Laboratory automated system handling of subsequent tests

Abstract

A laboratory automation system may perform a test on a biological sample. This may include performing a first test on a first test portion contained in the first container. After the first test has been performed, the laboratory automation system may obtain an indication to perform a subsequent test, and may then make a container determination that includes determining a container from which the second test portion should be extracted. After the container determination, a subsequent test may be performed on the second test portion.

Description

BACKGROUND

[0001] Various instruments exist for analyzing biological samples. For example, hematology analyzers such as those described in U.S. Patent 9,322,752, “flow cell systems and methods for particle analysis in blood samples,” filed March 17, 2014, which is incorporated by reference herein in its entirety, can be used to determine information such as populations of various types of cells in a sample. Similarly, immunoassay analyzers such as those described in Application PCT / US19 / 68650, “clinical analyzer automated system diagnostics,” filed December 27, 2019, which is incorporated by reference herein in its entirety, can be used to process samples to determine the presence and quantity of various analytes. Other types of instruments (e.g., chemistry analyzers) also exist, and can be used for sample analysis as appropriate.

[0002] Often, obtaining appropriate information from a biological sample can require the use of a set of tests, the results of at least some of which cannot be determined until the results of the at least some of the set of tests are available. For example, if a first test provides a result indicating an elevated risk of a particular condition, a second test that is inappropriate at the outset can be required to confirm (or deny) the condition. Similarly, if a first test provides a result outside of an expected range, a re-run of the test can be appropriate to confirm that the first result was not anomalous. The need for sequential performance of tests, and the sequential determination of whether (and how) those tests should be performed, can significantly slow the processing of a biological sample, thereby significantly reducing, among other things, the throughput of a laboratory for performing sample analysis. Accordingly, techniques that can accelerate the processing of sequential tests of a biological sample are needed. SUMMARY

[0003] Aspects of the present disclosure can apply to processing of subsequent tests using a laboratory automation system. For example, in some implementations, a laboratory automation can perform an action comprising performing a preliminary test on a first test portion in a first container. After performing the preliminary test, the laboratory automation system can obtain an indication to perform a subsequent test, and can then make a container determination comprising determining a container from which a second test portion should be extracted. After the container determination, the subsequent test can be performed on the second test portion.

[0004] Other aspects and implementations are described herein. Accordingly, the exemplary aspects described in this Summary should be understood as illustrative only and should not be viewed as limiting. BRIEF DESCRIPTION OF DRAWINGS

[0005] While the specification concludes with claims particularly pointing out and distinctly claiming that which is regarded as the application, it is believed that the application will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like references refer to like elements, and in which:

[0006] Figure 1 A system including a laboratory automation system, a laboratory information system, and a middleware system is schematically illustrated.

[0007] Figure 2 Steps that can be performed in a method for performing tests on biological samples are illustrated.

[0008] Figure 3 A process that can be used for container determination is illustrated.

[0009] Figure 4 A set of aliquoting tasks and potential subsequent activities are illustrated.

[0010] Figure 5 Steps that can be performed in the case of a laboratory automation system applying error trapping functionality to containers are illustrated.

[0011] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the application can be carried out in a variety of other ways, including those not necessarily depicted in the drawings. The drawings are included to provide a description of several aspects of the application and, together with the description, serve to explain the principles of the application; however, it is to be understood that the application is not limited to the precise arrangements shown. DETAILED DESCRIPTION

[0012] The present disclosure relates to articles of manufacture, systems, and methods for performing tests on biological samples. In some aspects, the tests can include both a first test, which can be referred to as a primary test, and a second test, which can be referred to as a subsequent test. Using some aspects of the disclosed technology, the subsequent test can be efficiently processed, which can include automatically identifying a container from which a portion of a sample should be extracted for use in performing the subsequent test. Specific example implementations that can be used and implemented based on the present disclosure are described below. These implementations can be used for purposes such as reducing contamination between tests and / or maintaining high sample quality and extending the time period for which a sample can be used to provide reliable results.

[0013] Turning now to the drawings, Figure 1 A system that can be implemented based on the present disclosure is schematically illustrated. As Figure 1As shown in FIG. 1, such a system can include a laboratory information system 101, a laboratory automation system 102, and a middleware system 103 disposed on a network path between the laboratory information system 101 and the laboratory automation system 102. In implementations such as Figure 1 In implementations shown in FIG. 1, the laboratory information system 101 can serve as a central information repository for the laboratory and can include a database 104 having information such as patient sample identification, tests indicated for individual samples, demographic information, test results, and the like. The laboratory information system 101 can also include a computer 105 that can be configured to perform functions such as interfacing with a hospital information system (HIS) (not shown in FIG. 1), generating indications for subsequent tests based on application of rules to data in the database 104 by a rules engine, and / or presenting an interface on a display (not shown in FIG. 1) that a user (e.g., a physician) can use to view test results and possibly manually create indications for subsequent tests to be performed. In some implementations, other functions (e.g., encrypting information to ensure privacy of patient data during storage and / or transmission) can also be performed by the laboratory information system 101. Figure 1 In implementations shown in FIG. 1, the laboratory information system 101 can serve as a central information repository for the laboratory and can include a database 104 having information such as patient sample identification, tests indicated for individual samples, demographic information, test results, and the like. The laboratory information system 101 can also include a computer 105 that can be configured to perform functions such as interfacing with a hospital information system (HIS) (not shown in FIG. 1), generating indications for subsequent tests based on application of rules to data in the database 104 by a rules engine, and / or presenting an interface on a display (not shown in FIG. 1) that a user (e.g., a physician) can use to view test results and possibly manually create indications for subsequent tests to be performed. In some implementations, other functions (e.g., encrypting information to ensure privacy of patient data during storage and / or transmission) can also be performed by the laboratory information system 101. Figure 1 In implementations shown in FIG. 1, the laboratory information system 101 can serve as a central information repository for the laboratory and can include a database 104 having information such as patient sample identification, tests indicated for individual samples, demographic information, test results, and the like. The laboratory information system 101 can also include a computer 105 that can be configured to perform functions such as interfacing with a hospital information system (HIS) (not shown in FIG. 1), generating indications for subsequent tests based on application of rules to data in the database 104 by a rules engine, and / or presenting an interface on a display (not shown in FIG. 1) that a user (e.g., a physician) can use to view test results and possibly manually create indications for subsequent tests to be performed. In some implementations, other functions (e.g., encrypting information to ensure privacy of patient data during storage and / or transmission) can also be performed by the laboratory information system 101.

