 systems to perform automated testing
专利摘要:
METHODS TO PERFORM AUTOMATED TESTING IN VARIOUS SAMPLES AND DIFFERENT TESTS COMPATIBLE AT THE SAME TIME ON THE SAME AUTOMATED AND INSTRUMENT SYSTEM. The embodiments disclosed in this document refer to methods and systems for performing an automated test and, more specifically, for performing a test on multiple samples on an automated instrument. 公开号:BR112014018995B1 申请号:R112014018995-1 申请日:2013-02-01 公开日:2021-01-19 发明作者:Adam Steel；Thomas Wojeck；Mike Young；Mark Larsen 申请人:Becton, Dickson And Company； IPC主号:
专利说明:
DESCRIPTIVE REPORT REMISSIVE REFERENCE TO RELATED REQUESTS [001] This Order claims priority to US Provisional Order Serial No. 61/594867, entitled “EXTERNAL FILES FOR DISTRIBUTION OF MOLECULAR DIAGNOSTIC TESTS AND DETERMINATION OF COMPATIBILITY BETWEEN TESTS”, filed on February 3, 2012, whose contents is incorporated into this document in its entirety by reference. BACKGROUND OF THE INVENTION Field of the Invention [002] The modalities revealed in this document refer to methods and systems to perform an automated test and, more specifically, to perform several tests on several samples in an automated instrument. Description of the State of the Art [003] The medical diagnostics industry is a key element in today's healthcare infrastructure. Since the past decade, the use of nucleic acid-based assays for diagnostic tests has become increasingly common. The automation of sample processing and testing in diagnostic tests is fascinating because it minimizes experimental variability and reduces the need for highly trained technicians. In addition to the benefits in the field of diagnosis, automation in the processing and testing of samples has facilitated high-throughput testing. [004] Bearing in mind that sample processing for purposes such as diagnostic tests or high-throughput tests can be divided into several crucial steps, it is often desirable to automate one or more steps. For example, in the context of diagnostics, a biological sample, as obtained from a patient, can be used in nucleic acid amplification assays in order to amplify a target nucleic acid (for example, DNA, RNA or the like) from interest. After amplification, the presence of a target nucleic acid, or the amplification product of a target nucleic acid (for example, a target amplicon), can be detected, in which the presence of a target nucleic acid and / or target amplicon serves to identify and / or quantify the presence of a target (for example, a target microorganism or the like). Nucleic acid amplification assays often involve many steps, which can include nucleic acid extraction, nucleic acid amplification and detection. It is desirable to automate certain steps in these processes. [005] Enhanced methods and devices are needed to run tests on multiple samples in parallel. The modalities described in this document address this need and can be used advantageously in clinical or research settings. SUMMARY OF THE INVENTION [006] The present technology refers to methods and systems to perform an automated test and, more specifically, to perform several tests on several samples in an automated instrument. In some modalities of the present technology, these methods and systems allow the simultaneous execution of different test workflows on an instrument, when the test workflows are compatible, and prevent the simultaneous execution of incompatible tests on the same workstation. Some modalities refer to executing several user-defined protocols (UDP) in an automated instrument. Some modalities refer to executing several test definition files (ADF) developed by a test manufacturer. Some modalities refer to executing one or more UDPs, optionally together with one or more ADFs, at the same time on the same automated instrument. [007] In some modalities of the technology presented in this document, methods are proposed to perform an automated test on several samples that allow greater reliability and simplicity of use when performing a test on an automated instrument. Methods may include providing an automated instrument with a first workstation and a second workstation, each configured to receive and process multiple samples according to several different automated test workflows, each of which different automated assay has a unique assay definition file or associated user-defined protocol file; determine whether two separate test workflows are compatible or incompatible with one another for simultaneous processing in the automated instrument; and run the different test workflows at the same time on the instrument when the tests are compatible. [008] In some modalities, the test definition file or the user-defined protocol file comprises a level one compatibility index value, and the determination step comprises: (a) selecting a first test from a first list of available tests; and (b) assess which of several other available tests have a test definition file with the same level one compatibility index value as the first test, where the same level one compatibility index value indicates level compatibility. a. [009] In some modalities, the evaluation step comprises: (b1) identifying any tests that have a level one compatibility index value different from the level one compatibility index value of the first test; and (b2) offering a second list of second tests, in which the second list excludes any test with a level one compatibility index value other than the level one compatibility index value of the first test. [0010] In some embodiments, each test definition file comprises a level two compatibility index value, and the determining step further comprises: (c) assessing which of several other available tests have a test definition file with the same level two compatibility index value as the first test, where the same level two compatibility index value indicates level two compatibility. [0011] In some modalities, the evaluation step comprises: (c1) identifying any tests that have a level two compatibility index value different from the level two compatibility index value of the first test; and (b2) offering a second list of second tests, where the second list excludes any test with a level two compatibility index value other than the level two compatibility index value of the first test. [0012] In some modalities, level one compatibility comprises compatibility to perform two tests at the same time on the same workstation, whose parameters are selected from the group consisting of: incubation time, lysis time, volume of reagent, reagent type, incubation temperature, lysis temperature, workstation time demands, regulatory classification, commercial considerations and a combination of these. [0013] In some modalities, level two compatibility comprises compatibility to perform two tests at the same time on the automated instrument, whose parameters are selected from the group consisting of: regulatory classification, workflow incompatibility, commercial considerations and a combination of these . [0014] In some modalities, the instrument prevents the simultaneous execution of incompatible tests on the same workstation when the level one compatibility indexes are different. In some embodiments, the two different test workflows are run on the same workstation. In some embodiments, the instrument is prevented from running tests with two different level compatibility index values at the same time. In some embodiments, two tests have the same level one compatibility index value and have different level two compatibility index values. In some embodiments, the difference in the level two compatibility index values is due to a commercial reason. In some modalities, the difference in the level two compatibility index values results from a regulatory classification. [0015] In some modalities, if the tests are compatible, the method also comprises one or more of the following steps: (d) start a sample preparation script specific to the test on the instrument; (e) comparing identification signs on the packaging of a consumption reagent to a set of identification data specific to the test stored on the instrument; (f) start a cartridge loading script specific to the test on the instrument; (g) comparing levels of detectable signals in a loaded cartridge to a set of test-specific detectable signal data stored in the instrument to determine whether the cartridge was loaded correctly; (f) start a specific reaction script to the test on the instrument; (f) start a data analysis script specific to the test on the instrument; or (j) derive a final call for the trial, based on one or more algorithms or result scripts specific to the trial. [0016] In some modalities, the test protocol comprises a reaction selected from the group consisting of: Polymerase Chain Reaction (PCR), Transcription Mediated Amplification (TMA), Oligonucleotide Binding Assay (OLA), Chain Reaction Ligase (LCR), Rolling Circle Amplification (RCA), Ribbon Displacement Amplification (SDA) and a hybridization reaction. [0017] Also presented in this document is a system for performing an automated test, the system comprising an automated instrument with a first workstation and a second workstation, each configured to receive and process multiple samples according to various flows different automated test workflows, where each different automated test workflow has a test definition file or a unique associated user-defined protocol file; a processor; a storage space; and a program to perform an automated test, the program containing instructions for determining whether two separate test workflows are compatible or incompatible with one another for simultaneous processing on the automated instrument; and run the different test workflows at the same time on the instrument when the tests are compatible. [0018] In some modalities of the system above, the test definition file or the user-defined protocol file comprise a level one compatibility index value, and the determination step comprises: (a) selecting a