Biological sample analysis system

Abstract

The present invention provides an analysis system (100, 300, 400) for analyzing a biological sample (108), the analysis system comprising an analyzer (102), the analyzer comprising an analysis unit (106) for analyzing the biological sample to obtain an analysis result (140). The analyzer is configured to receive a test kit (110), the test kit comprising an identifier (114) and containing at least one reagent for analyzing the biological sample. The analyzer comprises an identification unit (116) for reading the identifier. The analyzer receives the test kit if the identifier is valid. The analysis system also comprises a protocol creation system (150, 104). Instructions cause the processor to: receive (200) analysis protocol parameters (164) from a user interface (158); generate (202) a customized analysis protocol (138) using the analysis protocol parameters; link (204) the customized analysis protocol to an invalid identifier, which changes the invalid identifier to a valid identifier, and transmit (206) the user-created analysis protocol associated with the now valid identifier to the analyzer controller.

Description

[0001] This application is a divisional application of an invention patent application with an application date of April 4, 2014, application number 201410136129.5, and name “Biological Sample Analysis System”. Technical Field

[0002] The present invention relates to an analytical system for analyzing biological samples, and more particularly to the creation of customized analytical protocols in a fully automated analytical high-throughput system. Background Art

[0003] Fully automated diagnostic analysis systems rely on validated assays and / or workflows. However, in many situations, it would be beneficial if the laboratory could prescribe custom assays for such fully automated diagnostic analyzer systems. For example, developing assays to detect emerging outbreaks or for conducting research studies.

[0004] US Patent No. 8,035,485 discloses a system for automation of laboratory analyzers utilizing radio frequency identification tags.

[0005] U.S. patent application US2009 / 0088336A1 discloses a test cartridge for automated detection of analytes in body fluids, comprising: a sample collection unit configured to receive a body fluid sample; and an array of test units configured to receive a portion of the sample collection unit and perform a chemical reaction that produces a detectable signal indicating the presence of an analyte; and an array of reagent units containing reagents for performing the chemical reaction.

[0006] U.S. Patent Application 2008 / 0213872A1 discloses a test box inserted into the housing area of ​​a flow-through automated instrument, which is equipped with sensors to ensure proper placement and use of the test box. The application also discloses that the test box can be identified with a bar code to prevent the insertion of the wrong test box or the reuse of the test box, and the warning that the system can notify the user.

[0007] U.S. Patent Application 2011 / 0093249A1 discloses a device also referred to as an assay cartridge. The device includes a housing having a location for accommodating an assay unit and a reagent unit. The application also discloses that many different sequences can be performed for any chemical reaction to be performed on the device, and that this can be done without changing the type of reagent in the assay cartridge. The application also discloses that the device can have an identifier that is detected or read by an identifier detector. Summary of the invention

[0008] The invention provides an analysis system and a method according to the independent claims. Embodiments are given in the dependent claims.

[0009] As used herein, a controller includes a device, machine or apparatus for controlling the operation and / or function of one or more other devices. Examples of controllers may include, but are not limited to, computers, processors, embedded systems or controllers, programmable logic controllers, and microcontrollers. As used herein, a "computing device" or "computer" includes any device that includes a processor. As used herein, a "processor" includes an electronic component that can execute a program or machine executable instructions.

[0010] As used herein, a "computer-readable storage medium" encompasses any tangible storage medium that can store instructions that are executable by a processor of a computing device. A computer storage medium may be referred to as a computer-readable non-transitory storage medium.

[0011] "Computer memory" or "memory" is an example of a computer-readable storage medium. Computer memory is any memory directly accessible to a processor or other controller. "Computer storage" or "storage" is an example of a computer-readable storage medium. Computer storage is any non-volatile computer-readable storage medium.

[0012] As used herein, a "user interface" is an interface that allows a user or operator to interact with a computer or computer system.

[0013] As used herein, a "hardware interface" includes an interface that enables a processor or other controller to interact with and / or control an external computing device and / or apparatus. A hardware interface may allow a processor to send control signals or instructions to an external computing device and / or apparatus. A hardware interface may enable a processor or other controller to receive sensor data and control the dispensing of body fluids. A hardware interface may be used to form a closed control loop in some embodiments.

[0014] As used herein, "biological sample" refers to a material suspected of containing an analyte of interest. The sample may be derived from any biological source, such as physiological fluids, including blood, saliva, ocular lens fluid, cerebrospinal fluid, sweat, urine, milk, ascites, mucus, synovial fluid, peritoneal fluid, amniotic fluid, tissue, cells, etc. The test sample may be pretreated before use, such as preparing plasma from blood, diluting viscous fluids, dissolving, etc.; the method of treatment may involve filtration, distillation, concentration, inactivation of interfering components, and addition of reagents. The sample may be used directly as obtained from the source, or after pretreatment to modify the properties of the sample, such as after dilution with another solution, or after having been mixed with a reagent, the sample may be used, for example, to achieve one or more diagnostic tests such as, for example, clinical chemistry assays, immunoassays, coagulation assays, nucleic acid detection, etc. The term "sample" as used herein is therefore not only used for the original sample, but also relates to a sample that has been processed (absorbed, diluted, mixed with a reagent, concentrated, purified, amplified, etc.). As used herein, the term "analyte" refers to a complex or compound in a biological sample to be detected or measured.

[0015] The term "reagent" is used to indicate the composition required for processing the sample. A reagent can be any liquid, such as a solvent or a chemical solution, that needs to be mixed with the sample and / or other reagents to react or enable detection, for example. A reagent can be, for example, a diluent liquid including water, which can include an organic solvent, which can include a detergent, which can be a buffer. A reagent can also be, for example, a dry reagent suitable for being dissolved by a sample, another reagent, or a diluent. A reagent in the stricter sense of the term can be a liquid solution containing a reactant, which is typically a complex or agent that can, for example, be combined with one or more analytes presented in the sample or chemically change one or more analytes presented in the sample. Examples of reactants are enzymes, enzyme substrates, conjugated dyes, protein binding molecules, nucleic acid binding molecules, antibodies, chelating agents, promoters, inhibitors, epitopes, antigens, etc.

