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YY/T 1789.6-2023In vitro diagnostic test systems - Performance evaluation method - Part 6: Precision, diagnostic sensitivity and specificity of qualitative reagents (English PDF)

体外诊断检验系统性能评价方法第6部分：定性试剂的精密度、诊断灵敏度和特异性

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

January 13, 2023

Implementation date

January 15, 2024

Scope

YY/T 1789.6-2023 is the English-translated version of 体外诊断检验系统性能评价方法第6部分：定性试剂的精密度、诊断灵敏度和特异性.

YY/T 1789.6-2023 is the Chinese standard "In vitro diagnostic test systems - Performance evaluation method - Part 6: Precision, diagnostic sensitivity and specificity of qualitative reagents".

Its scope clause reads: This document specifies the performance evaluation methods for the precision, diagnostic sensitivity and specificity of qualitative reagents for in vitro diagnostic test systems.

This document applies to manufacturers' evaluation of the precision, diagnostic sensitivity and specificity of in vitro diagnostic test systems for qualitative tests.

This document does not apply to the performance evaluation of in vitro diagnostic test systems whose results are reported as semiquantitative. This document does not apply to performance verification in medical laboratories, nor does it apply to product type inspection. Its clauses include terms and definitions.

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Document preview — YY/T 1789.6-2023

National Standard of the People's Republic of China

ICS: 11.100.10
Classification: C30

Issued by: National Medical Products Administration

Preface
Introduction
1 Scope
2 Normative references
3 Terms and Definitions
4 General
4.1 General requirements
4.2 Evaluation method
4.3 Products to be evaluated
4.4 Test Notes
4.5 Data Analysis
5 Precision Evaluation
5.1 Overview
5.2 Precision study of analyte concentrations close to C50
5.3 Determine the concentration near C50
5.4 Sample preparation
5.5 Measurement method
5.6 Results Analysis
6 Diagnostic sensitivity and specificity
7 Example
Appendix A (informative) C50, C5~C95 interval evaluation example
Appendix B (Informative) Example of Diagnostic Sensitivity and Specificity Analysis

1 Scope

This document specifies the performance evaluation methods for the precision, diagnostic sensitivity and specificity of qualitative reagents for in vitro diagnostic test systems.

This document applies to manufacturers' evaluation of the precision, diagnostic sensitivity and specificity of in vitro diagnostic test systems for qualitative tests.

This document does not apply to the performance evaluation of in vitro diagnostic test systems whose results are reported as semiquantitative.

This document does not apply to performance verification in medical laboratories, nor does it apply to product type inspection.

2 Normative references

The content in the following documents constitutes the essential provisions of this document through normative references in the text. Among them, dated references

For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable 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

A set of operations for identifying or classifying substances based on their chemical or physical properties.

Examples. chemical reactions, solubility, relative molecular mass, melting point, radiation properties (emission, absorption), mass spectrometry, nuclear half-life.

[Source. GB/T 29791.1-2013, A.3.43]

3.2 Measurement precision

precision precision

Under specified conditions, repeated measurements are made on the same or similar measured objects to obtain the degree of consistency between the measured indications or the measured values.

Note 1 to entry. Measurement precision is usually expressed numerically by measures of imprecision, such as standard deviation, variance and coefficient of variation under specified measurement conditions.

Note 2.The specified conditions can be, for example, repeatability conditions of measurement, intermediate precision conditions of measurement or reproducibility conditions of measurement (see GB/T 6379.5).

Note 3.Measurement precision is used to define measurement repeatability, intermediate measurement precision and measurement reproducibility.

Note 4.Repeated measurements refer to results obtained on the same or similar samples in a manner that is not affected by previous results.

[Source. GB/T 29791.1-2013, A.3.29]

3.3 C5~C95intervalC5~C95interval

The analyte concentration near the critical value, it can be considered that the test results of the analyte outside this concentration range are always negative (concentration < C5) or always negative.

Finally positive (concentration >C95).

Note 1.The existence of imprecision makes the test results within this interval not always consistent.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 13 pages — is available in the English PDF.

Referenced standards

Normative references

YY/T 1441General requirements of performance evaluation of in vitro diagnostic medical devices

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