first test from among a first list of available tests; and (b) assess which of several other available tests have a test definition file with the same level one compatibility index value as the first test, where the same level one compatibility index value indicates level compatibility. a. [0019] In some modalities of the system above, the evaluation step comprises: (b1) identifying any tests that have a level one compatibility index value different from the level one compatibility index value of the first test; and (b2) offering a second list of second tests, in which the second list excludes any test with a level one compatibility index value other than the level one compatibility index value of the first test. [0020] In some of the above system modalities, each test definition file comprises a level two compatibility index value, and the determining step further comprises: (c) evaluating which of several other available tests have a definition file test with the same level two compatibility index value as the first test, where the same level two compatibility index value indicates level two compatibility. [0021] In some modalities of the system above, the evaluation step comprises: (c1) identifying any tests that have a level two compatibility index value different from the level two compatibility index value of the first test; and (b2) offering a second list of second tests, where the second list excludes any test with a level two compatibility index value other than the level two compatibility index value of the first test. [0022] In some modalities of the system above, level one compatibility comprises compatibility to run two tests at the same time on the same workstation, whose parameters are selected from the group consisting of: incubation time, lysis time, volume reagent type, reagent type, incubation temperature, lysis temperature, workstation time demands, regulatory classification, business considerations, and a combination of these. [0023] In some of the above system modalities, level two compatibility comprises compatibility to run two tests at the same time on the automated instrument, whose parameters are selected from the group consisting of: regulatory classification, workflow incompatibility, commercial considerations and a combination of these. [0024] In some modalities of the system above, the instrument prevents the simultaneous execution of incompatible tests on the same workstation when the level one compatibility indexes are different. In some embodiments, the two different test workflows are run on the same workstation. In some embodiments, the instrument is prevented from running tests with two different level compatibility index values at the same time. In some embodiments, two tests have the same level one compatibility index value and have different level two compatibility index values. In some embodiments, the difference in the level two compatibility index values is due to a commercial reason. In some modalities, the difference in the level two compatibility index values results from a regulatory classification. [0025] In some modalities of the system above, if the tests are compatible, the system also includes instructions for one or more of the following steps: (d) start a sample preparation script specific to the test on the instrument; (e) comparing identification signs on the packaging of a consumption reagent to a set of identification data specific to the test stored on the instrument; (f) start a cartridge loading script specific to the test on the instrument; (g) comparing levels of detectable signals in a loaded cartridge to a set of test-specific detectable signal data stored in the instrument to determine whether the cartridge was loaded correctly; (f) start a specific reaction script to the test on the instrument; (f) start a data analysis script specific to the test on the instrument; or (j) derive a final call for the trial, based on one or more algorithms or result scripts specific to the trial. [0026] In some modalities of the system above, the test protocol comprises a reaction selected from the group consisting of: Polymerase Chain Reaction (PCR), Transcription Mediated Amplification (TMA), Oligonucleotide Binding Assay (OLA), Ligase Chain Reaction (LCR), Rolling Circle Amplification (RCA), Ribbon Displacement Amplification (SDA) and a hybridization reaction. [0027] In some modalities of the system above, the system also comprises a barcode reader. In some modalities of the system above, the identification signs comprise a bar code. [0028] Also presented in this document is a method for performing several different compatible tests at the same time on the same automated instrument, the method comprising, for each different test: providing an automated instrument with a first workstation and a second workstation , each configured to receive and process multiple samples according to several different automated test workflows, where each different automated test workflow has a unique test definition file or associated user-defined protocol file with a level one compatibility index value and a level 2 compatibility index value; select a first trial from a first list of available trials; evaluate which of several other available tests have a test definition file or user-defined protocol file with the same level one compatibility index value as the first test, where the same level one compatibility index value indicates compatibility for simultaneous processing on the same workstation as the automated instrument; evaluate which of several other available tests have a test definition file or user-defined protocol file with the same level two compatibility index value as the first test, where the same level two compatibility index value indicates compatibility for simultaneous processing in the automated instrument; and run the different test workflows at the same time on the instrument when the tests are compatible. BRIEF DESCRIPTION OF THE DRAWINGS [0029] FIG. 1 is a schematic drawing illustrating a method for assigning level one and two compatibility index values to a specific test workflow or user-defined protocol (UDP). [0030] FIG. 2 is a schematic drawing illustrating a method for identifying level one and two compatibilities between two test protocols according to one modality. [0031] FIG. 3 is a schematic drawing illustrating a method for selecting and executing simultaneous test protocols according to a modality. [0032] FIG. 4 is a schematic drawing that illustrates an automated instrument with independent workstations and a shared service according to a given modality. [0033] FIG. 5 is a look-up table to illustrate shelf compatibility and execution compatibility according to a particular modality. DETAILED DESCRIPTION [0034] Automated diagnostic instruments are now able to perform the processing and testing of several samples in parallel. These devices can be used advantageously in high performance to facilitate sample preparation and testing. By way of example, automated diagnostic instruments can prepare samples for nucleic acid amplification assays and perform amplification and detection. Depending on the type of samples and the type of test, however, two test protocols are often not compatible with each other on the same instrument, either because of physical restrictions on the instrument or for commercial reasons. For example, any two assay protocols may have different incubation times, lysis times, reagent volumes, types of reagent, incubation temperatures, lysis temperatures, workstation time demands or other different parameters that make the instrument impossible. to perform different tests on samples on the same workstation or even on the same instrument. In addition to physical restrictions, regulatory classifications and commercial considerations are factors that can prevent the instrument from processing certain samples at the same time. To solve this problem, users had to compare test protocols by hand on a graph or table in order to determine whether they could be run at the same time on the same shelf or even on different shelves on the same instrument. These manual approaches can be prone to error, as well as inefficient and laborious. Therefore, improved methods are greatly needed to identify compatible test protocols and prevent incompatible test protocols from being executed at the same time. [0035] In accordance with the provisions above, this document proposes methods and systems for executing a test protocol in an automated instrument. In some modalities of the present technology, these methods and systems allow the simultaneous execution of different test workflows on an instrument, when the test workflows are compatible, and prevent the simultaneous execution of incompatible tests on the same workstation. The methods proposed in this document allow for greater reliability and simplicity of use when performing a test on an automated instrument. [0036] Therefore, this document proposes a method to provide an automated instrument with a first workstation, a second workstation and a common service shared by both workstations, each of the first and second workstations being configured to receive and process multiple samples according to several different automated test workflows, where each different automated test workflow has a test definition file or a unique associated user-defined protocol file; determine whether two separate test workflows are compatible or incompatible with one another for simultaneous processing in the automated instrument; and run the different test workflows at the same time on the instrument when the test protocols are compatible. [0037] As used in this document, the terms "workstation", "shelf" and similar terms refer to a unit that can hold multiple samples within an instrument designed to process these samples together. Therefore, two workflows that can be run at the same time on the same shelf are referred to in this document as “shelf compatible”. [0038] Two