System and method for designing quality control (QC) ranges for multiple clinical diagnostic instruments for testing same analyte

Abstract

Systems and methods are disclosed for performing a test of a single analyte on a set of multiple clinical diagnostic analyzers, or a single clinical diagnostic analyzer having multiple analysis units, or a combination thereof. The average value and SD of each individual instrument, along with the QC rule to be used, the false rejection probability function of the QC rule, and the desired false rejection rate, are input to at least one instrument. The group average and group SD are calculated to meet the desired false rejection rate and QC rules and loaded into each individual instrument for testing a single analyte at each individual instrument.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application is related to U.S. Provisional Application Serial No. 63 / 368,994 filed on July 21, 2022, the disclosure of which is incorporated herein by reference in its entirety. Background Art

[0003] The present invention relates generally to clinical diagnostic processes, and more particularly to systems and methods for designing and implementing quality control (QC) coverage for multiple clinical diagnostic analyzers and systems for testing the same analyte.

[0004] In real-world laboratory testing, clinical diagnostic laboratories often use multiple instruments or analyzers to test the same analyte or test sample. In some cases, this is due to the total amount of patient samples to be tested - that is, there are too many patient samples to be tested on a single diagnostic analyzer instrument within an acceptable time frame. In other cases, the diagnostic analyzer instrument itself may include multiple analytical units that test the same analyte - that is, the analyzer itself is essentially composed of multiple analyzers within the housing or cabinet of the same unit.

[0005] Known QC design methods have primarily focused on QC procedures for analytes tested on a single instrument in a laboratory, where QC design typically requires achieving: the QC target for the instrument (typically the mean of the QC evaluations); the QC range for the instrument (typically the standard deviation (SD) of the QC evaluations); and the QC rules implemented on the instrument (typically as a function of the QC target and QC range) that determine whether a QC result should be accepted or rejected.

[0006] For example, a representative QC design for a single instrument might include: QC target = 100 (mean of the responses from the QC material on the instrument); QC range = 15 (SD of the responses from the QC material on the instrument); and a 1:2s QC rule (where a QC result is accepted if it is within + / - 2QC of the QC target.

[0007] Traditional QC design provides little or no guidance on design

[0008] QC methods for analytes tested on multiple instruments (or tested on multiple analytical units within the same analyzer). Therefore, faced with testing a single analyte on multiple instruments, most laboratories and clinicians simply test the analyte on several different individual instruments and attempt to aggregate the results of those separate tests after the testing is completed. However, this aggregation inevitably leads to unsatisfactory results because the differences between the instruments themselves are not taken into account, and only the results of subsequent changes are attempted to be compensated. Therefore, higher and / or lower readings from one or two instruments may skew the average, increasing the number of false rejections beyond the expected number when the analyte is tested on a single instrument.

[0009] Thus, it can be seen that there remains a need in the art for effective QC systems and methods that address the problem of testing analytes on multiple instruments. Summary of the invention

[0010] The present invention relates to systems and methods for designing and implementing quality control (QC) ranges for multiple clinical diagnostic instruments testing the same analyte.

[0011] Although many QC design systems and methods are known to ensure the accuracy of clinical diagnostic processes and analyzers for testing analytes, those known QC schemes address testing individual analytes on individual QC instruments (such as clinical diagnostic analyzers). However, many real-world scenarios dictate that analytes can actually be tested on multiple analyzers or on analyzers with multiple analytical units. The use of multiple instruments raises the problem of selecting appropriate parameters to be used or applied on a collection of multiple instruments, such as a suitable standard deviation (SD) or a suitable mean value to be applied on a collection of multiple instruments. For example, it is not known in the prior art to design a QC range in which the false rejection rate of a collection of instruments testing the same analyte using a QC target of the mean value of the instrument matches the false rejection rate of a collection of instruments in which the QC target is set to the mean value of the individual instrument and the QC range is set to the SD of the individual instrument.

[0012] Embodiments of the systems and methods of the present invention as described herein address the SD and mean selection problems, and further describe how to design and implement QC ranges for multiple instruments testing the same analyte, where the QC target is the mean of the group of instruments, and the QC range is a single value selected so that for a given QC rule, the average false rejection rate of the set of instruments matches the desired design parameters.

