Method and apparatus for sampling volume of biological sample for testing

Abstract

According to the invention, a method is provided. The method includes accessing test indication data, where the test indication data includes information specifying a clinical test set to be performed on a biological sample, where the clinical test set includes at least a clinical test, and the biological sample is contained in a sample container; obtaining test volume data by using the test indication data, where the test volume data includes information specifying a test volume; and instructing a pipetting device of the laboratory instrument to draw a draw volume of the biological sample from the sample container, the draw volume based on the test volume data; wherein the test volume is the volume of the biological sample required to perform the following tests: clinical test; and one or more supplemental tests associated with the clinical test, each time the one or more test volume conditions associated with the clinical test are met, the one or more test volume conditions include a condition that the one or more rules require that one or more supplemental tests should be performed whenever one or more supplemental test conditions with respect to the clinical test are met.

Description

[0001] Related Applications

[0002] This application is related to and claims the benefit of Provisional Patent Application No. 63 / 356,120, entitled “Method and Instrument for Drawing a Volume of a Biological Sample for Testing”, filed in the U.S. Patent Office on June 28, 2022. The provisional patent application is incorporated herein by reference in its entirety. Technical Field

[0003] The following description relates to the field of biological sample testing. Background Art

[0004] Analytical and clinical laboratories typically include laboratory instruments that are configured to automatically perform one or more clinical tests (eg, immunoassay tests) on biological samples (eg, blood samples).

[0005] Typically, when a tube containing a biological sample is introduced into a laboratory instrument, the instrument reads a barcode on the tube and queries a test indication based on the barcode (in a connected laboratory information system or in the local instrument console software). Upon receiving a test indication, the instrument draws a sample volume based on the volume required to perform the test in the test indication, as well as an additional volume (hereinafter also referred to as a "reserve volume"), which is used for possible rerun tests and / or possible reflex tests associated with the test in the test indication. After aspirating (also referred to as "drawing") the sample volume, the instrument immediately releases the tube so that it can be used for a different purpose (e.g., moved to another instrument).

[0006] In particular, the reflex test associated with the test in the test indication is a different test from the test in the test indication and is performed if the result of the test in the test indication meets one or more reflex criteria. For example, the reflex criteria may be specified in a rule that may be set by a user of the laboratory instrument, for example.

[0007] The reserve volume is a fixed, predetermined sample volume that is drawn to account for the possibility of having to rerun a test or run a reflex test. However, in conventional instruments, the draw of the reserve volume does not take into account whether the possibility of a rerun or reflex test is even anticipated. Thus, for tests that will not require a rerun or reflex test, sample volume may be wasted by drawing additional volume (the reserve volume).

[0008] Furthermore, typically, the reserve volume is a fixed amount that does not take into account the actual volume required to rerun a test or perform a possible reflex test. Thus, in some cases, the reserve volume may be insufficient to rerun a particular test or to run a particular reflex test, prompting the instrument to require the user to introduce additional sample volume into the instrument, thereby causing a delay in test processing as the tube needs to be rerouted to the instrument. Summary of the invention

[0009] An object of the present invention is to improve sample volume aspiration to reduce sample waste and improve the efficiency of sample testing.

[0010] The achievement of this object according to the invention is set forth in the independent claim. Further developments of the invention are the subject matter of the dependent claims.

[0011] According to a first aspect, a method is provided, such as a computer-implemented method. The method comprises:

[0012] - accessing test indication data, for example by a first computing device, wherein the test indication data comprises information specifying a clinical test set to be performed on the biological sample, wherein the clinical test set comprises at least a clinical test (hereinafter also referred to as a “first clinical test”), and the biological sample is contained in a sample container;

[0013] - obtaining test volume data, for example by the first computing device using the test indication data, wherein the test volume data comprises information specifying the test volume; and

[0014] - instructing a pipetting device of a laboratory instrument, for example by the first computing device, to extract a withdrawal volume of the biological sample from the sample container, the withdrawal volume being based on the test volume data;

[0015] Where test volume is the volume of biological specimen required to perform the following tests:

[0016] ○Clinical testing, and

[0017] o one or more supplemental tests associated with the clinical test if one or more test volume conditions associated with the clinical test are met,

[0018] Therein, the one or more test volume conditions include the following condition: one or more rules require that one or more supplementary tests should be performed if one or more supplementary test conditions regarding the clinical test are met.

[0019] According to the present invention, the computing device may include at least one memory and at least one processor. The computing device may also include one or more input / output units. In particular, the computing device may include multiple processors and / or multiple memories. According to the present invention, the computing device (e.g., the first computing device) may be a distributed computing system (e.g., a computing network). For example, the first computing device may include a computing device integrated with a laboratory instrument and another computing device remote from the computing device integrated with the laboratory instrument.

[0020] In particular, the first computing device accesses test indication data comprising information specifying a set of clinical tests to be performed on the biological sample according to one or more rules, wherein the clinical test set comprises at least a clinical test and the biological sample is contained in a sample container.

[0021] A biological sample (or simply "sample") can be a sample of a body fluid of a human or animal subject. For example, the body fluid can be a physiological fluid, such as blood, saliva, urine, sweat, amniotic fluid, cerebrospinal fluid, ascites, etc. The biological sample can be placed in a sample container after collection and can be kept in the container during processing. The sample container can be a sample tube. Typically, the sample tube includes a closed tube end and an end opposite thereto. The latter end defines an opening for inserting the sample into the sample tube. The opening can be closed, for example, sealed, by a cover.

[0022] A clinical test may include one or more procedures that, when performed on a biological sample, allow the value of a parameter (e.g., a clinical parameter) to be estimated. In particular, a clinical test may include a physical procedure, a biological procedure, an optical procedure, a mechanical procedure, an immunological procedure, and / or a chemical procedure. Exemplarily, a clinical test may be an immunoassay test.

[0023] Typically, a set may include one or more elements. Thus, a clinical test set includes at least one clinical test, i.e., one or more clinical tests. In the following, the method will be described with reference to one clinical test, however it will be appreciated that if a clinical test set includes a plurality of clinical tests, the same applies to each clinical test in the clinical test set.

[0024] The test indication data may include a set of identifiers. In particular, each identifier in the set of identifiers uniquely identifies a corresponding clinical test in the clinical test set, wherein each identifier contains information specifying the corresponding clinical test. The identifiers in the set of identifiers may be alphanumeric strings. For example, the alphanumeric string "TSH" uniquely identifies a thyroid stimulating hormone test, and the string "Lp-PLA2" uniquely identifies a lipoprotein-associated phospholipase A2 test.

[0025] In the present disclosure, "accessing data" may include, for example, retrieving data from at least one memory of the first computing device, from a memory of another computing device, or from another remote data storage (database, secondary storage, cloud storage, etc.). Thus, in some cases, retrieving data may include downloading data.