workflows that can be performed at the same time on the same instrument are referred to in this document as "compatible in operation" In certain embodiments, two compatible workflows in operation are not compatible on the same shelf, but can be performed in different shelves in the instrument. In certain embodiments, two compatible workflows in operation are compatible on the same shelf. In some other modalities, two incompatible workflows in operation are compatible on the same shelf, but cannot, for any of several reasons, be executed at the same time on the same instrument. [0039] As used in this document, the terms "workflow", "test workflow", "test", "test protocol", "test" and similar terms refer to a procedure for processing a sample . In typical embodiments, a workflow includes steps for sample preparation, such as cell lysis, nucleic acid extraction, nucleic acid purification, nucleic acid digestion, nucleic acid modification, protein extraction, protein purification and your peers. Various methods for extracting nucleic acids useful in the embodiments disclosed herein are known in the art. Examples of discussions on nucleic acid extraction can be found, for example, in U.S. Patent Application 12 / 172,214, filed on July 11, 2008, in US Patent Application 12 / 172,208, filed on July 11, 2008, and in US Patent Application No. 11 / 281,247, filed on November 16, 2005, all of which are incorporated herein in full by reference. Similarly, examples of discussions on protein extraction can be found, for example, in U.S. Patent Nos. 8,053,239 and 6,864,100, both of which are incorporated herein in full by reference. [0040] In some typical embodiments, a workflow can also include nucleic acid amplification reactions. In some typical modalities, a workflow can also include data analysis procedures. [0041] Therefore, in certain modalities, two workflows are not directly compatible with each other because of physical differences, such as incubation time, lysis time, reagent volume, type of reagent, incubation temperature, temperature lysis, time demands of the workstation and the like. Each of these parameters brings physical restrictions unique to the movement and capacity of the station itself or of a shared service resource within the automated instrument. For example, an RNA extraction protocol, a DNA extraction protocol, and a protein extraction protocol may each require different movements by a pipetting head on an instrument, and therefore cannot be processed at the same time on the same workstation. By way of another example, a PCR assay and an assay based solely on the hybridization of detectable probes to a target may require different temperature cycling and timing requirements, and therefore cannot be processed at the same time. It will be realized that any physical, temporal or other limitations can represent a reason why two workflows are not directly compatible with each other. [0042] In certain modalities, the incompatibility is due to physical restrictions on movement and the capacity of a shared service resource within the automated instrument that is shared by two or more workstations. As Figure 4 illustrates, two or more independent workstations can use a shared resource. The shared resource can be, for example, a pipette, a robotic arm, a simple detector unit or any other resource shared by two or more workstations. [0043] Physical, temporal or other parameters do not need to be identical between tests to indicate compatibility. Instead, parameters can fall within a range that provides compatibility, for example, on a shared resource. Table 2 in Example 1 below provides an example for tests with parameters that vary within a range, but still maintain compatibility, while parameters outside any of the ranges are no longer compatible. [0044] In addition, workflows that are normally physically compatible on an instrument can still be incompatible for other reasons. In certain embodiments, two workflows cannot be performed at the same time in order to meet regulatory restrictions. For example, if a testing protocol has been approved by a regulatory agency, such as the United States Food and Drug Administration (FDA), that agency may stipulate that the testing protocol is not carried out at the same time as a testing protocol. not approved. Similarly, in certain modalities, a manufacturer or user of instruments, consumables or reagents may be subject to contractual restrictions or other commercial limitations, according to which two workflows cannot be performed at the same time on the same instrument. It will be realized that the incompatibility can be due to any reason why a manufacturer or user determines that two workflows are incompatible. The methods and systems proposed in this document make it possible to identify compatible workflows and execute several compatible workflows on the same instrument at the same time. [0045] As shown in Figure 3, shelf or operating compatibility can be determined by any of several workflow parameters. For example, parameters that can determine shelf or operating compatibility include, but are not limited to, reagent strip model, number and type of consumption reagents, and specific processes performed during the workflow, such as nucleic acid extraction or the complete analysis of a sample of nucleic acids after extraction. Assay Definition Files [0046] In the modalities of the methods and systems proposed in this document, each different automated test workflow has a unique test definition file or protocol file defined by the associated user. As used in this document, the term “assay definition file (ADF)” refers to a file that provides at least part of the parameters, usually all of them, specific to the assay for that workflow. In addition, an ADF can provide compatibility index values for a specific workflow. In typical modalities, the ADF can contain all the information necessary to perform the test in an automated instrument. One function of the ADF is to provide a layer of independence between the instrument and the test. This independence makes it possible for the manufacturer of an instrument or the manufacturer of a test reagent to launch some new test protocols for an instrument without producing major revisions to the instrument's software. [0047] An ADF can comprise one or more of the components set out in Table 1 below. In particular, the ADF can include both levels of index values for shelf and operating compatibility. Table 1. ADF parameters and structures [0048] Therefore, in some modalities of the methods and systems proposed in this document, if the assay protocols are compatible, the ADF includes instructions to perform one or more of the following steps: start a sample preparation script specific to the assay in instrument; compare identification signs on the packaging of a consumption reagent to a set of test-specific identification data stored on the instrument; start a cartridge loading script specific to the test on the instrument; compare levels of detectable signals in a loaded cartridge to a set of test-specific detectable signal data stored in the instrument to determine if the cartridge was loaded correctly; start a specific reaction script to the test on the instrument; start a data analysis script specific to the test on the instrument; or derive a final call for the trial, based on one or more algorithms or result scripts specific to the trial. The detectable signals that are compared during a cartridge loading script can be any suitable detectable signal that indicates correct loading. In typical embodiments, the detectable signal is fluorescence, and the fluorescence ratio at various wavelengths in a sample or reagent can be compared to a set of predetermined fluorescence data to determine whether the cartridge has been loaded correctly. [0049] In some embodiments, the ADF may also comprise a reaction that includes, among others: Polymerase Chain Reaction (PCR), Transcription Mediated Amplification (TMA), Oligonucleotide Binding Assay (OLA), Chain Reaction Ligase (LCR), Rolling Circle Amplification (RCA), Ribbon Shift Amplification (SDA) and a hybridization reaction. [0050] Example 5 below describes an exemplary use of an ADF file to run test protocols on an instrument. [0051] Normally, when a new test is made available to the customer, the corresponding ADF is installed on the instrument. After installing an ADF on the instrument, this test is then available for execution on the instrument. The instrument software can then use the index values to control the addition of tests to an operation worklist. If certain test protocols share the same shelf index value, it is because they are allowed to be on the worklist in adjacent positions on the same shelf. If two test protocols have a different index of operation, it is because they cannot be on the same operation worklist. When the user selects the first test to be included in an operation, the software checks the compatibility index values of all other test protocols available on the instrument and modifies the list of test protocols that the user can select according to the rules listed above, thus ensuring that the customer does not select incompatible test protocols. [0052] An ADF can be provided in any suitable format. For example, the ADF can be supplied by a manufacturer on a storage medium, such as a CD-ROM or USB key, or downloaded from the manufacturer and then transferred to the terminal that controls the instrument. In this way, several ADFs, each defining a different test protocol, can be installed on the same instrument. For greater advantage, the methods and systems proposed in this document make it possible for the system to identify test protocols with the same compatibility index values, instead of forcing the user to consult a graph or table. User-Defined Protocols [0053] In certain modalities, the user determines test parameters, instead of the manufacturer. These user-defined protocols (UDP) can also be assigned level one and two compatibility index values to ensure compatibility with other commercially developed test protocols. One of the benefits of test definition indexes and files is that they offer a protective barrier between user-defined test protocols and commercially developed test protocols that also address compatibility. Index values can be used to define controls unique to user-defined protocols that are different from index values for commercially developed assay protocols. In the modality illustrated in Figure 1, User Defined Protocols are represented by the boxes marked by UDP and Extraction Only. [0054] Therefore, as shown in Figure 1, level one and level two compatibility values for a UDP can be assigned according to similar factors that determine compatibility for ADFs. These factors include, for example, the extraction kit and type of PCR selected by the user, the reagent strip model, the number of MM (master mixtures) and the specific process (extraction vs. complete process). UDP can therefore include compatibility index values as part of the complete code when there is no manufacturer-supplied ADF. A demonstration of this process is given in Example 6 below. [0055] It will be noticed that new extraction kits, types of PCR assays and other reagents can be supplied by a manufacturer with a file similar to an ADF. Therefore, when these files are installed on an instrument, and a new UDP is created, the index values for one or more UDPs can be updated accordingly. Level One Compatibility Index Value [0056] In some embodiments, the test definition file or the user-defined protocol file may comprise a level one compatibility index value. Typically, the level one compatibility index value refers to shelf compatibility. However, in some other embodiments, the level one compatibility index value refers to operating compatibility, while the level two compatibility index value refers to shelf compatibility. Thus, the method comprises: (a) selecting a first test protocol from a first list of available test protocols; and (b) assess which of several other available test protocols have a test definition file with the same level one compatibility index value as the first test. In typical embodiments, the fact that two test protocols have the same level one compatibility index value indicates level one compatibility. It will be realized, however, that any suitable mechanism that can assign and identify compatibility values for individual tests can serve the methods and systems proposed in this document. Thus, in some embodiments, two compatible test protocols may have different level one compatibility index values. However, for convenience, in this specification, two test protocols with level one compatibility are assumed to have the same level one compatibility index value. [0057] The list of available test protocols changes as the user selects one or more test protocols to run and level one compatibility is assessed. The assessment step itself (b) comprises the steps of: (b1) identifying any test protocols that have a level one compatibility index value other than the level one compatibility index value of the first trial; and (b2) offering a second list with second test protocols, the second list excluding any test with a level one compatibility index value other than the level one compatibility index value of the first test. [0058] In some modalities, level one compatibility can take into account any parameter that could prevent the execution of two test protocols at the same time on the same workstation. These parameters are known to those skilled in the art and may include, for example, physical parameters, such as incubation time, lysis time, reagent volume, type of reagent, incubation temperature, lysis temperature, station time demands and their peers. In addition, other parameters may include considerations such as regulatory classification, commercial considerations and the like. Level Two Compatibility Index Value [0059] In some embodiments, the test definition file or the user-defined protocol file may comprise a level two compatibility index value. Typically, the level two compatibility index value refers to shelf compatibility. However, in some other embodiments, the level two compatibility index value refers to shelf compatibility, while the level one compatibility index value refers to operating compatibility. Thus, the method comprises: (c) evaluating which of several other available tests have a test definition file with the same level two compatibility index value as the first test, in which the same test compatibility index value level two indicates level two compatibility. In typical embodiments, the fact that two test protocols have the same level two compatibility index value indicates level two compatibility. It will be realized, however, that any suitable mechanism that can assign and identify compatibility values for individual tests can serve the methods and systems proposed in this document. Therefore, in some embodiments, two compatible test protocols may have two different level of compatibility index values. However, for convenience, in this Specification Report, two test protocols with level two compatibility are assumed to have the same level two compatibility index value. [0060] The list of available test protocols changes as the user selects one or more test protocols to run and level two compatibility is assessed. The assessment step itself (c) comprises the steps of: (c1) identifying any test protocols that have a level two compatibility index value other than the level two compatibility index value of the first trial; and (c2) provide a second list with second test protocols, where the second list excludes any test with a level two compatibility index value other than the level two compatibility index value of the first test. [0061] In some modalities, level two compatibility can take into account any parameter that could prevent the execution of two test protocols at the same time on the same workstation. These parameters are known to those skilled in the art and may include, for example, physical parameters, such as incubation time, lysis time, reagent volume, type of reagent, incubation temperature, lysis temperature, station time demands and their peers. In addition, other parameters may include considerations such as regulatory classification, commercial considerations and the like. [0062] In some modalities, the instrument prevents the simultaneous execution of incompatible test protocols on the same workstation, when the level one compatibility indexes are different. In some embodiments, the two different test workflows are run on the same workstation. In some embodiments, the instrument is prevented from running test protocols at the same time with different level two compatibility index values. In some embodiments, two test protocols have the same level one compatibility index value and have different level two compatibility index values. In some embodiments, the difference in the level two compatibility index values is due to a commercial reason. In some modalities, the difference in the level two compatibility index values results from a regulatory classification. [0063] It will be realized that the level two index described above can be expanded from a system with two workflows to larger numbers of workflows that are desired to operate at the same time on an instrument, but may have restrictions simultaneous operation based on physical or commercial restrictions. Therefore, as shown in Figure 3, additional workflows can be added to one shelf or multiple shelves as needed, and the methods described in this document will ensure that compatibility between all tests is maintained. Instruments and Systems [0064] Also presented in this document is a system for performing an automated test, the system comprising an automated instrument with a first workstation and a second workstation, each configured to receive and process several samples according to various flows different automated test works and supported by the same service resource. Each different automated assay workflow typically comprises a unique assay definition file or associated user-defined protocol file. The system also comprises a processor; a storage space; and a program to perform an automated test, the program containing instructions for determining whether two separate test workflows are compatible or incompatible with one another for simultaneous processing on the automated instrument; and run the different test workflows at the same time on the instrument when the tests are compatible. [0065] Automated instruments that can execute several test protocols at the same time are known to those skilled in the art. Exemplary discussions of typical automated instruments for use with the methods proposed in this document can be found, for example, in U.S. Patent Application 12 / 173,023, filed on July 14, 2008, which is incorporated into this document in its entirety. by reference. [0066] It will be realized that the methods and systems described in this document can apply to instruments with 2, 3, 4 or more workstations, in which at least two of the workstations are supported by a service feature in ordinary. For example, an instrument with four workstations and a single pipette head could still be controlled based on compatibility using the two index concept described in this document. [0067] As used in this document, the terms "storage space", "storage device", "storage" and similars refer to any medium, device or medium for storing information. Storage may include, but is not limited to, a disk drive device, such as a hard disk drive, floppy disk, optical disk or magnetic optical disk, memory, such as RAM or ROM chips, and any other means used to record or store data. In some embodiments, a storage space connects to a processor, which sends information to be recorded in the storage space after purchasing it. In specific