[0013] In an exemplary embodiment, a group of multiple clinical diagnostic analyzers, or a single clinical diagnostic analyzer with multiple analytical units, or a combination thereof is employed to test a single analyte - that is, a single analyte is tested on multiple clinical diagnostic analyzers. The mean and SD of each analyzer / instrument (and / or each analytical unit), together with the QC rules to be used, the false rejection probability function of the QC rules, and the desired false rejection rate, are input to at least one of the instruments, and the group mean and group SD that meet the desired false rejection rate and QC rules are calculated.

[0014] In one aspect, the QC range for each of the individual instruments is set from a single group SD so that the false rejection rate is allocated to each instrument in proportion to their performance (a false rejection is when the test method is not wrong, but the QC result is rejected). Thus, the worst performing instruments (i.e., instruments with the highest SD) will have the largest allocation of false rejections, which is highly desirable because reducing the impact of the worst performing instruments also reduces the worst-case risk of patient harm from erroneous results compared to using an individual instrument QC arrangement. In contrast, when the QC range is set from the individual instrument SD, as is currently the case in the prior art, the false rejection rate for each instrument will be evenly distributed.

[0015] In one aspect, the QC ranges for a collection of instruments testing the same analyte are determined such that the average false rejection rate for the collection of instruments meets a desired false rejection rate criterion.

[0016] On the other hand, the group mean and group standard deviation are calculated from the mean and standard deviation of the group of individual instruments (and / or analytical units) used to test the analyte. On the one hand, the calculated group mean and group standard deviation are then used as the mean and SD on each individual instrument for testing a single analyte.

[0017] In another aspect, the probability of a false rejection is determined for a given QC rule.In one aspect, the probability of a false rejection is calculated based on the QC target, the QC range, and the individual mean and standard deviation of each instrument in the group.

[0018] On the other hand, the calculated group mean and group SD are provided to each clinical diagnostic analyzer in the group. On the other hand, each clinical diagnostic analyzer or instrument is a dedicated device for testing an analyte and may include a processor, memory, measurement hardware, and an input panel / display. Each analyzer may prompt a user to start testing of an analyte, and prompt a user to load or automatically load an analyte, and initiate testing and analysis of the analyte.

[0019] In another aspect, upon completion of testing of an analyte, each instrument in the group stores the results and / or provides the results to a central server for further presentation and / or analysis.

[0020] In another aspect, a group of laboratories (each laboratory including one or more clinical diagnostic analyzers) communicate with each other in a peer group configuration, wherein information and data are shared among members of the peer group. The shared information may include data about the analyses performed and information related to analyte test data and / or quality control materials used in the laboratory.

[0021] On the other hand, the use of group mean and group SD provides an improvement in the art of clinical diagnostic testing and analyte testing, and allows laboratories to minimize the likelihood of reporting erroneous patient results compared to the use of individual instrument mean and SD values. The minimized number of erroneous patient results reduces retesting and saves time, labor and material costs compared to systems and methods known in the prior art.

[0022] Reference to the remainder of the specification, including the drawings and claims, will recognize other features and advantages of the present invention. Other features and advantages of the present invention, as well as the structure and operation of various embodiments of the present invention, are described in detail below with reference to the drawings and claims. In the drawings, the same reference numerals represent the same or functionally similar elements. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The present invention will be described in more detail in the following detailed description of the invention with reference to the accompanying drawings which form a part hereof, in which:

[0024] Figure 1 Depicted is a block diagram of a clinical diagnostic analyzer system having a plurality of clinical diagnostic analyzers in communication with a server via a network, according to an exemplary embodiment of the present invention.

[0025] Figure 2 Depicted Figure 1 Block diagram of a single clinical diagnostic analyzer of the system.

[0026] Figure 3A Is Figure 2 A depiction of a first exemplary prompt screen presented by a clinical diagnostic analyzer.

[0027] Figure 3B Is Figure 2 A depiction of a second exemplary prompt screen presented by a clinical diagnostic analyzer.

[0028] Figure 3C Is Figure 2 A depiction of a third exemplary prompt screen presented by a clinical diagnostic analyzer.

