Systems and methods for designing quality control (QC) ranges for multiple clinical diagnostic instruments testing the same analyte

Abstract

Systems and methods are disclosed for testing a single analyte on a group of clinical diagnostic analyzers, a single clinical diagnostic analyzer with multiple analytical units, or a combination thereof. The mean and SD of each individual analyzer are input into at least one of the analyzers, along with the QC rule to be used, the false rejection probability function for the QC rule, and the desired false rejection rate. A group mean and group SD are calculated to satisfy the desired false rejection rate and QC rule, and loaded into each individual analyzer for use in testing the single analyte on each individual analyzer.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is related to U.S. Provisional Application Serial No. 63 / 368,994, filed July 21, 2022, the entire disclosure of which is incorporated herein by reference.

[0002] The present invention relates generally to clinical diagnostic processes, and more particularly to systems and methods for designing and implementing quality control (QC) ranges for multiple clinical diagnostic analyzers and systems that test the same analyte. [Background technology]

[0003] In real-world laboratory testing, it is common for clinical diagnostic laboratories to use multiple meters or analyzers to test the same analyte or test specimen. In some cases, this is due to the volume of patient specimens to be tested, i.e., more patient specimens than a single diagnostic analyzer can test in an acceptable time. In other cases, the diagnostic analyzer itself may contain multiple analytical units that test for the same analyte, i.e., the analyzer itself may actually consist of multiple analyzers within the same unit housing or cabinet.

[0004] Known QC design methodologies primarily focus on QC procedures for analytes tested on a single instrument within a laboratory, and the QC design typically requires the implementation of the following: a QC target for the instrument (typically the mean of the QC ratings), a QC range for the instrument (typically the standard deviation (SD) of the QC ratings), and QC rules (typically as a function of the QC target and QC range) implemented on the instrument that determine whether to pass or fail the QC result.

[0005] For example, a typical QC design for a single instrument might include a QC target = 100 (from the average response of the QC materials on the instrument), a QC range = 15 (from the SD of the response of the QC materials on the instrument), and a 1:2s QC rule (pass if the QC result is within ±2 QC of the QC target). Summary of the Invention [Problem to be solved by the invention]

[0006] Traditional QC design provides little or no guidance for designing QC methods for analytes tested on multiple instruments (or on multiple analytical units within the same analyzer). Thus, when a single analyte is tested on multiple instruments, most laboratories and clinicians simply test the analyte on several different individual instruments and then aggregate the results of those separate tests after the tests are complete. However, such aggregation inevitably leads to unsatisfactory results because it only attempts to compensate for the variability in results ex post without considering differences between the instruments. Thus, high or low readings on one or two of the instruments can skew the average and result in more false rejects than would be expected if the analyte were tested on a single instrument.

[0007] 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 one analyte on multiple instruments. [Means for solving the problem]

[0008] The present invention relates to a system and method for designing and implementing quality control (QC) ranges for multiple clinical diagnostic instruments that test the same analyte.

[0009] Numerous QC design systems and methods are known to ensure the accuracy of analytical devices used in clinical diagnostic processes and analyte testing. However, these known QC schemes address the testing of individual analytes on individual QC instruments, such as a single clinical diagnostic analyzer. However, in many real-world scenarios, a single analyte may be tested on multiple analyzers or on analyzers with multiple analytical units. When multiple instruments are used, the selection of parameters suitable for use or application across a set of instruments, such as a standard deviation (SD) or mean suitable for application across a set of instruments, becomes an issue. For example, designing QC ranges such that the false rejection rate of a set of instruments testing the same analyte using a QC target of the instrument mean matches the false rejection rate of the set of instruments, and setting the QC target to the mean of the individual instruments and the QC range to the SD of the individual instruments, is unknown in the prior art.

[0010] The system and method embodiments of the invention described herein address the issues of SD and mean selection and further describe how to design and implement QC ranges for multiple instruments testing the same analyte, where the QC target is the mean for the group of instruments and the QC range is a single value selected such that the average false rejection rate of the collection of instruments for a given QC rule matches the desired design parameters.