modalities, data is acquired by a system and recorded in a storage space. In other modalities, the data is acquired by a system and the information is first processed, and then this processed information is recorded in a storage space. [0068] The files and programs proposed in this document can be in any suitable programming language. In certain modalities, the ADF uses XML as a mechanism to format files. Furthermore, in certain modalities, the ADF uses Python as a scripting language to provide a mechanism for executing result logic using common technologies available on the instrument. It will be realized that any suitable file format and programming language can be used with the methods and systems proposed in this document. In certain embodiments, files can be encrypted to protect against the use of counterfeit reagents and to control details of specific parameters in assay operations. [0069] As used in this document, an "entry" may include, for example, data received via a keyboard, pen, mouse, speech recognition system or other device capable of transmitting user information to the computer. The input device can also be a touchscreen associated with the display, in which case the user responds to commands on the display by touching the screen. The user can enter textual information through an input device, such as a keyboard or touchscreen. [0070] The invention is operational in various environments or different configurations of general or specific computing systems. Examples of well-known computer systems, environments and / or configurations that may be suitable for use with the invention include, but are not limited to, microcontrollers, personal computers, server computers, portable devices, laptops, multiprocessor systems, microprocessor-based systems, programmed electronic components by the consumer, network PCs, microcomputers, large computers, distributed computing environments that include any of the systems or devices above, among others. [0071] As used in this document, "instructions" refers to steps implemented by the computer to process information in the system. The instructions can be implemented in software, firmware or hardware and include any type of programmed step performed by system components. [0072] A "microprocessor" or "processor" can be any general purpose microprocessor with one or more cores, such as a Pentium® processor, an Intel® Core ™ processor, an 8051 processor, a MIPS® processor or an ALPHA processor ®. In addition, the microprocessor can be any conventional, specific-use microprocessor, such as a digital signal processor or a video processor. “Processor” can also refer, among others, to microcontrollers, field programmable port arrangements (FPGAs), application-specific integrated circuits (ASICs), complex programmable logic devices (CPLDs), programmable logic arrangements (PLAs), microprocessors or other similar processing devices. [0073] The system consists of several modules as discussed in detail in this document. As those skilled in the art will realize, each of the modules comprises several subroutines, procedures, definition instructions and macros. Each method is usually compiled separately and linked to the same executable program. Therefore, the following description of each module serves for convenience purposes when describing the functionality of the preferred system. Thus, the processes executed by each of the modules can be redistributed arbitrarily to one of the other modules, combined in the same module, or made available, for example, in a library of shareable dynamic links. [0074] Certain modalities of the system can be used in relation to various operating systems such as SNOW LEOPARD®, iOS®, LINUX, UNIX or MICROSOFT WINDOWS®. [0075] Certain modalities of the system can be written in any conventional programming language such as Assembly, C, C ++, C #, BASIC, Pascal or Java, and be executed in a conventional operating system. [0076] In addition, modules and instructions can be stored on one or more programmable storage devices, such as FLASH drives, CD-ROMs, hard drives and DVDs. A certain modality includes a programmable storage device with instructions stored on it . [0077] In some embodiments of the system above, it also comprises a device for reading identification signs on the reagent packaging. It will be realized that any device suitable for reading identification signs can be used in the systems proposed in this document. Similarly, it is possible to use any identification signs that are compatible with the device on the instrument. Examples include bar codes, QR codes, RFID tags, color codes and the like. In typical embodiments, the device may be a barcode reader and the identification signs may comprise a barcode. Example 4 below describes the use of barcode labels to properly identify consumption reagents. Advantages and Improvements [0078] The methods and systems presented in this document offer several advantages over existing approaches. For example, the use of an ADF by a manufacturer for the distribution of test protocols makes it possible to launch new or modified test protocols on the instrument platform without the need for a coordinated update of the instrument software. By eliminating the need for revisions to the instrument's software, this approach offers a more direct route to testing. In addition, as needed, the manufacturer can modify the compatibility between test protocols to meet commercial or other needs without having to revise the instrument's software. [0079] Traditionally, compatibility was controlled using a table or other means maintained within the system and required an update to expand the menu. The use of a two-level index does not require updating a table or any other means in the software in order to expand the menu. In addition, users do not need to have any specific knowledge about assay compatibility because the instrument software controls which assay protocols are available to mix in the same operation. [0080] Another advantage of using an ADF is that information about bar codes in the ADF can be used to confirm that the reagents were loaded correctly in the instrument, thus avoiding user errors and the consequent waste of time and resources. [0081] Having described the present invention in general terms, a broader understanding can be obtained with reference to certain specific examples given in this document for the purpose of clarification only, and in no way limiting. EXAMPLE 1 Assigning Level One and Level Two Compatibility Index Values to User Defined Protocols and Commercially Provided Test Protocols [0082] This example demonstrates the process for assigning level one and two compatibility index values to a specific test workflow or user-defined protocol (UDP). An automated instrument for the processing and analysis of samples is capable of executing two workflows for the processing of samples, or shelves, which are different at the same time (operation compatibility). However, there are certain actions within a workflow for sample processing that modify and still maintain compatibility (shelf compatibility), as well as certain actions that make workflows incompatible in the same operation (incompatibility) . In addition to physical restrictions, there may be commercial requirements to prevent test protocols from being performed together on the same instrument. [0083] To manage this range of execution demands, a two-level index was created that identifies compatible test protocols on the shelf and compatible in operation. The index is assigned and maintained by the instrument manufacturer. Level one index involves shelf compatibility, that is, test protocols with the same level one index value can be run on the same shelf. The level two index involves the compatibility of operation, that is, test protocols that can be practiced on the second shelf on an instrument together with the test on the first shelf; by definition, shelf-compatible test protocols are also compatible in operation. If two test protocols do not share the same compatible level index on the shelf or in operation, the instrument is prevented from executing these test protocols on the instrument at the same time. [0084] Figure 1 illustrates an exemplary modality of this process. In the process illustrated in Figure 1, operating compatibility (level two compatibility) is indicated by protocols at the same vertical height. Shelf compatibility (level one compatibility) is indicated by protocols at the same horizontal level. Therefore, for example, two samples must be in the same box in the diagram so that they can be on the same shelf in a worklist. Boxes on the same horizontal level share the same Level 2 compatibility index, that is, testing protocols for different boxes can be on different shelves within the same operation, but not on the same shelf. [0085] As Figure 1 illustrates, factors that determine compatibility include reagent strip model, MM number (master mixtures), use of a UDP or ADF (user-defined protocol vs. assay definition file) and the specific process (extraction vs. complete process). [0086] Table 2 below illustrates several parameters that can influence compatibility. For example, in Table 2, cells with italic text highlight the parameters in Tests 4 and 5 that break compatibility with Safety Family A. More specifically, in the case of Test 4, the suction height, the lysis temperature , the number of washes and the speed of the magnet are outside the limits for each parameter defined for Tests 1 to 3. Similarly, in the case of Test 5, the suction height and lysis time are outside the limits for these parameters. Table 2. [0087] Table 2, therefore, demonstrates that the physical, temporal or other parameters do not need to be identical between the tests in order to indicate compatibility. Instead, parameters can fall within a range that provides compatibility, for example, on a shared resource. [0088] Table 3 below is an example of a table that assigns shelf