YY/T 1789.2-2021 English PDF

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YY/T 1789.2-2021: In vitro diagnostic test systems - Performance evaluation method - Part 2: Trueness
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Basic data

Standard ID: YY/T 1789.2-2021 (YY/T1789.2-2021)
Description (Translated English): In vitro diagnostic test systems - Performance evaluation method - Part 2: Trueness
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C30
Word Count Estimation: 25,262
Issuing agency(ies): State Drug Administration

YY/T 1789.2-2021: In vitro diagnostic test systems - Performance evaluation method - Part 2: Trueness

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
In vitro diagnostic test systems -- Performance evaluation method -- Part 2: Trueness ICS 11:100:10 C30 People's Republic of China Pharmaceutical Industry Standard Performance evaluation method of in vitro diagnostic test system Part 2: Correctness Part 2:Trueness Published on 2021-12-06 2023-05-01 Implementation Released by the State Drug Administration

content

Preface III Introduction IV 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 General 2 4:1 General Requirements 2 4:2 Correctness evaluation method 2 4:3 Products to be evaluated 3 4:4 Test Notes 3 4:5 Data Analysis 3 5 Evaluation of the correctness of the use of reference substances 3 5:1 Reference material requirements3 5:2 Test time and number of tests 3 5:3 Data Analysis 3 5:3:1 Bias Estimation 3 5:3:2 Calculating confidence intervals 3 5:3:3 Example 4 6 Evaluation of correctness using patient samples4 6:1 Sample Requirements 4 6:2 Choice of Comparison Method 4 6:3 Test time and number of tests 4 6:4 Data Analysis 4 6:4:1 Scatter or Deviation Plot 4 6:4:2 Outlier Test 5 6:4:3 Preliminary estimates of bias 5 6:4:4 Regression Analysis 5 6:4:5 Bias at the medical decision level 5 6:4:6 Data Analysis Example 6 7 Recovery test 7 7:1 Applicable conditions 7 7:2 Test method 7 7:3 Data Analysis 7 Appendix A (Informative Appendix) Example of Data Analysis for Correctness Evaluation Using Reference Substances 8 Appendix B (Informative) Example of Data Analysis for Correctness Assessment Using Patient Samples 10 Reference 20

foreword

YY/T 1789 "In Vitro Diagnostic Test System Performance Evaluation Method", consists of the following parts: --- In vitro diagnostic test system performance evaluation method Part 1: Precision; --- In vitro diagnostic test system performance evaluation method Part 2: Accuracy; --- In vitro diagnostic test system performance evaluation method Part 3: detection limit and quantification limit; --- In vitro diagnostic test system performance evaluation method Part 4: Linear interval and reportable interval; --- In vitro diagnostic test system performance evaluation method Part 5: Analysis specificity; --- In vitro diagnostic testing system performance evaluation method Part 6: Precision, diagnostic sensitivity and specificity of qualitative reagents: This part is Part 2 of YY/T 1789: This section is drafted in accordance with the rules given in GB/T 1:1-2009: Please note that some content of this document may be patented: The issuing authority of this document assumes no responsibility for identifying these patents: This part is under the jurisdiction of the National Standardization Technical Committee of Medical Clinical Laboratory and In Vitro Diagnostic System (SAC/TC136): This section is drafted by: Beijing Medical Device Inspection Institute, Meikang Biotechnology Co:, Ltd:, Sysmex Medical Electronics (Shanghai) Co:, Ltd:, Shanghai Clinical Testing Center, Beijing Medical Device Technology Review Center, China National Institute for Food and Drug Control, Mike Biotechnology Co:, Ltd: Co:, Ltd:, Zhengzhou Antu Biological Engineering Co:, Ltd:, Aiwei Technology Co:, Ltd:, Beckman Coulter Trading (China) Co:, Ltd: Company, Soling Diagnostic Medical Equipment (Shanghai) Co:, Ltd: The main drafters of this section: Wang Jun, Shen Min, Yang Zongbing, Wang Hualiang, Sun Rong, Qu Shoufang, Sun Keqi, Li Zhongxin, Zhou Fengliang, Yang Yuejuan, Wang Chengmei:

Introduction

In the performance evaluation of in vitro diagnostic medical device products, in vitro diagnostic instruments, reagents, calibrators, etc: Therefore, this series of standards adopts the concept of system to describe the performance of the measurement system composed of instruments, reagents, calibrators, etc: Evaluation of analytical performance refers to an estimate of the reliability of a measurement system to detect patient samples: Analytical performance of in vitro diagnostic test systems Including precision, correctness, accuracy, detection limit and quantification limit, linear interval and reportable interval, analytical specificity, etc: Measurement correctness is a performance characteristic that evaluates systematic measurement error in a series of measurements of a homogeneous sample: Correctness is a qualitative notion, but measurement bias can be assessed: Assessment of bias requires an appropriate reference substance or reference measurement procedure that can be used to determine the value of the reference quantity being measured: sequence: Correctness is to be distinguished from "accuracy": Accuracy is the difference between a measured quantity and the true quantity being measured: The error includes the systematic measurement error component estimated by the measurement bias and the random measurement error component estimated by the standard deviation, and the accuracy is the correctness and precision: combination of densities: In general, the accuracy evaluation is carried out only after the precision evaluation of the measurement system and the requirements are met: This section provides three positive Accuracy evaluation methods, the first method is to analyze an appropriate reference material with the value of the reference quantity to be measured, and the second method is to use patient samples for The third method is to use the recovery test: Evaluate the correctness and estimate the bias, the purpose of which is to know the magnitude of the bias: small and correct as needed: Performance evaluation method of in vitro diagnostic test system Part 2: Correctness

1 Scope

This part of YY/T 1789 specifies the method for evaluating the correctness performance of in vitro diagnostic test systems: This section applies to the manufacturer's evaluation of the correctness of in vitro diagnostic test systems for quantitative testing: This section does not apply to in vitro diagnostic test systems in which results are reported as nominal and ordinal scales, such as for blood cell identification, microbiological Characterization of the in vitro diagnostic test system for genotyping, nucleic acid sequence identification, urine particle identification, and results reported as negative, positive, or 1, 2, and 3 can evaluate: This section also does not apply to qualitative in vitro diagnostic test systems (such as enzyme-linked immunosorbent assays) that are based on quantitative measurements and judge the results by thresholds: The performance evaluation of the pathogenic microorganism antigen or antibody detection kit by immunosorbent method: This section does not apply to medical laboratory accuracy performance verification, nor does it apply to product type inspection:

2 Normative references

The following documents are essential for the application of this document: For dated references, only the dated version applies to this article pieces: For undated references, the latest edition (including all amendments) applies to this document: YY/T 1441 General requirements for performance evaluation of in vitro diagnostic medical devices

3 Terms and Definitions

The following terms and definitions apply to this document: 3:1 measurementsbias bias An estimate of the systematic measurement error: Note 1: Bias is inversely related to accuracy: Note 2: The estimate of bias is the mean of a series of measurements minus the reference value: [GB/T 29791:1-2013, Definition A:3:25] 3:2 measurementtrueness trueness The degree of agreement between the mean value of an infinite number of repeated measurements and a reference value: Note 1 to entry: Measurement accuracy is not a quantity and therefore cannot be expressed numerically: A measure of the degree of conformity is given in GB/T 6379:3: Note 2: The measurement accuracy is inversely related to the systematic measurement error, but not to the random measurement error: Note 3: The term measurement accuracy should not be used to measure correctness, and vice versa: [GB/T 29791:1-2013, Definition A:3:34] 3:3 referencemeasurementprocedure Accepted as a measurement procedure that provides measurement results suitable for its intended use including the evaluation of other methods of measuring the same quantity ......

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