[0014] In addition to the laboratory information system 101, Figure 1 The system of FIG. 1 also includes a laboratory automation system 102. This laboratory automation system 102 can be used to control and integrate activities of multiple components in the physical transport and processing of biological samples (e.g., patient samples). To support this, the laboratory automation system 102, as shown in FIG. 1, can include one of more analytical instruments 108 and a conveyor track 106 that can be used to transport sample material (e.g., portions of patient samples contained in tubes) to appropriate equipment or locations within the laboratory. The laboratory automation system 102 can also include a controller 110 that can be implemented as a computing device configured to control aliquoting of samples and / or to control the laboratory automation system (e.g., generate a routing plan for tubes, control routing of tubes) and / or host and run a rules engine and / or act on the output outcome of the results of the rules engine. Figure 1 In implementations shown in FIG. 1, the laboratory information system 101 can serve as a central information repository for the laboratory and can include a database 104 having information such as patient sample identification, tests indicated for individual samples, demographic information, test results, and the like. The laboratory information system 101 can also include a computer 105 that can be configured to perform functions such as interfacing with a hospital information system (HIS) (not shown in FIG. 1), generating indications for subsequent tests based on application of rules to data in the database 104 by a rules engine, and / or presenting an interface on a display (not shown in FIG. 1) that a user (e.g., a physician) can use to view test results and possibly manually create indications for subsequent tests to be performed. In some implementations, other functions (e.g., encrypting information to ensure privacy of patient data during storage and / or transmission) can also be performed by the laboratory information system 101.

[0015] When a sample is provided to the laboratory automation system 102, the laboratory automation system 102 can read the unique identifier of the sample (e.g., with a barcode reader) and the controller 110 can correlate the identifier with information stored in its memory (e.g., instructions sent from the laboratory information system 101) to determine how the sample should be processed. Based on this determination, the laboratory automation system 102 can convey the sample along the conveyor track 106, transfer the sample from the track to the intake portion of the appropriate device (e.g., using a diverter arm) as the sample reaches the location of those devices along the conveyor track 106, and send instructions to those devices indicating how the sample should be processed by those devices. The laboratory automation system 102 can also perform certain error checking activities to ensure that the sample is processed correctly. For example, if the instructions for a sample require activities that can not be feasible for that sample (e.g., the instructions require that the sample be aliquoted into multiple portions for multiple tests, but the sample does not have sufficient volume to be divided into multiple portions), the laboratory automation system can detect this condition (e.g., can include a sample volume detector such as a camera and appropriate image analysis algorithms) and route the sample to an error area 109 (e.g., a drawer or portion of a drawer) so that a user can react appropriately to the problem(s) preventing the test(s).

[0016] Figure 1 The system of FIG. 1 also includes a middleware system 103 disposed on the network path between the laboratory information system 101 and the laboratory automation system 102. In different implementations, this middleware system 103 can serve various purposes. For example, in some cases, the middleware system 103 can host a rules engine and / or software that presents an interface that will allow physicians to create new instructions. This can be done, for example, if such a rules engine and or software does not exist on the laboratory information system 101, or if they exist but have interfaces that make them difficult to use. The middleware system 103 can also facilitate communication between the laboratory information and automation systems (e.g., transforming the output format of the laboratory information system into the input format of the laboratory automation system) and / or communication with other systems (e.g., a hospital information system) not shown in FIG. 1. Figure 1

[0017] ​As a specific illustration of how the laboratory automation system 102 can integrate the operations of various devices needed to process a sample, consider the case where a sample is received at the laboratory automation system with an indication to run a complete blood count and a test for metabolites of commonly used recreational drugs using the sample. In such a case, the controller 110 of the laboratory automation system 102 can determine that the sample needs to be split into two portions because the complete blood count will be run on a first instrument (i.e., a hematology analyzer) 108-1 from among the one or more analytical instruments 108 included by the laboratory automation system 102, while the metabolite test will be performed by a second instrument (e.g., an immunoassay analyzer) 108-2 from among the one or more analytical instruments of the laboratory automation system. Based on this determination, the laboratory automation system 102 can route the sample to an aliquoter 107, where a portion of the sample can be removed from the sample container and placed into a second container (e.g., a tube). The laboratory automation system can then apply a barcode with a unique identifier to the second container and send a message to the middleware system 103 indicating the unique identifier of the second container and informing the middleware system 103 that the sample in the second container is an aliquot of the original patient sample. The laboratory automation system 102 can also send instructions to the aliquoter 107 to separate out an additional portion of the sample and place it in a holding container, which can then be routed to a refrigerated storage area (not shown in FIG. 1) for storage for possible use in additional testing. Figure 1

[0018] ​After the samples have been aliquoted, the containers containing the samples can be routed to the appropriate analytical instruments, in this case a hematology analyzer 108-1 and an immunoassay analyzer 108-2. The controller 110 of the laboratory automation system can communicate with the local controllers on each of these analyzers to inform them which tests should be run on their respective sample portions. Then, when the containers with their sample portions arrive, those analyzers can extract the test portions from their containers and perform the appropriate test(s) on them. For example, the hematology analyzer 108-1 can flow its test portion through a flow cell and take measurements of cells as they move through the flow cell, while the immunoassay analyzer 108-2 can mix the test portion with reagents that will bind to the analyte of interest (in this case a drug metabolite) and then can allow the presence and concentration of that analyte of interest to be measured. The test results will then be sent back to the controller 110, which can send the test results on to the middleware system 103. The middleware system 103 can then associate the second container's identifier with the original sample and send both results to the laboratory information system 101 using the original sample identifier, informing the system (and any of its users) that the indicated tests have been completed and their results are ready.