compatibility and operating values to a set of test protocols. Table 3. [0089] In Table 3, Families A, B and C represent workflows that are not directly compatible with each other due to physical differences, such as incubation time, lysis time, reagent volume, type of reagent, incubation temperature, lysis temperature or workstation time demands. In the diagram and table, families A and B are compatible in operation, which means that a first workstation could practice tests in Family A (not in B) and that a second workstation could practice tests in Family B ( not on A, if B is selected for the first workstation). As Figure 1 illustrates, Family C is not compatible on the shelf or in operation with other workflows. [0090] In Table 3, three different Family A tests have a different compatibility index. Although the workflows indicate that they would be physically compatible, there may be other reasons why the manufacturer chose not to practice them on the instrument at the same time. For example, when the manufacturer partners with another company, it may be desirable to prevent the user from running tests provided by the manufacturer and tests provided by the other company on the instrument at the same time, even though the testing workflow allows it. EXAMPLE 2 Identification of Test Compatibility [0091] This example demonstrates the identification of level one and level two compatibilities between two test protocols according to one modality. In the exemplary methods illustrated in Figure 2, the compatibility between a first test and a second test is determined by comparing the two levels of compatibility index values. Previously, to avoid running incompatible tests simultaneously, users had to manually compare test protocols on a graph or table to determine whether they could be run at the same time on the same shelf or even on different shelves on the same instrument. Figure 5 illustrates an example of a query table of this type. These manual approaches can be prone to error, as well as inefficient and laborious. This example provides an example of an automated method for identifying compatible test protocols and preventing incompatible test protocols from being run at the same time. [0092] Test protocols on the same shelf. As described in the schematic drawing illustrated in Figure 2, the user selects a first test from a list of all available test protocols. Based on user input, the level one compatibility index (shelf) value for the first selected assay is obtained from the assay definition file (ADF) for the first assay, or from the UDP if the assay selected is user-defined. Then, this compatibility index value is compared to the level one compatibility index value (obtained from the ADF or UDP for each respective test) of each of the other available test protocols. All test protocols that share the same level one compatibility index value as the selected test are identified, and any incompatible test protocols are excluded from further consideration. [0093] Next, the system obtains the level two compatibility index value (operation) for the first selected test and compares the value to the level two compatibility index value of all the remaining test protocols. All assay protocols that share the same level two compatibility index value as the selected assay are identified, and any incompatible assay protocols are excluded from further consideration. After that, a list is displayed that contains only compatible test protocols at level one and at level two. The user selects a second test from this list and, after that, the system starts to run both test protocols at the same time on the same shelf, or on different shelves if desired. [0094] Test protocols on different shelves. Alternatively, the system can identify and run test protocols on different shelves when they are not compatible for operation together on the same shelf. As described in the schematic drawing illustrated in Figure 2, the user selects a first test from a list of all available test protocols. Based on user input, the level one compatibility index (shelf) value for the first selected assay is obtained from the assay definition file (ADF) for the first assay, or from the UDP if the assay selected is user-defined. Then, this compatibility index value is compared to the level one compatibility index value (obtained from the ADF or UDP for each respective test) of each of the other available test protocols. If no test protocol is identified that shares the same level one compatibility index value as the selected test, the system obtains the level two compatibility index (operation) value for the first selected test and compares it to the value level two compatibility index of all other available test protocols. All test protocols that share the same level two compatibility index value as the selected test are identified, and any incompatible test protocols are excluded from future consideration. After that, a list is displayed that contains only compatible test protocols to operate on different shelves at the same time. The user selects a second test from this list and, after that, the system starts to run both test protocols at the same time on different shelves. [0095] No other compatible testing protocol. If the system does not identify any other protocol that is compatible on the shelf or compatible in operation, the user can choose to run a single test protocol, using one or more samples, on the same shelf or on different shelves. EXAMPLE 3 Adding Tests to an Operation Worklist [0096] This example demonstrates the process for preparing an operation worklist, including identification of test protocols that can operate at the same time on the same worklist, either on the same shelf or on different shelves. [0097] A user has a predetermined number of samples, each of which must be assigned a test protocol. As shown in Figure 3, a blank work list is provided, establishing a complete list of available test protocols. The user selects a first test from the list of tests. After user selection, the system automatically deletes all protocols with a different level of compatibility index value and displays a list only of the test protocols that have not been excluded. From the list with the remaining protocols, the user selects another protocol. This process is repeated until a test protocol has been assigned to all samples, or until the first shelf is full. [0098] If the first shelf is filled, the system allows the user to start selecting test protocols for the second shelf. The system displays all protocols with the same level two index values (operating compatibility) as the protocols on the first shelf. The user then selects a protocol from this list of compatible protocols in operation. After making a first selection for the second shelf, the system automatically deletes all protocols with a different level of compatibility index value and displays a list only of the test protocols that have not been excluded. From the list with the remaining protocols, the user selects another protocol. This process is repeated until a test protocol has been assigned to all samples, or until the second shelf is full. EXAMPLE 4 Use of bar codes [0099] This example demonstrates the use of bar codes as identification signs for consumer reagent packaging. [00100] Consumption reagents obtained from a supplier include a barcode label that the instrument is able to read. When creating a test, the expected bar codes are identified in the ADF. When the operation of an instrument begins, it performs a catagolation process that confirms that the user has loaded the right consumption reagents on the instrument. The barcode data stored in the ADF is used to enable this verification. If the bar code is not read, the instrument warns the user and waits for assistance to obtain the bar code. If the bar code is read, but does not match what was expected for the test test requested by the user, the instrument warns the user and waits for assistance to correct the difference, for example, by changing reagents. The use of bar codes in the reagents and bar code information in the ADF ensures that the user operates the assay correctly. EXAMPLE 5 Using the ADF to Run a Test Protocol on an Instrument [00101] This example demonstrates the use of an ADF to accurately run test protocols on an instrument. [00102] The instrument first checks the ADF to determine the sample preparation script needed to complete the operation. The script data is then combined with the sample preparation parameters defined in the ADF and the sample preparation process begins. [00103] Upon completion of the sample preparation, the instrument checks the ADF again and executes the cartridge loading script identified in the ADF. [00104] When the cartridge is finished loading, the instrument searches the ADF for the fluorescence ratios necessary to determine if the cartridge has been loaded correctly and compares these ratios with readings taken. If the instrument determines that the cartridge has been loaded correctly, it searches the ADF to determine the PCR scripts to be used and the required PCR protocol. After recovering these values, the instrument starts the PCR process. [00105] Upon completion of the PCR, the instrument retrieves the parameters necessary to execute data analysis algorithms from the ADF and performs the data analysis. [00106] When the data analysis ends, the instrument combines the values returned from the data analysis engine to the result logic and the result script identified in the ADF to derive a final call for that specific test. EXAMPLE 6 Generation of UDP and Assignment of Compatibility Values of Level One and Level Two [00107] This example demonstrates the creation of a UDP and the assignment of compatibility index values to the UDP to accurately operate test protocols on an instrument. [00108] The user generates a new UDP by responding to commands on a display medium with a touch screen, selecting the type of test, the test