[0016] In one aspect, the present invention provides an analysis system for analyzing a biological sample. The analysis system includes an analyzer. The analyzer includes an analysis unit for analyzing the biological sample to obtain an analysis result. The analysis unit can perform measurements on the biological sample to obtain an analysis result. As used herein, an analyzer can also refer to multiple analyzers. In addition, an analyzer can also refer to one or more analysis units. In this way, the analysis system can include more than one analyzer, and each analyzer can include more than one analysis unit.

[0017] The term "measurement" relates to any measurement that can be performed on a biological sample, either directly or after processing the biological sample, after adding at least one reagent. Processing of the biological sample may include separation and / or purification of the analyte. In one embodiment, the reagent used for the measurement may be a specific analyte.

[0018] The term "analysis result" relates to the result of an analysis. The analysis result is obtained based on the measurement of a biological sample. The analysis result can be qualitative (the amount of the analyte is above or below a threshold) or quantitative.

[0019] The analyzer includes an analyzer controller. The analyzer is operable or configured to receive an assay cartridge including an identifier. The identifier is an attribute or label or tag that enables the assay cartridge to be identified as a specific assay cartridge or as an assay cartridge of a specific class.

[0020] In some embodiments, the identifier may be a tag such as a barcode or an RFID tag.

[0021] In other embodiments, the identifier may also include such attributes as the size or color of the test box. The test box contains at least one reagent for analyzing biological samples. The analyzer includes an identification unit for reading the identifier. Of course, the identification unit depends on the type of the identifier, for example, if the identifier is an RFID chip, the identification unit may include something for reading the RFID chip. Similarly, if the identifier includes a barcode, the identification unit includes a barcode reader. If the identifier is loaded into the shape or size or color of the test box, the identification unit includes a device that is operable or configured to read or measure the attribute. The analyzer is operable or configured to receive the test box.

[0022] The analyzer is operable or configured to check the validity of the identifier using the identification unit. For example, the validity can be compared or checked by comparing the identifier with a list of valid test kits or protocol identifiers. The system is operable or configured to receive the test kit when the identifier is valid. The analyzer controller includes a controller memory containing a set of analysis protocols. Each of the set of analysis protocols defines a protocol and parameters for performing an analysis of a biological sample and is referenced by a protocol identifier.

[0023] The term "protocol" relates to the conditions in an analytical system to which a biological sample is subjected in order to obtain an analytical result.

[0024] The term "parameter" or "regimen parameter" relates to the parameters that define a regimen.

[0025] The analyzer controller is operable or configured to receive the identifier from the identification unit. If the test box does not have a valid identifier, the analyzer can refuse to use the test box and does not allow the analysis of the biological sample to be performed.

[0026] The analysis system also includes a solution creation system, which includes a processor. The solution creation system also includes a solution creation system memory containing machine executable instructions. The solution creation system memory is a computer memory or storage. The execution of the machine executable instructions causes the processor to receive analysis solution parameters from a user interface. For example, an operator can input data or parameters to a user interface that can be used to generate an analysis solution.

[0027] The execution of the machine executable instructions also causes the processor to generate a customized analysis scheme using the analysis scheme parameters. The execution of the instructions also causes the processor to link the customized analysis scheme to the scheme identifier. The execution of the machine executable instructions also causes the processor to pass the user-created analysis scheme associated with the scheme identifier to the analyzer controller. If the invalid identifier corresponds to the scheme identifier, the user-created analysis scheme associated with the scheme identifier is passed to the analyzer controller, and the invalid identifier of the specific test box is changed to a valid identifier.

[0028] The analyzer controller is operable or configured to append a customized analysis protocol to the set of analysis protocols.

[0029] The analyzer controller receives an assay cartridge including a now valid identifier that enables the biological sample to be processed according to a customized analysis protocol. This can be accomplished in the analyzer using an assay cartridge including a now valid identifier.

[0030] Because the present embodiment enables the analyzer to load the test kit and perform a customized analysis scheme that the analyzer could not load, the present embodiment is advantageous. For example, many analysis systems used in laboratories have specific tests that are specified and proven. Their architecture prevents use in an unspecified manner. Embodiments of the present invention can provide a convenient means for enabling such analysis systems to perform customized test kits and / or customized analysis schemes.

[0031] The term "identifier" relates to an identifier of the test kit described herein.

[0032] The term "protocol identifier" relates to an identifier to which a protocol can be linked and which corresponds to an identifier of a test cartridge.

[0033] The transfer of a user created analysis protocol associated with a protocol identifier to the analyzer controller may be performed in a number of different ways. For example, in one embodiment, the transfer may occur across a network.

[0034] In another embodiment, a user-created analysis protocol may be written to storage on the assay cartridge (such as an RFID chip), which is then transferred to the analyzer via the assay cartridge.

[0035] In another embodiment, the analyzer controller includes a controller memory containing a set of analysis protocols.

[0036] In another embodiment, the analyzer controller includes a controller memory containing a set of analysis protocols.

[0037] In another embodiment, the analyzer is configured to use the identification unit to check the validity of the identifier by comparing the identifier with the group of analysis schemes. The analyzer is configured to receive the test kit if the identifier is valid. The analyzer is configured to reject the test kit if the identifier is invalid. The analyzer can determine whether the identifier is valid or invalid by checking whether the identifier is one of the group of analysis schemes or listed in the group of analysis schemes. If the identifier is one of the group of analysis schemes, it is valid. If the identifier is not one of the group of analysis schemes, it is invalid.

[0038] In another embodiment, the execution of the instruction causes the processor to change the invalid identifier on the test box to a valid identifier by attaching the user-created analysis scheme associated with the scheme identifier to the group of analysis schemes in the analyzer controller. In some cases, this can be done when the invalid identifier corresponds to the scheme identifier. This can then lead to acceptance of the current valid identifier in the analyzer controller, which allows the use of the test box including the valid identifier in the analyzer to process biological samples according to the customized analysis scheme. This has converted the invalid identifier to a valid identifier.

[0039] The combination of the above-mentioned embodiments can provide a means for expanding the functionality of an analysis system that includes an analysis unit and uses an identifier on a test box filled with reagents to control the selection of an analysis protocol.