[0019] As a further illustration of how the laboratory automation system can operate, consider Figure 2which shows steps that can be performed in a method for performing tests on a biological sample, including performing both a primary test and a subsequent follow-up test. In this method, initially, a first test portion of a biological sample is extracted 201 from a first container (e.g., a primary tube into which the sample was initially provided to the laboratory automation system, or a secondary tube obtained by removing an aliquot from the primary tube and placing it in a new tube). This can be performed, for example, by routing the biological sample to one of the one or more analytical instruments 108, and sending instructions to that analytical instrument to remove a portion of the biological sample for which a test of the biological sample is to be performed. For example, the controller 110 of the laboratory automation system can route a blood sample to an immunoassay analyzer 108-2, and send instructions to that analyzer to test for a certain drug metabolite. The analyzer 108-2 will in turn perform a set of steps that can include using a pipettor to extract a portion of the biological sample (i.e., the test portion) from the container, and placing that portion into a reaction vessel to be mixed with appropriate reagents, and otherwise processed to determine whether the metabolite is present. Once the first test portion is extracted 201, the primary test can be performed 202 on the first test portion. For example, in the case of testing for a drug metabolite using the immunoassay analyzer 108-2, this can be performed by mixing the test portion in the reaction vessel with one or more reagents to bind the metabolite to a detectable label, washing unbound material away from the test portion, and then detecting the remaining label to determine the amount of metabolite (if any) in the test portion. Other types of testing activities are also possible, and can be performed depending on the nature of the tests indicated for the sample (e.g., in the case of a test run using a hematology analyzer 108-1, causing the test portion to flow through a flow cell).

[0020] As Figure 2 shown in FIG. 2, the method for performing tests on a biological sample can also include preparing 203 a holding container for the biological sample. This can be performed, for example, by removing 204 liquid from the sample and placing 205 the liquid into a separate container (i.e., the holding container). The holding container can then be routed to a storage area where it can be maintained, so that even if the remaining portion of the biological sample is not available, material will be available for later testing.

[0021] Subsequently, after the primary test is performed 202, Figure 2The method continues with the laboratory automation system 102 obtaining 206 an indication to perform a follow-up test on the biological sample. For example, a rule engine in the middleware system 103 or the laboratory information system 101 or on the controller 110 of the laboratory automation system 102, or a physician using an interface presented by the laboratory information system 101 or the middleware system 103 or the laboratory automation system 102 can determine that a follow-up test needs to be run based on the results of the primary test. This can be, for example, simply repeating the primary test (re-running it), which can be appropriate if the results provided by the primary test are outside of an expected range, and repeating the test will increase the confidence that the results are correct, rather than reflecting an error in the testing process or some other type of anomaly. Alternatively, the follow-up test can be a different test generated at the laboratory information system, the laboratory automation system, or the middleware system, a test automatically generated by the rule engine (a reflex test), or a test instructed by the physician (an add-on test), as can be the case where the results of the primary test indicate an elevated risk of a certain condition, and a follow-up test is desired to confirm (or rule out) that the patient from which the biological sample was obtained actually does have the condition in question. Once the test is determined, the laboratory automation system 102 can obtain the test by the system on which the test was determined (e.g., the middleware system or the laboratory information system, if the test was not determined by the laboratory automation system itself), the system sends the test to the laboratory automation system 102, and the laboratory automation system receives the test over the network connection and stores the test in the memory of the controller 110 that can process the test. Alternatively, if the indication for the follow-up test is generated locally at the laboratory automation system, the "obtaining" of the follow-up test indication can be performed by the generation of the follow-up test indication.

[0022] Turning now to this process, once the follow-up test indication is obtained 206, the laboratory automation system 102 can make 207 a container determination based on the execution of instructions stored in a non-transitory computer readable medium, such as the memory of the controller 110 of the laboratory automation system 102, the container determination including determining a container from which a portion of the biological sample (i.e., a second test portion) should be extracted for use in the follow-up test. To illustrate how this container determination can occur, consider Figure 3 , which Figure 3 depicts a process that can be used for this purpose. Initially, at Figure 3the first condition is that the subsequent test is a re-run of the primary test. If the first condition is met, the container determination can include determining 302 that the second test portion should be extracted from the first container. That is, if the first test was performed on a portion of the biological sample extracted from the container in which the biological sample was originally provided, then the second portion should be extracted from the container in which the biological sample was originally provided, whereas if the first test was performed on a portion of the biological sample extracted from a different container (e.g., a container placed by an aliquoter), then the second test portion should be extracted from the different container rather than the container in which the biological sample was originally provided to the laboratory automation system.

[0023] Continuing Figure 3 If the subsequent test is not a re-run, then a second check 303 can be made as to whether a set of rules engine rules (e.g., resident in the controller 110) on the laboratory automation system specify that the second test portion should be extracted from a container. For example, to reduce the risk that a low-sensitivity test can contaminate a subsequent, higher-sensitivity test, a rule can be defined to create an aliquot when a low-sensitivity test is indicated, such that the low-sensitivity test can be run on the aliquot, and the subsequent test (which can be a higher-sensitivity test) can be run on the other tube. An example of such a rule would be:

[0024] If (test type of test == chemistry) then aliquot.