[0029] Figure 3D Is Figure 2 A depiction of a fourth exemplary prompt screen presented by a clinical diagnostic analyzer.

[0030] Figure 4 Is arranged in a peer group configuration such as Figure 1 Block diagram of multiple clinical diagnostic analyzers in.

[0031] Figure 5 is a flow chart of an exemplary method for performing testing of a single analyte on multiple clinical diagnostic instruments according to an exemplary embodiment of the present invention. DETAILED DESCRIPTION

[0032] Described herein is a system and method for designing quality control (QC) scopes for multiple clinical diagnostic analyzers for testing the same analyte according to an exemplary embodiment of the present invention. Although the present invention will be described in detail below with reference to the exemplary embodiments and alternative embodiments depicted, it should be understood that the present invention is not limited to the specific configurations shown and described in these embodiments. On the contrary, it will be appreciated by those skilled in the art that various configurations can be realized according to the present invention. As used herein, the terms "clinical diagnostic analyzer", "analyzer", "instrument" and variations thereof may be used to refer to a dedicated diagnostic device for testing analytes, patient samples, etc., to determine the various characteristics of an analyte.

[0033] First Look Figure 1 , a clinical diagnostic system according to an exemplary embodiment of the present invention is generally depicted by the number 100. The system 100 generally includes a plurality of clinical diagnostic analyzers 110a, 110b, 110c, 110n and a server 112 in communication with a database 114. The group of clinical diagnostic analyzers 110a, 110b, 110c, 110n communicates with a network 116, which facilitates the transmission of instructions, information and data between each clinical diagnostic analyzer 110a, 110b, 110c, 110n and the server 112, and between each of the clinical diagnostic analyzers 110a, 110b, 110c, 110n and any other diagnostic analyzer, or between any combination of clinical diagnostic analyzers and / or servers. It should be understood that the number of analyzers can be any number from 1 to n, such as a group of 2, 6, 10 or 100 analyzers.

[0034] Network 116 may be any local area network (LAN), wide area network (WAN), ad hoc network, or other network configurations known in the art, or any combination thereof. Figure 1 In the exemplary embodiment depicted in , the network 116 may include a LAN that allows communication between the clinical diagnostic analyzers 110a, 110b, 110c, 110n, such as in a single laboratory setting with multiple clinical diagnostic analyzers, and may also include a WAN, such as the Internet or other wide area network, to allow communication between the LAN and the server 112 and / or between the clinical diagnostic analyzers and the server.

[0035] It should be understood that Figure 1 The configurations depicted in are exemplary and non-limiting, and the invention as described herein may be embodied in a single clinical diagnostic analyzer, in a group of clinical diagnostic analyzers co-located in a single laboratory or facility, and in a group of clinical diagnostic analyzers that are geographically dispersed to allow a group of such interconnected clinical diagnostic analyzers to each test a single analyte.

[0036] For example, multiple systems 100, each including one or more clinical diagnostic analyzers and a server, may be located in a single laboratory, or in multiple laboratories dispersed across a facility or around the world, all of which communicate via a WAN. It should also be understood that the present invention may be embodied in a single clinical diagnostic analyzer, or in a group of clinical diagnostic analyzers that communicate with each other via a LAN or WAN, without the need for one or more servers. These and other variations and embodiments will be apparent to those skilled in the art.

[0037] In an exemplary embodiment, if Figure 4 As shown, such as Figure 1 The multiple clinical diagnostic systems 150a, 150b, 150c, 150n shown communicate via a network such as the Internet or other WAN. The set of separate systems includes a peer system group 152, wherein each system 150a, 150b, 150c, 150n represents a laboratory with one or more clinical diagnostic analyzers, and wherein each laboratory performs testing of patient specimens and quality control materials. In some embodiments, each member 150a, 150b, 150c, 150n of the peer group 152 is a laboratory at a location geographically dispersed from other peer group member laboratories, wherein each laboratory has a similar type of clinical diagnostic analyzer, runs similar types of tests and uses quality control materials and / or patient specimens or analytes similar to those used by other peer members of the peer group.

