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

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.

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.

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 document. 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.