.g. by means of adhesive, to the sample container, for instance to its wall or its cap. The test order data may be retrieved by the computing device by reading indicium data from the indicium on the sample container. To this aim, a data reading unit may be comprised in the computing device or functionally connected to the computing device. The data reading unit may comprise an optical scanner configured to decode a barcode or a QR code. In another example, the indicium may be an RFID tag and the data reading unit may comprise an RFID reader.
In one example, the test order data may be fully comprised in or coincide with the indicium data. In this case, the test order data are “directly” read from the sample container, meaning that the information content of the test order data is fully present on the sample container, more precisely in the indicium. In another example, the test order data may be “indirectly” read from the sample container, meaning that the sample container only acts as an intermediary between the source of the test order data (e.g. a remote database) and the computing device. In other words, the data reading unit may obtain from the indicium a link (the indicium data) for retrieving the test order data from a source. For instance, a QR code on the sample tube may be scanned by the data reading unit to obtain such a link. In this case, the test order data and the indicium data are distinct. In yet another example, a portion of the test order data may be directly read and another portion may be indirectly read. In this case, the test order data may partially overlap with the indicium data. For instance, the indicium data may comprise the identifier identifying the clinical test, wherein the identifier is also part of the test
order data. By using the identifier stored in the indicium, the computing device may retrieve the rest of the test order data from another source, e.g. its own memory or a remote data storage.
In particular, the set of clinical tests is to be carried out by the laboratory instrument. In particular, the laboratory instrument may comprise at least one analyser (i.e. one or more analysers) configured to carry out the set of clinical tests. Each analyser may comprise an aspiration unit configured to aspirate a volume of sample from the sample container and then dispense it, as well as an analytical unit configured to carry out one or more clinical tests on said volume. Exemplarily, in case the test order comprises information specifying a plurality of clinical tests, all these clinical tests are to be carried out by a single analyser. Alternatively, for example, a first subset of the clinical tests is to be carried out by a first analyser of the laboratory instrument and a second subset of the clinical tests is to be carried out by a second analyser of the laboratory instrument.
The laboratory instrument may comprise a plurality of areas, e.g. physically delimited portions of space, wherein each area is configured to receive and support sample containers, e.g. to receive and support racks holding sample containers. The laboratory instrument may comprise a moving component configured to move sample containers among the plurality of areas, e.g. from a first area to a second area. Each area may comprise a (region of a) horizontal plate onto which a rack may be placed. The moving component may be configured to move at least in two dimensions e.g. which may be mutually orthogonal.
Exemplarily, the plurality of areas may comprise a loading/unloading area, a buffer area (or “waiting area”) and at least one queue area, in particular a queue area for each analyser comprised in the laboratory instrument. The loading/unloading area is an area accessible to a user and/or a machine to load sample containers in the laboratory instrument and unload sample containers from the laboratory instrument. The buffer area is an area where the sample containers can be located while awaiting further processing. In particular, the buffer area may be located in the laboratory instrument so that the samples cannot be altered while at the buffer area. The queue area for a given analyser is an area accessible to the given analyser, e.g. to the
aspiration unit of the analyser. Typically, the queue area is located in the vicinity of the analyser associated thereto, so that the aspiration unit of the analyser may aspirate a portion of the biological sample contained in a sample container located in the queue area.
Exemplarily, the computing device may be comprised in the laboratory instrument and may be configured to control the operations of the (other components of the) laboratory instrument, and, in particular, of its analyser(s) and of the moving component. Alternatively, the computing device may be external to (e.g. remote from) the laboratory instrument and configured to communicate with another computing device within the laboratory instrument, which is configured to control the laboratory instrument. In yet another example, as described above, the computing device may be a distributed computing system comprising a computing device integrated with the laboratory instrument and another computing device remote from the computing device integrated with the laboratory instrument.
Exemplarily, the method comprises causing, by the computing device, the set of clinical tests to be carried out by the laboratory instrument, in particular by one or more analyser(s) in it.
In particular, the laboratory instrument may be configured to process the sample according to one or more rules. In particular, a rule specifies one or more actions that the laboratory instrument is required to carry out, if one or more conditions are met. More particularly, the laboratory instrument is configured, when carrying out clinical tests, to abide by each rule of the one or more rules, i.e. to carry out, if the one or more conditions associated with said rule are met, the one or more actions required by said rule.
Exemplarily, a rule may be defined by statements including strings and variables, e.g. in a specific data format or following a specific syntax, such as the syntax of a programming language. The rules for a laboratory instrument may be stored as rule data in the memory of computing device, or in the memory of another computing device, or any other remote data storage.
When a rule refers to a clinical test, the rule and the respective clinical test are associated with one another. In particular, the rule specifies one or more actions that the laboratory instrument is required to carry out if one or more conditions on the clinical test, e.g. on the result of the clinical test, are met. A clinical test may have zero, one or a plurality of rules associated with it. Exemplarily, a rule associated to a clinical test may comprise the identifier associated with the clinical test.
For example, a rule may require that a supplementary test shall be carried out by the laboratory instrument if a respective supplementary test condition is met. In other words, the supplementary test is carried out if the supplementary test condition is met, while the supplementary test is not carried out if the supplementary test condition is not met. In some cases, a rule may require that a plurality of supplementary tests shall be carried out if one supplementary test condition is met. In other cases, a rule may require that a plurality of supplementary tests shall be carried out if a plurality of respective supplementary test conditions are met.
Thus, exemplary, a rule may comprise information specifying (i) the respective clinical test associated thereto, (ii) the one or more supplementary tests, and (iii) the one or more supplementary tests conditions that, if met, prompt the laboratory instrument to carry out the one or more supplementary tests. Accordingly, the computing device may be configured to: (a) assess the presence of one or more rules associated with said test, (b) check whether the one or more supplementary tests conditions are met and (c) if the one or more supplementary tests conditions are met, cause the laboratory instrument to carry out the one or more supplementary tests.
Since the one or more supplementary test conditions are conditions on the clinical test with which the rule is associated, it may be said that the one or more supplementary tests are associated with the clinical test. The latter may also be referred to as “primary test”. Accordingly, the test order data may comprise information specifying one or more primary tests. In particular, a rule may require that the one or more supplementary test are carried out by the laboratory instrument after the primary test to which they are associated has been carried out.
A supplementary test is also a clinical test, however its execution is contingent on the supplementary test condition(s) being met, while the primary test, if present in the test order, is always to be performed. In some examples, the execution of one supplementary test may be contingent on one supplementary test condition, while in other examples the execution may be contingent on a plurality of supplementary test conditions. One or more supplementary tests may be associated with each clinical test of the set of clinical tests.
As explained, the one or more supplementary test conditions are conditions that, when met, trigger the execution of one or more supplementary tests. The one or more supplementary test conditions are met if the clinical test satisfies certain criteria. In one example, the one or more supplementary test conditions may consist of the condition that the clinical test is a predetermined clinical test. In this case, every time the primary test is run, the supplementary test is also run. In another example, the one or more supplementary test condition may consist of a result condition on a result of the clinical test. In other words, if the result of the clinical test meets the result condition, the supplementary test is performed. Accordingly, a rule may require that a supplementary test shall be carried out by the laboratory instrument if a result condition on the result of the clinical test is met.
The execution of a clinical test may lead to one or more results, wherein each result may be a numerical value or an alphanumeric string. The result condition may be a match condition, according to which the result has to be identical to a predetermined value or string. For instance, the result of a primary clinical test may be either the string “acceptable” or the string “unacceptable”. If this is the case, the match condition may be the condition that the result of the primary test is equal to “unacceptable”. Alternatively, the result condition may be a threshold condition, according to which the result has to be less than or greater than a predetermined value, or the result has to be within a predetermined range, i.e. between two predetermined values.
Exemplarily, the supplementary test may be a rerun test, i.e. the supplementary test may coincide with the primary test. If this is the case, the primary test may be
performed two or more times, e.g. if a result indicates an anomaly (e.g. the result is outside a predetermined range). Accordingly, if the clinical test meets the one or more supplementary test condition, one or more reruns of the clinical test are performed, that is, the clinical test is repeated one or more times.
Exemplarily, the supplementary test may be a reflex test, i.e. the supplementary test may be different from the primary test, and it may be a clinical test carried out e.g. to confirm a result of the primary test by different means or to disambiguate a result of the primary test. In some examples, a rule of the one or more rules may require to carry out the same reflex test a plurality of times. In this case, the reflex test may also be referred to as “replicate reflex test”. Accordingly, a rule may specify that a given supplementary test may be carried out more than once.
In particular, the one or more rules may be generated by a user of the laboratory instrument, e.g. to implement the workflow of the laboratory comprising the laboratory instrument. The one or more rules may be generated by the user with the aim of improving the reliability of the test results. For example, the one or more rules may require to run a secondary test if the result of the first test falls within a range of values that renders this result inconclusive and/or, according to some reliability requirements, not reliable enough.