[0038] review Figure 1, the server 112 preferably includes a processor 118, a memory 120, and a logic and control circuit 122, all of which communicate with each other. The server 112 can be any server, server system, computer or computer system known in the art, preferably configured to communicate instructions and data between the server 112 and the network and / or with any device connected to the network, and store data and information to and retrieve data and information from the database 114. The processor 118 can be any microprocessor, controller or multiple such devices known in the art. The processor 118 preferably runs a server operating system, such as Linux-based, Windows-based or other server operating systems known in the art. Preferably, the processor 118 is configured to control the operation of the server 112 in conjunction with the operating system, thereby allowing the server to communicate with the database 114 and the network 116 and / or with a device (such as a clinical diagnostic analyzer 110a, 110b, 110c, 110n) connected to the network. In some embodiments, the server can control the operation of the clinical diagnostic analyzers, such as allowing operation of the analyzers during specific time periods, collecting data from the analyzers for storage in the database 114, transmitting data to the analyzers for viewing and / or analysis, collecting test data from the analyzers, and providing data, instructions, or prompts to the analyzers individually or in groups.

[0039] The memory 120 may be volatile or non-volatile memory and is used to store data and information associated with the operation of the server and data for transmission to and from the server. For example, the memory stores a server operating system for execution by the processor 118 and may also store data associated with the clinical diagnostic analyzers 110a, 110b, 110c, 110n communicating with the server 112 via the network 116. In some embodiments, the memory 120 on the server may be used in addition to or in place of the database 114.

[0040] The database 114 is preferably used to store control information related to the operation of the server 112 and the operation and control of the clinical diagnostic analyzers 110a, 110b, 110c, 110n, and may also be used to store data related to the processing of samples by the clinical diagnostic analyzers. For example, the database may contain instructions or programming for execution by a processor on the clinical diagnostic analyzer or for execution on the server, or may store data related to the number of samples processed, the frequency of testing, the results of analyses performed on the analyzer, and data related to the samples themselves, such as tracking information, batch number, sample size, sample weight, percentage of remaining samples, etc. Preferably, the database 114 includes non-volatile memory, such as a hard disk drive, solid-state memory, and combinations thereof.

[0041] Logic and control circuitry 122 provides interface circuitry to allow the processor and memory to communicate, and provides other operating functions to the server, such as facilitating data communications to and from network 116 .

[0042] Go to Figure 2 , depicting Figure 1 Detailed view of a single clinical diagnostic analyzer 110a of the system of FIG. The clinical diagnostic analyzer 110a preferably includes a processor 124 , a memory device 126 , measurement hardware 128 , and an input panel / display 130 .

[0043] The processor 124 can be any controller, microcontroller or microprocessor known in the art, and communicates with a memory device 126, which stores instructions executed by the processor to control and communicate with the measurement hardware 128 and the input panel / display 130 to cause the clinical diagnostic analyzer to perform desired steps, such as sampling, to command the measurement hardware to load a test sample or perform a test on a loaded sample, or to instruct or prompt a user to perform a specific operation, such as replacing a test sample, starting a test, or viewing collected data. The processor 124 can also execute instructions to receive data from the measurement hardware 128 and perform one or more analyses on the received data, and display test results or other information on the input panel / display panel 130.

[0044] The measurement hardware 128 preferably includes a sample receptacle configured to receive one or more samples or specimens into the analyzer for testing. Preferably, the measurement hardware is configured to receive samples stored in vials, and most preferably is configured to receive multiple vials and extract analytes from any desired vial for analysis. In further embodiments, the measurement hardware 128 may include an external turntable, loader, or other mechanism to facilitate loading and unloading of samples to allow samples to be loaded at the command of the analyzer.

[0045] like Figure 2As shown, the measurement hardware is configured to be used with analyte samples 132a, 132b, 132c, 132d, and the analyte samples 132a, 132b, 132c, 132d can be QC materials, patient test specimens or other specimens or analytes known in the art. In one embodiment, the material sample is contained in a vial loaded or inserted into the clinical diagnostic analyzer 110a by a user. The sample can be loaded individually or in groups, for example, in a tray loaded into the analyzer. In an alternative embodiment, an automated loading mechanism (such as a turntable or other mechanism) can be used to load the sample according to a command from the analyzer 110a. The material sample in the form of QC material is usually provided in batches, wherein a unique batch number is assigned to a batch of samples substantially the same as from the same batch material source. The analyzer 110a preferably allows the user to register information related to the QC material, including statistical information, such as the mean value or standard deviation of the batch material. In other embodiments, the QR code on the sample bottle or container can be used, for example, to obtain information through a network or from a server to uniquely identify the sample or batch number.