[0011] In an exemplary embodiment, a single analyte is tested using a group of clinical diagnostic analyzers, a single clinical diagnostic analyzer with multiple analytical units, or a combination thereof. That is, a single analyte is tested on multiple clinical diagnostic analyzers. The mean and SD for each analyzer / instrument (and / or each analytical unit), along with the QC rule to be used, the false rejection probability function for that QC rule, and the desired false rejection rate, are entered into at least one of the instruments, and a group mean and group SD are calculated that satisfy the desired false rejection rate and QC rule.

[0012] In one embodiment, the QC ranges for each individual instrument are established from a single group SD so that the false reject rates are distributed proportionally to each instrument's performance (a false reject is a QC result that fails despite a clean test method). Thus, the worst-performing instruments (i.e., the instruments with the highest SD) will have the largest share of false rejects. This is highly desirable because mitigating the impact of the worst-performing instruments also reduces the worst-case risk of patient harm from erroneous results compared to using the QC average of the individual instruments. In contrast, if the QC ranges are established from the SDs of the individual instruments, as is currently done in the prior art, the false reject rates for each instrument will be uniformly distributed.

[0013] In one embodiment, the QC range for a collection of instruments testing the same analyte is determined so that the average false rejection rate for the collection of instruments meets a desired false rejection rate criterion.

[0014] In another embodiment, a group mean and group standard deviation are calculated from the mean and standard deviation of a group of individual instruments (and / or analytical units) used to test an analyte. In some embodiments, the calculated group mean and group standard deviation are then used as the mean and SD on each individual instrument to test said single analyte.

[0015] In yet another embodiment, the false rejection probability is determined for a given QC rule. In one embodiment, the false rejection probability is calculated from the QC target, QC range, and the individual mean and standard deviation of each of the instruments in the group.

[0016] In another embodiment, the calculated group mean and group SD are provided to each clinical diagnostic analyzer in the group. In yet another embodiment, 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 prompts the user to begin testing an analyte, prompts the user to load an analyte, or automatically loads, and prompts for testing and analysis of the analyte.

[0017] In another embodiment, upon completion of analyte testing, each meter in the group stores the results and / or provides the results to a central server for further presentation and / or analysis.

[0018] In another embodiment, a group of laboratories, each having one or more clinical diagnostic analyzers, communicate with each other in a peer group configuration, where information and data are shared among members of the peer group. The shared information may include data regarding analyses performed, as well as information regarding analyte test data and / or quality control materials used in the laboratories.

[0019] In another aspect, the use of group means and group SDs provides an improvement to the art of clinical diagnostic testing and analyte testing, allowing laboratories to minimize the likelihood of reporting erroneous patient results compared to using individual instrument mean and SD values. Minimizing the number of erroneous patient results reduces retesting and saves time, labor, and material costs compared to systems and methods known in the prior art.

[0020] Reference to the remaining portions of the specification, including the drawings and claims, will reveal other features and advantages of the present invention. Further 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 accompanying drawings and claims. In the drawings, like reference numbers indicate identical or functionally similar elements. [Brief explanation of the drawings]

[0021] The invention will be described in more detail in the following detailed description of the invention, taken in conjunction with the accompanying drawings, which form a part hereof.

[0022] [Figure 1] FIG. 1 shows a block diagram of a clinical diagnostic analyzer system having multiple clinical diagnostic analyzers in communication with a server over a network, according to an exemplary embodiment of the present invention.

[0023] [Figure 2] FIG. 2 shows a block diagram of a single clinical diagnostic analyzer of the system of FIG.

[0024] [Figure 3A] FIG. 3A is a diagram of a first exemplary prompt screen presented by the clinical diagnostic analyzer of FIG.

[0025] [Figure 3B] FIG. 3B is a diagram of a second exemplary prompt screen presented by the clinical diagnostic analyzer of FIG.

[0026] [Figure 3C] 3C is a diagram of a third exemplary prompt screen presented by the clinical diagnostic analyzer of FIG. 2.

[0027] [Figure 3D] 3D is a diagram of a fourth exemplary prompt screen presented by the clinical diagnostic analyzer of FIG. 2.

[0028] [Figure 4] FIG. 4 is a block diagram of a plurality of the clinical diagnostic analyzers of FIG. 1 arranged in a peer group configuration.