According to the invention, each clinical test in the set of clinical tests is associated with a respective set of retain conditions, i.e. one set of retain conditions for one clinical test. In particular, the retain conditions are conditions that determine, depending on whether they are met or not, whether the sample container shall be further retained within the laboratory instrument while and/or after the one or more clinical tests of the set of clinical tests are being/have been performed. As explained, the test order data specify a set of clinical tests to be carried out on a sample in a sample container. Thus, a sample (and its container) is associated with the set of clinical tests. Consequently, there are one or more sets of retain conditions associated with the sample container containing the sample on which the set of clinical tests is to be performed. If there is only one clinical test in the set of clinical tests, there is one set of retain conditions associated with the sample container. If the set of clinical tests comprises a plurality of
clinical tests, there is a plurality of sets of retain conditions associated with the sample container. A set of retain conditions may comprise one or more retain conditions. In the present disclosure, a set of retain conditions associated with a clinical test is met if each and every retain condition in the set is met. A set of retain conditions associated with a clinical test is not met if at least one of the retain conditions in the set is not met.
In particular, a set of retain conditions associated with a clinical test may be implemented by one or more computer instructions that, when executed by the computing device, cause the computing device to check whether the retain conditions associated to the clinical tests are met or not. For example, the one or more computer instructions may cause the computing device to parse the one or more rules to determine whether at least a rule of the one or more rules is associated with the clinical test. The computer instructions may be defined by statements including strings and variables, e.g. in a specific data format or following a specific syntax, such as the syntax of a programming language. In some examples, a retain condition associated with a given clinical test may be specifically defined for the given clinical test. In this case, the retain condition for the specific clinical may be implemented by computer instructions defined by a portion of software specific to the given clinical test. In other cases, the set of retain conditions associated with any clinical tests may be implemented by using a general function, e.g. a subroutine, that depends on one or more arguments. In particular, the set of retain conditions associated with each clinical test may be implemented by the computer instructions that are executed by the processor when the general function is invoked with an argument associated with said each clinical test. For instance, the function may carry out a regular expression search on the one or more rules to find a string that depends on an argument of the function. In this case, the set of retain conditions associated with each clinical test may be implemented by the computer instructions that are executed by the processor when the general function is invoked with the test identifier of said clinical test as argument.
The set of retain conditions for a given clinical test comprises at least a condition that one or more rules require that one or more supplementary tests shall be carried out if their respective supplementary test conditions (associated with the given clinical test) are met. Herein, this retain condition may also be referred to as “rule condition”. In
particular, the rule condition associated with a clinical test is the existence of at least one rule of the one or more rules that: (i) is associated with the clinical test and (ii) introduces the possibility of having to run one or more supplementary tests. Indeed, as mentioned above, a clinical test may or may not be associated with a rule encompassing potential supplementary test(s). Accordingly, each set of retain conditions comprises a respective rule condition.
The method further comprises determining whether at least one set of retain conditions of the one or more sets of retain conditions associated with the sample container is met, namely determining whether all retain conditions of at least one set are met.
In particular, each set of retain conditions comprises the rule condition. Accordingly, it is at least determined whether the rule condition associated with at least one clinical test is met. Determining whether a rule condition associated with a given clinical test is met may comprise parsing the rules of the laboratory instrument to identify whether at least a rule exists that (i) refers to the given clinical test and (II) requires that, whenever one or more supplementary test conditions are met, one or more supplementary tests shall be carried out.
If the sample container is associated with a plurality of sets of retain conditions, the sets may be checked sequentially or in parallel or partially sequentially and partially in parallel. In the case of a sequential determination, the determination may stop as soon as one met set of retain conditions is found.
If at least one set of retain conditions associated with the sample container is met, the method comprises causing the sample container to be retained in the laboratory instrument, e.g. even after each test of the set of clinical tests has been at least initiated. In other words, causing the sample container to be retained in the laboratory instrument may comprise causing the sample container to remain within the laboratory instrument after the sample container is no longer needed for carrying out the set of clinical tests. In particular, causing the sample container to be retained in the laboratory instrument may comprise causing the sample container to be retained in the laboratory instrument after the set of clinical tests has been at least initiated by the laboratory instrument, e.g.
by one or more analysers of the laboratory instrument. Specifically, each clinical test of the set of clinical tests may have been initiated. A clinical test may be considered initiated if the volume of sample needed for the clinical test has been aspirated from the sample container containing the sample. According to the present invention, the computing device may cause the sample container to be retained in the laboratory instrument at least until it has been assessed, e.g. by the computing device, whether one or more second release conditions (discussed below) are met.
Exemplarily, causing the sample container to be retained in the laboratory instrument may comprise causing the sample container to be placed at the waiting area of the laboratory instrument. For example, the sample container may be moved from the queue area of the analyser that has carried out the last clinical test of the set of clinical tests to the waiting area of the laboratory instrument and may be held at the waiting area, e.g. until supplementary test(s) shall be carried out or until it may be released (as discussed below).
The following exemplary scenarios illustrate various possible cases and, for each case, under which circumstances the computing device causes the sample container to be retained in the laboratory instrument.
Scenario I - The test order data specify only one clinical test, e.g. clinical test A, and clinical test A is associated with a set of retain conditions comprising only one retain condition, a1 (which is the rule condition for test A). Whenever a1 is met, the sample container is retained.
Scenario II - The test order data specify only clinical test A and clinical test A is associated with a set of retain conditions comprising retain condition a1 (which is the rule condition for test A) and retain condition a2 (e.g. a probability condition, discussed below). Whenever both a1 and a2 are met, the sample container is retained.
Scenario III - The test order data specify two clinical tests, clinical test A and clinical test B. Clinical test A is associated with a set of retain conditions comprising retain condition a1 and retain condition a2, while clinical test B is associated with a set of
retain conditions comprising only one retain condition, b1 (which is the rule condition for test B). If both a1 and a2 are met or if b1 is met, the sample container is retained.
The computing device causes the sample container to be retained in any case in which there is a possibility of having to carry out one or more supplementary tests as followup to a clinical test in the test order data. It should be noted that, for the sample container to be retained, it is sufficient that one clinical test has the potential to trigger one or more supplementary tests on the sample. The sample container is caused to be retained in the laboratory instrument (e.g. at the waiting area), so that, if a supplementary test must indeed be carried out, the sample container is promptly available to the analyser. Accordingly, there is no delay in processing the sample, which may be otherwise caused e.g. by having to reroute the sample container to the laboratory instrument. Therefore, the method leads to an increase in the efficiency of sample testing.
As mentioned, the sample container may be accommodated in a rack and the rack may further accommodate one or more additional sample containers. If sample containers are in a rack and the sample containers may not be moved singularly in and out of racks within the laboratory instrument, the racks may be the units that are moved. Thus, exemplarily, the moving component may be configured to move racks. A rack accommodating a plurality of sample container may be retained if at least one sample container is to be retained, i.e. if at least one sample container has at least one associated set of retain conditions that is met. In other words, a sample container in a rack comprising additional sample container(s) may be retained if at least one of its associated set of retain conditions is met but also if at least one set of retain conditions associated to at least one of the additional sample containers is met.
Exemplarily, the method may be considered as comprising: accessing, by a computing device, test order data for each sample container of a plurality of sample containers accommodated in a rack, wherein the test order data comprise information specifying a set of clinical tests to be carried out by a laboratory instrument on a biological sample contained in said each sample container, wherein
each clinical test is associated with a set of retain conditions so that said each sample container is associated with one or more sets of retain conditions; determining, by the computing device, whether at least one set of retain conditions associated with at least one sample container of the plurality of sample containers accommodated in the rack is met; and if at least one set of retain conditions associated with at least one sample container of the plurality of sample containers accommodated in the rack is met, causing, by the computing device, the rack to be retained in the laboratory instrument; wherein each set of retain conditions associated with a respective clinical test comprises a condition that one or more rules require that one or more supplementary tests shall be carried out whenever one or more supplementary test conditions on the respective clinical test are met.
As mentioned, the laboratory instrument may comprise one or more analysers and the set of clinical test may be carried out by a single analyser or by a plurality of analysers of the laboratory instrument. For instance, considering the case in which a plurality of analysers, e.g. P analysers, are to carry out a set of clinical tests, e.g. C clinical tests, each analyser may be configured to carry out a respective subset of the set of clinical tests. In particular, there may be P disjoint subsets, each subset having tj clinical tests, with j= 1, P, such that
The workflow for processing the sample container may be as follows: the sample container may be moved to a first queue area of a first analyser configured to carry out ti clinical tests, then to a second queue area of a second analyser configured to carry out t2 clinical tests and so on until the sample container is moved to a P-th queue area of a P-th analyser configured to carry out tp clinical tests. Afterwards, if at least one set of retain conditions associated with the sample container is met, the computing device causes the sample to be retained in the laboratory instrument, e.g. at the waiting area. The met set of retain conditions may be associated with a clinical test carried out at any of the P analysers.
Optionally, the sample container may pass through the waiting area every time it is moved from a queue area to another queue area. In other words, moving the sample
container from a first queue area to a second queue area may comprise moving the sample container from the first queue area to the waiting area and moving the sample container from the waiting area to the second queue area.
In one example, causing the sample container to be retained in the laboratory instrument may comprise instructing, by the computing device, the laboratory instrument to retain the sample container. In this case, the computing device may be external to the laboratory instrument. For example, in this case, the computing device may instruct the laboratory instrument to retain the sample container and/or the rack in which the sample container is accommodated. Exemplarily, the computing device may communicate with a second computing device within the laboratory instrument and transmit the instruction to retain the sample container, wherein the second computing device may control the moving component to retain the sample container.
In another example, causing the sample container to be retained in the laboratory instrument may comprise controlling, by the computing device, one or more components of the laboratory instrument to retain the sample container. In this case, the computing device may be a component of the laboratory instrument and may control other components of the laboratory instrument so that the sample container is retained. For example, the computing device may control the moving component to place the sample container in the waiting area.