[0025] In such a case (and considering only the rule above), then the second check 303 can be considered to be satisfied if the subsequent test is a chemistry test, and can be considered to not be satisfied if the subsequent test is not a chemistry test.

[0026] If the set of rules engine rules does specify a container from which the second test portion should be extracted, then the container determination can include determining 304 that the second portion should be extracted from the container specified by the rules. In addition, and depending on the rules at issue, additional actions can also be performed. For example, in the case where the rules indicate that the subsequent immunoassay test should be performed on a separate aliquot (in addition to a re-run), then the laboratory automation system 102 can also perform actions such as: Figure 4The set of aliquoting tasks 401 can be performed by the middleware system 103 as shown in FIG. 4. These tasks can include moving 402 (e.g., using the aliquoter 107) an aliquot of the biological sample from a first container (i.e., the container from which the test portion has been extracted, which can be, for example, the primary container) to a second container (i.e., the container from which the second test portion will be extracted). A label including a unique identifier of the second container (e.g., a numerically identifier encoded in a barcode) can then be added 403 to the second container, and a message can be sent 404 to the middleware system 103 associating the unique identifier of the second container with a similar unique identifier of the first container (i.e., the container from which the biological sample was moved to the second container). This can enable the laboratory automation system 102 to use the unique identifier of the second container to send 405 results of the subsequent test to the middleware system 103, as the middleware system 103 can associate the unique identifier of the second container with the unique identifier of the first container and then use the unique identifier of the first container to send 406 results of the subsequent test to the laboratory information system 101.

[0027] Continuing the discussion of Figure 3 If the subsequent test is not a rerun and the container from which the second test portion should be extracted is not specified by a rules engine rule, a determination can be made 305 whether a save container was created. If a save container was created, the container determination can include determining 306 that the second test portion should be extracted from the save container. Otherwise, as a default, the container determination can include determining 307 that the second portion should be extracted from the primary container, i.e., the container from which the sample was initially provided to the laboratory automation system.

[0028] Now returning to Figure 2 After the container determination is made 207, the second test portion can be extracted 208 based on the container determination. For example, if the container determination indicates that the second test portion should be extracted from a new container created after aliquoting the biological sample, the new container can be routed to an analytical instrument that will perform the subsequent test, and then that instrument can extract 208 the second test portion for actual performance of the test. Alternatively, if the container determination indicates that the second test portion should be extracted from the same container as the first test portion, or from a save container, that container can be routed to the appropriate analytical instrument (e.g., removed from storage and sent via track to storage, or if the container is already on the track, such as if the container is a contents save container and the container is headed to storage, redirected to the appropriate analytical instrument) so that the instrument can extract 208 and process the second test portion. Finally, after the second test portion is extracted 208, that test portion can then be used to perform 209 the subsequent test.

[0029] The method for performing a test on a biological sample can also be used withFigure 1 The method shown in FIG. 6 and discussed above differs in that the testing includes both the primary testing and the subsequent testing. For example, as described above, the laboratory automation system 102 can include an error detection function, such as a camera or other volume detector, that can determine that the biological sample in the container is insufficient to perform the indicated test. In some cases, this function can be integrated into the method for performing a test that includes both the primary testing and the subsequent testing. For example, as shown in FIG. 6, after the container determination 207, the laboratory automation system 102 can confirm 601 that the material extracted from the container determined to be from which the second test portion should be extracted (e.g., by testing the volume of the material in such a container, or confirming that there is even enough material available to create a second container in the case where the container determination determined that the second test portion should be extracted from a second container) can be used to perform the subsequent testing. If it is confirmed that the subsequent testing can be performed with such material, the second test portion can be extracted 602, and the subsequent testing can be performed 603 on the second test portion. Alternatively, if the subsequent testing cannot be performed with the material extracted from the container determined to be from which the second test portion should be extracted, the laboratory automation system can prevent 604 the subsequent testing from being performed with such material. For example, a command can be sent to the analytical instrument that will perform the subsequent testing instructing it not to extract 602 the second test portion or not to otherwise continue with the subsequent testing, the container can simply not be transferred to the analytical instrument and / or the analytical instrument can not be instructed to continue with the subsequent testing. The laboratory automation system 102 can also route 605 the container from which the second test portion was extracted to an error area. Figure 5

[0030] ​Other variations are also possible and will be readily apparent to those skilled in the art given the content of this disclosure. Therefore, the examples, figures, descriptions, and variations above should be understood as illustrative only and should not be construed as implying any limitation on the protection provided by this document or any related documents. To illustrate the possibility of further variations, the following examples are provided as non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to limit the scope of any claim that may be filed at any time in this application or in a subsequent filing of this application. No disclaimer is intended. The following examples are provided for illustrative purposes only. It is contemplated that the various teachings herein may be arranged and applied in a variety of other ways. It is also contemplated that some variations may omit certain features mentioned in the following examples. Therefore, unless expressly indicated by the inventor or by the inventor's successors at a later date, the aspects or features mentioned below should not be considered critical. If any claim (which includes additional features in addition to those mentioned below) is filed in this application or in a subsequent filing related to this application, those additional features should not be considered added for any reason related to patentability.

[0031] Example 1

[0032] A method for performing tests on a biological sample, the method comprising: a) performing a first test on a first test portion of the biological sample, the first test portion being contained in a first container; b) obtaining an instruction to perform subsequent tests on the biological sample; c) determining a container based on the execution of a set of computer-executable instructions stored on a non-transitory computer-readable medium, wherein determining the container includes determining a container from which a second test portion of the biological sample should be extracted; and d) performing subsequent tests on the second test portion.