[0040] In another embodiment, a data carrier such as a computer-readable storage medium such as a contact disk or USB stick or the like may have the analysis protocol written to it. The operator may then later transfer this analysis protocol to the analyzer.

[0041] In another embodiment, the analyzer and protocol creation system are integrated into a single computer or computer system. In this case, the transfer may occur by transferring data between programs or by running data files to storage on the analyzer controller.

[0042] In another embodiment, the protocol creation system is operably linked to the analyzer controller. As used herein, operably linked includes the ability to share data or functionality between the protocol creation system and the analyzer controller, and enables them to operate in conjunction with each other. For example, there may be a network connection between the protocol creation system and the analyzer controller.

[0043] In another embodiment, the identifier includes an identification tag. The identification unit includes an identification tag reader. In this embodiment, some types of tags are installed or attached to the test box. The identification unit then uses the identification tag reader at least in part to read the identifier from the identification tag.

[0044] In another embodiment, the identification tag comprises an RFID tag. In this case, the identification unit will comprise an RFID reader.

[0045] In another embodiment, the identifier is a unique identifier.

[0046] In another embodiment, the scheme creation system includes an identification label maker for generating a customized identification label. The identification label maker is, for example, a system that produces a label that can be attached to a test kit. In other examples, the identification label maker is a system for modifying an existing label. For example, the test kit includes an RFID chip simply programmed by the identification label maker. The execution of the machine executable instruction also causes the processor to generate a customized identification label including an identifier before linking the customized analysis scheme to the identifier.

[0047] In another embodiment, the customized identification tag includes an RFID tag. The identification tag generator includes a first RFID interface. The protocol creation system is operable or configured to write RFID data to the RFID tag using the first RFID interface. The identification tag reader includes a second RFID interface. The analyzer controller is operable or configured to at least partially determine the identifier by reading the RFID data using the second RFID interface.

[0048] In another embodiment, the identification tag maker is operable or configured to exchange write RFID data to the RFID tag via the first password data. The identification tag reader is operable or configured to exchange read RFID tags via the second password data. For example, a pair of public keys or encryption keys shared between analysis system and scheme creation system can be used to safely read and write data from the RFID tag. This may have the benefit of preventing someone from producing unauthorized test kits or customized analysis schemes.

[0049] The cryptographic data exchange can be performed in different ways, for example, the scheme creation system can generate a symmetric key for encrypting the RFID data, and then transmit the symmetric key to the analyzer. In another embodiment, the workflow manager generates a pair of public keys or uses a pair of pre-existing keys of the RFID tag that are then used to encrypt the data. The analyzer controller and the RFID chip use each other's public keys to exchange data. In another example, a key exchange is completed. For example, the Diffie-Hellman algorithm is used to securely exchange keys, and then they use their keys to securely communicate via the RFID chip.

[0050] In another embodiment, the RFID data includes analysis scheme modification data. The analysis scheme modification data used herein includes data that can be used to generate or modify the analysis scheme. For example, a customized analysis scheme can be stored on an RFID chip. In some embodiments, the use of the first and second cryptographic data exchanges can be used to verify that the scheme modification data on the RFID tag or chip is indeed valid and allows the creation of a customized analysis scheme on the analyzer.

[0051] In another embodiment, the identifier is at least partially determined using a unique identifier.

[0052] In another embodiment, the analyzer is an automated nucleic acid analyzer system.

[0053] In another embodiment, the analysis system protocol parameters include any of the following: analysis protocol identifier, identifier, channel target assignment, internal control effective range, sample type, sample processing input volume, polymerase chain reaction profile, calculated sensitivity, dilution factor, incubation time, reagent addition, volume, temperature setting, wash steps, and combinations thereof.

[0054] The advantage of the system and method described herein is that it allows the operator to perform customized assays on a fully automated and validated analytical system. The present invention allows the operator to perform customized assays on a validated high-throughput analytical system that supports drawing samples from primary / secondary test tubes, analyte separation, preparation of specific analyte reagents, measurements, and calculations to obtain analytical results. The analytical system and method described herein also provide increased flexibility and optimized throughput, which enables a specific high-throughput system to respond to seasonal or emerging infectious diseases that are not provided with validated assay reagents. Another advantage is that the operator can use validated reagents that lack specific analyte components to prepare specific analyte reagents. This optimizes the quality of the customized specific analyte reagents, and thereby also optimizes the quality of the analytical results obtained by the operator.

[0055] In another embodiment, the analyzer is an immunoassay analyzer or a coagulation analyzer or a nucleic acid analyzer.

[0056] The advantage of the present invention is that it allows operators to perform customized assays on a fully automated and validated analytical system. The present invention allows operators to perform customized assays on an analytical and fully integrated nucleic acid testing system that supports sample aspiration from primary / secondary test tubes, nucleic acid separation, preparation of specific amplification reagents, amplification and detection, calculation and output of intermediate results, reporting of analytical results, and release of analytical results to LIS and / or HIS systems.

[0057] The term "amplification" generally refers to the generation of multiple nucleic acid molecules from a target nucleic acid, wherein primers are mixed into specific sites on the target nucleic acid molecules to provide a starting site for extension by a polymerase. Amplification can be performed by any method generally known in the art, such as, but not limited to, standard PCR, long PCR, hot start PCR, qPCR, RT-PCR, real-time PCR, and isothermal amplification (such as 3SR, NASBA or TMA / TAA).

[0058] In another embodiment, the identifier uniquely identifies a specific test cartridge.

[0059] In another embodiment, the identifier of the test cartridge uniquely identifies the specific test cartridge.

[0060] In another embodiment, the identifier of the test cartridge uniquely identifies the test cartridge.

[0061] In another embodiment, the identifier specifies a selected analysis protocol. The selected analysis protocol is one of the set of analysis protocols.

[0062] In another embodiment, the customized identification label comprises a bar code. The identification label generally comprises a bar code printer. The identification label reader comprises a bar code reader. The analyzer controller is operable or configured to determine the identifier based at least in part on the bar code.

[0063] In another embodiment, the analytical system further comprises an assay cartridge.