Exemplarily, the method may further comprise retaining, e.g. by the laboratory instrument, the sample container in the laboratory instrument. In other words, responsive to the directives of the computing device, the laboratory instrument retains the sample container, e.g. by placing it in the waiting area. For example, the moving component of the laboratory instrument may move the sample container to the waiting area, e.g. from a queue area.
Exemplarily, the method may further comprise determining, by the computing device, whether one or more first release conditions are met, and, if the one or more first release conditions are met, causing, by the computing device, a release of the sample container to be initiated; wherein the one or more first release conditions comprise the
condition that all sets of retain conditions associated with the sample container are not met.
In particular, causing the release of the sample container from the laboratory instrument to be initiated may comprise causing the sample container to be moved to the loading/unloading area of the laboratory instrument, e.g. so that the sample container may be unloaded by an operator or a robot.
As mentioned, the one or more first release conditions comprise the first release condition that each and every set of retain conditions associated with the sample container is not met. In general, all of the one or more first release conditions have to be met for the release of the sample to be initiated. In one instance, the one or more first release conditions may consist of the first release condition that each and every set of retain conditions associated with the sample container is not met.
In this latter case, it may be said that, if all sets of retain conditions associated with the sample container are not met, the computing device causes the laboratory instrument to initiate the release of the sample container. Thus, exemplarily, for the illustrative scenarios discussed above, the circumstances for initiating the release of the sample container may be as follows:
Scenario Whenever a1 is not met, release of the sample container is initiated.
Scenario Whenever a1 is not met, or a2 is not met, or neither a1 nor a2 are met, release of the sample container is initiated.
Scenario III Whenever b1 is not met and, at the same time, at least one of a1 and a2 is not met, release of the sample container is initiated.
By means of the first release condition(s), in a case in which there is no possibility of having to carry out any supplementary test on the sample in the sample container, the sample container is not retained in the laboratory instrument and is put into condition to be released from the laboratory instrument. This way, the sample container is freed,
e.g. for further processing by another laboratory instrument within the laboratory, and it does not occupy space within the laboratory instrument unnecessarily. Therefore, the method leads to an increase in the efficiency of sample testing.
In one example, causing the release of the sample container to be initiated may comprise instructing, by the computing device, the laboratory instrument to initiate the release of the sample container. In this case, the computing device may be external to the laboratory instrument. For example, in this case, the computing device may instruct the laboratory instrument to initiate the release of the sample container and/or the rack in which the sample container is accommodated. In another example, causing the release of the sample container to be initiated may comprise controlling, by the computing device, one or more components of the laboratory instrument to initiate the release of the sample container. In this case, the computing device may be internal to the laboratory instrument and may control other components of the laboratory instrument so that the release is initiated. For example, the computing device may control the moving component to place the sample container in the loading/unloading area.
Exemplarily, the method may further comprise initiating, e.g. by the laboratory instrument, the release of the sample container from the laboratory instrument. In other words, responsive to the directives of the computing device, the laboratory instrument initiates the release of the sample container, e.g. by placing it in the loading/unloading area. For example, the moving component of the laboratory instrument may move the sample container to the loading/unloading area, e.g. from a queue area. The method may also further comprise releasing the sample container from the laboratory instrument, e.g. unloading the sample container from the loading/unloading area, e.g. by an operator or a machine.
Exemplarily, the one or more first release conditions may further comprise additional first release conditions besides the one that all sets of retain conditions associated with the sample container are not met. As mentioned, the sample container may be accommodated in a rack and the rack may further accommodate one or more additional sample containers. The one or more first release conditions may further
comprise, for each additional sample container, the condition that all sets of retain conditions associated with said each additional sample container are not met.
Accordingly, the release of a sample container in a rack may be initiated only if all sample containers in the rack can be released. Indeed, if sample containers are in a rack and the sample containers may not be moved singularly in and out of racks within the laboratory instrument, the racks may be the units that are moved. Thus, exemplarily, the moving component may be configured to move racks.
If the rack accommodates a plurality of N sample containers, including the sample container and N-1 additional sample containers, the computing device causes the laboratory instrument to initiate the release of the sample container if, for each and every sample container, all the respective associated sets of retain conditions are not met. The release of the sample container implies the release of the whole rack, namely of all additional sample containers.
Thus, the one or more first release conditions may comprise A/ first release conditions, each first release condition being associated with a respective sample container and requiring that all sets of retain conditions associated with the respective sample container are not met.
Exemplarily, the method may further comprise accessing test order data for each of the additional sample containers.
Illustrative scenarios with two sample containers X and Y accommodated in a rack may be as follows:
Scenario IV The test order data specify only clinical test A for sample container X and only clinical test C for sample container Y. Clinical test A is associated with a set of retain conditions comprising retain condition a1 (which is the rule condition for test A) and retain condition a2 (e.g. a probability condition, discussed below). Clinical test C is associated with a set of retain conditions comprising retain condition d (which is the rule condition for test C) and retain condition c2 (e.g. a probability condition, discussed
below). If (I) at least one of a1 and a2 is not met and (ii) at least one of c1 or c2 is not met, the release of the rack and, thus, of the sample containers X and Y, is initiated.
Scenario V - The test order data specify for sample container X two clinical tests, clinical test A and clinical test B, and for sample container Y two clinical tests, clinical test C and clinical test D. Clinical test A is associated with a set of retain conditions comprising only retain condition a1 and clinical test B is associated with a set of retain conditions comprising only retain condition b1 . Clinical test C is associated with a set of retain conditions comprising only retain condition c1 and clinical test D is associated with a set of retain conditions comprising only retain condition d1 (which is the rule condition for test D). If none of a1 , b1 , c1 and d1 is met, the release of the rack and, thus, of the sample containers X and Y, is initiated.
Also for sample containers accommodated in racks the efficiency of sample testing is increased by causing racks having samples on which there is no possibility of having to carry out any supplementary test to be released.
As explained above, a supplementary test condition may be a result condition. According to an example, the one or more supplementary test conditions on one clinical test (referred to as “first clinical test”) of the set of clinical tests comprise at least a result condition on a result of the first clinical test. Exemplarily, the method may further comprise: obtaining, by the computing device, probability data, wherein the probability data comprise information specifying a probability that a result of the first clinical test meets the result condition; and determining, by the computing device, by using the probability data, whether the probability that the result of the first clinical test satisfies the result condition exceeds a probability threshold; wherein the set of retain conditions associated with the first clinical test further comprises the condition - hereinafter referred to as “probability condition” - that the probability that the result of the first clinical test satisfies the result condition exceeds the probability threshold.
In the present disclosure, “obtaining data” may comprise accessing the data as discussed above. Alternatively, “obtaining data” may comprise generating the data, e.g. creating the data based on one or more inputs. In yet another example, “obtaining data” may comprise accessing a first portion of the data and generating a second portion of the data e.g. from the first portion of the data.
The probability data may comprise a probability value, expressed e.g. as a percentage or as a real number between 0 and 1 , that indicates the probability that a result of a clinical test meets the result condition. In particular, the probability value quantifies the likelihood that the one or more supplementary tests will actually be carried out.
In particular, the step of obtaining the probability data and the step of determining whether the probability that the result of the first clinical test satisfies the respective result condition exceeds a probability threshold may be carried out if the rule condition is met, i.e. if one or more rules require that the one or more supplementary tests shall be carried out if the one or more supplementary test conditions on the first clinical test are met. Furthermore, the probability data may be obtained based on the specific result condition, e.g. by using a value in the result condition as input for a probability distribution function.
In particular, determining whether the probability exceeds a probability threshold is equivalent to checking whether the probability condition is met. The probability threshold is a numerical value which, like the probability, may be expressed as a percentage or as a real number between 0 and 1 . The probability threshold may be a fixed value, e.g. a hardcoded value, that is always the same for the related result condition. The probability threshold may be stored in the memory of computing device, or in the memory of another computing device, or any other remote data storage.
After obtaining the probability data, the computing device may determine, by using the probability data, whether the probability that the result of the first clinical test satisfies the result condition exceeds a probability threshold. In other words, the probability is evaluated against the probability threshold and it is assessed whether the probability
is greater than the probability threshold. Thus, a comparison between two numerical values is carried out.
In this example, the set of retain conditions for the first clinical test comprises at least two conditions, namely the rule condition and the probability condition. Besides the mere possibility of the supplementary test(s) having to be carried out, the likelihood of it happening is also factored in. Thus, the approach is more fine-tuned and, in particular, it may reduce a waste of time by avoiding that the sample container is retained when supplementary tests will only be performed in very few cases.
Of course, there may be more than one clinical test in the set of clinical tests whose set of retain conditions comprise the probability condition. Exemplarily, all sets of retain conditions may comprise the probability condition. Indeed, for each clinical test of the set of clinical tests, the one or more supplementary test conditions may comprise at least a result condition on a result of said each clinical test. Thus, the method may further comprise, for each clinical test of the set of clinical tests: obtaining, by the computing device, probability data, wherein the probability data comprise information specifying a probability that a result of said each clinical test meets the result condition; and determining, by the computing device, by using the probability data, whether the probability that the result of said each clinical test satisfies the result condition exceeds a probability threshold; wherein each set of retain conditions further comprises the condition that the probability that the result of said each clinical test satisfies the result condition exceeds the probability threshold.