[0033] Example 2

[0034] According to the method of Example 1, the container determination includes: if a first condition is met, determining that a second test portion should be extracted from the first container, wherein the first condition is that the subsequent test is a rerun of the first test.

[0035] Example 3

[0036] According to the method in Example 2, the container determination includes: determining whether a second condition is met if a first condition is not met, wherein the second condition is a set of rule engine rules specifying from which a second test portion should be extracted.

[0037] Example 4

[0038] According to the method of Example 3, wherein a) the method includes preparing a preservation container for a biological sample by performing actions including: i) removing liquid from the biological sample; and ii) placing the liquid removed from the biological sample into the preservation container; and b) determining the container includes: determining that a second test portion should be extracted from the preservation container if neither a first condition nor a second condition is met.

[0039] Example 5

[0040] According to the method of Example 3, the container determination includes: determining that the second test portion should be extracted from the primary container if the first condition, the second condition, and the third condition are not met, and wherein the third condition is that a preservation container has been prepared for the biological sample prior to the container determination.

[0041] Example 6

[0042] According to the method of Example 3, where: a) a set of rule engine rules includes rules that require the creation of equally spaced sample containers for the second test; and b) the method includes creating equally spaced sample containers for the second test.

[0043] Example 7

[0044] According to the method described in 3, wherein: a) the following actions are all performed by a laboratory automation system: i) performing a first test; ii) determining a container; and iii) performing a subsequent test; b) determining a container includes determining that a second test portion should be extracted from a second container; and c) the method includes: i) performing a set of aliquoting tasks, the set of aliquoting tasks including: A) moving aliquots of a biological sample from a first container to a second container; B) adding a tag to the second container, wherein the tag includes a unique identifier of the second container; and C) sending a message to a remotely located middleware system associating the unique identifier of the second container with the unique identifier of the first container; and ii) the laboratory automation system sending the results of the subsequent test to the remotely located middleware system using the unique identifier of the second container; and iii) the remotely located middleware system sending the results of the subsequent test to a remotely located laboratory information system using the unique identifier of the first container.

[0045] Example 8

[0046] According to the method in Example 7, a set of equally divided tasks is determined based on containers to be the second test portion to be extracted from the second container for execution.

[0047] Example 9

[0048] According to any one of Examples 7 to 8, wherein: a) a determination is performed to extract a second test portion from a second container by evaluating a set of rule engine rules using a local rule engine included in the laboratory automation system; and b) the method includes determining, prior to container determination, to perform subsequent tests using a rule engine located remotely from the laboratory automation system.

[0049] Example 10

[0050] According to the method of Example 9, wherein: a) the method further includes, after the laboratory automation system determines the container, executing an instruction to confirm that subsequent tests can be performed using material extracted from the container from which the second test portion should be extracted; b) the laboratory automation system is configured with an instruction operable to prevent the use of material extracted from the container from which the second test portion should be extracted for subsequent tests if the laboratory automation system does not confirm that subsequent tests can be performed using material extracted from the container from which the second test portion should be extracted.

[0051] Example 11

[0052] According to the method of Example 10, wherein a) the instruction for confirming that subsequent testing can be performed using material extracted from a container from which the container is determined to extract the second test portion includes an instruction for confirming, in cases where the container is determined to extract the second test portion from the second container after the aliquots are moved to the second container, that: i) there is a sufficient sample volume for the aliquots to be moved to the second container; and ii) for the second test portion to be extracted from the aliquots in the second container; b) the instruction for preventing the performance of subsequent testing using material extracted from a container from which the container is determined to extract the second test portion includes an instruction for preventing the aliquots from being moved from the first container to the second container in cases where: i) the container is determined to extract the second test portion from the second container after the aliquots are moved from the first container to the second container; and ii) the laboratory automation system has not confirmed that the first container contains a sufficient sample volume for the aliquots to be moved from the first container to the second container.

[0053] Example 12

[0054] According to the method of Example 10, wherein the laboratory automation system is configured with instructions that are operable to route the container from which the second test portion is determined to be extracted to an error area of ​​the laboratory automation system if the laboratory automation system does not confirm that the subsequent test can be performed using material extracted from the container from which the container is determined to extract the second test portion.

[0055] Example 13

[0056] According to any one of Examples 1 to 12, wherein: performing a first test on a first test portion includes extracting the first test portion from a first container; and b) performing a subsequent test on a second test portion includes determining the extraction of the second test portion based on the container.

[0057] Example 14

[0058] According to any one of Examples 1 to 13, the method includes moving an aliquot of the biological sample from the primary container to the first container before performing a first test on the first test portion of the biological sample.

[0059] Example 15

[0060] A system comprising: a) a laboratory information system; b) a laboratory automation system located remotely from the laboratory information system and including a divider and one or more analytical instruments; c) a middleware system on a network path between the laboratory automation system and the laboratory information system, the middleware system being located remotely from both the laboratory automation system and the laboratory information system; wherein the laboratory automation system is configured to perform a method for performing tests, the method comprising: A) performing a primary test on a first test portion of a biological sample, the first test portion being contained in a first container; B) receiving instructions to perform a subsequent test on the biological sample; C) determining a container, wherein determining a container includes determining a container from which a second test portion should be extracted; and D) performing a subsequent test on the second test portion.

[0061] Example 16

[0062] According to the system of Example 15, the container determination includes: if a first condition is met, determining that a second test portion should be extracted from the first container, wherein the first condition is that the subsequent test is a rerun of the primary test.

[0063] Example 17

[0064] According to the system of Example 16, the container determination includes: determining whether a second condition is met if a first condition is not met, wherein the second condition is a set of rule engine rules specifying from which a second test portion should be extracted.