[0064] In another embodiment, the test kit includes an identifier and also contains at least one reagent for analyzing a biological sample.

[0065] In another embodiment, at least one reagent comprises a specific assay reagent provided by an operator. In some embodiments, a specific assay target reagent is provided by an operator and can be added to an empty assay box by the operator. The assay box can also include reagents that are not specific assays, that is, they can also be used by the operator for any assay, and are not specific to the assay of the use procedure.

[0066] Some specific examples of specific assay reagents are specific oligonucleotides for amplification and / or detection of target nucleic acids. They can also be specific antibodies, but also other reagents used in specific assays, such as enzymes, cations or detergents.

[0067] In another embodiment, the analysis system further comprises a network connection for exchanging analysis protocols between the protocol creation system and the analyzer controller.Execution of the machine executable instructions causes the processor to transfer the user created analysis protocol to the analyzer using the network connection.

[0068] On the other hand, the present invention provides a method for analyzing a biological sample in an automated analysis system, the automated analysis system comprising an analyzer. The analyzer is operable or configured to receive a test kit with a valid identifier and reject a test kit with an invalid identifier. The method includes the step of providing a test kit including an invalid identifier and containing at least one reagent for analyzing a biological sample. The method also includes the step of generating a customized analysis scheme using a scheme creation system. The method also includes the step of linking a customized analysis scheme to a scheme identifier corresponding to the invalid identifier. The method also includes transferring the customized analysis scheme associated with the scheme identifier from the scheme creation system to an analyzer controller of the analyzer, thereby changing the invalid identifier on the test kit to a valid identifier.

[0069] The analyzer controller allows the analyzer to accept a test kit with a now valid identifier. The method also includes the step of selecting a customized analysis protocol linked to a protocol identifier corresponding to the now valid identifier. The method also includes the step of loading the test kit with the now valid identifier into the automated analyzer. The method also includes the step of reading the identifier. The identifier is read by an identification unit. The analyzer includes the identification unit. The method also includes the step of analyzing the biological sample using at least one aliquot of the at least one reagent included in the test kit according to the selected customized analysis protocol.

[0070] The term "aliquot of a reagent" relates to the portion of a reagent used to test a biological sample. An aliquot is typically generated by aspirating a portion of the reagent into a test tube or cuvette or well for additional processing. When two or more aliquots of a reagent are required, for example, a volume of the reagent can be aspirated and portions of the volume discharged into two or more wells. The term reagent aliquot is also intended to cover aliquots of reagent mixed with biological samples and other body fluids, as these are typically necessary for testing biological samples.

[0071] In another embodiment, the identifier comprises an identification tag.

[0072] In another embodiment, the identifier is a unique identifier on an identification tag.The controller memory includes a cross-tab that assigns unique identifiers to analysis protocols, the cross-tab including protocol identifiers corresponding to the unique identifiers.

[0073] In another embodiment, the identifier is generated on an identification tag by an identifier generator, and the protocol identifier is used to store the customized analysis protocol.

[0074] In another embodiment, the step of generating a customized analysis protocol using a protocol creation system includes receiving analysis protocol parameters from a user interface, generating the customized analysis protocol using the analysis protocol parameters, and linking the customized analysis protocol to a protocol identifier.

[0075] In another embodiment, a custom analysis protocol is created on a protocol creation system. The custom analysis protocol is transferred from the analysis protocol creation system to the analyzer controller using a network connection. The custom analysis protocol is referenced by a protocol identifier.

[0076] In another embodiment, the method further comprises adding at least one reagent to the assay cartridge prior to providing the assay cartridge comprising the invalid identifier and containing at least one reagent for analyzing the biological sample.

[0077] In another embodiment, the step of transferring said customized analysis protocol associated with the protocol identifier from the protocol creation system to an analyzer controller of the analyzer to the step of transferring the identifier to said analyzer controller is fully automated.

[0078] In another embodiment, the at least one reagent comprises an oligonucleotide specific for the target nucleic acid.

[0079] The present invention also includes the following embodiments:

[0080] Embodiment 1. An analysis system (100, 300, 400) for analyzing a biological sample (108), comprising:

[0081] - an assay cartridge (110) comprising an identifier (114) and containing at least one reagent for analyzing said biological sample;

[0082] - an analyzer (102), wherein the analyzer comprises an analysis unit (106) for analyzing the biological sample to obtain an analysis result (140), wherein the analyzer comprises an analyzer controller (104), wherein the analyzer is configured to receive the test cartridge, wherein the analyzer comprises an identification unit (116) for reading the identifier, wherein the analyzer controller comprises a controller memory (128) containing a set of analysis protocols (134), wherein the analyzer is configured to use the identification unit to check the validity of the identifier by comparing the identifier with the set of analysis protocols, wherein the analyzer is configured to receive the test cartridge if the identifier is valid, wherein the analyzer is configured to reject the test cartridge if the identifier is invalid, wherein each of the set of analysis protocols defines a protocol and parameters for performing an analysis of the biological sample, and each of the set of analysis protocols is referenced by a protocol identifier, wherein the analyzer controller is configured to receive the identifier from the identification unit,

[0083] - A solution creation system (150, 104) comprising a processor (152), wherein the solution creation system further comprises a solution creation system memory (162), the solution creation system memory containing machine executable instructions (166);

[0084] - wherein execution of the machine executable instructions causes the processor to:

[0085] Receiving (200) analysis protocol parameters (164) from a user interface (158);

[0086] · generating (202) a customized analysis protocol (138) using the analysis protocol parameters;

[0087] linking (204) the custom analysis protocol to a protocol identifier, and

[0088] If the invalid identifier corresponds to a protocol identifier, the invalid identifier on the assay cartridge is changed to a valid identifier by appending (206) a user-created assay protocol associated with the protocol identifier to the set of assay protocols in the analyzer controller, and wherein the analyzer controller receives the assay cartridge including the now valid identifier, which allows the biological sample to be processed in accordance with the customized assay protocol using the assay cartridge including the now valid identifier in the analyzer.

[0089] Example 2. An analysis system as described in Example 1, wherein the protocol creation system is operably linked (156) to the analyzer controller.