In one example, the computing may determine whether a set or retain conditions is met by checking the conditions in the following order: (i) the rule condition; and (ii) (if present) the probability condition.
If probability data cannot be accessed for a given clinical test, the probability that a result of the given clinical test meets the result condition may be set to a default value, e.g. 0 or 1 .
In some examples, obtaining the probability data may comprise: accessing history data, the history data comprising information specifying how often the result condition is met; and generating the probability data using the history data.
The probability data may be data derived e.g. from medical literature and/or from history data, wherein the history data comprise information specifying how often the result condition is met by the result of the first clinical test, namely how often the result of the first clinical test has satisfied the result condition in past executions of the clinical test. Thus, the history data may comprise a record of all the times the first clinical test was carried out and a record of the results of the first clinical test in all these instances. Additionally or alternatively to the record of the results, the history data may comprise statistics about the results in relation to the result condition, e.g. a flag for each execution of the first clinical test indicating whether the result in that occurrence met the result condition.
Generally, the history data may be data collected from previous executions of the clinical test and stored e.g. in a database, such as a local database or a cloud database. In some examples, the history data may relate to the laboratory instrument that is to carry out the set of clinical tests. In other examples, the history data may be collected from a plurality of laboratory instruments of the same type of the laboratory instrument that is to carry out the set of clinical tests. The plurality of laboratory instruments may include instruments within the same laboratory or instruments across different laboratories, e.g. within the same geographical region as defined by national or other administrative borders.
For instance, the computing device may determine a number indicating how many times the result condition was met, e.g. by looking at the results themselves or by looking at the flags, and compute the probability value by dividing this number by the total number of times the clinical test was carried out. In other examples, the probability data may have been previously derived from the medical literature and/or from history data and the computing device may simply access the probability data.
The use of history data for generating the probability data makes the estimation of the probability more accurate. In particular, it can be more accurately determined in which cases it is unlikely that the supplementary test(s) would be carried out, and, thus, retaining the sample container is more likely to lead to a waste of time than not.
In one example, the probability threshold may be dynamically selected, e.g. based on circumstances of the first clinical test. In some examples, the probability threshold may be selected among a plurality of predetermined probability thresholds based on one or more selection criteria, the one or more selection criteria comprising information specifying any or any combination of: the laboratory instrument, a laboratory configured to carry out the first clinical test, a priority of the biological sample.
In particular, the method may comprise the step of selecting, by the computing device, the probability threshold among a plurality of predetermined probability thresholds based on one or more selection criteria.
In particular, each predetermined probability threshold may be associated with one or more selection criteria, in that, whenever the one or more selection criteria apply to the specific conditions under which the first clinical test is carried out by the laboratory instrument, the probability threshold will be selected to be said predetermined probability threshold. Accordingly, the probability threshold may take on different values depending on which criteria apply to the specific case. A selection criterium may comprise information about the laboratory instrument, such as a model or a manufacturer of the instrument. For instance, when the model is an older model that takes a longer time to receive/release the sample container, when compared to a newer model, the probability threshold for the older model may be lower than the probability threshold for the newer model, for the sake of processing efficiency. Another selection criterium may comprise information about a laboratory in which the clinical test will be carried out, e.g. a size of the laboratory, which may be expressed by means of various quantities, such as physical size, number of instruments, throughput. For instance, in a laboratory with a bigger size, the transport of sample containers may take considerably more time than in a laboratory of a smaller size, so that rerouting a sample container may be rather undesirable. Accordingly, the
probability threshold for the bigger laboratory may be lower than the probability threshold for the smaller laboratory, for the sake of processing efficiency. Another selection criterium may comprise information about a priority of the sample. A sample with priority (such as a STAT sample) may have a lower probability threshold with respect to a sample without priority, such as about 0 or 0%.
The plurality of probability thresholds with their associated criteria may be stored in a database. The computing device may determine whether a selection criterium applies by accessing biological sample data, wherein the biological sample data may comprise information specifying features of the biological sample (e.g. priority), and/or equipment data comprising information about the instrument and the laboratory. Exemplarily, the biological sample data and the test order data may form a single data set.
By having a probability threshold that changes depending on the circumstances of the clinical test, the determination of whether to retain the sample container may be adapted case by case.
In case of a plurality of supplementary tests, the probability data may comprise a plurality of probability values, each probability value indicating the probability that the result of the first clinical test meets a respective result condition. For example, this may be the case whenever the first clinical test is associated to a plurality of rules, each rule of the plurality of rules specifying a respective result condition.
In particular, according to an example, the one or more supplementary tests consist of a plurality of supplementary tests. If the one or more rules require that the plurality of supplementary tests shall be carried out if the one or more supplementary test conditions on the first clinical test are met, the method may further comprise: obtaining, by the computing device, probability data, wherein the probability data comprise information specifying, for each supplementary test of the plurality of supplementary tests, a respective probability that a result of the first clinical test meets the respective result condition; and
determining, by the computing device by using the probability data and for each supplementary test of the plurality of supplementary tests, whether the probability that the result of the first clinical test satisfies the respective result condition exceeds a respective probability threshold.
In this example, the set of retain conditions for the first clinical test further comprise the condition that, for at least one supplementary test of the plurality of supplementary tests, the probability that the result of the first clinical test satisfies the respective result condition exceeds a respective probability threshold.
There may be a single threshold applicable to each probability associated with a respective supplementary test associated with the first clinical test, e.g. all the respective probability thresholds are equal with one another, or they may be a plurality of thresholds, each threshold applicable to a respective probability.
Exemplarily, the method may further comprise: determining, whether, for at least one clinical test, according to the one or more rules associated with said at least one clinical test, at least one supplementary test of the one or more supplementary tests shall be carried out; and if the at least one supplementary test of the one or more supplementary clinical tests shall be carried out, causing, by the computing device, the at least one supplementary test of the one or more supplementary tests to be carried out.
In particular, after causing the sample container to be retained in the laboratory instrument, because of the possibility of having to carry out supplementary test(s), it may be determined whether supplementary test(s) shall indeed be carried out and, if so, the computing device may cause such supplementary test(s) to be carried out.
Exemplarily, causing the at least one supplementary test to be carried out may comprise causing the retained sample container to be moved from the waiting area to the queue area of the analyser configured to carry out the at least one supplementary test and causing the analyser to perform the at least one supplementary test.
In one example, causing the at least one supplementary test to be carried out may comprise instructing, by the computing device, the laboratory instrument to carry out the at least one supplementary test. In this case, the computing device may be external to the laboratory instrument. In another example, causing the at least one supplementary test to be carried out may comprise controlling, by the computing device, one or more components of the laboratory instrument to carry out the at least one supplementary test. In this case, the computing device may be internal to the laboratory instrument and may control other components of the laboratory instrument so that the at least one supplementary test is carried out. For example, the computing device may control the moving component to place the sample container in the queue area and the analyser to carry out the at least one supplementary test.
Exemplarily, the method may also further comprise carrying out, by the laboratory instrument (in particular by an analyser), the at least one supplementary test.
Determining, whether, according to the one or more rules associated to a given clinical test, at least one supplementary test of the one or more supplementary tests shall be carried out may comprise determining whether the one or more supplementary test conditions on said given clinical test are met. As mentioned, the execution of one supplementary test may be contingent on one supplementary test condition or on a plurality of supplementary test conditions. Thus, in some cases, a supplementary test may be carried out, if only one supplementary test condition is met. In other cases, a supplementary test may be carried out if a plurality of supplementary test conditions is met. Accordingly, it may be determined that at least one supplementary test shall be carried out if at least a subset of the one or more supplementary test conditions is met, wherein the subset may be proper or may coincide with the whole set of supplementary test conditions.
Exemplarily, for the at least one clinical test of the set of clinical tests, the one or more supplementary test conditions may comprise at least a result condition on a result of said at least one clinical test. Accordingly, the method may further comprise, for the at least one clinical test of the set of clinical tests, accessing, by the computing device, test result data, wherein the test result data comprise information specifying a test
result of said at least one clinical test; wherein determining, whether, according to the one or more rules, at least one supplementary test of the one or more supplementary tests shall be carried out comprises determining whether the result condition on the test result of said at least one clinical test is met.
Exemplarily, it may be checked for all clinical tests in the set whether one or more supplementary tests shall be carried out. Accordingly, the method may further comprise, for each clinical test of the set of clinical tests: determining whether according to the one or more rules associated with said each clinical test, at least one supplementary test of the one or more supplementary tests shall be carried out; and if the at least one supplementary test of the one or more supplementary clinical tests shall be carried out, causing, by the computing device, the at least one supplementary test of the one or more supplementary tests to be carried out.
Between determining that, according to the one or more rules, at least one supplementary test shall be carried out and causing the at least one supplementary test to be carried out there may be a delay, e.g. in case the analyser is not promptly available or in case the moving component is busy with other operations.
In a particular example, if one or more second release conditions are met, the method may further comprise: causing, by the computing device, a release of the biological sample to be initiated; wherein the one or more second release conditions comprise the condition that, according to the one or more rules, none of the one or more supplementary tests shall be carried out for any clinical test of the set of clinical tests.
In particular, the one or more second release conditions may comprise the condition that the one or more supplementary test conditions are not met for any clinical test of the set of clinical tests. In this example, it may be determined for each clinical test of the set of clinical tests whether, according to the one or more rules associated with
said each clinical test, at least one supplementary test of the one or more supplementary tests shall be carried out.