[0029] [Figure 5] FIG. 5 is a flow diagram of an exemplary method for performing single-analyte testing on multiple clinical diagnostic instruments according to an exemplary embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0030] In accordance with exemplary embodiments of the present invention, a system and method for designing quality control (QC) ranges for multiple clinical diagnostic analyzer meters testing the same analyte is described. While the present invention is described in detail below with reference to illustrative and alternative embodiments, it is understood that the present invention is not limited to the specific configurations shown and described in these embodiments. Rather, those skilled in the art will appreciate that a variety of configurations may be implemented in accordance with the present invention. As used herein, the terms "clinical diagnostic analyzer," "analyzer," "meter," and variations thereof may be used to refer to dedicated diagnostic devices for testing analytes, patient samples, etc. to determine various characteristics of the analytes.

[0031] Referring initially to FIG. 1, a clinical diagnostic system in accordance with an exemplary embodiment of the present invention is generally designated by the numeral 100. 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 to facilitate the transmission of commands, information, and data between each of the clinical diagnostic analyzers 110a, 110b, 110c, 110n and the server 112, and between each of the clinical diagnostic analyzers 110a, 110b, 110c, 110n and other diagnostic analyzers, or any combination of clinical diagnostic analyzers and / or servers. Herein, clinical diagnostic analyzers may also be referred to as analyzers or meters. It should be understood that the number of analytical devices can be any number from 1 to n, such as a group of 2, 6, 10 or 100 analytical devices.

[0032] Network 116 may be a local area network (LAN), a wide area network (WAN), an ad hoc network, or any other network configuration known in the art, or a combination thereof. For example, in the exemplary embodiment shown in Figure 1, network 116 may include a LAN that enables communication between clinical diagnostic analyzers 110a, 110b, 110c, 110n, such as in a single laboratory environment having multiple clinical diagnostic analyzers. It may also include a WAN, such as the Internet or other wide area network, that enables communication between the LAN and server 112 and / or between the clinical diagnostic analyzers and the server.

[0033] It should be understood that the configuration shown in FIG. 1 is exemplary and not limiting, and the invention described herein may be implemented 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 geographically dispersed clinical diagnostic analyzers, such that a group of interconnected clinical diagnostic analyzers each tests for a single analyte.

[0034] For example, multiple systems 100, each including one or more clinical diagnostic analyzers and a server, may be located at a single laboratory, or at multiple laboratories distributed across a facility or the world, all of which may communicate over a WAN. It is further 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 over a LAN or WAN without going through a server(s). These and other variations and embodiments will be apparent to those skilled in the art.

[0035] In one exemplary embodiment, as shown in Figure 4, multiple clinical diagnostic systems 150a, 150b, 150c, 150n, such as those shown in Figure 1, communicate over a network such as the Internet or other WAN. This collection of separate systems constitutes a peer group 152 of systems, where each system 150a, 150b, 150c, 150n represents a laboratory having one or more clinical diagnostic analyzers, each performing 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 that is geographically dispersed from the other peer group member laboratories, and each laboratory has a similar type of clinical diagnostic analyzer, performs similar types of tests, and uses similar quality control materials and / or patient specimens or analytes to those used by other peer members in the peer group.

[0036] Referring again to FIG. 1 , server 112 preferably includes processor 118, memory 120, and logic and control circuitry 122, all of which are in communication with each other. Server 112 may be any server, server system, computer, or computer system known in the art and is preferably configured to communicate instructions and data between server 112 and a network and / or any devices connected to the network, and to store and retrieve data and information from database 114. Processor 118 may be any microprocessor, controller, or multiple such devices known in the art. Processor 118 preferably runs a server operating system, such as a Linux-based, Windows-based, or other server operating system known in the art. Preferably, processor 118 is configured to control the operation of server 112 in conjunction with the operating system, thereby enabling the server to communicate with database 114 and network 116 and / or devices connected to the network, such as clinical diagnostic analyzers 110a, 110b, 110c, and 110n. In some embodiments, the server may control the operation of the clinical diagnostic analyzers. For example, it may authorize operation of the analytical devices for a particular period of time, collect data from the analytical devices for recording in the database 114, transfer data to the analytical devices for viewing and / or analysis, collect test data from the analytical devices, and provide data, instructions, or prompts to the analytical devices individually or in groups.

[0037] Memory 120, which may be volatile or non-volatile, is used to store data and information related to the operation of the server, as well as data for transmission to and from the server. For example, the memory may store a server operating system executed by processor 118. It may also store data related to clinical diagnostic analyzers 110a, 110b, 110c, 110n, which communicate with server 112 via network 116. In some embodiments, memory 120 on the server may supplement or replace database 114.