[0090] Embodiment 3. The analytical system of any one of Embodiments 1 or 2, wherein the identifier comprises an identification tag, and wherein the identification unit comprises an identification tag reader.

[0091] Embodiment 4. The analysis system as described in any of the preceding embodiments, wherein the protocol identifier is a unique identifier.

[0092] Embodiment 5. An analysis system as described in any of the preceding embodiments, wherein the protocol creation system includes an identification label generator (402) for generating a customized identification label, and wherein execution of the machine executable instructions causes the processor to generate a customized identification label including a customized identifier before linking the customized analysis protocol to the identifier.

[0093] Embodiment 6. An analysis system as described in any of the preceding embodiments, wherein the analysis protocol parameters include any one of the following: an analysis protocol identifier, an assay cartridge identifier, a channel target assignment, an internal control effective range, a sample type, a sample processing input volume, a polymerase chain reaction profile, a calculated sensitivity, a dilution factor, an incubation time, reagent additions, volumes, temperature settings, flushing steps, and combinations thereof.

[0094] Embodiment 7. An analysis system as described in any of the preceding embodiments, wherein the identifier of the test box uniquely identifies the test box.

[0095] Embodiment 8. An analytical system as described in any of the preceding embodiments, wherein the at least one reagent comprises a specific assay reagent provided by an operator.

[0096] Embodiment 9. An analysis system as described in any of the preceding embodiments, wherein the analysis system further comprises a network connection for exchanging analysis protocol data between the protocol creation system and the analyzer controller, and wherein execution of the machine executable instructions causes the processor to transmit the user-created analysis protocol to the analyzer using the network connection.

[0097] Embodiment 10. A method for analyzing a biological sample (108) in an automated analysis system, the automated analysis system comprising an analyzer (100, 300, 400), wherein the analyzer is configured to receive an assay cartridge (110) having a valid identifier and reject an assay cartridge having an invalid identifier, the method comprising the following steps:

[0098] a) providing (500) an assay kit comprising a null identifier and containing at least one reagent for analyzing said biological sample;

[0099] b) generating (502) a customized analysis protocol (138) using a protocol creation system (150), wherein steps a) and b) can be interchanged or can be performed in parallel;

[0100] c) linking (504) the custom analysis protocol to a protocol identifier corresponding to the invalid identifier;

[0101] d) changing the invalid identifier to a valid identifier by transferring (506) the customized analysis protocol associated with the protocol identifier from the protocol creation system to a set of analysis protocols stored by an analyzer controller of the analyzer, wherein the analyzer controller includes a controller memory (128) containing the set of analysis protocols (134), wherein the analyzer controller allows the analyzer to receive the assay cartridge if the invalid identifier corresponds to the protocol identifier by comparing the identifier to the set of analysis protocols;

[0102] e) selecting (508) said customized analysis protocol linked to the protocol identifier corresponding to the now active identifier,

[0103] f) loading (510) the test kit into the automated analyzer;

[0104] g) reading (512) the identifier, wherein the identifier is read by an identification unit comprising an identifier reader included in the analyzer;

[0105] as well as

[0106] h) analyzing (514) the biological sample using at least one aliquot of the at least one reagent included in the assay kit in accordance with the selected customized analysis protocol.

[0107] Embodiment 11. The method of embodiment 10, wherein the identifier is included on an identification tag.

[0108] Embodiment 12. The method of embodiment 10, wherein the identifier is a unique identifier on an identification tag, and the controller memory includes a cross-table that assigns unique identifiers to analysis protocols, the cross-table including protocol identifiers corresponding to the unique identifiers.

[0109] Embodiment 13. The method of embodiment 11, wherein the identifier is generated on an identification tag by an identifier generator (402), and the customized analysis protocol is stored with reference to the protocol identifier.

[0110] Embodiment 14. The method of embodiment 10, wherein the generating a customized analysis plan in step b) comprises:

[0111] - receiving analysis protocol parameters from a user interface;

[0112] - generating said customized analysis protocol using said analysis protocol parameters; and

[0113] - linking said custom analysis protocol to a protocol identifier.

[0114] Embodiment 15. A method as described in any one of embodiments 10 to 14, wherein the customized analysis protocol is created on a protocol creation system, and wherein the customized analysis protocol is transmitted from the analysis protocol creation system to the analyzer controller using a network connection, wherein the customized analysis protocol is referenced by the protocol identifier.

[0115] It can be understood that one or more of the aforementioned embodiments of the present invention may be combined as long as the combined embodiments are not mutually exclusive. BRIEF DESCRIPTION OF THE DRAWINGS

[0116] In the following, embodiments of the present invention will be explained in more detail, by way of example only, with reference to the accompanying drawings, in which:

[0117] Figure 1 An example of an analysis system having a solution creation system is shown;

[0118] Figure 2 The diagram shows Figure 1 A flowchart of the steps performed by the solution creation system;

[0119] Figure 3 Another example of an analysis system is shown;

[0120] Figure 4 Another example of an analysis system is shown;

[0121] Figure 5 A flow chart showing a method of illustrating;

[0122] Figure 6 Shows a method for developing a custom utility channel workflow;

[0123] Figure 7 Shows how the diagram is executed Figure 6 Flow chart of step 601;

[0124] Figure 8 Show more detailed diagram Figure 6 Flowchart of step 602; and

[0125] Fig. 9 A flow chart illustrating the creation of a customized utility channel assay kit is shown. DETAILED DESCRIPTION

[0126] Like numbered elements in these figures are equivalent elements or perform the same function. If the function is equivalent, it will not be necessary to discuss an element that has been discussed previously in the following figures.

[0127] Figure 1 An example of an analysis system 100 is shown. The analysis system 100 includes an analyzer 102. The analyzer 102 includes an analyzer controller 104, an analysis unit 106, a dispenser 112 of an assay cartridge 110, and an identification unit 116. A biological sample 108 can be seen to be present adjacent to the analysis unit 106. The analysis unit 106 is operable or configured to obtain an analysis result by performing measurements on the biological sample 108. The assay cartridge 110 is seen to be mounted to the analyzer 102. The assay cartridge 110 contains at least one reagent for analyzing the biological sample 108. The assay cartridge 110 is shown in combination with a dispenser 112 for dispensing at least one reagent into the biological sample 108.