[0026] Additionally or alternatively, "accessing data" may include, for example, receiving data from a user or a computing device different from the first computing device. These two options are not mutually exclusive. For example, accessing data may include receiving data, storing the data in a memory of the first computing device, and retrieving the data by accessing the memory.

[0027] Exemplarily, the sample container may include a mark (e.g., a barcode), such as a mark that may be securely fixed to the sample container, such as by means of an adhesive, such as a wall of the sample container or a lid of the sample container. The test indication data may be retrieved, for example, by the first computing device reading the mark data from the mark on the sample container. For this reason, the data reading unit may be included in the first computing device or may be functionally connected to the first computing device. The data reading unit may include an optical scanner configured to decode a barcode or a QR code. In another example, the mark may be an RFID tag, and the data reading unit may include an RFID reader.

[0028] In one example, the test indication data may be completely included in the label data or consistent with the label data. In this case, the test indication data is read "directly" from the sample container, which means that the information content of the test indication data is completely present on the sample container, more precisely, in the label.

[0029] In another example, the test indication data can be read "indirectly" from the sample container, which means that the sample container only acts as an intermediary between the source of the test indication data (e.g., a remote database) and the first computing device. In other words, the data reading unit can obtain a link (tag data) for retrieving the first data from the source from the tag. For example, a QR code on the sample tube can be scanned by the data reading unit to obtain such a link. In this case, the test indication data and the tag data are completely different.

[0030] In yet another example, a portion of the test indication data may be read directly, and another portion may be read indirectly. In this case, the test indication data may partially overlap with the tag data. For example, the tag data may include an identifier that identifies the clinical test, where the identifier is also part of the test indication data. By using the identifier stored in the tag, the first computing device may retrieve the remainder of the test indication data from another source (e.g., its own memory or a remote data storage device).

[0031] In particular, the laboratory instrument may be configured to process the sample according to one or more rules (hereinafter also referred to as “instrument rules”). In particular, a rule specifies one or more actions that the laboratory instrument needs to perform if one or more conditions are met.

[0032] For example, a rule may require that a laboratory instrument should perform a supplementary test if a corresponding supplementary test condition is met. In other words, if the supplementary test condition is met, the supplementary test is performed, and if the supplementary test condition is not met, the supplementary test is not performed. In some cases, a rule may require that multiple supplementary tests should be performed if one supplementary test condition is met. In other cases, a rule may require that multiple supplementary tests should be performed if multiple corresponding supplementary test conditions are met.

[0033] For example, a rule refers to a corresponding clinical test in the clinical tests that the laboratory instrument is configured to perform. If this is the case, the rule and the corresponding clinical test are associated with each other. Exemplarily, a rule may include: (i) information specifying the corresponding clinical test associated therewith, (ii) one or more supplementary tests, and (iii) one or more supplementary test conditions, which prompt the laboratory instrument to perform the one or more supplementary tests when the one or more supplementary test conditions are met.

[0034] A clinical test in a clinical test set may have zero, one, or more rules associated therewith. For example, at least one of the clinical tests that the laboratory instrument is configured to perform may not refer to any of the one or more rules. For example, two different rules may be associated with the same clinical test in the clinical tests that the laboratory instrument is configured to perform. Therefore, more specifically, some clinical tests in a clinical test set may be associated with at least a corresponding rule in the one or more rules, while some other clinical tests in the clinical test set are not associated.

[0035] Typically, a laboratory instrument can be configured to perform an instrument-specific clinical test set, for example according to one or more rules. An instrument-specific clinical test set is a set consisting of each clinical test that the instrument can perform. In particular, the clinical test set according to the first aspect of the invention is a subset, such as a true subset, of the instrument-specific clinical test set. In practice, the clinical test set includes those tests indicated for a specific sample, while the instrument-specific clinical test set includes all tests that the instrument can perform (e.g., depending on the configuration / design of the instrument).

[0036] More specifically, the laboratory instrument is configured to comply with each of the one or more rules when performing a clinical test, i.e., to perform one or more actions required by the rule if one or more conditions associated with the rule are satisfied. For example, the laboratory instrument is configured to: (i) evaluate the existence of one or more rules associated with the test, (ii) check whether one or more supplementary test conditions are satisfied, and (iii) perform one or more supplementary tests if one or more supplementary test conditions are satisfied when performing a clinical test in an instrument-specific clinical test set.

[0037] Since one or more supplementary test conditions are conditions on a clinical test associated with a rule, it can be said that one or more supplementary tests are associated with a clinical test. The latter may also be referred to as a "primary test". Therefore, a clinical test set may include one or more primary tests. In particular, a rule may require that one or more supplementary tests be performed by a laboratory instrument after the primary test associated therewith has been performed.

[0038] Supplementary tests are also clinical tests, but the execution of the supplementary test depends on the supplementary test condition being met, while the main test is always executed. In some examples, the execution of a supplementary test can depend on one supplementary test condition, while in other examples, the execution can depend on multiple supplementary test conditions. One or more supplementary tests can be associated with a clinical test.

[0039] As illustrated, one or more supplementary test conditions are conditions that trigger the execution of one or more supplementary tests when met. In the case where a clinical test meets certain criteria, one or more supplementary test conditions are met. In one example, one or more supplementary test conditions can be composed of the condition that the clinical test is a predetermined clinical test. In this case, each time the main test is run, the supplementary test will also be run. In another example, one or more supplementary test conditions can be composed of the result condition about the clinical test result. In other words, in the case where the clinical test result meets the result condition, the supplementary test is performed. Therefore, the rule can require that in the case of meeting the result condition about the clinical test result, the laboratory instrument should perform the supplementary test.

[0040] The execution of a clinical test may produce one or more results, wherein each result may be a numerical value or an alphanumeric string. The result condition may be a matching condition, according to which the result must be identical to a predetermined value or string. For example, the result of a primary clinical test may be the string "acceptable" or the string "unacceptable". If this is the case, the matching 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 must be less than or greater than a predetermined value, or the result must be within a predetermined range, i.e., between two predetermined values.

[0041] Exemplarily, the supplementary test may be a rerun test, i.e. the supplementary test may be consistent with the primary test. If this is the case, for example if the result indicates an abnormality (e.g. the result is outside a predetermined range), the primary test may be performed twice. Thus, in the event that the clinical test satisfies one or more supplementary test conditions, a rerun test is performed, that is, the clinical test is repeated.

[0042] Exemplarily, the supplementary test may be a reflex test, ie the supplementary test may be different from the primary test, and the supplementary test may be a clinical test performed, for example, to confirm the result of the primary test by different means or to disambiguate the result of the primary test.

[0043] In some examples, a rule in one or more rules may require that the same reflex test be performed multiple times. In this case, the reflex test may also be referred to as a "repeated reflex test". Thus, a rule may specify that a given supplemental test may be performed more than once.

[0044] In particular, one or more rules may be generated by a user of the laboratory instrument, for example to implement a workflow of a laboratory including the laboratory instrument. One or more rules may be generated by a user for the purpose of improving the reliability of a test result. For example, one or more rules may require a second test to be performed in case the result of a first test falls within a range of values ​​that makes the result uncertain and / or not reliable enough according to some reliability requirement.