[0038] Database 114 is preferably used to record control information related to the operation of server 112 and the operation and control of clinical diagnostic analyzers 110a, 110b, 110c, 110n, and may also be used to record data related to the processing of samples by the clinical diagnostic analyzers. For example, the database can include instructions or programming executed by a processor on the clinical diagnostic analyzer or executed on the server, or can store data related to the samples themselves, such as the number of samples processed, frequency of testing, results of analyses performed on the analyzer, and tracking information, lot number, sample size, sample weight, percentage of sample remaining, etc. Preferably, database 114 includes non-volatile storage, such as a hard drive, solid-state memory, or a combination thereof.

[0039] The logic and control circuitry 122 provides interface circuitry that allows the processor and memory to communicate and provides other operational functions for the server, such as facilitating data communication to and from the network 116 .

[0040] Referring to Figure 2, there is shown a detailed diagram of a single clinical diagnostic analyzer 110a of the system of Figure 1. Clinical diagnostic analyzer 110a preferably includes a processor 124, a memory device 126, measurement hardware 128, and an input panel / display 130.

[0041] The processor 124 may be any controller, microcontroller, or microprocessor known in the art. The processor 124 communicates with a memory device 126 that stores instructions executed by the processor to control and communicate with the measurement hardware 128 and the input panel / display 130, thereby causing the clinical diagnostic analyzer to perform desired steps. Desired steps may include instructing the measurement hardware to load a test specimen or run a test on a loaded sample, or instructing or prompting a user to perform a particular operation, such as replacing a test sample, initiating a test, or viewing collected data. The processor 124 may also execute instructions to receive data from the measurement hardware 128, perform one or more analyses on the received data, and display test results or other information on the input panel / display panel 130.

[0042] The measurement hardware 128 preferably includes a sample receptacle configured to accept one or more samples or specimens into the analytical device for testing. Preferably, the measurement hardware is configured to receive samples stored in vials. Most preferably, it is configured to receive multiple vials and extract analytes from any desired vial for analysis. In further embodiments, the measurement hardware 128 can include an external turntable, loader, or other mechanism to facilitate sample loading and unloading and allow samples to be loaded under command of the analytical device.

[0043] As shown in FIG. 2, the measurement hardware is configured for use with analyte samples 132a, 132b, 132c, and 132d, which may be QC material, patient test specimens, or other specimens or analytes known in the art. In one embodiment, the material samples are contained in vials, which are loaded or inserted into the clinical diagnostic analyzer 110a by a user. Samples can be loaded individually or in groups, for example, into trays that are loaded into the analyzer. In another embodiment, samples can be loaded using an automated loading mechanism, such as a turntable, in response to commands from the analyzer 110a. Material samples in the form of QC material are typically provided in lots, with each lot of essentially identical samples derived from the same batch source of material being assigned a unique lot number. The analyzer 110a preferably allows the user to input information related to the QC material, including statistical information such as the mean or standard deviation for that material lot. In other embodiments, information can be obtained over a network or from a server, for example, using a QR code on the sample vial or container, to uniquely identify the sample or lot.

[0044] The input panel / display 130 is operable to communicate with the processor, present controls to facilitate operation of the analytical device, present prompts and instructions to the user, and receive input commands and / or data from the user. The input panel / display 130 is preferably a touchscreen capable of displaying text and graphics as well as icons, push buttons, a keyboard, etc., for presenting data to the user and receiving input from the user of the analytical device. Preferably, the input panel / display 130 includes an audible alarm device, such as a buzzer or beeper.

[0045] It is understood that the clinical diagnostic analyzer 110a (as well as analyzers 1-n shown in FIG. 1) is not a general-purpose computer, but rather a dedicated testing equipment unit in which measurement hardware 128 interacts with a physical specimen (i.e., an analyte) to determine specific characteristics of the analyte. It is further understood that the systems and methods of the present invention provide improvements to the field of clinical diagnostics and improve the operation of the technology by minimizing the likelihood of reporting erroneous patient results compared to using mean and SD values from individual instruments. Compared to systems and methods known in the prior art, minimizing the number of erroneous patient results reduces retesting, saving time, labor, and material costs.