In particular, causing a release of the sample container to be initiated may comprise causing the sample container to be moved to the loading/unloading area of the laboratory instrument, e.g. so that the sample container may be unloaded by an operator or a robot.
As mentioned, the one or more second release conditions comprise the second release condition that all supplementary test conditions collectively associated with the set of clinical tests are not met. In other words, no supplementary test condition is met. This means that none of the (primary) clinical tests has actually triggered a supplementary test.
By means of the second release condition(s), in a case in which there is no supplementary test to be carried out on the sample in the sample container, the sample container is no longer retained in the laboratory instrument and is put into condition to be released from the laboratory instrument. This way, the sample container is freed, e.g. for further processing by another laboratory instrument within the laboratory, and it does not occupy space within the laboratory instrument unnecessarily. Therefore, the method leads to an increase in the efficiency of sample testing.
Exemplarily, the one or more second release conditions may further comprise additional second release conditions besides the one that all supplementary test conditions collectively associated with the set of clinical tests (that were carried out on the sample in the sample container) are not met. As mentioned, the sample container may be accommodated in a rack and the rack may further accommodate one or more additional sample containers, wherein each additional sample container contains a sample on which a respective set of clinical test is carried out. The one or more second release conditions may further comprise, for each additional sample container, the condition that the one or more supplementary test conditions are not met for any clinical test of the set of clinical tests associated with said each additional sample container.
Accordingly, the release of a sample container in a rack may be initiated only if all sample containers in the rack can be released. Indeed, if sample containers are in a rack and the sample containers may not be moved singularly in and out of racks within the laboratory instrument, the racks may be the units that are moved. Thus, exemplarily, the moving component may be configured to move racks.
If the rack accommodates a plurality of N sample containers, including the sample container and N-1 additional sample containers, the computing device causes the laboratory instrument to initiate the release of the sample container if, for each and every sample container, all the respective associated supplementary test conditions are not met. The release of the sample container implies the release of the whole rack, namely of all additional sample containers.
Accordingly, the one or more second release conditions may comprise N second release conditions, each second release condition being associated with a respective sample container and requiring that all supplementary test conditions associated with the respective sample container are not met.
A second aspect of the present invention relates to a computing device comprising a processor configured to perform the method described herein. In particular, the computing device according to the second aspect of the present invention is configured to:
• cause the sample container to be retained in the laboratory instrument at least by controlling the laboratory instrument to retain the sample container and/or the rack in which the sample container is accommodated, and/or
• cause a release of the sample container from the laboratory instrument to be initiated by controlling the laboratory instrument to initiate the release of and/or to release the sample container.
Yet another aspect of the present invention relates to a laboratory instrument configured to perform one or more clinical tests on a biological sample. The laboratory instrument comprises the computing device according to the previous aspect.
In particular, the laboratory instrument is the laboratory instrument described herein when discussing the first aspect of the present invention. For instance, the laboratory instrument according to the present invention comprises a buffer area, a loading/unloading area and a moving component. The moving component is configured to move the sample container, e.g. the rack in which the sample container is accommodated, to the buffer area and to the loading/unloading area, thereby (i) causing the sample container to be retained in the laboratory instrument and (ii) initiating the release of the sample container, respectively.
According to another aspect of the invention, a computer program product is provided. The computer program product comprises instructions which, when the program is executed by a computer, cause the computer to carry out the method described herein. In particular, the computer may be the computing device according to the second aspect of the present invention.
A further aspect of the present invention refers to a computer-readable medium, e.g. a transitory computer readable medium comprising instructions which, when executed by a computer, cause the computer to carry out the method described herein. In particular, the computer may be the computing device according to the second aspect of the present invention.
Brief Description of the Drawings
Details of exemplary embodiments are set forth below with reference to the exemplary drawings. Other features will be apparent from the description, the drawings, and from the claims. It should be understood, however, that even though embodiments are separately described, single features of different embodiments may be combined to further embodiments.
Figure 1 a shows a schematic representation of a laboratory instrument comprising one analyser and of a computing device external to the laboratory instrument.
Figure 1 b shows a schematic representation of a laboratory instrument comprising one analyser and of a computing device comprised in the laboratory instrument.
Figure 2 shows a schematic representation of a laboratory instrument comprising two analysers and of a computing device external to the laboratory instrument.
Figure 3 shows a flow chart of an exemplary method for determining the processing of a sample container within a laboratory instrument comprising one analyser.
Figures 4a to 4d show examples of rules.
Figure 5 shows a flow chart of an exemplary method for determining the processing of a rack holding a plurality of sample containers within a laboratory instrument comprising one analyser.
Figures 6a to 6d show a flow chart of an exemplary method for determining the processing of a rack holding a plurality of sample containers within a laboratory instrument comprising two analysers.
Detailed Description
In the following, a detailed description of examples will be given with reference to the drawings. It should be understood that various modifications to the examples may be made. Unless explicitly indicated otherwise, elements of one example may be combined and used in other examples to form new examples.
Figure 1a shows a schematic representation of a laboratory instrument 400 comprising one analyser 230 and of a computing device 100 external to the laboratory instrument 400. In this example, the computing device 100 is physically distinct from the laboratory instrument 400 and may be e.g. located remotely from the laboratory instrument 400.
Exemplarily, the computing device 100 comprises a processor 11 1 (e.g. a CPU, a GPU, or the like), and a memory 1 12. The memory 112 may comprise a primary memory and a secondary memory (not shown). The computing device 100 may also comprise a
input output (I/O) interface 1 10 for communicating with input/output units, such as a screen, a keyboard, a touch screen, a printer, or the like.
Furthermore, the computing device 100 may comprise a Network Interface Controller (NIC) 1 14 configured to connect said device with one or more networks (e.g. an intranet, the internet, a cellular network, or the like). In other examples, the computing device may comprise a plurality of NICs. The computing device 100 is in data communication 12 with the laboratory instrument 400 (e.g. with the computing device 231 discussed below), for example by means of the NIC 1 14 or by other means.
The laboratory instrument 400 is configured to receive sample containers, such as sample tubes, containing respective biological samples, and to analyse such biological samples. In particular, the sample containers may be accommodated within racks 320a-320f. Exemplarily, a rack may hold a plurality of sample containers arranged in a line. The figure shows three sample containers in each rack, however this example is not limiting. For example, each rack may accommodate seven sample containers.
The laboratory instrument 400 comprises an analyser 230 as well as a plurality of areas, namely the loading/unloading area 220, the buffer area (or “waiting area”) 260 and the queue area 210 for the analyser 230. Furthermore, the laboratory instrument 400 comprises a moving component (or “carrier”) 270 configured to move sample containers among the plurality of areas, e.g. from a first area to a second area. Each area may comprise a (region of a) horizontal plate onto which a rack may be placed. The carrier 270 is configured to move along two mutually orthogonal directions A1 and A2. In particular, the carrier 270 picks up a rack positioned in the loading/unloading area 220 or in the buffer area 260 and moves that rack to the queue area 210 for the analyser 230.
The analyser 230 comprises a computing device 231 and a pipettor 232. The computing device 231 may be referred to as “second computing device”, while the computing device 100 may be referred to as “first computing device”. The second computing device 231 may comprise a processor and memory as well as the other components discussed for the first computing device 100. The second computing
device 231 is configured to control the analyser 230, in particular the pipettor 232. In some examples, the carrier is controlled by the second computing device 231 , while in other examples the carrier is controlled by the first computing device 100.
The pipettor 232 is configured to draw a portion of biological sample from a sample container. The pipettor 232 may include a pipette for aspirating/dispensing the biological sample and a motor for moving the pipette inside the sample container and retracting it. The motor may further move the pipettor 232 along a circular trajectory from a position over the queue area 232 (and specifically over a sample container at the queue area 232), where a portion of the sample is aspirated, to a position within the body of the analyser 230, where the portion of the sample is dispensed, and back.
In a first example, the first computing device 100 may be configured to carry out the method according to the first aspect of the present invention alone. In particular, the processor 11 1 may be configured to carry out the method. For instance, the secondary memory may store a computer program comprising instructions which, when executed by the processor 1 1 1 , cause the computing device 100 to carry out the method according to the first aspect of the present invention.
In a second example, the first computing device 100 and the second computing device 231 may be configured to carry out the method according to the first aspect of the present invention together. In this case, the first computing device 100 and the second computing device 231 may be considered parts of a distributed computing device. Some steps of the method may be carried out by the first computing device 100 and other steps of the method may be carried out by the second computing device 231 .
Figure 1 b shows a schematic representation of a laboratory instrument 400 comprising one analyser 230 and of a computing device 100 comprised in the laboratory instrument 400. The system of Figure 1 b is identical to the system of Figure 1 a except for the fact that, in this example, the computing device 100 is physically part of the laboratory instrument 400 and may be e.g. located within the laboratory instrument 400. The data communication between the computing device 100 and the
other components of the laboratory instrument 400 (e.g. the second computing device 231 ) may occur via a bus or via an internal network.
Figure 2 shows a schematic representation of a laboratory instrument 400 comprising two analysers 230a, 230b and of a computing device 100 external to the laboratory instrument 400. The laboratory instrument 400 of Figure 2 is similar to the laboratory instrument 400 of Figure 1 a, wherein the only difference is that there are two analysers 230a, 230b instead of only one.