[0046] The input panel / display 130 is in communication with the processor and is operable to present controls to facilitate operation of the analyzer, as well as present prompts and instructions to a user, and receive input commands and / or data from a user. The input panel / display 130 is preferably a touch screen having the ability to display text and graphics as well as icons, buttons, keyboards, etc., to present data to the user and receive input from a user of the analyzer. Preferably, the input panel / display 130 includes an audible alert device, such as a buzzer or pager.

[0047] It should be understood that the clinical diagnostic analyzer 110a (as well as Figure 1 The analyzers 1 to n) shown are not general purpose computers, but rather are dedicated test equipment units in which measurement hardware 128 interacts with the physical specimen being tested (i.e., the analyte) to determine specific characteristics of the analyte. It should be further understood that the systems and methods of the present invention provide improvements in the field of clinical diagnostic technology compared to the use of individual instrument mean and SD values, and improve the operation of the technology by minimizing the likelihood of reporting erroneous patient results. The minimized number of erroneous patient results reduces retesting and saves time, labor, and material costs compared to systems and methods known in the prior art.

[0048] See also Figure 3A , Figure 3B , Figure 3C and Figure 3D For example, the input panel / display may present a prompt to the user to load the analytes to be tested and once completed to press the ready button ( Figure 3A), sending the SD (and / or mean) to or receiving the SD (and / or mean) from another analyzer or server as described in more detail below ( Figure 3B ) allows calculation of group SD and / or group mean, calculation of group SD and / or group mean ( Figure 3C ) or start analysis of loaded analytes or store data from an analysis ( Figure 3D ). It should be understood that the clinical diagnostic analyzer 100a may have a plurality of available programs and functions, wherein menus or selection prompts are preferably presented to guide the user through the operation of the analyzer and the selection of desired functions and operations.

[0049] The clinical diagnostic analyzer 110a can be any type of analyzer known in the art, such as a biochemical analyzer, a blood analyzer, an immunologically based analyzer, or any other clinical diagnostic analyzer known in the art, preferably, the analyzer 110a is configured to test an analyte such as a patient specimen. The clinical diagnostic analyzer 110a can also be configured to be used with various quality control materials, whether in liquid or lyophilized form, and can be configured for use in immunoassays, serum chemistry, immunology, hematology, and other fields.

[0050] Combined Figure 1 3, in a typical use of designing and implementing QC ranges for multiple clinical diagnostic instruments testing the same analyte, the analyzer 110a prompts the user to load the analyte for testing, such as Figure 3A The user can also send or receive the mean and SD of a specific analyzer to another analyzer or to a server to calculate the group mean and group SD (such as Figure 3B ), or the group SD and group mean can be calculated (as Figure 3C As described in more detail herein, any of the analyzers / instruments may receive the SD and mean from the other instrument, and any of the analyzers / instruments may perform calculations to determine the group SD and group mean. It should be understood that FIG. 3A to FIG. 3D The screen descriptions in FIG. 1 are exemplary in nature, and data transfer between other screens and / or instruments may also be implemented in accordance with the present invention. Figure 3D As depicted in , with the group SD and group mean loaded into the individual analyzer, the user can run an analysis on the analyte. Upon completion of the test, the analyzer can prompt the user to store or review the data.

[0051] It should be understood that the operations of the analyzer 100a may be performed locally at the analyzer, or when the analyzer is in a Figure 1When operating in the illustrated system 100, operations may be coordinated through a server 112. It should also be understood that any data may be stored locally on the analyzer 110a, server 112, or database 114, and that the data may be made available throughout the system 100 and network 115, such that remote servers and analyzers may also access the stored data. Similarly, analysis may be run on the analyzer itself, on a server, or may be distributed among multiple analyzers and / or servers.