[0128] The test box 110 also has an identifier 114. In different embodiments, it can be a label, a bar code, an RFID chip or other parameters that can be measured. There is an identification unit 116 for measuring or obtaining the identifier 114 from the test box 110. The analysis unit 106, the dispenser 112 and the identification unit 116 are all connected to the hardware interface 122 of the analyzer controller 104. The analyzer controller 104 also includes a processor 120. The processor 120 communicates with the hardware interface 122, the network interface 124, the computer storage 128 and the computer memory 130. The computer storage 120 is shown as including a test box database 132.

[0129] The test kit database 132 contains information about test kits with valid identifiers. The computer storage 128 is shown as also including an analysis scheme database 134. The analysis scheme database 134 contains a set of analysis schemes that can be used by the analyzer 102 to analyze the biological sample 108 of a specific test kit. There can be links between various test kits in the test kit database 132 and the analysis scheme database 134. The computer storage 128 is shown as also including an identifier 136. The identifier 136 has been read from the identifier 114 and the test kit 110 by the identification unit 116. The identifier 136 can be checked for the test kit database 132 to determine whether the test kit is valid. If valid, then find the associated analysis scheme in the analysis scheme database 134.

[0130] The computer storage 128 is also shown as containing a custom analysis protocol 138. The custom analysis protocol 138 is constructed using a protocol creation system 150. The computer storage 128 is also shown as containing analysis results 140 measured by the analysis unit 106 based on the biological sample 108.

[0131] The computer memory 130 is also shown to contain a control module 142. The control module 142 enables the processor 120 to control the operation and functionality of the analyzer 102. Specifically, the control module 142 may use an analysis protocol to control the analysis unit 106 to obtain the analysis result 140.

[0132] The analysis system 100 is also shown as including a protocol creation system 150. The protocol creation system 150 includes a network interface 154. There is a network connection connecting the network interface 154 to 124. The protocol creation system 150 also includes a processor 152. The processor 152 is connected to the network interface 154, the user interface 158, the computer storage 160 and the computer memory 162. The computer storage 160 is shown as containing the analysis protocol parameters 164 that have been received from the user interface 158. The analysis protocol parameters 164 are then used to create a customized analysis protocol 138, which is also shown as being stored in the computer storage 160. The customized analysis protocol 138 is passed to the analyzer controller 104 via the network connection 156. The computer memory 162 is shown as containing an analysis protocol creation module 166, which contains executable code that enables the processor 152 to create a customized analysis protocol 138 using the analysis protocol parameters 164.

[0133] Figure 2 The diagram shows Figure 1 FIG. 1 is a flow chart of steps performed by the protocol creation system 150 of FIG. 1. First, in step 200, analysis protocol parameters are received from a user interface. Next, in step 204, a customized analysis protocol (UCAP) is generated using the analysis protocol parameters. Then, in step 206, a link is formed between the customized analysis protocol and the protocol identifier. Finally, in step 208, the user created protocol associated with the protocol identifier is passed to the analyzer controller.

[0134] Figure 3 Another example of an analysis system 300 is shown. Figure 3 The embodiment shown in Figure 1 Then, in this case, Figure 1 The analyzer controller 104 and the protocol creation system 150 have been combined into a single analyzer controller 104 . Figure 1 The contents of computer storage 128 and 160 in have been merged, and the contents of computer memory 130 and 162 have also been merged. A user interface 158 for inputting analysis protocol parameters 164 is now also part of the analyzer controller 104.

[0135] Figure 4 Another example of an analysis system 400 is shown. The analysis system 400 is similar to Figure 3 The analysis system 300 shown in FIG. Figure 4 In the embodiment, there is an additional identification label generator 402. The identification label 402 can be used to create and / or program the identifier 114 on the test box 110. For example, the identification label generator 402 can include a barcode generator and / or an RFID chip programmer in some embodiments.

[0136] Figure 5 A flow chart of the illustrated method is shown. First, in step 500, a test kit with an invalid identifier is provided, and the test kit comprises at least one reagent. Then, in step 502, a custom analysis scheme (UCAP) is generated. Then, in step 504, the custom analysis scheme is linked to the invalid identifier. At this point, the invalid identifier becomes a valid identifier. Whenever the analysis system encounters an identifier, the analysis scheme will be called and used to analyze the biological sample. Then, in step 506, the custom analysis scheme is transferred to the analyzer controller of the analyzer. Optionally, in step 508, a custom analysis scheme is selected. Then, in step 510, the test kit is loaded to the automatic analyzer. In step 512, the identifier is read using an identification unit. In certain embodiments, the identifier is transferred to the analyzer controller, for example, via a network connection. The identifier of the link test kit is to the custom analysis scheme, so that the analyzer controller can call the custom analysis scheme thereby, to analyze the biological sample. Finally, in step 514, at least one aliquot of the reagent from the test kit is used to analyze the biological sample, and this is completed according to the custom analysis scheme.

[0137] Diagnostic laboratories need high flexibility to perform their own assays on a fully integrated high throughput analysis system. For example, a laboratory can develop assays for different flus. The present invention can provide a practical channel workflow or UCW that allows customers to perform their own assays on the system, which reports sample aspiration from the main / secondary test tubes, nucleic acid separation from the sample, preparation of a specific PCR mixture, amplification and detection, calculation and output of intermediate results, reporting of results, and release of results to the LIS system. LIS is a laboratory information system. An important aspect of the practical channel workflow is the definition and installation of customer-defined assay parameters, which include the assay cartridge ID on the analysis system.

[0138] Figure 6 A flow chart illustrating the processing is shown. First, the method starts with step 600. Then, in step 601, a custom analysis plan (UCAP) is generated. Then, in step 602, a lot number (lot) of one or more specific custom analysis plan UCW test boxes is prepared. Then, in step 604, a run is performed at the measurement biological sample. In step 606, it is a decision block. The question is whether to start a new run using the remaining UCW test boxes. If the answer is "yes", step 604 is performed again. If not, the question proceeds to step 608, and the question is whether to prepare a new lot number of a specific custom analysis plan UCW test box. If the answer is "yes", step 602 is performed again. If the answer is "no", step 610, which is also a question box, is executed. The question is whether the custom solution system should be updated. If the answer is "yes", the method returns to step 601. If otherwise, the method ends in step 612.