[0045] The test volume data may include a numerical value indicating a volume value, for example expressed in cubic centimeters, milliliters or microliters, in particular, the volume value is the test volume. The test volume always takes into account the volume of the biological sample required to perform the first clinical test (which may be referred to as the "primary volume"). In other words, the test volume includes at least the primary volume.

[0046] The test volume may also take into account the volume of the biological sample required to perform one or more supplementary tests. In particular, this is the case when one or more test volume conditions associated with the first clinical test are met. The volume required to perform a given supplementary test may be referred to as a "supplementary volume". Therefore, when one or more test volume conditions are met, the test volume includes (in addition to the main volume) one or more supplementary volumes.

[0047] One or more test volume conditions include at least the following conditions: one or more rules require that one or more supplementary tests should be performed if their respective supplementary test conditions are met. In this document, the latter condition may also be referred to as: "rule condition". In particular, the rule condition is the existence of at least one of the one or more rules, which at least one rule: (i) is associated with the first clinical test, and (ii) introduces the possibility that a supplementary test must be run. In fact, as mentioned above, the first clinical test may be associated with a rule containing potential supplementary tests, or may not be associated.

[0048] Thus, the method may also be considered to include:

[0049] - accessing test indication data, e.g. by a first computing device, wherein the test indication data comprises information specifying a clinical test set to be performed on the biological sample, wherein the clinical test set comprises at least a clinical test (also referred to as a “first clinical test”), and the biological sample is contained in a sample container;

[0050] - obtaining, for example by the first computing device, test volume data by using the test indication data, wherein the test volume data comprises information specifying the test volume;

[0051] - instructing a pipetting device of a laboratory instrument, for example by the first computing device, to extract a withdrawal volume of the biological sample from the sample container, the withdrawal volume being based on the test volume data;

[0052] Where test volume is the volume of biological specimen required to perform the following tests:

[0053] ○Clinical testing, and

[0054] o one or more supplemental tests associated with the clinical test whenever one or more test volume conditions associated with the clinical test are met,

[0055] The one or more test volume conditions include the following condition: at least one rule is defined for the clinical test, wherein the rule requires that the one or more supplementary tests should be performed whenever one or more supplementary test conditions for the clinical test are met.

[0056] As mentioned above, the test volume may include an additional volume in addition to the volume required to run the first clinical test only if there is actually the possibility that further tests can be run. In particular, in such a case, the additional volume corresponds to the volume actually required to run one or more supplementary tests associated with the first clinical test.

[0057] In the present disclosure, "obtaining data" may include accessing data as discussed above. Alternatively, "obtaining data" may include generating data, such as creating data based on one or more inputs. In yet another example, "obtaining data" may include accessing a first portion of data and generating a second portion of data, such as from the first portion of data.

[0058] According to a first aspect of the invention, a pipetting device of a laboratory instrument is instructed, for example by a first computing device, to extract an extraction volume. In particular, the pipetting device of the laboratory instrument is instructed, for example by the first computing device, to extract an extraction volume of a biological sample from a sample container before performing a first clinical test.

[0059] A laboratory instrument may be configured to perform an instrument-specific set of clinical tests and may therefore be an analytical instrument. In particular, an analytical instrument (e.g., an analyzer) is an instrument configured to perform one or more analytical steps, such as measuring one or more characteristics of a sample, such as the concentration of a given analyte.

[0060] The laboratory instrument comprises a pipetting device configured to extract a portion of a biological sample from a sample container. In other words, the pipetting device is capable of contacting the biological sample contained in the sample container (e.g., by moving a mechanical arm and at least partially entering the sample container) and aspirating a portion of the biological sample (e.g., by means of a pipette).

[0061] Exemplarily, the first computing device may be included in a laboratory instrument and may be configured to control the operation of the laboratory instrument, and in particular, the operation of a liquid handling device of the laboratory instrument. Alternatively, the laboratory instrument may include another computing device (a second computing device). In this case, the first computing device may be remote from the laboratory instrument and configured to communicate with the second computing device, which is configured to control the laboratory instrument. In another example, as described above, the first computing device may be a distributed computing system including a computing device integrated with the laboratory instrument and another computing device remote from the computing device integrated with the laboratory instrument.

[0062] The extraction volume is based on the test volume data, in that the extraction volume is consistent with the test volume, or the extraction volume is calculated by using the test volume data. For example, in the case where the clinical test set includes only one clinical test (i.e., the first clinical test), the extraction volume can be consistent with the test volume. Alternatively, in the case where the clinical test set includes multiple clinical tests, the extraction volume can be calculated by adding the test volumes of all clinical tests.

[0063] In particular, according to the present invention, there are two possible situations that may unfold when a clinical test is to be performed on a biological sample. In the first case, whenever the first clinical test (in particular, the result of the first clinical test) satisfies one or more supplementary test conditions, one or more supplementary tests will also have to be performed, and whenever the first clinical test does not satisfy any supplementary test conditions, no supplementary test will be performed. In the second case, the first clinical test is performed, and the execution of one or more supplementary tests will not be triggered in any case.

[0064] According to the above method, the extraction volume provided to the laboratory instrument for aspiration corresponds to the amount of biological sample required for the laboratory instrument to perform the first clinical test, without the possibility of having to perform any supplementary test. In this way, the amount of unnecessary volume extracted from the biological sample is reduced, thereby reducing the amount of wasted biological sample (i.e., the amount of biological sample that is not used to perform the analytical test).

[0065] Conversely, in the event that there is a possibility that one or more supplementary tests must be performed, the extraction volume provided to the laboratory instrument for aspiration corresponds to the amount of biological sample that the laboratory instrument needs to perform the first clinical test and the one or more supplementary tests. Thus, in the event that a supplementary test does have to be performed, the laboratory instrument already has the amount of biological sample that it needs. Thus, there is no delay in processing the sample, which might otherwise be caused, for example, by having to reroute the sample container to the laboratory instrument.

[0066] Therefore, the method reduces sample waste and improves the efficiency of sample testing.

[0067] Exemplarily, the first clinical test may be associated with an identifier identifying the first clinical test (hereinafter also referred to as: "first identifier"). If this is the case, obtaining the test volume data may include querying a database using the first identifier.

[0068] More generally, where a laboratory instrument is configured to perform an instrument-specific set of clinical tests (eg, K clinical tests), then each of the K different identifiers is associated with a respective clinical test in the instrument-specific set of clinical tests.

[0069] In a first example, the database can be a relational table that associates each of K different identifiers with a corresponding volume value, wherein the volume is the volume required to perform the following tests: the clinical test associated with each of the identifiers; and the supplemental tests associated with the clinical test associated with each of the identifiers, when considered by one or more rules.