[0046] See Figures 3A, 3B, 3C, and 3D. The input panel / display may present prompts to the user to, for example, load the analytes to be tested and press a READY button when complete (Figure 3A), transmit or receive SDs (and / or means) to or from another analyzer or server to enable calculation of group SDs and / or group means (Figure 3B), calculate group SDs and / or group means (Figure 3C), or begin analysis of the loaded analytes or record data from the analysis (Figure 3D), as described in more detail below. It will be understood that the clinical diagnostic analyzer 100a may have multiple programs and functions available, and menus or selection prompts are preferably presented to guide the user through operation of the analyzer and selection of desired functions and operations.

[0047] The clinical diagnostic analyzer 110a may be any type of analyzer known in the art, such as a biochemistry analyzer, a hematology analyzer, an immunoassay analyzer, or any other clinical diagnostic analyzer known in the art. Preferably, the analyzer 110a is configured to test analytes, such as patient specimens. The clinical diagnostic analyzer 110a may also be configured for use with a variety of quality control materials, whether in liquid or lyophilized form, and may be configured for use in immunoassays, serum chemistry, immunology, hematology, and other fields.

[0048] 1 through 3 combined, in a typical use in 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, as shown in FIG. 3A. The user can send or receive the mean and SD of a particular analyzer to another analyzer or server for calculation of the group mean and group SD, as shown in FIG. 3B, or can calculate the group SD and group mean, as shown in FIG. 3C. As described in more detail herein, any one of the analyzers / meters may receive the SD and mean from the other meters, and any one of the analyzers / meters may perform the calculations to determine the group SD and group mean. It should be understood that the screen illustrations in FIGS. 3A-3D are exemplary in nature, and other screens and / or transfers of data between devices may similarly be implemented in accordance with the present invention. With the group SD and group mean loaded on the individual analyzers, as shown in FIG. 3D, the user can perform the analysis of the analyte. Once the test is complete, the analyzer can prompt the user to store or review the data.

[0049] It should be understood that operations of analytical device 100a may be performed locally on the analytical device, or, if the analytical device is operating in a system 100 as shown in Figure 1, operations may be coordinated by server 112. It should further be understood that any data may be stored locally on analytical device 110a, on server 112, or on database 114, or may be made available throughout system 100 and via network 116 so that remote servers and analytical devices can access the stored data as well. Similarly, analyses may be performed on the analytical device itself, on a server, or distributed among multiple analytical devices and / or servers.

[0050] It should also be understood that data collected and / or stored at an individual clinical diagnostic analyzer within any system may be shared and communicated to other clinical diagnostic analyzers within that same system or laboratory, to servers and databases within that system, and to other systems, and to clinical diagnostic analyzers and servers and databases within those other systems.

[0051] In one exemplary embodiment, as shown in Figure 4, multiple clinical diagnostic systems 150a, 150b, 150c, and 150n, each similar to that shown in Figure 1, communicate over a network 152, such as the Internet or other WAN. This collection of separate systems constitutes a peer group 154 of systems, with each system 150a, 150b, 150c, and 150n representing a laboratory with one or more clinical diagnostic analyzers, each performing testing of patient samples and quality control materials. Most preferably, each member 150a, 150b, 150c, and 150n of the peer group 154 is a laboratory that is geographically dispersed from the other peer group member laboratories, and each laboratory has a similar type of clinical diagnostic analyzer, performs similar types of tests, and uses similar quality control materials as the other members of the peer group.

[0052] In the embodiments of the invention described herein, analyses performed on multiple analytical devices can be combined with data collected by members of a peer group to provide an output or result based on data collected across multiple analytical devices and based on data collected by other members of the peer group.

[0053] Next, a clinical diagnostic analyzer, a system using the clinical diagnostic analyzer, and a peer group configuration of clinical diagnostic analyzers will be described, followed by a description of a system and method for conducting a virtual crossover test according to the present invention.

[0054] 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:

[0055] For n instruments / analyzers (eg, analyzers 1-n in FIG. 1), the group mean (μ) can be calculated as follows:

[0056]

number

[0057] The group standard deviation (SD) can be calculated as follows:

[0058]

number

[0059] where:

[0060] inst_mean i is the mean of individual instrument i (for each of instruments 1 to n), inst_mean (no subscript) is the vector of all the means of the i individual instruments, and

[0061] inst_SD i is the standard deviation (SD) of individual instrument i (for each of instruments 1 to n), and inst_SD (no subscript) is the vector of all standard deviations of the i individual instruments.