[0139] An important aspect of the practical channel workflow is the definition and installation of customer defined assay parameters including the assay cartridge ID on the analytical system. Figure 6 The appropriation of the customized test kit corresponds to and the marking of the customer test kit using the test kit corresponds to Figure 6 Step 602 in the example of FIG. 602. The loading of a customized assay cartridge to perform a customer defined assay on the system corresponds to Figure 6 Step 604 in .

[0140] Figure 7 Shows a more detailed diagram of how to perform Figure 6 601 of step 602. That is, how to generate a custom analysis plan. The custom analysis plan or utility channel analysis package contains all necessary test parameters to perform sample processing, amplification, detection and calculation of intermediate results. The operator can use the UCW tool or utility channel tool, which in some embodiments is a stand-alone software on the consumer's PC, to generate a custom analysis plan. After generating the custom analysis plan, the operator can save the custom analysis plan for further modification or export the custom analysis plan from the UCW system to the analysis system. This is in Figure 7 . First, in step 700, the method starts. Next, in step 702, a customized analysis plan is provided for editing. Next, in step 704, the customized analysis plan is modified. Step 706 is a decision box, and the question is whether the customized analysis plan should be saved or made public. If only saved, the method repeats step 702. If it is determined to be made public, the method proceeds to step 708. In step 708, the customized analysis plan is installed on the analysis system. Finally, in step 710, the customized analysis plan is made available for inspection. In step 704, the customized analysis plan is modified.

[0141] Several basic parameters that can be defined by the operator can be the identification of the customized analysis scheme ID or equivalent to the identifier, UCW test box ID. This identification can be used to link the customized analysis scheme to the operator-defined test box formulation (formulation). The operator can also define channel target allocation, IC effective range, sample type and sample processing input volume, PCR profile (profile) and possible calculated sensitivity.

[0142] Figure 8 Show more detailed diagram Figure 6 Flowchart of step 602 in FIG. Figure 8The flowchart in is divided into two parts. The first part 800 shows the preparation of a specific customized analysis scheme test box. The second step 802 illustrates the preparation of the customized PCR master mixture used in some embodiments. The method starts with a universal practical channel test box and a PCR master mixed reagent (MMX-R2) in step 804, without primers and probes. Then step 806 is performed from the part 802 of the flow chart. In step 806, prepare universal MMX-R2 reagent. Then, in step 808, adopt universal MMX-R2 reagent and add 810 specific target primers and probes. In step 812, the test box is filled to the final volume. In the final step 814, prepare the final MMX-R2. Then step 804 proceeds to step 816, which receives the final MMX-R2 mixture prepared in step 814.

[0143] Then, in step 818, the test box is filled into the practical channel test box with MMX-R2. Then, in step 820, the practical channel test box is re-labeled. Finally, in step 822, the practical channel test box is ready for use. Basically, UCW includes the use of universal PCR master mix, MMX-R2 reagents that do not contain specific target primers, and universal practical channel test box based on the general concept of the analysis system. The operator can prepare a specific customized analysis protocol test box by adding his specific target primer to the universal PCR master mix and filling the customized PCR master mix in the universal test box. Figure 8 The process is illustrated in FIG.

[0144] Fig. 9 A flow chart illustrating the filling of a practical channel test box is shown. Figure 6 In order to use the specific customized analysis scheme test box in the fully integrated analysis system, the UCW test box has to provide a corresponding identification label to be recognized by the system. Two alternative labeling methods are mentioned: First, the UCW test box identifier will be written into the unprotected data area of ​​the RFID or barcode and attached to the box using the UCW tool and the connected RFID and barcode writer. Fig. 9 First, at step 900, a filled UC test kit is provided. Next, at step 902, the test kit is placed on an RFID reader and / or writer.

[0145] Next, in step 904, use the UCW tool to select a properly disclosed custom analysis scheme. Next, in step 906, select write identifier. Next, in step 904, the UCW tool reads and verifies the RFID. Step 910 is a decision box. The question is whether the box is a UCW test box. If the answer is "no", the test box RFID is not changed, and the method ends. If the answer is "yes", the user-defined reagent batch number is entered in step 914. Next, in step 916, the UCW tool is used to write the UCW test box name and batch number to the RFID of the test box. Then, finally in step 918, the UCW test box is ready for use.

[0146] Alternatively, the unique identifier of the RFID chip can be used as an identification tag. The unique identifier of the RFID can be linked to the corresponding customized analysis scheme via a cross table stored on the analysis system. Thus the cross table includes a scheme identifier that allows an invalid identifier to be changed to a valid identifier. Finally, when the execution is carried out, the practical channel is similar to a standard workflow. The operator can load the analysis system with a specific customized scheme test box, which is used in the same way as the test box containing the manufacturer to provide the test. UCW w uses the same bulk reagents and consumables.