[0070] In this example, obtaining the test volume data may include accessing the test volume data, the test volume data consisting of a volume value associated with the first identifier. In this instance, the distinction between situations where the execution of the clinical test may cause the execution of the supplemental test and situations where the execution of the clinical test will never cause the execution of the supplemental test is implicit in the volume value. In other words, the distinction is made before the volume value is stored in the database (e.g., when the volume value is determined).

[0071] In a second example, the database may associate each of the K different identifiers with a corresponding first volume value and, in the event that the test associated with each identifier is associated with one or more supplementary tests, associate each identifier with at least a corresponding second volume value. In particular, the corresponding first volume value is the volume required to perform the clinical test associated with each identifier and, when present, the corresponding second volume value is the volume required to perform the supplementary test associated with the clinical test associated with each identifier.

[0072] In this example, obtaining the test volume data may include accessing the test volume data, the test volume data consisting of: a first volume value associated with the first identifier; and a second volume value associated with the first identifier whenever the test volume condition is met. Additionally, obtaining the test volume data may include generating the test volume data by adding the first volume value associated with the first identifier and the second volume value associated with the first identifier whenever the test volume condition is met.

[0073] In an example, a method according to the invention may include determining whether one or more test volume conditions are satisfied by using rule data.According to the invention, for example, the step of determining whether one or more test volume conditions are satisfied may be performed by a first computing device.

[0074] Exemplarily, obtaining the test volume data may include: accessing rule data, for example by the first computing device, the rule data including one or more rules; and determining whether one or more test volume conditions are satisfied by using the rule data.

[0075] The test indication data may include rule data, in which case the step of accessing the rule data may be included in the step of accessing the test indication data. Alternatively, the rule data may be separate from the test indication data. Exemplarily, the rule data may be accessed by using the test indication data, for example by retrieving the rule data associated with the first clinical test.

[0076] The rule data may include statements including strings and variables used to define the rules, such as in a specific data format or following a specific syntax (such as the syntax of a programming language). Determining whether one or more test volume conditions are satisfied may include parsing the rule data to identify whether at least one rule in the rule data (i) relates to a first clinical test, and (ii) requires that whenever one or more supplemental test conditions are satisfied, one or more supplemental tests should be performed.

[0077] Thus, in a third example, it is checked according to one or more rules whether the first clinical test will never trigger the execution of a supplementary test, or whether there is a possibility that one or more supplementary tests will be performed. In the latter case, and if one or more test volume conditions are met, the method may also include determining one or more supplementary tests associated with the clinical test. For example, the computing device may determine the one or more supplementary tests by using rule data (e.g., by parsing the rule data).

[0078] Greater flexibility is achieved by, for example, checking by the first computing device whether one or more test volume conditions are met rather than retrieving fixed values ​​from a database. In fact, different rules may be associated with the first clinical test, for example by different users and / or in different environments. In this example, the test volume is dynamically calculated each time the first clinical test is run, and the test volume is not hard-coded.

[0079] Exemplarily, the method according to the present invention may include: for example, accessing rule data by a first computing device; and for example, generating a database by using the rule data by the first computing device. In particular, the database may be the database of the first example and the second example described above. The step of creating a database may include determining whether one or more test volume conditions are met by using the rule data.

[0080] For example, in the case where the database is the database of the second example above, determining whether one or more test volume conditions are satisfied allows determining the volume value associated with the first identifier. In particular, in the case where the database is the database of the second example above, determining whether one or more test volume conditions are satisfied allows determining whether the database should store a second volume value associated with the first identifier, and in the affirmative, allows determining the value of the second volume.

[0081] In some examples (e.g., in the second example and in the third example), obtaining the test volume data may also include:

[0082] • obtaining a primary value indicative of a volume required to perform a first clinical test and at least a secondary value indicative of a volume required to perform one or more supplemental tests associated with the first clinical test; and

[0083] · Calculate the test volume by using the primary value and at least the secondary value.

[0084] In some examples, such as the second example, the primary value is a first value associated with the first identifier and the secondary value is a second value associated with the first identifier.

[0085] In particular, the step of obtaining the primary value and at least the secondary value may be performed if one or more test volume conditions are met. Thus, the step of calculating the test volume may be performed if one or more test volume conditions are met.

[0086] As already mentioned above, when the clinical test set includes multiple clinical tests, the steps described herein may be performed for each clinical test in the clinical test set. In particular, the method may be considered to include:

[0087] - accessing, by a computing device, test indication data, wherein the test indication data comprises information specifying a set of clinical tests to be performed on the biological sample according to one or more rules, wherein the clinical test set comprises a plurality of clinical tests and the biological sample is contained in a sample container;

[0088] - obtaining, by the computing device, test volume data by using the test indication data, wherein the test volume data includes information specifying a set of test volumes, each test volume in the test volume set corresponding to a respective clinical test in the clinical test set;

[0089] - obtaining, by a computing device, the extraction volume by using the test volume data; and

[0090] - the computing device instructs a pipetting device of the laboratory instrument to extract a biological sample of an extraction volume from the sample container;

[0091] Where, for each clinical test in the clinical test set, the corresponding test volume is the volume of the biological sample required to perform the following test:

[0092] ○ Each clinical test described, and

[0093] o whenever one or more test volume conditions associated with said each clinical test are met, one or more corresponding supplemental tests associated with said each clinical test,

[0094] The one or more test volume conditions associated with each of the clinical tests include the following condition: one or more rules require that whenever one or more corresponding supplementary test conditions for each of the clinical tests are met, one or more corresponding supplementary tests should be performed.

[0095] In particular, the extraction volume may be equal to the sum of the test volumes specified in the test volume data. More specifically, the clinical test set consists of N clinical tests C1, C2, ..., C N Composition and clinical testing C j (j=1, 2, ..., N) The associated test volume is V j In this case, for example, the extraction volume V d is read as follows:

[0096] According to an example, the one or more supplementary test conditions may include at least a result condition. According to an example, the method may further include:

[0097] - obtaining probability data, such as by a first computing device, wherein the probability data comprises information specifying a probability that a result of the first clinical test satisfies the result condition; and

[0098] - determining, for example by the first 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;

[0099] Among them, the one or more test volume conditions also include the following condition (hereinafter also referred to as a “probability condition”): the probability that the result of the first clinical test meets the result condition exceeds a probability threshold.

[0100] In particular, if one or more rules require that one or more supplementary tests should be performed if one or more supplementary test conditions with respect to the first clinical test are met, the steps of obtaining probability data and determining whether the probability that the result of the first clinical test satisfies the result condition exceeds a probability threshold can be performed.

[0101] The probability data may include a probability value, for example expressed as a percentage or as a real number between 0 and 1, indicating the probability that the result of the first clinical test satisfies the result condition. In particular, the probability value quantifies the likelihood that one or more supplementary tests will actually be performed.

[0102] In particular, determining whether the probability exceeds a probability threshold is equivalent to checking whether a probability condition is satisfied.