parameters and the reagents for the protocol. The selected factors include, for example, type of extraction kit and PCR parameters. More specifically, when selecting from among several available options, the user selects a specific reagent strip model, a specific MM and the specific process (extraction vs. complete process). The user chooses to program a complete process and, as such, can define cycle times, temperatures and other parameters for the PCR. [00109] Following a process shown in Figure 1, the system assigns level one and level two compatibility index values to the UDP according to factors similar to those that determine the compatibility for ADFs. Based on these parameters, which include suction height, lysis temperature, lysis time, number of washes and magnet speed, the new UDP is assigned a level index value one equal to '2' and an index value of level two equals '2'. [00110] Thus, later on, when the user adds protocols to an operation worklist, he will be able to execute the new UDP at the same time as other ADFs or UDPs with level one and two index values equal to 2 and 2, respectively. [00111] It should be kept in mind that the present invention is not limited to the specific modalities described, as these may, of course, vary. It should also be borne in mind that the terminology used in this document serves only the purpose of describing specific modalities without the intention of limiting the invention. [00112] Unless otherwise indicated, all technical and scientific terms used in this document have the same meaning commonly recognized by those versed in the technique to which the modalities belong. Although any methods and materials similar or equivalent to those described in this document can also be used in practice or in testing the modalities, the preferred methods and materials are described here. [00113] The term "understand", as used in this document, is synonymous with "include", "contain" or "characterized by", is inclusive and open, and does not exclude additional elements or methodical steps not mentioned. [00114] It is also worth noting that, as used in this Descriptive Report and in the appended Claims, the singular forms “one”, “one”, “o” and “a” include their inflections in the plural, except when the context clearly dictates the contrary. Thus, for example, a reference to "a method" includes several methods of the type and equivalents to this one known to those skilled in the art, and so on. [00115] All references cited in this document, including, among others, published and unpublished applications, patents and references to literature, are incorporated into this document in its entirety by reference and, through this, constitute part of this Descriptive Report. Insofar as publications and patents or patent applications incorporated by reference contradict the disclosure contained in this Descriptive Report, it is intended that this alternate and / or has priority over any contradictory material of the type. [00116] The steps of a method or algorithm described in this document with reference to the modalities revealed in this document can be realized directly in hardware, in a software module executed by a processor or in a combination of both. A software module can reside in RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, hard disk drive, removable disk, CD-ROM or any other form of storage medium known in the art. An exemplary storage medium can be connected to the processor for it to read information on the storage medium or write information to the storage medium. Alternatively, the storage medium can be integrated with the processor. The processor and storage medium can reside in an ASIC. The ASIC can reside on a user terminal. Alternatively, the processor and the storage medium can reside in the form of separate components in a user terminal.
权利要求:
Claims (31) [0001] 1. System for Performing Automated Testing, characterized in that the system comprises: an automated instrument comprising a first workstation and a second workstation, each of the aforementioned first and second workstations configured to receive and process a plurality of samples according to a plurality of different automated test workflows, each different automated test workflow having a unique test definition file or associated user-defined protocol; a processor; a storage capacity; and a program to perform an automated test, the program comprising instructions for: determining whether two discrete test workflows are compatible or incompatible with one another for concurrent processing in the automated instrument: (a) selecting a first test from a first list of available tests; and (b) evaluating which of a plurality of other available tests have a user defined test or protocol definition file comprising the same first level compatibility index value as said first test, where the same index value first level compatibility is indicative of first level compatibility, and where the test workflows are compatible with the first level when no parameters associated with the said test workflows are outside a range that gives compatibility to at least a shared resource; and execute the said discrete test workflows each according to their own one or more exclusive parameters, concurrently in a single workstation on the said instrument when the result of said determinant step is that said two test workflows discrete are compatible with the first level. [0002] 2. System for Performing Automated Assay, according to Claim 1, characterized in that said assessment step comprises: (b1) identifying any assays that have first level of compatibility index values different from the first compatibility index value level of the aforementioned first trial; and (b2) providing a second list of second tests, wherein said second list excludes any test that has a first level of compatibility index value different from the first level of compatibility index value of said first test. [0003] 3. System for Performing Automated Assay, according to Claim 1, characterized in that each assay definition file or user-defined protocol file comprises a second level compatibility index value, and in which said determination step comprises further: (c) to assess which of a plurality of other available tests have a test definition or protocol definition file defined by the user comprising the same second level compatibility index value as said first test, in which the same value of second level compatibility index is indicative of second level compatibility. [0004] 4. System for Performing Automated Assay, according to Claim 2, characterized in that said assessment step comprises: (c1) identifying any assays that have second level compatibility index values different from the second compatibility index value the level of that first test; and (c2) providing a second list of second tests, wherein said second list excludes any test having a second level compatibility index value different from the second level compatibility index value of said first test. [0005] 5. System for Performing Automated Testing according to any one of Claims 1 to 4, characterized in that said first level compatibility comprises compatibility to run two tests concurrently on a single workstation and because the said first level compatibility is determined based on parameters selected from the group consisting of: incubation time, lysis time, reagent volume, type of reagent, incubation temperature, lysis temperature, workstation time demands, regulatory classification, commercial considerations and a combination of them. [0006] 6. System for Performing Automated Testing, according to any one of Claims 3 to 5, characterized in that said second level compatibility comprises the compatibility of running two tests concurrently in said automated instrument and in which said second level compatibility it is determined based on parameters selected from the group consisting of: regulatory classification, workflow incompatibility, business considerations and a combination of them. [0007] 7. System to Perform Automated Testing, according to Claim 5, characterized in that said instrument prevents the concurrent execution of incompatible tests on the same workstation when the first values of the first level of compatibility index are different. [0008] 8. System for Performing Automated Testing according to Claim 7, characterized in that said two discrete testing workflows are performed on the same workstation. [0009] 9. System for Performing Automated Testing, according to Claim 6, characterized in that said instrument is prevented from performing tests concurrently with different values of second compatibility index. [0010] 10. System for Performing Automated Testing, according to any one of Claims 3 to 9, characterized in that the two tests have the same first-level compatibility index value and have different second-level compatibility index values. [0011] 11. System for Performing Automated Testing according to Claim 10, characterized in that said difference in the values of the second level compatibility index comprises a commercial reason. [0012] 12. System for Performing Automated Testing, according to Claim 10, characterized in that said difference in the values of the second level compatibility index comprises a regulatory classification. [0013] 13. System for Performing Automated Testing according to Claim 1, characterized in that when the result of said determination step is that said discrete test workflows are compatible with the first level, said program further comprises instructions for one or more of the following: (d) start a sample preparation script specific to the test on the instrument; (e) comparing identification signs on consumer packaging with a set of test-specific identification data stored on the instrument; (f) start a specific test script to load a cartridge in the instrument; (g) comparing the fluorescence ratios in a loaded cartridge with a set of assay specific fluorescence ratio data