[0052] It should also be understood that data collected and / or stored on any individual clinical diagnostic analyzer in any system can be shared and communicated to other clinical diagnostic analyzers in the same system or laboratory, can be shared and communicated to servers and databases within the system, and can be shared and communicated to other systems, and shared and communicated to clinical diagnostic analyzers and servers and databases within those other systems.

[0053] See also Figure 4 In an exemplary embodiment, a plurality of clinical diagnostic systems 150a, 150b, 150c, 150n (each of which is similar to Figure 1 150a, 150b, 150c, 150n represent a laboratory having one or more clinical diagnostic analyzers, and wherein each laboratory performs testing of patient specimens and quality control materials. Most preferably, each member 150a, 150b, 150c, 150n of the peer group 154 ​​is a laboratory at a geographically dispersed location from the other peer group member laboratories, wherein each laboratory has a similar type of clinical diagnostic analyzer, runs similar types of tests, and uses quality control materials similar to those used by the other members of the peer group.

[0054] In embodiments of the invention described herein, analysis performed on multiple analyzers and data collected on members of a peer group may be combined to provide an output or result based on data collected across multiple analyzers and based on data collected by other members of the peer group.

[0055] With the configuration of a clinical diagnostic analyzer, a system employing a clinical diagnostic analyzer, and a peer group of clinical diagnostic analyzers illustrated, a system and method for conducting a virtual crossover study in accordance with the present invention will now be described.

[0056] For a group of clinical diagnostic analyzers, each analyzing a single analyte, the group mean and group SD can be calculated based on the mean and SD of each individual analyzer as follows:

[0057] For n instruments / analyzers (e.g., Figure 1 For analyzers 1 to n), the group mean (μ) can be calculated as:

[0058]

[0059] And the group standard deviation (SD) can be calculated as:

[0060]

[0061] in:

[0062] inst_mean i is the mean of individual instrument i (for each of instruments 1 to n), and inst_mean (with no subscript) is the vector of all i individual instrument means; and

[0063] inst_SD i is the standard deviation (SD) of individual instrument i (for each of instruments 1 to n), and inst_SD (with no subscript) is the vector of standard deviations of all i individual instruments.

[0064] Can be based on QC target, QC range, inst_mean i , and inst_SD i To calculate the probability of false rejection for an individual instrument i and a given QC rule (QCrule) specified with a QC target and a QC range.

[0065] QCrulePfr(QC target, QC range, inst_mean i , inst_SD i ) calculate the false rejection rate of instrument i using the QC rule using the specified QC target and QC range;

[0066] For n instruments / analyzers:

[0067]

[0068] Pfrgrp is the average false rejection rate for a group of n instruments using the QC rule where QC target = group mean, and QC range = sr * group SD

[0069] in:

[0070] sr is the factor to be determined to give a desired false rejection rate (Pfr).

[0071] The value of sr is determined so that Pfrgrp=Pfr.

[0072] The value of sr may be calculated using any number of well-known algorithms, such as the bisection method.

[0073] Using the above equations and calculations in the manner described below, the group mean and group SD values ​​can be provided to each individual clinical diagnostic analyzer when performing a test / analysis on the analyte, as described above with respect to FIG. 3A to FIG. 3D As also described above, using group mean and group SD values ​​(as opposed to each separate instrument using its own mean and SD values) minimizes the likelihood of reporting erroneous patient results compared to using individual instrument mean and SD values. The minimized number of erroneous patient results reduces retesting and saves time, labor, and material costs compared to systems and methods known in the prior art.

[0074] Using the initial parameters and equations described for calculating group means and group SD values ​​for analytes tested on multiple instruments, Figure 5 The steps for achieving a group mean and a group SD on a group of instruments according to an exemplary embodiment of the present invention are depicted in the flowchart of FIG.

[0075] See first Figure 5 , a method for designing and implementing QC ranges for multiple clinical diagnostic instruments testing the same analyte begins at block 200. At block 200, the mean and SD of each individual instrument in a set of instruments for testing the analyte are collected. As described above, it should be understood that the mean and SD data from each of the individual instruments can be collected at any one of the individual instruments, or can be collected at a server, wherein further calculations of the collected data are performed at the individual instrument or server where the data is collected. Similarly, the calculated or determined data can be sent or transmitted to other instruments for testing the analyte as described herein.