[0103] The probability threshold is a numerical value, which, like the probability, can be expressed as a percentage or a real number between 0 and 1. The probability threshold can be a fixed value that is always the same for the associated outcome condition, such as a hard-coded value.

[0104] In this example, one or more test volume conditions include at least two conditions, i.e., a rule condition and a probability condition. In addition to the possibility that only supplementary tests must be performed, the possibility that supplementary tests occur is also considered. Therefore, the method is more finely tuned, and in particular, the method can reduce sample waste by avoiding the pipetting device from extracting additional volume when additional volume is only needed in rare cases. More specifically, considering probability makes it possible to weigh the risk of sample waste with the efficiency of the test and determine a test volume that optimizes both.

[0105] In some examples, obtaining the probability data may include: accessing historical data including information specifying how often the outcome condition is met; and generating the probability data using the historical data.

[0106] The probability data may be data derived, for example, from the medical literature and / or from historical data, wherein the historical data includes information specifying how often the result of the first clinical test satisfies the result condition (i.e., how often the result of the first clinical test satisfies the result condition in past executions of the clinical test). Thus, the historical data may include a record of all the times the first clinical test was performed and a record of the results of the first clinical test in all of these instances. In addition to or as an alternative to the record of the results, the historical data may include statistical data about the results associated with the result condition, for example, a flag for each execution of the first clinical test indicating whether the result in that event satisfies the result condition.

[0107] Typically, historical data can be data collected from a previous execution of a clinical test and stored in, for example, a database (e.g., a local database or a cloud database). In some examples, historical data can be related to a single instrument (i.e., a laboratory instrument to which the pipetting device belongs). In other examples, historical data can be collected from multiple laboratory instruments that can perform clinical tests. Multiple laboratory instruments can include instruments within the same laboratory or instruments across different laboratories, such as within the same geographic region defined by a country or other administrative boundaries. These instruments are instruments of the same type configured to perform the first clinical test.

[0108] For example, the first computing device may determine a number indicating the number of times the outcome condition is met, such as by looking at the outcome itself or by looking at a flag, and calculate a probability value by dividing that number by the total number of times the clinical test has been performed.

[0109] In other examples, the probability data may have been previously derived from the medical literature and / or from historical data, and the first computing device may only have access to the probability data.

[0110] After obtaining the probability data, the first computing device can determine whether the probability that the result of the first clinical test satisfies the result condition exceeds a probability threshold by using the probability data. In other words, the probability is evaluated relative to the probability threshold, and whether the probability is greater than the probability threshold. Therefore, a comparison between two numerical values ​​is performed.

[0111] The use of historical data to generate probability data makes the estimate of probability more accurate. In particular, it can be more accurately determined in which cases it will be unlikely that a supplemental test will be performed, and therefore drawing a reserve volume is more likely to result in sample waste than not drawing it. Thus, a greater reduction in waste is achieved.

[0112] For example, the probability threshold can be dynamically selected, for example, based on the circumstances of the clinical test. In some examples, the probability threshold can be selected from a plurality of predetermined probability thresholds based on one or more selection criteria, the one or more selection criteria including information specifying any or any combination of the following: an instrument configured to perform the clinical test, a laboratory configured to perform the clinical test, a volume of the biological sample contained in the sample container, a category of the subject to which the biological sample belongs, a priority of the biological sample.

[0113] In particular, the method according to the first aspect of the invention comprises the following steps: selecting a probability threshold among a plurality of predetermined probability thresholds, for example by a first computing device, based on one or more selection criteria.

[0114] In particular, each predetermined probability threshold can be associated with one or more selection criteria, in that each time one or more selection criteria are applicable to a particular condition of performing the first clinical test by the laboratory instrument, the probability threshold will be selected as the predetermined probability threshold. Thus, the probability threshold can take different values ​​depending on the criteria applicable to a particular situation.

[0115] The selection criteria may include information related to the instrument on which the clinical test is to be performed, such as the model or manufacturer of the instrument. For example, when the model is an older model, it takes longer to receive / release a sample container and extract a certain volume of biological sample from 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 purpose of processing efficiency.

[0116] Another selection criterion may include information about the laboratory in which the clinical test will be performed, such as the size of the laboratory, which may be represented by various quantities (e.g., physical size, number of instruments, throughput). For example, in a laboratory with a larger size, the transport of sample containers may take significantly more time than in a laboratory of smaller size, such that rerouting sample containers may be undesirable. Therefore, for the purpose of processing efficiency, the probability threshold for a larger laboratory may be lower than the probability threshold for a smaller laboratory.

[0117] Another selection criterion may include information about the volumetric amount of the biological sample contained in the sample container.The probability threshold associated with a smaller available volume may be greater than the probability threshold associated with a larger available volume to avoid wasting precious biological material.

[0118] The same may apply to selection criteria related to the class of subject from which the biological sample is taken. The probability threshold associated with more fragile subjects may be greater than the probability threshold associated with less fragile subjects to avoid wasting precious biological material. For example, in the case of pediatric subjects, the probability threshold may be about 1 or 100%.

[0119] Conversely, samples with priority (eg, STAT samples) may have a lower probability threshold, such as approximately 0 or 0%, relative to samples without priority.

[0120] The plurality of probability thresholds and their associated criteria may be stored in a database. The first computing device may determine whether the selection criteria are applicable by accessing biological sample data, wherein the biological sample data may include information specifying characteristics of the biological sample (e.g., priority and / or volume of the sample, and / or subject category), and / or equipment data including information related to the instrument and the laboratory. Exemplarily, the biological sample data and the test indication data may form a single data set.

[0121] By having a probability threshold that varies depending on the circumstances of the clinical test, the determination of the test volume can be tailored to the specific circumstances.

[0122] In the case of multiple supplementary tests, the probability data may include multiple probability values, each probability value indicating the probability that the result of the first clinical test satisfies a corresponding result condition. For example, it may be the case that whenever the first clinical test is associated with multiple rules, each of the multiple rules specifies a corresponding result condition.

[0123] In particular, according to an example, the one or more supplementary tests consist of a plurality of supplementary tests. If one or more rules require that a plurality of supplementary tests should be performed if one or more supplementary test conditions regarding the first clinical test are met, the method may further include:

[0124] - obtaining probability data, for example by a first computing device, wherein the probability data comprises information specifying, for each of a plurality of supplementary tests, a respective probability that a result of the first clinical test satisfies a respective result condition; and

[0125] - determining, for example by the first computing device, by using the probability data and for each 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.

[0126] In this example, the one or more test volume conditions also include a condition that, for each of the plurality of supplemental tests, a probability that the result of the first clinical test satisfies the corresponding result condition exceeds a corresponding probability threshold.

[0127] There may be a single threshold that applies to all probabilities, eg, all respective probability thresholds are equal to each other, or there may be multiple thresholds, each applicable to a respective probability.