[0062] The false rejection probability for an individual instrument i and a given QC rule (QCrule) specified by the QC target and QC range is defined as QC target, QC range, inst_mean i , and inst_SD i It can be calculated from

[0063] QCrulePfr(QC target, QC range, inst_mean i ,inst_SD i ) calculates the false rejection rate for device i due to the QC rule with the specified QC target and QC range.

[0064] For n instruments / analyzers,

[0065]

number

[0066] Pfrgrp is QC target = GroupMean, QC range = sr*GroupSD is the average false rejection rate for a group of n instruments using the QC rule.

[0067] where sr is a factor determined to give a desired false rejection rate (Pfr).

[0068] The value of sr is determined so that Pfrgrp=Pfr.

[0069] The value of sr can be calculated using several well-known algorithms, such as the Bisection method.

[0070] By using the above formulas and calculations in the manner described below, Group Mean and Group SD values can be provided to individual clinical diagnostic analyzers when performing tests / analytes as described above with respect to Figures 3A-3D. Also as described above, using the Group Mean and Group SD values (rather than each individual 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. Minimizing the number of erroneous patient results reduces retesting, saving time, labor, and material costs compared to systems and methods known in the prior art.

[0071] The initial parameters and formulas for calculating group mean and group SD values for testing an analyte on multiple instruments are provided. Steps for performing group mean and group SD on a group of instruments according to an exemplary embodiment of the present invention are shown in the flow diagram of FIG.

[0072] Referring first to FIG. 5 , a method for designing and implementing QC ranges for multiple clinical diagnostic instruments testing the same analyte begins at block 200. In block 200, the mean and SD from each individual instrument in a group of instruments used to test the analyte are collected. As discussed above, the mean and SD data from each of the individual instruments may be collected at any one of the individual instruments or at a server, and it should be understood that further calculations on the collected data may similarly be performed at the individual instrument or server from which the data was collected. Similarly, the calculated or determined data may be sent or transmitted to other instruments for use in testing the analyte, as described herein.

[0073] Group mean and group SD values are calculated in block 202. As described above, the group mean and group SD values are calculated from the individual instrument means and SDs as follows:

[0074]

number

[0075]

number

[0076] In block 204, for a given QC rule and desired false rejection rate (Pfr), the false rejection probability for that QC rule and false rejection rate may be calculated from the QC target, QC range, instrument mean, and instrument SD vector, as described above.

[0077] In block 206, the difference in Pfr for the instrument cluster and instrument group is calculated as described above.

[0078] Once the desired group mean and group SD are determined, in block 208, the group mean and group SD are sent to each individual instrument in the group for use in testing the analyte by each instrument, such that all instruments in the group testing the same analyte use the same group SD and group mean.

[0079] In block 210, as shown in Figure 3D, each individual meter in the group performs a test for the analyte loaded into it, and the results may be saved or sent to other meters or a server for display, alert generation, further storage, or presentation to a user. It is understood that each individual meter in the group may perform the test for the analyte at a different time, and the data may be compiled and stored as it is obtained. That is, the tests on each individual meter need not occur simultaneously.

[0080] Thus, as described herein, the design and implementation of a test for a single analyte on multiple individual clinical diagnostic analyzers or instruments is performed using a group mean and group SD, rather than each instrument using its individual instrument mean and SD.

[0081] The systems and methods described herein provide improvements in clinical diagnostic and analyte testing techniques and minimize the likelihood of reporting erroneous patient results compared to using mean and SD values from individual instruments. Minimizing the number of erroneous patient results reduces retesting and saves time, labor, and material costs compared to systems and methods known in the prior art.

[0082] As will be appreciated, the systems and methods of the present invention are an improvement over the commonly accepted method of testing analytes across multiple individual meters and simply aggregating the test data at a later time.

[0083] While the invention has been described and illustrated herein with reference to various exemplary embodiments, it should be understood that various changes can be made to these embodiments without departing from the scope of the invention. Accordingly, the invention is not limited to the exemplary embodiments described and illustrated herein, except insofar as such limitations are included in the scope of the following claims.