[0076] At block 202, a group mean and group SD values ​​are calculated. As described above, the group mean and group SD values ​​are calculated from the mean and SD of the individual instruments as:

[0077] and

[0078]

[0079] At block 204, for a given QC rule and a desired false rejection rate (Pfr), the false rejection probability and false rejection rate for the QC rule may be calculated from the QC target, QC range, and instrument mean and instrument SD vectors as described above.

[0080] At block 206 , the difference between the Pfr of the instrument and the instrument cluster may be calculated as described above.

[0081] Once the desired group mean and group SD have been determined, at box 208, the group mean and group SD are sent to each of the individual instruments in the group for use by each instrument when testing the analyte, so that each instrument in the group testing the same analyte uses the same group SD and group mean.

[0082] At block 210, if Figure 3D As depicted in , each individual instrument in the group performs a test on the analyte loaded in the respective instrument, and the results may be stored or sent to other instruments or a server for display, generating an alarm, further storage, or presentation to a user. It should be understood that each individual instrument in the group may perform its test on the analyte at a different time, with data being aggregated and stored as it becomes available, i.e., the testing at each individual instrument need not occur simultaneously.

[0083] Thus, as described herein, the design and implementation of testing a single analyte on multiple individual clinical diagnostic analyzers or instruments is performed using the group mean and group SD, rather than each instrument using the mean and SD for that individual instrument.

[0084] Therefore, the systems and methods described herein provide improvements to clinical diagnostics and analyte testing techniques and minimize the likelihood of reporting erroneous patient results compared to using individual instrument mean and SD values. The minimized number of erroneous patient results reduces retesting and saves time, labor, and material costs compared to systems and methods known in the prior art.

[0085] It can be seen that the systems and methods of the present invention provide improvements over the generally accepted method of testing an analyte between several individual instruments where the test data is only aggregated after testing.

[0086] Although the present invention has been described and illustrated with reference to various exemplary embodiments above, it should be understood that various modifications may be made to these embodiments without departing from the scope of the present invention. Therefore, the present invention is not limited to the exemplary embodiments described and shown above, unless these limitations are included in the appended claims.

Claims

1. A clinical diagnostic analyzer for conducting a virtual crossover study, comprising: processor; measurement hardware in communication with the processor and configured to measure a characteristic of an analyte; a memory device having executable instructions stored thereon, the executable instructions, when executed by the processor, causing the clinical diagnostic analyzer to perform operations, the operations comprising: obtaining individual instrument mean and standard deviation data from each of a plurality of clinical diagnostic analyzers; Calculate group mean and group SD values ​​from the individual instrument mean and SD data obtained; transmitting the calculated group mean and group SD values ​​to each of the plurality of clinical diagnostic analyzers; loading the analyte onto the clinical diagnostic analyzer; testing the analyte on the clinical diagnostic analyzer using the group mean and group SD values; collecting analyte test results from each of the plurality of clinical diagnostic analyzers; and Presenting the analyte test result data on a display, generating an alarm based on the analyte test result data, storing the analyte test result data, and combinations thereof.

2. The clinical diagnostic analyzer according to claim 1, wherein: The memory device includes instructions that, when executed, further cause the clinical diagnostic analyzer to perform operations including: A difference between the false rejection rate of the individual instrument and the false rejection rates of the plurality of clinical diagnostic analyzers is determined.

3. The clinical diagnostic analyzer according to claim 1, wherein: The memory device includes instructions that, when executed, further cause the clinical diagnostic analyzer to perform operations including: A difference between the false rejection rate of the individual instrument and the false rejection rates of the plurality of clinical diagnostic analyzers is determined.

4. The clinical diagnostic analyzer according to claim 1, wherein: The memory device includes instructions that, when executed, further cause the clinical diagnostic analyzer to perform operations including: presenting a prompt to a user on the input panel and display to load a specimen into the measurement hardware; and Accepting input from the user indicating that the sample has been loaded.

5. The clinical diagnostic analyzer according to claim 1, wherein: The memory device includes instructions that, when executed, further cause the clinical diagnostic analyzer to perform operations including: If the data of the analyte test result exceeds a predetermined threshold, a user is alerted.