[0065] Example 18

[0066] According to the system of Example 17, wherein: a) the method for performing the test includes preparing a preservation container for the biological sample by performing actions including: i) removing liquid from the biological sample; and ii) placing the liquid removed from the biological sample into the preservation container; and b) performing container determination including determining that a second test portion should be extracted from the preservation container if neither a first condition nor a second condition is met.

[0067] Example 19

[0068] According to the system of Example 17, the container determination includes: determining that a second test portion should be extracted from the primary container if a first condition, a second condition, and a third condition are not met, and wherein the third condition is that a preservation container has been prepared for the biological sample prior to the container determination.

[0069] Example 20

[0070] According to the system of Example 17, where: a) a set of rule engine rules includes rules requiring the creation of equally spaced sample containers for the second test; and b) the method for performing the test includes creating equally spaced sample containers for the second test.

[0071] Example 21

[0072] According to the system of Example 17, wherein: a) the laboratory automation system is configured to: in the case of determining a container, including determining that a second test portion should be extracted from a second container: i) perform a set of aliquoting tasks, the set of aliquoting tasks including: A) moving aliquots of a biological sample from a first container to a second container; B) adding a tag to the second container, wherein the tag includes a unique identifier of the second container; and C) sending a message to a middleware system associating the unique identifier of the second container with the unique identifier of the first container; ii) sending the results of a subsequent test to the middleware system using the unique identifier of the second container; and b) the middleware system is configured to send the results of a subsequent test to a laboratory information system using the unique identifier of the first container based on receiving the results of the subsequent test sent using the unique identifier of the second container.

[0073] Example 22

[0074] According to any one of Examples 20 to 21, the system includes: a) a laboratory automation system configured to determine, by evaluating a set of rule engine rules using a local rule engine included in the laboratory automation system, that a second test portion should be extracted from a second container; and b) a system including a remotely located rule engine configured to operate to determine whether subsequent tests should be performed, wherein the remotely located rule engine resides on a laboratory information system or middleware system.

[0075] Example 23

[0076] According to the system of Example 22, wherein: a) the laboratory automation system is configured to: after container determination, confirm that subsequent tests can be performed using material extracted from the container from which the container determination determined that a second test portion should be extracted; b) the laboratory automation system is configured with instructions operable to prevent the use of material extracted from the container from which the container determination determined that a second test portion should be extracted from for subsequent tests if the laboratory automation system does not confirm that subsequent tests can be performed using material extracted from the container from which the container determination determined that a second test portion should be extracted from.

[0077] Example 24

[0078] According to the system of Example 23, wherein: a) the instruction for confirming that subsequent testing can be performed using material extracted from a container from which the container determined that a second test portion should be extracted includes an instruction for confirming, in cases where the container determined that a second test portion should be extracted from the second container after the aliquots are moved to the second container, that: i) there is a sufficient sample volume for the aliquots to be moved to the second container; and ii) for the second test portion to be extracted from the aliquots in the second container; b) the instruction for preventing the performance of subsequent testing using material extracted from a container from which the container determined that a second test portion should be extracted includes an instruction for preventing the aliquots from being moved from the first container to the second container if: i) the container determined that a second test portion should be extracted from the second container after the aliquots are moved from the first container to the second container; and ii) the laboratory automation system did not confirm that the first container contains a sufficient sample volume for the aliquots to be moved from the first container to the second container.

[0079] Example 25

[0080] According to the system of Example 23, the laboratory automation system is configured with instructions that can be operated to route the container from which the second test portion is determined to be extracted to an error area of ​​the laboratory automation system if the laboratory automation system does not confirm that the subsequent test can be performed using material extracted from the container from which the container is determined to extract the second test portion.

[0081] Example 26

[0082] According to any one of Examples 15 to 25, in a system where: a) performing a first test on a first test portion includes extracting the first test portion from a first container; and b) performing a subsequent test on a second test portion includes determining the extraction of the second test portion based on the container.

[0083] Example 27

[0084] According to any one of Examples 15 to 26, the method for performing the test includes: moving an aliquot of the biological sample from a primary container to a first container before performing a first test on a first test portion of the biological sample.

[0085] Each of the calculations or operations described herein can be performed using a computer or other processor having hardware, software, and / or firmware. Various method steps can be performed by modules, and modules can include any of a wide variety of digital and / or analog data processing hardware and / or software arranged to perform the method steps described herein. Modules optionally include data processing hardware adapted to perform one or more of these steps by having appropriate machine programming code associated with it. Modules for two or more steps (or portions thereof) are integrated into a single processor board or separated into different processor boards in any of a wide variety of integrated and / or distributed processing architectures. These methods and systems will typically employ tangible media containing machine-readable code with instructions for performing the method steps described above. Suitable tangible media can include memory (including volatile and / or non-volatile memory), storage media (such as magnetic recording on floppy disks, hard disks, magnetic tapes, etc.; magnetic recording on optical storage such as CDs, CD-R / Ws, CD-ROMs, DVDs, etc.; or any other digital or analog storage media), etc.

[0086] All patents, patent publications, patent applications, journal articles, books, technical references, etc., discussed in this disclosure are incorporated herein by reference in their entirety for all purposes.

[0087] Different arrangements of components depicted in the accompanying drawings or described above, as well as components and steps not shown or described, are possible. Similarly, some features and sub-combinations are useful and can be employed without reference to other features and sub-combinations. Embodiments have been described for illustrative and non-limiting purposes, and alternative embodiments will become apparent to the reader of this patent. In some cases, method steps or operations may be performed or implemented in a different order, or operations may be added, deleted, or modified. It will be understood that in some aspects, a single component may be replaced by multiple components, and multiple components may be replaced by a single component to provide an element or structure or to perform one or more given functions. Such substitutions are considered to be within the scope of the invention, except that they are not operable to practice certain embodiments of the invention. Therefore, the claims should not be considered as limited to the examples, drawings, embodiments, and illustrations provided above, but should be understood to have the scope provided when their terms are given their broadest reasonable interpretation as provided by a general dictionary, except that when a term or phrase is indicated to have a particular meaning under the explicit definition in the title, it should be understood to have that meaning when used in the claims.