[0128] In an illustrative example, four supplementary tests {T1, T2, T3, T4} may be associated with the first clinical test, wherein the supplementary tests have respective supplementary volumes {V1, V2, V3, V4} and respective probabilities {0.9, 0.8, 0.4, 0.3} that the respective outcome conditions are met. The (single) threshold probability may be 0.5, so that only the probability conditions relating to the outcome conditions of T1 and T2 are met. Thus, the test volume VT will be given by the sum of the primary volumes VP, V1 and V2 for the first clinical test, i.e. VT=VP+V1+V2.

[0129] In addition to the rule condition and the probability condition (if any), one or more volume test conditions may include additional conditions. In an example, the volume test condition may include a condition on the volume of the biological sample contained in the sample container, and / or a condition on the category of the subject to which the biological sample belongs.

[0130] The condition on the volume of the biological sample contained in the sample container may require that the volume is greater than a volume threshold. Thus, in this case, if the available volume is too small, no additional volume may be drawn, for example, to avoid hindering further processing of the sample by collecting its entire volume.

[0131] The condition on the category of subject to which the biological sample belongs may require that the subject does not belong to a fragile category, such as elderly, pediatric, or chronic / long-term patients. Thus, ensuring that the amount of biological sample is not wasted in an attempt to save additional sample collection procedures for fragile subjects.

[0132] As discussed above, in some examples, obtaining test volume data includes determining whether one or more test volume conditions are satisfied. In the case of multiple test volume conditions, the different conditions can be checked one after another, for example, sequentially according to a hierarchy. The order in the hierarchy can be determined by the computational effort required to check a given condition, wherein the most computationally intensive conditions are located at the bottom of the hierarchy, i.e., are only checked last when needed, such as whenever a previously checked condition is satisfied. Additionally or alternatively, a second condition can be dependent on the first condition being satisfied, such that the second condition is lower in the hierarchy. For example, a probability condition depends on a rule condition.

[0133] In one example, the calculation can determine whether one or more test volume conditions are satisfied by checking the conditions in the following order: (i) (if any) a condition regarding the category of the subject; (ii) (if any) a condition regarding the volume of the biological sample contained in the sample container; (iii) a rule condition; and (iv) (if any) a probability condition.

[0134] In another example, the calculation can determine whether one or more test volume conditions are satisfied by checking the conditions in the following order: (i) a rule condition; (ii) (if any) a condition regarding the category of the subject; (iii) (if any) a condition regarding the volume of the biological sample contained in the sample container; and (iv) (if any) a probability condition.

[0135] In certain examples, the method may further include withdrawing a volume of the biological sample from the sample container via a pipetting device.

[0136] In an example, the method according to the first aspect of the invention may comprise the following steps: obtaining the extraction volume, for example by the first computing device, by using the test volume data. In this example, the extraction volume may be obtained by adding the test volume to the additional volume. In particular, the additional volume is the volume required to perform other tests in the instrument-specific test set, which are not included in the clinical test set. For example, the additional volume is the volume required to perform the following tests: each of these other tests, and when each test is associated with one or more corresponding supplementary tests, the corresponding supplementary tests.

[0137] A second aspect of the invention relates to a computing device comprising a processor configured to perform the method described so far. In particular, the first computing device is a computing device according to the second aspect of the invention.

[0138] Another aspect of the present invention relates to an analytical instrument configured to perform one or more clinical tests on a biological sample. At least one analytical instrument includes a computing device and a pipetting device according to the previous aspect. The computing device is configured to instruct the pipetting device to extract a biological sample of an extraction volume from a sample container, and the pipetting device is configured to extract a biological sample of an extraction volume from the sample container.

[0139] According to another aspect of the present invention, a computer program product is provided. The computer program product comprises instructions which, when executed by a computer, cause the computer to perform the method described herein. In particular, the computer may be a computing device according to the second aspect of the present invention.

[0140] Another aspect of the invention relates to a computer readable medium, for example a transitory computer readable medium, comprising instructions which, when executed by a computer, cause the computer to perform the method described herein. In particular, the computer may be a computing device. BRIEF DESCRIPTION OF THE DRAWINGS

[0141] The details of the exemplary embodiments are described below with reference to the exemplary drawings. Other features will become apparent from the description, drawings and claims. However, it should be understood that although the embodiments are described separately, individual features of different embodiments may be combined into other embodiments.

[0142] Figure 1 A schematic representation of an analytical instrument and a first computing device is shown.

[0143] Figure 2 A flow chart of a method for determining a volume to be extracted is shown.

[0144] Figure 3a to Figure 3c A flow chart of a method for obtaining a test volume is shown.

[0145] Figures 4a to 4d An example of a rule is shown.

[0146] Figure 5 A flow chart of a method for determining a volume to be extracted is shown.

[0147] Figure 6 A flow chart of a method for obtaining a test volume is shown. DETAILED DESCRIPTION

[0148] Hereinafter, a detailed description of the examples will be given with reference to the accompanying drawings. It should be understood that various modifications may be made to the examples. Unless otherwise expressly indicated, elements of one example may be combined and used in other examples to form new examples.

[0149] Figure 1Schematic representations of an analytical instrument 120 and a first computing device 100 are shown. In one example, the analytical instrument 120 includes the first computing device 100. In another example, the first computing device 100 is separate from the analytical instrument 120. In any case, the first computing device 100 is configured to control the analytical instrument 120, which is configured to analyze a biological sample.

[0150] Exemplarily, the first computing device 100 includes a processor 111 (e.g., a CPU, a GPU, etc.) and a memory 112. The processor 111 is configured to execute the method according to the first aspect of the present invention. The memory 112 may include a main memory and an auxiliary memory (not shown). In particular, the auxiliary memory stores a computer program including instructions, which, when executed by the processor 111, causes the first computing device 100 to execute the method according to the first aspect of the present invention. The first computing device 100 may also include an input-output (I / O) interface 110 for communicating with an input / output unit such as a screen, a keyboard, a touch screen, a printer, etc.

[0151] Additionally, the first computing device 100 may include a network interface controller (NIC) 114 configured to connect the device to one or more networks (eg, an intranet, the Internet, a cellular network, etc.) In other examples, the first computing device may include multiple NICs.

[0152] The first computing device 100 is in data communication 12 with the analytical instrument 120, for example by means of the NIC 114 or by other means. In particular, the first computing device 100 may be part of the analytical instrument 120, and the data transfer may occur via a bus.

[0153] The analysis instrument 120 is configured to receive a sample container 130 (eg, a sample tube) containing a biological sample 131. To this end, the analysis instrument 120 may include a holder 121 for holding the sample container 130, the holder including a recess 122 for inserting the sample container 130.

[0154] The analysis instrument 120 is also configured to extract a portion of the biological sample 131 from the sample container 130. To this end, the analysis instrument 120 may include a pipetting device, such as a pipette 123, which may be positioned along the vertical axis 140 corresponding to the recess 122. The pipette 123 includes a pipette 1231 for aspirating / dispensing fluid, and a motor 1232 for moving the pipette 1231 (particularly along the vertical axis 140) in the sample container 130 and retracting it.