[0147] Reference Number List

[0148] 100 Analysis System

[0149] 102 Analyzer

[0150] 104 Analyzer Controller

[0151] 106 Analysis Unit

[0152] 108 Biological samples

[0153] 110 Test Kit

[0154] 112 Dispenser

[0155] 114 Identifier

[0156] 116 Identification Unit

[0157] 120 processors

[0158] 122 Hardware Interface

[0159] 124 Network Interfaces

[0160] 128 Computer storage

[0161] 130 Computer memory

[0162] 132 Test Kit Database

[0163] 134 Analysis Solution Database

[0164] 136 Identifier

[0165] 138 Customized analysis solutions

[0166] 140 Analysis Results

[0167] 142 Control Module

[0168] 150 Solution Creation System

[0169] 152 Processor

[0170] 154 Network Interfaces

[0171] 156 Network Connections

[0172] 158 User Interface

[0173] 160 Computer Storage

[0174] 162 Computer memory

[0175] 164 Analysis scheme parameters

[0176] 166 Analysis plan creation module

[0177] 300 Analysis System

[0178] 400 Analysis System

[0179] 402 Identification Tag Generator

Claims

1. A method for analyzing a biological sample (108) in a fully automated and validated analysis system (100, 300, 400), the fully automated and validated analysis system (100, 300, 400) comprising an analyzer (102), wherein the analyzer is configured to receive assay cartridges having valid identifiers and to reject assay cartridges having invalid identifiers, the associated analysis protocols of which are not included in a set of valid analysis protocols (134), the method comprising the following steps: a) providing an assay cartridge (110) comprising a null identifier and containing at least one reagent for analyzing the biological sample; b) generating a customized analysis protocol (138) using a protocol creation system (150), wherein steps a) and b) are interchangeable or can be performed in parallel; c) linking the customized analysis protocol (138) to the protocol identifier corresponding to the invalid identifier; d) changing the invalid identifier to a valid identifier by transferring the customized analysis protocol (138) associated with the protocol identifier from the protocol creation system (150) to the set of valid analysis protocols (134) stored by an analyzer controller (104) of the analyzer (102), wherein the analyzer controller (104) includes a controller memory (128) containing the set of valid analysis protocols (134), wherein each of the set of valid analysis protocols (134) defines a protocol and parameters for performing an analysis of the biological sample, and each of the set of valid analysis protocols (134) is referenced by a protocol identifier, and wherein the analyzer controller (104) allows the analyzer (102) to receive the assay cartridge (110) if the invalid identifier corresponds to the protocol identifier by comparing the invalid identifier to the set of valid analysis protocols (134); e) selecting said customized analysis protocol (138) linked to the protocol identifier corresponding to the now active identifier, f) loading the assay cartridge (110) with the now valid identifier into the analyzer; g) reading the identifier, wherein the identifier is read by an identification unit (116) comprising an identifier reader included in the analyzer (102); as well as h) analyzing the biological sample using at least one aliquot of the at least one reagent included in the assay kit (110) according to the selected customized analysis protocol (138).

2. The method of claim 1, wherein: The identifier is included on an identification tag.

3. The method of claim 2, wherein: The identifier is a unique identifier on the identification tag, and the controller memory (128) includes a cross-table that assigns the unique identifier to valid analysis protocols (134), the cross-table including protocol identifiers corresponding to the unique identifier.

4. The method of claim 2, wherein: The identifier is generated on an identification tag by an identifier generator (402), and the customized analysis protocol (138) is stored with reference to the protocol identifier.

5. The method of claim 1, wherein: The generating of a customized analysis plan (138) in step b) comprises: - receiving analysis protocol parameters (164) from a user interface (158); - generating the customized analysis protocol (138) using the analysis protocol parameters (164); and - Linking said customized analysis protocol (138) to a protocol identifier.

6. The method of any one of claims 1 to 5, wherein the customized analysis protocol (138) is created on a protocol creation system (150), and wherein, A custom created analysis protocol (138) is communicated from the protocol creation system (150) to the analyzer controller (104) using a network connection (156), wherein the custom analysis protocol (138) is referenced by the protocol identifier.

7. A fully automated and validated analytical system (100, 300, 400) for analyzing a biological sample (108), comprising: - an analyzer (102), The analyzer (102) comprises an analysis unit (106) for analyzing the biological sample to obtain an analysis result (140). The analyzer (102) includes an analyzer controller (104), wherein the analyzer (102) is configured to receive an assay cartridge (110) comprising an identifier (114) and containing at least one reagent for analyzing the biological sample, The analyzer (102) includes an identification unit (116) for reading an identifier of the test box (110). wherein the analyzer controller (104) includes a controller memory (128) containing a set of valid analysis protocols (134), wherein each of the set of valid analysis protocols (134) defines a protocol and parameters for performing an analysis of the biological sample, and each of the set of valid analysis protocols (134) is referenced by a protocol identifier, wherein the analyzer controller (104) is configured to check the validity of the identifier of the test cartridge (110) by receiving the identifier of the test cartridge (110) from the identification unit (116) and comparing the identifier with the set of valid analysis protocols (134), wherein the analyzer is configured to receive the test kit (110) if the identifier is valid, wherein the analyzer is configured to reject the test kit (110) if the identifier is invalid, Wherein, when the test kit (110) is rejected: The analyzer controller (104) is configured to: generating a customized analysis protocol (138) using a protocol creation system (150); linking the custom analysis protocol (138) to the protocol identifier corresponding to the invalid identifier, changing the invalid identifier to a valid identifier by transferring the customized analysis protocol (138) associated with the protocol identifier from the protocol creation system (150) to the set of valid analysis protocols (134) stored by an analyzer controller (104) of the analyzer (102), Thus, by comparing the invalid identifier with the set of valid analysis protocols (134), the analyzer (102) is allowed to receive the test cartridge (110) if the invalid identifier corresponds to the protocol identifier; And the analyzer (102) is configured to: selecting the customized analysis protocol (138) linked to the protocol identifier corresponding to the now active identifier, According to the customized analysis protocol (138), the biological sample is analyzed using at least one aliquot of the at least one reagent included in the test kit (110).

8. The analysis system according to claim 7, wherein: The identifier is included on an identification tag.

9. The analysis system according to claim 8, wherein: The identifier is a unique identifier on the identification tag, and the controller memory (128) includes a cross-table that assigns the unique identifier to valid analysis protocols (134), the cross-table including protocol identifiers corresponding to the unique identifier.

10. The analysis system of claim 8, further comprising an identification tag generator (402) configured to generate the identifier on an identification tag and store the customized analysis protocol (138) with reference to the protocol identifier.

11. The analysis system according to claim 7, wherein: The protocol creation system (150) is configured to generate the customized analysis protocol (138) by: - receiving analysis protocol parameters (164) from a user interface (158); - generating the customized analysis protocol (138) using the analysis protocol parameters (164); and - Linking said customized analysis protocol (138) to a protocol identifier.

12. The analysis system according to any one of claims 7 to 11, wherein: The protocol creation system (150) is configured to communicate a custom created analysis protocol (138) from the protocol creation system (150) to the analyzer controller (104) using a network connection (156), wherein the custom analysis protocol (138) is referenced by the protocol identifier.

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