Claims

1. 1. A clinical diagnostic analyzer for conducting a virtual crossover study, comprising: a processor; measurement hardware in communication with the processor and configured to measure a property of an analyte; a memory device storing executable instructions; Equipped with The instructions, when executed by the processor, cause the clinical diagnostic analyzer to: obtaining individual instrument mean and standard deviation data from each of a plurality of clinical diagnostic analyzers; calculating group mean and group SD values from the acquired 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 into 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 alert based on the analyte test result data, storing the analyte test result data, and combinations thereof. a clinical diagnostic analyzer that performs an operation including:

2. 10. The clinical diagnostic analyzer of claim 1, wherein the memory device includes instructions that, when executed, cause the clinical diagnostic analyzer to perform further operations including determining a difference between a false reject rate of an individual meter and a false reject rate of the plurality of clinical diagnostic analyzers.

3. 10. The clinical diagnostic analyzer of claim 1, wherein the memory device includes instructions that, when executed, cause the clinical diagnostic analyzer to perform further operations including determining a difference between a false reject rate of an individual meter and a false reject rate of the plurality of clinical diagnostic analyzers.

4. the memory device, when executed, causes the clinical diagnostic analyzer to present a prompt on the input panel and display prompting a user to load a sample into the measurement hardware; and receiving input from the user indicating that the sample has been loaded; 10. The clinical diagnostic analyzer of claim 1, further comprising instructions for performing operations including:

5. 10. The clinical diagnostic analyzer of claim 1, wherein the memory device includes instructions that, when executed, cause the clinical diagnostic analyzer to perform further operations including alerting a user of the data if an analyte test result exceeds a predetermined threshold.

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

7. 1. A system for performing testing for a single analyte on a group of clinical diagnostic analyzers, comprising: a plurality of clinical diagnostic analyzers in communication with a server; each of the plurality of clinical diagnostic analyzers a processor; measurement hardware in communication with the processor and configured to measure a property of an analyte; a memory device storing executable instructions; Equipped with 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: obtaining individual instrument mean and standard deviation (SD) data from each of the individual clinical diagnostic analyzers of the plurality of clinical diagnostic analyzers; calculating 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 into each of the plurality of clinical diagnostic analyzers; testing the analyte on each of the individual clinical diagnostic analyzers of the plurality of clinical diagnostic analyzers, wherein in testing, each of the individual clinical diagnostic analyzers uses the group mean and group SD values; collecting test results for the analyte from each of the plurality of clinical diagnostic analyzers on a single clinical diagnostic analyzer; and Presenting the analyte test result data on a display, generating an alert based on the analyte test result data, storing the analyte test result data, and combinations thereof. A system that performs an operation including:

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

9. 8. The system of claim 7, wherein the memory device includes instructions that, when executed, cause the clinical diagnostic analyzer to perform further operations including determining a difference between an individual meter's false reject rate and the false reject rate of the plurality of clinical diagnostic analyzers.

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

11. 10. The system of claim 7, wherein the memory device includes instructions that, when executed, cause the clinical diagnostic analyzer to perform further actions including alerting a user of the data if an analyte test result exceeds a predetermined threshold.

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

13. 1. A method for performing testing for a single analyte on a group of clinical diagnostic analyzers, comprising: obtaining individual instrument mean and standard deviation (SD) data from each individual clinical diagnostic analyzer of the plurality of clinical diagnostic analyzers; calculating 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 into each of the plurality of clinical diagnostic analyzers; testing the analyte on each of the individual clinical diagnostic analyzers of 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 test results for the analyte from each of the plurality of clinical diagnostic analyzers on a single clinical diagnostic analyzer; presenting the analyte test result data on a display, generating an alert based on the analyte test result data, storing the analyte test result data, and combinations thereof; A method comprising:

14. The method of claim 13 , further comprising calculating a false rejection probability for a given QC rule and a desired false rejection rate.

15. 14. The method of claim 13, further comprising determining a difference between an individual meter's false reject rate and the false reject rate of the plurality of clinical diagnostic analyzers.

16. presenting a prompt to a user on an input panel and display of a clinical diagnostic analyzer to load the analyte into the measurement hardware; and receiving input from the user indicating that the sample has been loaded; 14. The method of claim 13, further comprising:

17. 14. The method of claim 13, further comprising alerting a user of the data if an analyte test result exceeds a predetermined threshold.

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