[0088] Clear definition

[0089] It should be understood that, in the examples and claims above, the statement that a thing is “based on” other things should be interpreted as meaning that it is determined at least in part by the thing it is indicated to be based on. In order to indicate that a thing must be based on other things to be fully determined, it is described as being “exclusively based on” whatever it must be fully determined by.

[0090] It should be understood that in the above examples and claims, the term "group" should be understood as one or more things grouped together.

[0091] It should be understood that adjectives such as “first,” “second,” “primary,” and “secondary” are used for identification purposes only and are not intended to imply substantive requirements. For example, a statement that something is the “first” test performed on a sample should not be interpreted as implying that no test was performed on the sample prior to the “first” test. Similarly, a statement that a test is the “second” test performed on a sample should not be interpreted as implying that no test was performed between the “first” test and the “second” test.

[0092] It should be understood that the statement of "remote positioning" between one component and another implies that the two components are located in places separated from each other by a wide area network (WAN). For example, the statement of remote positioning between a middleware system and a laboratory automation system should be understood as meaning that the middleware system and the laboratory automation system are in different locations and communicate with the laboratory automation system via a WAN. Similarly, the statement of remote positioning between a laboratory information system and a middleware system should be understood as meaning that the middleware system and the laboratory information system are in different locations and communicate with the laboratory information system via a WAN.

Claims

1. A method for performing a test on a biological sample, the method comprising: a) Perform a first test on a first test portion of the biological sample, the first test portion being contained in a first container; b) Obtain instructions to perform subsequent tests on the biological sample; c) Container determination based on the execution of a set of computer-executable instructions stored on a non-transitory computer-readable medium, wherein the container determination includes determining a container from which a second test portion of the biological sample should be extracted; as well as d) Perform the subsequent tests on the second test section.

2. The method according to claim 1, wherein, The container determination includes: if a first condition is met, determining that the second test portion should be extracted from the first container, wherein the first condition is that the subsequent test is a rerun of the first test.

3. The method according to claim 2, wherein, The container determination includes: if the first condition is not met, determining whether a second condition is met, wherein the second condition is a set of rule engine rules specifying from which the second test portion should be extracted.

4. The method according to claim 3, wherein: a) The method includes preparing a preservation container for the biological sample by performing actions, the actions including: i) Remove the liquid from the biological sample; and ii) The liquid removed from the biological sample is placed in the preservation container; and b) Determining the container includes: if neither the first condition nor the second condition is met, determining that the second test portion should be extracted from the storage container.

5. The method according to claim 3, wherein, The container determination includes: determining that the second test portion should be extracted from the primary container if the first condition, the second condition, and the third condition are not met, and wherein the third condition is that a preservation container has been prepared for the biological sample prior to the container determination.

6. The method according to claim 3, wherein: a) The set of rule engine rules includes rules requiring the creation of equally spaced sample containers for the second test; and b) The method includes creating the aliquot sample container for the second test.

7. The method according to claim 3, wherein: a) All of the following actions are performed by the laboratory automation system: i) Perform the first test; ii) Determine the container; as well as iii) Perform the subsequent tests; b) Determining the container includes determining that the second test portion should be extracted from the second container; as well as c) The method includes: i) Execute a set of equally divided tasks, the set of equally divided tasks including: A) Move the aliquots of the biological sample from the first container to the second container; B) Add a label to the second container, wherein the label includes a unique identifier for the second container; and C) Send a message to the remotely located middleware system associating the unique identifier of the second container with the unique identifier of the first container; and ii) The laboratory automation system uses the unique identifier of the second container to send the results of the subsequent test to the remotely located middleware system; and iii) The remotely located middleware system uses the unique identifier of the first container to send the results of the subsequent test to the remotely located laboratory information system.

8. The method according to claim 7, wherein, The set of equally divided tasks is determined based on the container to be the second test portion to be extracted from the second container for execution.

9. The method according to claim 7, wherein: a) Determining that the second test portion should be extracted from the second container by evaluating the set of rule engine rules using a local rule engine included in the laboratory automation system; as well as b) The method includes: prior to determining the container, using a rule engine located remotely from the laboratory automation system to determine which subsequent tests should be performed.

10. The method according to claim 9, wherein: a) The method further includes, after the laboratory automation system performs the container determination, executing instructions to confirm that the subsequent tests can be performed using material extracted from a container from which the container determination has determined that the second test portion should be extracted; (b) The laboratory automation system is configured with instructions operable to prevent the use of material extracted from the container from which the second test portion should be extracted for the subsequent test if the laboratory automation system does not confirm that the subsequent test can be performed using material extracted from the container from which the container has determined that the second test portion should be extracted.

11. The method of claim 10, wherein: a) Instructions for confirming that the subsequent test can be performed using material extracted from a container from which the second test portion is determined to be extracted include instructions for confirming the following if the container determines that the second test portion should be extracted from the second container after the aliquot sample has been moved to the second container: i) There is a sufficient sample volume for the aliquots to be moved to the second container; and ii) The second test portion to be extracted from the aliquots in the second container; b) Instructions for preventing the use of material extracted from a container from which the second test portion should be extracted to perform the subsequent test include instructions for preventing the movement of the aliquot sample from the first container to the second container in the following circumstances: i) The container determination determines that the second test portion should be extracted from the second container after the aliquot sample has been moved from the first container to the second container; as well as ii) The laboratory automation system failed to confirm that the first container contained a sufficient sample volume for the aliquots to be moved from the first container to the second container.