[0155] The motor 1232 can also move the pipette 123 along the horizontal axis 141 so that the pipette can be positioned above other containers. In particular, the analytical instrument 120 can be equipped with at least one container 124 (referred to as a "sample container") for collecting the volume extracted from the sample container 130. In one example, the sample container 124 can contain the entire volume extracted from the biological sample 131. In other examples, the volume can be divided between the sample container 124 and another container 125. In particular, the container 124 can be designated for the main volume, while the container 125 can be designated for the supplementary volume.

[0156] The first computing device 100 is configured to execute Figure 2 At step 215, the first computing device 100 accesses the test indication data and obtains the test volume data at step 270, and then instructs the pipetting device 123 to extract the extraction volume from the sample container 130. Optionally, at step 210, the first computing device 100 may access the biological sample data.

[0157] The biological sample data at least comprises a value of the (initial) volume of the biological sample present in the sample container 130 (i.e. before any extraction volume is drawn from the sample container 130). Furthermore, the biological sample data may comprise one or more flags indicating other characteristics of the sample, such as whether the sample has a priority and / or whether the subject is a pediatric patient. The test indication data comprises at least a first identifier, which is associated with a first clinical test to be performed on the sample.

[0158] For example, the first computing device 100 can read a barcode on the sample container 130 and retrieve the test instruction data and the biological sample data from the remote computer using the information contained in the barcode. For example, the remote computer is located where the biological sample 131 is collected from the subject.

[0159] The first computing device 100 obtains the test volume data by using the test indication data, wherein the test volume data contains the value of the test volume, which is then used as the extraction volume of the pipetting device 123. The sample amount indicated by the test volume always includes the amount required to perform the first clinical test identified by the test indication data (i.e., the main volume). In addition, in some cases, the sample amount indicated by the test volume may also include the amount required to perform one or more supplementary tests (i.e., the supplementary volume). Specifically, these are situations where one or more test volume conditions are met.

[0160] exist Figure 3a to Figure 3cIn the example shown in , the first computing device 100 determines whether one or more test volume conditions are satisfied to obtain test volume data (step 270). The test volume condition common to these three examples is a rule condition, i.e., the following condition: one or more rules require that one or more supplementary tests be performed whenever the supplementary test condition is satisfied. In particular, the rule condition is satisfied whenever at least one of the one or more rules specifies one or more supplementary tests associated with the first clinical test. In other words, the first computing device 100 checks whether there is a possibility that one or more supplementary tests may have to be performed after performing the first clinical test.

[0161] A supplementary test is a clinical test that is performed only when the first clinical test satisfies one or more corresponding supplementary test conditions. In particular, the supplementary test condition typically relates to the result of the first clinical test, so that the supplementary test condition is a result condition. For example, whenever the result of the first clinical test is a value that exceeds a predetermined value, a supplementary test may be performed to check whether the value is correct and / or to gain an understanding of why the result has such a value.

[0162] exist Figure 3c In the example of , the test volume condition also includes a probability condition, i.e., the following condition: the probability that the result of the first clinical test satisfies the result condition exceeds a probability threshold. In other words, the probability condition is a condition that indicates that a supplementary test will likely be performed when satisfied. The probability threshold may be a fixed value, such as 50%, or may be selected based on one or more selection criteria.

[0163] Another test volume condition common to all three examples is a condition related to the volume of the biological sample 131 in the sample container 130, i.e., that the volume exceeds a sample threshold. The sample threshold may be a fixed value for a given analytical instrument, or it may be input by a user, or it may be calculated based on one or more inputs.

[0164] We will now describe in more detail the implementation Figure 2 There are three examples of step 270. Some steps are common in different examples.

[0165] exist Figure 3a In the example of , at step 220, first computing device 100 determines whether the volume of the biological sample is above a predetermined sample threshold. Whenever the volume is not greater than the sample threshold, at step 235, first computing device 100 obtains test volume data, wherein the test volume is equal to the volume required to perform the first clinical test. For example, first computing device 100 retrieves the value of the primary value from a database using the first identifier.

[0166] Whenever the volume in the sample container 130 is greater than the sample threshold, at step 250, the first computing device 100 accesses rule data containing one or more rules for at least some clinical tests in the instrument-specific clinical test set, and determines at step 225 whether the one or more rules specify one or more supplemental tests associated with the first clinical test.

[0167] Figures 4a to 4d An example of a rule is shown. Figure 4a According to the rule shown in , whenever the result of the first clinical test identified as T1 has the flags "HH and "LL", a supplementary test, ie, a second T1, should be performed. In other words, the rule requires re-running the first clinical test.

[0168] according to Figure 4b According to the rule shown in , whenever the result of the first clinical test identified as T2 has a value greater than 100, a supplementary test, namely the reflex test T3, should be performed. Figure 4c According to the rule shown in , whenever the result of the first clinical test identified as T4 has a value greater than 150, two supplementary tests, namely reflex tests T5 and T6, should be performed. Figure 4d According to the rule shown in , whenever the result of the first clinical test identified as T7 has a value greater than 300, three supplementary tests T8 should be performed.

[0169] Thus, for example, if the first clinical test is test T2 and the rule data includes Figure 4b If the rule of step 225 is true, the determination at step 225 is positive. In the case of a positive determination, at step 230, the first computing device 100 obtains the volume required to perform the first clinical test and one or more supplementary tests as the test volume. Continuing with the previous example, the test volume would be V T2 +V T3 , where V Tj is the volume required to execute test Tj (j=1, 2, ..., 8). For example, the first computing device 100 retrieves V from the database using the identifiers associated with tests T2 and T3. T2 The value of V T3 The value of .

[0170] For example, if the first clinical test is test T1, T4 or T7, respectively, and the rule data includes Figures 4a to 4d , then the test volumes obtained by the first computing device 100 at step 230 will be: 2*V T1 、V T4 +V T5 +V T6 and V T7 +3*V T8.

[0171] In contrast, if it is determined at step 225 that there are no rules regarding a supplemental test associated with the first clinical test, then the test volume is obtained according to step 235 discussed above.

[0172] exist Figure 3b In the example of Figure 3a The same steps, but performed in a different order. In fact, it starts with accessing the rule data (step 250) and checking the rule conditions (step 225), and then when the determination at step 225 is positive, step 220 is executed, that is, determining whether the volume exceeds the sample threshold. According to the determination result at step 220, the determination of step 220 branches into steps 235 and step 230, that is, branching into obtaining a test volume equal to the main volume (step 235) or a test volume equal to the combination of the main volume and one or more supplementary volumes (step 230). In this example, the main volume and one or more supplementary volumes are combined by adding them together. When the determination in step 225 is negative, step 235 is also performed after step 225.