In particular, the laboratory instrument 400 comprises a first analyser 230a and a second analyser 230b as well as respective first queue area 210a and second queue area 210b. Figure 2 shows rack 320f at the second queue area 210b. The first analyser 230a comprises a computing device 231 a and a pipettor 232a, while the second analyser comprises a computing device 231 b and a pipettor 232b.
As mentioned, the computing device 100 may be referred to as “first computing device” and the computing device 231 a may be referred to as “second computing device”, while the computing device 231 b may be referred to as “third computing device”. The third computing device 231 b may comprise a processor and memory as well as the other components discussed for the first computing device 100. As explained, the method may be performed by the first computing device 100 alone or by the first computing device 100 and the second computing device 231 a together. In particular, the second computing device 231a may be configured to control the carrier 270, while the third computing device 231 b may not. In some examples, the method may be performed by the first computing device 100 together with the second computing device 231 a and/or the third computing device 231 b.
The second computing device 231 a is configured to control the first analyser 230a, in particular its pipettor 232a, while the third computing device 231 b is configured to control the second analyser 230b, in particular its pipettor 232b.
The first analyser 230a and the second analyser 230b may be different from each other in that they may be configured to carry out different clinical tests. For instance, the first
analyser 230a may be a chemistry analyser and the second analyser 230b may be an immunoassay analyser.
In an example not shown, the laboratory instrument 400 comprising two analysers 230a, 230b may also comprise the computing device 100, similarly to what shown in Figure 1 b.
Figure 3 shows a flow chart of an exemplary method 500a for determining the processing of a sample container within a laboratory instrument 400 comprising one analyser 230.
The first computing device 100 accesses test order data at step 510, wherein the test order data comprise information specifying a plurality of clinical tests to be carried out on a biological sample contained in the sample container. For instance, the test order data comprise a list of test identifiers in the form of alphanumeric strings. For example, the first computing device 100 may read a barcode on the sample container and retrieve the test order data from a remote computer by using the information contained in the barcode. For example, the remote computer is located where the biological sample was taken from the subject. Optionally, the first computing device 100 may access biological sample data at step 510.
The first computing device 100 and/or the second computing device 231 cause the analyser 230 to carry out the plurality of clinical tests.
Each clinical test is associated with a set of retain conditions and, thus, the sample container is associated with a plurality of sets of retain conditions. Each set of retain conditions associated with a respective clinical test comprises a condition that one or more rules require that one or more supplementary tests shall be carried out whenever one or more supplementary test conditions on the respective clinical test are met.
Then, the first computing device 100 accesses rule data at step 515, wherein the rule data comprise one or more rules for the laboratory instrument 400. In particular, the
rule data may or may not comprise rules associated with the clinical tests specified in the test order data.
Figures 4a to 4d show examples of rules. According to the rule shown in Figure 4a, whenever the result of the primary clinical test identified as T 1 has flags “HH” and “LL”, a supplementary test should be carried out. In this case the supplementary test is the clinical test identified as T1 , which, if the result has flags “HH” and “LL”, shall be carried out a second time. In other words, this rule requires a rerun of the primary clinical test.
According to the rule shown in Figure 4b, whenever the result of the primary clinical test identified as T2 has a value greater than 100, a supplementary test should be carried out, namely the reflex test identified as T3. According to the rule shown in Figure 4c, whenever the result of the primary clinical test identified as T4 has a value greater than 150, two supplementary tests should be carried out, namely the reflex test identified as T5 and the reflex test identified as T6. According to the rule shown in Figure 4d, whenever the result of the primary clinical test identified as T7 has a value greater than 300, the supplementary test identified as T8 should be performed three times.
Returning to Figure 3, using the test order data and the rule data, the first computing device 100 determines, at step 520, whether at least one set of retain conditions among the plurality of sets of retain conditions associated with the sample container is met.
In an illustrative example, the plurality of clinical tests specified by the test order data may be T1 , T4 and T9 and the rule data may comprise the rules of Figures 4a to 4d.
In a first exemplary case, each set of retain conditions comprises only the rule condition. In other words, each set of retain conditions consists of the condition that there exists a rule is associated with the clinical test that introduces the possibility of having to run one or more supplementary tests. In this first exemplary case, the set of retain conditions associated with test T1 is met because there is a rule that prescribes that the test T1 should be rerun if a given condition on the result of T1 is met. The set of retain conditions associated with test T4 is also met because there is a rule that
prescribes that reflex tests T5 and T6 should be run if a given condition on the result of T4 is met. The set of retain conditions associated with test T9 is not met because there is no rule associated with T9. Since at least one set of retain conditions is met (specifically, two sets), the determination of step 520 is affirmative. It should be noted that, if the first computing device 100 makes the determination for one set at the time, it may stop after finding the first set of retain conditions that is met.
In a second exemplary case, each set of retain conditions comprises the rule condition and a probability condition. It can be seen that the rules of Figures 4a-4d comprise result conditions (i.e. conditions on the result of the primary clinical test) that, when met, trigger the execution of one or more supplementary tests. The probability condition is the condition that the probability that the result of the clinical test satisfies the result condition exceeds a probability threshold. For instance, the probability threshold may be the same for all clinical tests, such as 60% (or 0.6).
In this second exemplary case, the first computing device 100 first determines whether the rule condition in each set of retain conditions is met and, if so, determines whether the corresponding probability condition is met. In particular, the first computing device 100 obtains probability data, wherein the probability data comprise information specifying a probability that a result of a clinical test meets the result condition. Specifically, the first computing device 100 obtains the probability data for those tests for which the rule condition is met, in this case T1 and T4. For instance, the probability data for test T 1 may state that there is a probability of 40% that the result of T 1 has the flag HH, LL, while the probability data for test T4 may state that there is a probability of 70% that the result of T4 has value greater than 150.
The first computing device 100 then uses the probability data to determine whether the probability conditions in the sets of retain conditions are met. The probability condition for test T1 is not met (because 40%<60%), while the probability condition for test T4 is met (since 70%>60%). Therefore, the set of retain conditions for T1 is not met (rule condition is met, but probability condition is not met), the set of retain conditions for T4 is met (both rule condition and probability condition are met) and the set of retain conditions for T9 is not met (rule condition is not met, probability condition is not even
checked). Since at least one set of retain conditions is met (specifically, one set), the determination of step 520 is affirmative.
A third exemplary case may be identical to the second exemplary case, except that the probability data for test T4 state that there is a probability of 30% that the result of T4 has value greater than 150. In this case, no set of retain conditions associated with the sample container is met, so that the determination of step 520 is negative.
Depending on whether the determination at step 520 is affirmative or not, the sample container may be released or retained after the pipettor 232 of the analyser 230 has drawn a volume of the biological sample. The determination of step 520 may be done upstream, e.g. before or as soon as the sample container is loaded in the laboratory instrument 400, or may be done right after the pipettor 232 has completed its operation.
A negative determination at step 520 corresponds to a determination that a first release condition is met, wherein the first release condition is the condition that all sets of retain conditions associated with the sample container are not met. Specifically, if the determination at step 520 is negative, the first computing device 100 causes the release of the sample container to be initiated at step 570 by causing the sample container to be moved to the loading/unloading area 220. If the first computing device 100 is comprised in the laboratory instrument 400, it may directly control the carrier 270 to move the sample container to the loading/unloading area 220. If the first computing device 100 is external to the laboratory instrument 400, it may instruct the second computing device 231 to control the carrier 270 to move the sample container to the loading/unloading area 220. In particular, the sample container may be moved from the queue area 210 to the loading/unloading area 220.
If the determination at step 520 is affirmative, the first computing device 100 causes the sample container to be retained within the laboratory instrument 400 at step 530 by causing the sample container to be moved to the buffer area 260. If the first computing device 100 is comprised in the laboratory instrument 400, it may directly control the carrier 270 to move the sample container to the buffer area 260. If the first computing device 100 is external to the laboratory instrument 400, it may instruct the
second computing device 231 to control the carrier 270 to move the sample container to the buffer area 260.
Whenever the sample container is retained, i.e. after step 530, the first computing device 100 accesses at step 535 test result data containing the results of the plurality of clinical tests carried out by the analyser 230, e.g. tests T1 , T4 and T9. Then, at step 540, the first computing device 100 determines whether according to the one or more rules, at least one supplementary test shall be carried out. In particular, the first computing device 100 verifies whether the results of the clinical tests satisfy the respective result conditions.
Continuing with the illustrative example discussed above, in a fourth exemplary case, the test result data may contain the following results: for test T1 , the result is 1000 and has the flag HH associated with it; for test T4, the result is 200; and for test T9, the result is 10. Based on the rule in Figure 4a, test T1 shall be rerun and based on the rule in Figure 4c, reflex tests T5 and T6 shall be run. Thus, three supplementary tests shall be carried out. Accordingly, the determination at step 540 is affirmative.
In a fifth exemplary case, the test result data may contain the following results: for test T1 , the result is 1000 and has the flag HH associated with it; for test T4, the result is 100; and for test T9, the result is 10. Based on the rule in Figure 4a, test T1 shall be rerun and based on the rule in Figure 4c, no reflex tests shall be run. Thus, one supplementary test shall be carried out. Accordingly, the determination at step 540 is affirmative.