12. The method according to claim 10, wherein, The laboratory automation system is configured with instructions that operate to route the container from which the second test portion is determined to be extracted to an error area of ​​the laboratory automation system if the laboratory automation system fails to confirm that the subsequent test can be performed using material extracted from the container from which the container has determined to extract the second test portion.

13. The method according to claim 1, wherein: a) Performing the first test on the first test portion includes retrieving the first test portion from the first container; as well as b) Performing the subsequent tests on the second test portion includes determining, based on the container, to extract the second test portion.

14. According to the method described in Example 1, wherein, The method includes: moving aliquots of the biological sample from a primary container to the first container before performing the first test on the first test portion of the biological sample.

15. A system comprising: a) Laboratory information system; b) A laboratory automation system located remotely from the laboratory information system and including a divider and one or more analytical instruments; c) A middleware system on the network path between the laboratory automation system and the laboratory information system, wherein the middleware system is located remotely from the laboratory automation system and the laboratory information system; The laboratory automation system is configured to perform a method for conducting tests, the method comprising: A) Perform a primary test on a first test portion of a biological sample, the first test portion being contained in a first container; B) Obtain instructions to perform subsequent tests on the biological sample; C) Determine the container, wherein determining the container includes determining the container from which the second test portion should be extracted; and D) Perform the subsequent tests on the second test section.

16. The system according to claim 15, wherein, The container determination includes: if a first condition is met, determining that the second test portion should be extracted from the first container, wherein the first condition is that the subsequent test is a rerun of the primary test.

17. The system according to claim 16, wherein, The container determination includes: if the first condition is not met, determining whether a second condition is met, wherein the second condition is a set of rule engine rules specifying from which the second test portion should be extracted.

18. The system according to claim 17, wherein: a) The method for performing the test includes preparing a preservation container for the biological sample by performing actions, said actions including: i) Remove the liquid from the biological sample; and ii) The liquid removed from the biological sample is placed in the preservation container; and b) Determining the container includes: if neither the first condition nor the second condition is met, determining that the second test portion should be extracted from the storage container.

19. The system according to claim 17, wherein, The container determination includes: determining that the second test portion should be extracted from the primary container if the first condition, the second condition, and the third condition are not met, and wherein the third condition is that a preservation container has been prepared for the biological sample prior to the container determination.

20. The system according to claim 17, wherein: a) The set of rule engine rules includes rules requiring the creation of equally spaced sample containers for the second test; and b) The method for performing the test includes creating the aliquot sample container for the second test.

21. The system according to claim 17, wherein: a) The laboratory automation system is configured to: in the event that the container determination includes determining that the second test portion should be retrieved from the second container: i) Execute a set of equally divided tasks, the set of equally divided tasks including: A) Move the aliquots of the biological sample from the first container to the second container; B) Add a label to the second container, wherein the label includes a unique identifier for the second container; and C) Send a message to the middleware system that associates the unique identifier of the second container with the unique identifier of the first container; ii) Send the results of the subsequent tests to the middleware system using the unique identifier of the second container; and b) The middleware system is configured to send the results of the subsequent test to the laboratory information system using the unique identifier of the first container, based on the receipt of the results of the subsequent test sent using the unique identifier of the second container.

22. The system according to claim 21, wherein: a) The laboratory automation system is configured to determine, by evaluating the set of rule engine rules using a local rule engine included in the laboratory automation system, that the second test portion should be extracted from the second container; as well as (b) The system includes a remotely located rule engine configured to operate to determine whether the subsequent test should be performed, wherein the remotely located rule engine resides on the laboratory information system or the middleware system.

23. The system according to claim 22, wherein: a) The laboratory automation system is configured to: after the container determination, confirm that the subsequent test can be performed using material extracted from the container from which the container determination has determined that the second test portion should be extracted; (b) The laboratory automation system is configured with instructions operable to prevent the use of material extracted from the container from which the second test portion should be extracted for the subsequent test if the laboratory automation system does not confirm that the subsequent test can be performed using material extracted from the container from which the container has determined that the second test portion should be extracted.

24. The system according to claim 23, wherein: a) Instructions for confirming that the subsequent test can be performed using material extracted from a container from which the second test portion is determined to be extracted include instructions for confirming the following if the container determines that the second test portion should be extracted from the second container after the aliquot sample has been moved to the second container: i) There is a sufficient sample volume for the aliquots to be moved to the second container; and ii) The second test portion to be extracted from the aliquots in the second container; b) Instructions for preventing the use of material extracted from a container from which the second test portion should be extracted to perform the subsequent test include instructions for preventing the aliquot from moving from the first container to the second container in the following circumstances: i) The container determination determines that the second test portion should be extracted from the second container after the aliquot sample has been moved from the first container to the second container; as well as ii) The laboratory automation system failed to confirm that the first container contained a sufficient sample volume for the aliquots to be moved from the first container to the second container.

25. The system according to claim 23, wherein, The laboratory automation system is configured with instructions that operate to route the container from which the second test portion is determined to be extracted to an error area of ​​the laboratory automation system if the laboratory automation system fails to confirm that the subsequent test can be performed using material extracted from the container from which the container has determined to extract the second test portion.

26. The system according to claim 15, wherein: a) Performing the first test on the first test portion includes retrieving the first test portion from the first container; as well as b) Performing the subsequent tests on the second test portion includes determining, based on the container, to extract the second test portion.

27. The system according to claim 15, wherein, The method for performing the test includes: moving equal portions of the biological sample from a primary container to the first container before performing the first test on the first test portion of the biological sample.

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