[0173] Figure 3c Examples include Figure 3a All steps of the example of and involve additional steps 310, 315. In particular, the determination at steps 220 and 225 is affirmative for the test volume to be given by the combination of the main volume and the supplementary volume is insufficient. When the determination at step 225 is affirmative, at step 310, the first computing device 100 obtains probability data, wherein the probability data includes a probability value indicating the likelihood that the result of the first clinical test meets the result condition that will trigger one or more supplementary tests. For example, the probability data can be generated by counting the frequency of triggering the execution of one or more supplementary tests in past executions of the first clinical test.

[0174] Subsequently, at step 315, the first computing device 100 determines whether the probability value exceeds a probability threshold. In the negative case, step 235 is performed, and in the positive case, step 230 is performed. Therefore, when the probability value is not greater than the probability threshold, the first computing device 100 does not include one or more supplemental volumes in the test volume.

[0175] The first computing device 100 is configured to also perform the same procedure shown for the first clinical test on the plurality of clinical tests specified in the test indication data. Figure 5 4 corresponds to the method 400 shown in FIG.

[0176] At step 210, the first computing device 100 accesses biological sample data, at step 220, determines whether a condition related to the volume within the sample container 130 is satisfied, and at step 215, accesses test indication data, as has been described with respect to the previous figures. However, in this case, the test indication data specifies a plurality of clinical tests (N tests), for example by including a plurality of corresponding identifiers.

[0177] If the determination at step 220 is negative, then at step 435, the first computing device 100, starting with a first clinical test in the plurality of clinical tests, obtains first test volume data that specifies a first test volume required to perform the first clinical test. The first computing device 100 continues to perform the same operation for each clinical test in the plurality of tests until it obtains an Nth test volume data that specifies an Nth test volume required to perform the Nth test volume. Each i-th test volume (TV i ) is just the main volume, i.e. the volume required to perform the i-th test.

[0178] If the determination at step 220 is affirmative, then at step 470, the first computing device 100 also determines the i-th test volume for each test in the plurality of clinical tests, however in this case, the i-th volume may in some cases include one or more supplemental volumes, as further discussed below.

[0179] After all N test volumes have been obtained, at step 240, first computing device 100 obtains extraction volume data, which includes information specifying the extraction volume. In particular, first computing device 100 combines all test volumes, such as by adding them together, to generate an extraction volume DV, such that Finally Figure 2 At step 245 , the first computing device 100 instructs the pipetting device 123 to extract the extraction volume from the sample container 130 .

[0180] Figure 6 A possible example of how each test volume for the i-th clinical test is obtained in step 470 is shown. In this example, the rule condition is applied as a test volume condition. In other examples (not shown), other test volume conditions may be applied.

[0181] At step 215, the first computing device 100 accesses the rule data, and at step 425, it determines whether one or more rules in the rule data specify one or more supplemental tests associated with the i-th clinical test. In other words, the first computing device 100 determines whether the one or more rules require that the one or more supplemental tests should be performed after the i-th clinical test if one or more corresponding supplemental test conditions are satisfied.

[0182] If the determination at step 425 is negative, then as described with reference to Figure 5 If the determination at step 425 is positive, then at step 430, the first computing device 100 obtains the i-th test volume as the volume required to perform the i-th clinical test and one or more supplementary tests associated with the i-th clinical test.

[0183] In summary, the first computing device 100 can control the pipetting device 123 to extract a sample of an extracted volume from the sample container 130 for analysis, thereby achieving an optimal balance between analysis efficiency and avoiding sample waste.

Claims

1. A computer-implemented method comprising: - accessing test indication data, wherein the test indication data comprises information specifying a clinical test set to be performed on a biological sample, wherein the clinical test set comprises at least a clinical test, and the biological sample is contained in a sample container; - obtaining test volume data by using the test indication data, wherein the test volume data comprises information specifying a test volume; and - instructing a pipetting device of a laboratory instrument to extract an extraction volume of the biological sample from the sample container, the extraction volume being based on the test volume data; The test volume is the volume of the biological sample required to perform the following test: ○ The clinical tests described, and o one or more supplemental tests associated with the clinical test whenever one or more test volume conditions associated with the clinical test are met, Wherein, the one or more test volume conditions include the following condition: one or more rules require that whenever one or more supplementary test conditions with respect to the clinical test are met, the one or more supplementary tests should be performed.

2. The method according to claim 1, wherein: The clinical test is associated with an identifier identifying the clinical test, and wherein obtaining the test volume data comprises querying a database using the identifier.

3. A method according to any one of the preceding claims, wherein: Obtaining the test volume data includes: accessing rule data, the rule data comprising the one or more rules; and • Determining whether the one or more test volume conditions are met.

4. A method according to any one of the preceding claims, wherein: Obtaining the test volume data includes: obtaining a primary value indicative of a volume required to perform the clinical test and at least a secondary value indicative of a volume required to perform the one or more supplemental tests associated with the clinical test; and - Calculating the test volume by using the primary value and the at least secondary value.

5. A method according to any one of the preceding claims, wherein: The one or more supplemental test conditions include one or more result conditions regarding a result of the clinical test.

6. The method according to claim 5, further comprising: - obtaining probability data, wherein the probability data comprises information specifying a probability that a result of the clinical test satisfies the result condition; and - determining by using the probability data whether the probability that the result of the clinical test satisfies the result condition exceeds a probability threshold; wherein the one or more test volume conditions further comprise the condition that the probability that the result of the clinical test satisfies the result condition exceeds the probability threshold.

7. The method according to claim 6, wherein: Obtaining the probability data includes: accessing historical data, the historical data comprising information specifying how often the outcome condition was met; and The probability data is generated by using the historical data.

8. The method according to claim 7, wherein: The historical data is collected from a plurality of laboratory instruments capable of performing the clinical test.

9. The method according to any one of claims 6 to 8, wherein: The probability threshold is selected from a plurality of predetermined probability thresholds based on one or more selection criteria, wherein the one or more selection criteria include information specifying any one or any combination of the following: an instrument configured to perform the clinical test, a laboratory configured to perform the clinical test, a volume of the biological sample contained in the sample container, a category of the subject to which the biological sample belongs, and a priority of the biological sample.

10. A method according to any one of the preceding claims, wherein: The one or more volume test conditions include: a condition regarding the volume amount of the biological sample contained in the sample container, and / or a condition regarding the category of the subject to which the biological sample belongs.

11. The method according to any of the preceding claims, further comprising withdrawing the withdrawal volume of the biological sample from the sample container by means of the pipetting device.

12. A computing device comprising a processor configured to perform the method of any one of claims 1 to 11.

13. An analytical instrument configured to perform one or more clinical tests on a biological sample, wherein: The at least one analytical instrument comprises: ○ A computing device according to claim 12; and ○Liquid handling equipment; The computing device is configured to instruct the pipetting device to extract the extracted volume of the biological sample from the sample container, and the pipetting device is configured to extract the extracted volume of the biological sample from the sample container.

14. A computer program product comprising instructions which, when executed by a computer, cause the computer to perform 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 perform the steps of any one of the methods of claims 1 to 11.

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