6. The clinical diagnostic analyzer of claim 1 further comprising an input panel and display operable to present information and data from the processor to a user and to accept input and selections from the user.

7. A system for performing a test for a single analyte on a set of clinical diagnostic analyzers, comprising: A plurality of clinical diagnostic analyzers in communication with a server, wherein each of the plurality of clinical diagnostic analyzers comprises: processor; measurement hardware in communication with the processor and configured to measure a characteristic of an analyte; A memory device having executable instructions stored thereon; Wherein, the executable instructions stored on the memory device of at least one of the clinical diagnostic analyzers, when executed by the corresponding processor, cause the clinical diagnostic analyzer to perform operations, the operations comprising: acquiring individual instrument mean and standard deviation (SD) data from each of the individual clinical diagnostic analyzers in the plurality of clinical diagnostic analyzers; Calculate group mean and group SD values ​​from the individual instrument mean and SD data; transmitting the calculated group mean and group SD values ​​to each of the plurality of clinical diagnostic analyzers; loading the analyte onto each of the plurality of clinical diagnostic analyzers; testing the analyte on each of the individual clinical diagnostic analyzers in the plurality of clinical diagnostic analyzers, wherein each of the individual clinical diagnostic analyzers uses the group mean and group SD values ​​in testing; collecting the analyte test results from each of the plurality of clinical diagnostic analyzers at a single clinical diagnostic analyzer; and Presenting the analyte test result data on a display, generating an alarm based on the analyte test result data, storing the analyte test result data, and combinations thereof.

8. The system according to claim 7, wherein: The memory device includes instructions that, when executed, further cause the clinical diagnostic analyzer to perform operations including: Compute the false rejection probability and expected false rejection rate for a given QC rule.

9. The system according to claim 7, wherein: The memory device includes instructions that, when executed, further cause the clinical diagnostic analyzer to perform operations including: A difference between the false rejection rate of the individual instrument and the false rejection rates of the plurality of clinical diagnostic analyzers is determined.

10. The system according to claim 7, wherein: The memory device includes instructions that, when executed, further cause the clinical diagnostic analyzer to perform operations including: presenting a prompt to a user on the input panel and display to load the analyte into the measurement hardware; and Accepting input from the user indicating that the sample has been loaded.

11. The system according to claim 7, wherein: The memory device includes instructions that, when executed, further cause the clinical diagnostic analyzer to perform operations including: If the data of the analyte test result exceeds a predetermined threshold, a user is alerted.

12. The system of claim 7, further comprising an input panel and display operable to present information and data from the processor to a user and to accept input and selections from the user.

13. A method for performing a test for a single analyte on a set of clinical diagnostic analyzers, comprising: acquiring individual instrument mean and standard deviation (SD) data from each of the individual clinical diagnostic analyzers in the plurality of clinical diagnostic analyzers; Calculate group mean and group SD values ​​from the individual instrument mean and SD data; transmitting the calculated group mean and group SD values ​​to each of the plurality of clinical diagnostic analyzers; loading the analyte onto each of the plurality of clinical diagnostic analyzers; testing the analyte on each of the individual clinical diagnostic analyzers in the plurality of clinical diagnostic analyzers, wherein each of the individual clinical diagnostic analyzers uses the group mean and group SD values ​​in testing; collecting the analyte test results from each of the plurality of clinical diagnostic analyzers at a single clinical diagnostic analyzer; and Presenting the analyte test result data on a display, generating an alarm based on the analyte test result data, storing the analyte test result data, and combinations thereof.

14. The method according to claim 13, further comprising: Compute the false rejection probability and expected false rejection rate for a given QC rule.

15. The method according to claim 13, further comprising: A difference between the false rejection rate of the individual instrument and the false rejection rates of the plurality of clinical diagnostic analyzers is determined.

16. The method according to claim 13, further comprising: presenting a prompt to a user on an input panel and display of a clinical diagnostic analyzer to load said analyte into said measurement hardware; and Accepting input from the user indicating that the sample has been loaded.

17. The method according to claim 13, further comprising: If the data of the analyte test result exceeds a predetermined threshold, a user is alerted.

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