In a sixth exemplary case, the test result data may contain the following results: for test T1 , the result is 300 and does not have the flag HH associated with it; for test T4, the result is 100; and for test T9, the result is 10. Based on the rule in Figure 4a, test T1 shall not be rerun and based on the rule in Figure 4c, no reflex tests shall be run. Thus, no supplementary test shall be carried out. Accordingly, the determination at step 540 is negative.
Depending on whether the determination at step 540 is affirmative or not, the sample container may be released or further processed after having been held at the buffer area 260.
A negative determination at step 540 corresponds to a determination that a second release condition is met, wherein the second release condition is the condition that according to the one or more rules, none of the one or more supplementary tests shall be carried out for any clinical test of the plurality of clinical tests. Specifically, if the determination at step 540 is negative, the first computing device 100 causes the release of the sample container to be initiated at step 570 by causing the sample container to be moved to the loading/unloading area 220, as explained above. In particular, the sample container may be moved from the buffer area 260 to the loading/unloading area 220.
If the determination at step 540 is affirmative, the first computing device 100 causes at step 550 the one or more supplementary tests that shall be carried out to be actually carried out by the laboratory instrument 400. In particular, the first computing device 100 may cause the sample container to be moved from the buffer area 260 to the queue area 210 and the analyser 230 to perform the one or more supplementary tests. In particular, the first computing device 100 may instruct the second computing device 231 to control the analyser 230 to perform the one or more supplementary tests. Thus, the analyser 230 performs the one or more supplementary tests.
If the first computing device 100 is comprised in the laboratory instrument 400, it may directly control the carrier 270 to move the sample container to the queue area 210 from the buffer area 260. If the first computing device 100 is external to the laboratory instrument 400, it may instruct the second computing device 231 to control the carrier 270 to move the sample container to the queue area 210 from the buffer area 260.
Figure 5 shows a flow chart of an exemplary method 500b for determining the processing of a rack holding a plurality of sample containers within a laboratory instrument 400 comprising one analyser 230. The method 500b is substantially the same as the method 500a discussed above, with the difference that the plurality of
sample containers, since they are in the same rack, can only be handled together, as a whole. Accordingly, a decision on whether to retain or release the rack has to take into account the circumstances of all sample containers. Hence, the method 500b will be briefly discussed below focussing on the differences with method 500a.
The first computing device 100 accesses test order data at step 510 and rule data at step 515, as discussed. In this case, the first computing device 100 accesses test order data for each sample container in the rack.
At step 555, the first computing device 100 determined whether at least one set of retain conditions associated with at least one sample container in the rack is met. In other words, the check of the sets of retain conditions discussed above is performed for each sample container in the rack, or at least for each sample container until a sample container having at least one met set of retain conditions is found.
Depending on whether the determination at step 555 is affirmative or not, the rack may be released or retained after the pipettor 232 of the analyser 230 has drawn a volume of biological samples from each sample container in the rack.
A negative determination at step 555 corresponds to a determination that the first release conditions for the rack are met, namely that, for each sample container, all sets of retain conditions associated with said each sample container are not met. Specifically, if the determination at step 560 is negative, the first computing device 100 causes the release of the rack to be initiated at step 560 by causing the rack to be moved to the loading/unloading area 220, similarly to step 570 but with the rack instead of a single sample container.
If the determination at step 555 is affirmative, the first computing device 100 causes the rack to be retained within the laboratory instrument 400 at step 585 by causing the rack to be moved to the buffer area 260. In the case of the rack, it is sufficient for one sample container in the rack to have at least one set of retain conditions met for the whole rack to be retained.
Whenever the rack is retained, i.e. after step 585, the first computing device 100 accesses, at step 535, test result data containing the results of the plurality of clinical tests carried out by the analyser 230 on the biological samples contained in the rack. Then, at step 540, the first computing device 100 determines whether, according to the one or more rules, at least one supplementary test shall be carried out. In particular, the check of the result conditions comprised in the rules discussed above is performed for each sample container in the rack.
Depending on whether the determination at step 540 is affirmative or not, the rack may be released or further processed after having been held at the buffer area 260.
A negative determination at step 540 corresponds to a determination that the second release conditions for the rack are met, i.e. none of the one or more supplementary tests shall be carried out for any clinical test of any sample container. Specifically, if the determination at step 540 is negative, the first computing device 100 causes the release of the rack to be initiated at step 560 by causing the rack to be moved to the loading/unloading area 220, as explained above. In particular, the rack may be moved from the buffer area 260 to the loading/unloading area 220.
If the determination at step 540 is affirmative, the first computing device 100 causes the one or more supplementary tests that shall be carried out to be actually carried out by the laboratory instrument 400, as explained above. In this case, the whole rack is retained within the laboratory instrument 400 and is moved from the buffer area 260 to the queue area 210, if at least one sample container in the rack holds a sample on which at least one supplementary test shall be carried out.
Figures 6a to 6d show a flow chart of an exemplary method for determining the processing of a rack holding a plurality of sample containers within a laboratory instrument 400 comprising two analysers 230a, 230b. The same principles of the methods 500a and 500b apply, with the difference that the clinical tests to be carried out on the biological samples contained in the sample containers may be carried out by two analysers 230a, 230b of the laboratory instrument 400. This implies that the
rack may be transported between the analysers 230a and 230b, more specifically between their respective queue areas 210a and 210b.
Starting with Figure 6a, the first computing device 100 accesses test order data at step 610 and rule data at step 615, as done in steps 510 and 515 of the method 500b, respectively. At step 620, the first computing device 100 determines whether the clinical tests to be carried out on the plurality of biological samples contained in the respective plurality of sample containers are to be carried out by the first analyser 230a, or the second analyser 230b, or both analysers 230a and 230b.
More specifically, the first computing device 100 determines whether condition A and condition B are met. As shown in figure 6a, condition A is the condition that the test order data of at least one sample container in the rack comprise one or more tests to be carried out by the first analyser 230a and condition B is the conditions that the test order data of at least one sample container in the rack comprise one or more tests to be carried out by the second analyser 230b. In other words, if a total of Zclinical tests has to be carried out on the biological samples in the rack taken all together, the first computing device 100 checks whether at least one clinical test of the Z tests is meant to be carried out by the first analyser 230a and whether at least one clinical test of the Z tests is meant to be carried out by the second analyser 230b.
If the test order of at least a sample container comprises at least a test to be carried out by the first analyzer, at step 620 the first computing device 100 further determines whether condition C is met, i.e. whether at least a set of retain conditions associated with a test to be carried out by the first analyser 230a is met. The determination of whether condition C is met corresponds to the determination of step 555 of the method 500b; it is, thus, determined whether, for at least a sample container in the rack, there is at least one set of retain conditions associated with a test to be carried out by the first analyser 230a that is met.
If the test order of at least a sample container comprises at least a test to be carried out by the second analyzer, at step 620 the first computing device 100 further determines whether condition D is met, i.e. whether at least a set of retain conditions
associated with a test to be carried out by the second analyser 230a is met. The determination of whether condition D is met corresponds to the determination of step 555 of the method 500b; it is, thus, determined whether, for at least a sample container in the rack, there is at least one set of retain conditions associated with a test to be carried out by the second analyser 230a that is met.
When there is at least one clinical test to be performed by the first analyser 230a and there is no test to be performed by the second analyser 230b, the first computing device 100 causes at step 625 the first analyser 230a to carry out the one or more tests it is configured to carry out. In particular, the first computing device 100 may cause the rack to be moved to the first queue area 210a and the analyser 230a to perform the one or more tests. In particular, the first computing device 100 may instruct the second computing device 231 a to control the first analyser 230a to perform the one or more clinical tests. Thus, the first analyser 230a performs the one or more clinical tests. If the first computing device 100 is comprised in the laboratory instrument 400, it may directly control the carrier 270 to move the rack to the first queue area 210a, e.g. from the loading/unloading area 220. If the first computing device 100 is external to the laboratory instrument 400, it may instruct the second computing device 231 a to control the carrier 270 to move the rack to the first queue area 210a from the loading/unloading area 220.
If condition C is not met, the first computing device 100 causes at step 640 the release of the rack to be initiated, as in step 560 discussed above. If condition C is met, the method proceeds to step 650 of Figure 6b. At step 650, the first computing device 100 causes the rack to be retained within the laboratory instrument 400 by causing the rack to be moved to the buffer area 260, as in step 585. Steps 651 to 654 of Figure 6b correspond to steps 535, 540, 560 and 550 of Figure 5, respectively, wherein the analyser in question is the first analyser 230a.
Going back to step 620 in Figure 6a, when there is no clinical test to be performed by the first analyser 230a and there is at least one test to be performed by the second analyser 230b, the first computing device 100 causes at step 635 the second analyser 230b to carry out the one or more tests it is configured to carry out. In particular, the
first computing device 100 may cause the rack to be moved to the second queue area 210b and the analyser 230b to perform the one or more tests. In particular, the first computing device 100 may instruct the third computing device 231 b to control the analyser 230b to perform the one or more clinical tests. Thus, the analyser 230b performs the one or more clinical tests. If the first computing device 100 is comprised in the laboratory instrument 400, it may directly control the carrier 270 to move the rack to the second queue area 210b, e.g. from the loading/unloading area 220. If the first computing device 100 is external to the laboratory instrument 400, it may instruct the second computing device 231 a to control the carrier 270 to move the rack to the second queue area 210b from the loading/unloading area 220. If condition D is not met, the first computing device 100 causes at step 640 the release of the rack to be initiated, as in step 560 discussed above. If condition D is met, the method proceeds to step 660 of Figure 6c. At step 660, the first computing device 100 causes the rack to be retained within the laboratory instrument 400 by causing the rack to be moved to the buffer area 260, as in step 585. Steps 661 to 664 of Figure 6b correspond to steps 535, 540, 560 and 550 of Figure 5, respectively, wherein the analyser in question is the second analyser 230b.