stored in the instrument to determine whether said cartridge was loaded successfully; (h) start a specific reaction script to the test on the instrument; (i) start a data analysis algorithm specific to the test on the instrument; (j) derive a final call for the trial, based on one or more algorithms or result scripts specific to the trial. [0014] 14. System for Performing Automated Assay, according to Claim 13, characterized in that an assay of said assays comprises a reaction selected from the group consisting of: Polymerase Chain Reaction (PCR), Transcription Mediated Amplification (TMA ), Oligonucleotide Binding Assay (OLA), Ligase Chain Reaction (LCR), Rolling Circle Amplification (RCA), Tape Displacement Amplification (SDA) and a hybridization reaction. [0015] 15. System for Performing Automated Testing, according to Claim 1, characterized in that said system further comprises a barcode reader. [0016] 16. System for Performing Automated Testing according to Claim 1, characterized in that when the result of said determination step is that said discrete test workflows are compatible with the first level, said program further comprises instructions for compare identification signs in a consumable package with a set of test-specific identification data stored on the instrument, where the said identification mark comprises a bar code. [0017] 17. System for Performing Automated Assay according to any one of Claims 1 to 16, characterized in that each of said first and second workstations comprises a rack configured to hold a plurality of samples to be processed concurrently by the automated instrument . [0018] 18. System for Performing Automated Assay, characterized in that the system comprises: an automated instrument comprising a first workstation and a second workstation, each of the first and second workstations configured to receive and process a plurality of samples according to a plurality of different automated test workflows, where each different automated test workflow has an associated unique test definition file or a user-defined protocol file comprising a first compatibility index value level and a second-level compatibility index value, and provides one or more parameters to perform the automated test workflow; a processor; a storage capacity; and a program, the program executing an automated test as follows: determining whether two discrete test workflows are compatible or incompatible with one another for concurrent processing in the automated instrument, where the determination step comprises: selecting a first flow test workflow from a first list of available test workflows; and assess which of a plurality of other available test workflows have a test definition file or user-defined protocol file comprising the same second-level compatibility index value as the first test workflow, where test workflows having a test definition file or user-defined protocol file that comprises the same second level compatibility index value are compatible with the second level; and run the two discrete test workflows, each according to its own one or more parameters, concurrently on different workstations of the automated instrument when the two discrete test workflows are compatible with the second level. [0019] 19. System for Performing Automated Testing according to Claim 18, characterized in that test workflows with the same second level compatibility index value can be processed concurrently only at different workstations of the automated instrument. [0020] 20. System for Performing Automated Assay according to Claim 18, characterized in that the automated instrument is configured to receive and process the plurality of samples according to a plurality of different automated assay workflows using at least one shared resource . [0021] 21. System for Performing Automated Testing according to Claim 20, characterized in that the two discrete test workflows are compatible with the second level when no parameters associated with the two discrete test workflows are outside a range that provides second-level compatibility for at least one shared resource. [0022] 22. System for Performing Automated Assay according to Claim 18, characterized in that assessing which of a plurality of other available assay workflows has a assay definition file or user-defined protocol file that comprises the same value second-level compatibility index that the first test workflow comprises: identifying any test workflows that have second-level compatibility index values different from the second-level compatibility index value of the first test workflow rehearsal; and providing a second list of second test workflows, where the second list excludes any test workflow having a second-level compatibility index value different from the second-level compatibility index value of the first workflow of test. [0023] 23. System for Performing Automated Testing, according to Claim 18, characterized in that the second level compatibility value is determined based on the parameters selected from the group consisting of: regulatory classification, workflow incompatibility, considerations and a combination of them. [0024] 24. System for Performing Automated Assay according to Claim 18, characterized in that the determination step further comprises, before assessing which of a plurality of other available assay workflows have a assay definition file or assay file. user-defined protocol that comprises the same second-level compatibility index value as the first test workflow: evaluating which of a plurality of other available test workflows have a test definition file or defined protocol file by the user, comprising the same first-level compatibility index value as the first test workflow; and determining that none of the pluralities of other available test workflows have a test definition file or user-defined protocol file that comprises the same top-level compatibility index value as the first test workflow. [0025] 25. System for Performing Automated Testing according to Claim 18, characterized in that test workflows with the same first level compatibility index value can be processed concurrently at the same or different workstations of the automated instrument . [0026] 26. System for Performing Automated Assay, according to Claim 18, characterized in that the first level compatibility index value is determined based on the parameters selected from the group consisting of: incubation time, lysis time, reagent volume, reagent type, incubation temperature, lysis temperature, workstation time demands, regulatory classification, commercial considerations and a combination of these. [0027] 27. System for Performing Automated Testing according to Claim 18, characterized in that the automated instrument prevents the concurrent execution of incompatible test workflows within the same workstation when the first level of compatibility index values are different . [0028] 28. System for Performing Automated Assay according to Claim 18, characterized in that if the two discrete assay workflows are compatible, the program will be additionally configured to run one or more of the following: start a sample preparation script specific to the test in the automated instrument; compare identification signs on a consumer packaging with a set of test-specific identification data stored in the automated instrument; start a cartridge loading script specific to the test on the automated instrument; compare fluorescence ratios in a loaded cartridge with a set of assay specific fluorescence ratio data stored in the automated instrument to determine if the cartridge was loaded successfully; start a specific reaction script to the test on the automated instrument; start a test-specific data analysis algorithm on the automated instrument; derive a final call for the trial, based on one or more algorithms or result scripts specific to the trial. [0029] 29. System for Performing Automated Assay, according to Claim 28, characterized in that the identification signs comprise a bar code. [0030] 30. System for Performing Automated Testing according to Claim 29, characterized in that the system further comprises a barcode reader. [0031] 31. System for Performing Automated Assay according to Claim 18, characterized in that at least one of the assay workflows comprises a reaction selected from the group consisting of: Polymerase Chain Reaction (PCR), Mediated Amplification by Transcription (TMA), Oligonucleotide Binding Assay (OLA), Ligase Chain Reaction (LCR), Rolling Circle Amplification (RCA), Tape Shift Amplification (SDA) and a hybridization reaction.
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同族专利:
公开号 | 公开日 CN107881219B|2021-09-10| US10822644B2|2020-11-03| US20130217013A1|2013-08-22| JP2018084585A|2018-05-31| JP6262152B2|2018-01-17| AU2019201418B2|2020-07-23| AU2013214849A1|2014-09-18| CA2863637A1|2013-08-08| WO2013116769A1|2013-08-08| JP6641345B2|2020-02-05| CN107881219A|2018-04-06| CA2863637C|2021-10-26| RU2014131606A|2016-03-27| AU2013214849B2|2016-09-01| CN104204812B|2018-01-05| AU2016265968A1|2016-12-15| AU2019201418A1|2019-03-21| CN104204812A|2014-12-10| RU2658773C2|2018-06-22| US20210147923A1|2021-05-20| JP2015511314A|2015-04-16| WO2013116769A8|2014-08-21| EP2810080A1|2014-12-10|
引用文献:
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法律状态:
2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]| 2019-12-10| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]| 2020-11-24| B09A| Decision: intention to grant [chapter 9.1 patent gazette]| 2021-01-19| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 01/02/2013, OBSERVADAS AS CONDICOES LEGAIS. |
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申请号 | 申请日 | 专利标题 US201261594867P| true| 2012-02-03|2012-02-03| US61/594,867|2012-02-03| PCT/US2013/024494|WO2013116769A1|2012-02-03|2013-02-01|External files for distribution of molecular diagnostic tests and determination of compatibility between tests| 相关专利
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