Going back to step 620 in Figure 6a, when there is at least one test to be performed by the first analyser 230a and there is at least one test to be performed by the second analyser 230b, the first computing device 100 causes at step 630 the first analyser 230a to carry out the one or more tests it is configured to carry out and the second analyser 230b to carry out the one or more tests it is configured to carry out. In particular, the first computing device 100 may cause:
- the rack to be moved to the first queue area 210a;
- the first analyser 230a to perform the one or more clinical tests;
- optionally, the rack to be moved to the buffer area 260;
- the rack to be moved to the second queue area 210b; and
- the second analyser 230b to perform the one or more clinical tests.
As discussed above, the first computing device 100 may directly control the carrier 270 or indirectly via the second computing device 231 a. Step 630 may comprise a combination of steps 625 and 635.
If neither condition C nor condition D is met, the first computing device 100 proceeds to step 640, causing the release of the rack to be initiated. If condition C is met and condition D is not met, the method proceeds to step 650 of Figure 6b and continues as described above. If condition C is not met and condition D is met, the method proceeds to step 650 of Figure 6c and continues as described above.
If both condition C and condition D are met, the method proceeds to step 670 of Figure 6d. At step 670, the first computing device 100 causes the rack to be retained within the laboratory instrument 400 by causing the rack to be moved to the buffer area 260, as in step 585. Then the first computing device 100 accesses at step 671 test result data containing the results of the one or more clinical tests carried out by the first analyser 230a as well as the results of the one or more clinical tests carried out by the second analyser 230b.
Then, at step 672, the first computing device 100 determines whether, according to the one or more rules, at least one supplementary test shall be carried out by the first analyser 230a and and/or at least one supplementary test shall be carried out by the second analyser 230b, similarly to step 540.
If no supplementary test shall be carried out by the laboratory instrument 400, i.e. either by the first analyser 230a or by the second analyser 230b, the first computing device 100 causes at step 674 the release of the rack to be initiated, as in step 640.
If there is at least one supplementary test shall be carried out by the first analyser 230a, the first computing device 100 proceeds to step 673, causing the first analyser 230a to carry out said at least one supplementary test. In particular, the first computing device 100 may cause the rack to be moved to the first queue area 210a e.g. from the buffer area 260 and the first analyser 230a to perform the at least one supplementary test.
If there is also at least one supplementary test that shall be carried out by the second analyser 230b, after step 673 the first computing device 100 causes at step 675 the second analyser 230b to carry out said at least one supplementary test. In particular,
the first computing device 100 may cause the rack to be moved to the second queue area 21 Ob (e.g. from the first queue area 21 Oa via the buffer area 260) and the second analyser 230b to perform the at least one supplementary test.
If there is no supplementary test that shall be carried out by the first analyser 230a but there is at least one supplementary test that shall be carried out by the second analyser 230b, after step 672 the first computing device 100 proceeds directly to step 675.
In some examples, at step 620, the first computing device 100 determines whether the test order data of at least one sample container in the rack comprise one or more tests to be carried out by the first analyser 230a and whether the test order data of at least one sample container in the rack comprise one or more tests to be carried out by the second analyser 230b. In these examples:
• If condition A is met and condition B is not, the determination of whether condition C is met may be carried out at the same time or after step 625;
• If condition A and condition B are met, the determination of whether condition C and condition D are met may be carried out at the same time or after step 630; and
• If condition A is not met and condition B is met, the determination of whether condition D is met may be carried out at the same time or after step 635.
In all examples described above, the first computing device 100 may, after the supplementary tests have been carried out (namely after step 550 or 654 or 664 or 675), cause the release of the rack/sample container to be initiated.
Claims
1 . A method comprising: accessing, by a computing device, test order data, wherein the test order data comprise information specifying a set of clinical tests to be carried out by a laboratory instrument on a biological sample contained in a sample container, wherein each clinical test is associated with a set of retain conditions so that the sample container is associated with one or more sets of retain conditions; determining, by the computing device, whether at least one set of retain conditions associated with the sample container is met; and if at least one set of retain conditions associated with the sample container is met, causing, by the computing device, the sample container to be retained in the laboratory instrument; wherein each set of retain conditions associated with a respective clinical test comprises a condition that one or more rules require that one or more supplementary tests shall be carried out whenever one or more supplementary test conditions on the respective clinical test are met.
2. The method according to claim 1 , wherein causing the sample container to be retained in the laboratory instrument comprises: instructing, by the computing device, the laboratory instrument to retain the sample container in the laboratory instrument.
3. The method according to claim 1 or 2, wherein the method further comprises: retaining the sample container in the laboratory instrument.
4. The method according to any one of the preceding claims, wherein the method further comprises: determining, by the computing device, whether one or more first release conditions are met; and if the one or more first release conditions are met, causing a release of the sample container to be initiated;
wherein the one or more first release conditions comprise the condition that all sets of retain conditions associated with the sample container are not met.
5. The method according to claim 4, wherein: the sample container is accommodated in a rack; the rack further accommodates one or more additional sample containers; and the one or more first release conditions further comprise, for each additional sample container, the condition that all sets of retain conditions associated with said each additional sample container are not met.
6. The method according to any one of the preceding claims, wherein the one or more supplementary test conditions on a first clinical test of the set of clinical tests comprise at least a result condition on a result of the first clinical test.
7. The method according to claim 6 further comprising: obtaining, by the computing device, probability data, wherein the probability data comprise information specifying a probability that a result of the first clinical test meets the result condition; and determining, by the computing device, by using the probability data, whether the probability that the result of the first clinical test satisfies the result condition exceeds a probability threshold; wherein the set of retain conditions associated with the first clinical test further comprises the condition that the probability that the result of the first clinical test satisfies the result condition exceeds the probability threshold.
8. The method of claim 7, wherein obtaining the probability data comprises: accessing history data, the history data comprising information specifying how often the result condition is met; and generating the probability data by using the history data.
9. The method of claim 7 or 8, wherein the probability threshold is selected among a plurality of predetermined probability thresholds based on one or more selection criteria, the one or more selection criteria comprising information specifying any or any
combination of: the laboratory instrument, a laboratory configured to carry out the first clinical test, a priority of the biological sample.
10. The method according to any one of the preceding claims, further comprising: determining, whether, for at least one clinical test, according to the one or more rules associated with said at least one clinical test, at least one supplementary test of the one or more supplementary tests shall be carried out; and if the at least one supplementary test of the one or more supplementary clinical tests shall be carried out, causing, by the computing device, the at least one supplementary test of the one or more supplementary tests to be carried out.
1 1. The method according to claim 10, wherein, if one or more second release conditions are met, the method further comprises: causing, by the computing device, a release of the biological sample to be initiated; wherein the one or more second release conditions comprise the condition that, according to the one or more rules, none of the one or more supplementary tests shall be carried out for any clinical test of the set of clinical tests.
12. A computing device comprising a processor configured to perform the method of any one of claims 1 to 1 1 .
13. A laboratory instrument configured to perform one or more clinical tests on a biological sample, wherein the laboratory instrument comprises the computing device according to claim 12 when dependent on any one of claims 1 and 3 to 1 1 .
14. A computer program product comprising instructions which, when the program is executed by a computer, cause the computer to carry out the steps of any one of the methods of claims 1 to 11 .
15. A computer-readable storage medium comprising instructions which, when executed by a computer, cause the computer to carry out the steps of any one of the methods of claims 1 to 11 .
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202363447106P | 2023-02-21 | 2023-02-21 | |
| PCT/US2024/016451 WO2024177962A1 (en) | 2023-02-21 | 2024-02-20 | Method and instrument for testing a volume of a biological sample |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| EP4670174A1 true EP4670174A1 (en) | 2025-12-31 |
Family
ID=90468735
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP24714085.8A Pending EP4670174A1 (en) | 2023-02-21 | 2024-02-20 | METHOD AND INSTRUMENT FOR TESTING A VOLUME OF A BIOLOGICAL SAMPLE |
Country Status (3)
| Country | Link |
|---|---|
| EP (1) | EP4670174A1 (en) |
| CN (1) | CN120380547A (en) |
| WO (1) | WO2024177962A1 (en) |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP5378859B2 (en) * | 2009-03-30 | 2013-12-25 | シスメックス株式会社 | Sample testing system |
| EP3139222B1 (en) * | 2015-09-04 | 2022-04-13 | F. Hoffmann-La Roche AG | Analytical test management system and method |
| WO2022195582A1 (en) * | 2021-03-15 | 2022-09-22 | G.T.A.I Innovation Ltd. | A method and apparatus for lab tests |
-
2024
- 2024-02-20 WO PCT/US2024/016451 patent/WO2024177962A1/en not_active Ceased
- 2024-02-20 CN CN202480005662.XA patent/CN120380547A/en active Pending
- 2024-02-20 EP EP24714085.8A patent/EP4670174A1/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| WO2024177962A1 (en) | 2024-08-29 |
| CN120380547A (en) | 2025-07-25 |
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