YY/T 1226-2022Detection and genotyping kits for human papillomavirus nucleic acid (English PDF)

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents" drafted.

This document replaces YY/T 1226-2014 "Human Papillomavirus Nucleic Acid (Type) Detection Reagents (Kits)", which is an Basis for the quality of acid (typing) detection kits.

Compared with YY/T 1226-2014, except for structural adjustment and editorial changes, the main technical changes in this document are as follows.

a) Scope. Added the intended use of human papillomavirus nucleic acid for auxiliary diagnosis of HPV infection and/or cervical cancer screening (section Type) detection kit, and supplemented with applicable methods.

b) Terminology. Changed the definition of "genotype" and updated HPV type in the note. c) Requirements.

1) Added the requirements for "internal standard and/or control", "nucleic acid extraction function" and "stability" (see 4.1.2, 4.1.3, 4.1.8, 4.2.2, 4.2.3, 4.2.8, 4.3.2, 4.3.3, 4.3.8);

2) "4.1.2 Accuracy (positive coincidence rate)" is revised to "4.1.4 Positive reference product coincidence rate"; "4.1.3 Specificity (negative coincidence rate)" rate)" was changed to "4.1.5 Negative reference product conformity rate"; "4.1.4 Repeatability (precision)" was changed to "4.1.6 Repeatability"; "4.1.5 Detection limit" is revised to "4.1.7 Detection limit";

3) "4.2.2 Accuracy (positive coincidence rate)" is revised to "4.2.4 Positive reference product coincidence rate"; "4.2.3 Specificity (negative coincidence rate)" rate)" was changed to "4.2.5 Negative reference product conformity rate"; "4.2.4 Repeatability (precision)" was changed to "4.2.6 Repeatability"; "4.2.5 Detection limit" is revised to "4.2.7 Detection limit";

4) "4.3.2 Accuracy (positive coincidence rate)" is revised to "4.3.4 Positive reference product coincidence rate"; "4.3.3 Specificity (negative coincidence rate)" rate)" was changed to "4.3.5 Negative reference product conformity rate"; "4.3.4 Repeatability (precision)" was changed to "4.3.6 Repeatability"; "4.3.5 Detection limit" is revised to "4.3.7 Detection limit";

5) Changed the content of "4.1.5 Negative Reference Conformance Rate" and "4.2.5 Negative Reference Conformance Rate". changed from "The cross-reaction rate is not "More than 20%" is changed to "There should be no cross-reaction for high-risk types, and the cross-reaction rate for low-risk types should not be greater than 10.0%", and make corresponding requirements for reference works;

6) Changed "4.3.5 Negative Reference Conformance Rate". from "Test results should meet the manufacturer's requirements" to "Cross-reaction" The rate is not more than 20%", and corresponding requirements are made for the reference;

7) Changed the content of "repeatability", and made corresponding requirements for the type selection and concentration of reference products;

8) Changed the content of "4.1.7 Detection Limit" and "4.2.7 Detection Limit". for two common high-risk types HPV16 and HPV18, The detection limit is required to be no higher than 103copies/reaction;

9) The test method in Chapter 5 shall be adjusted according to the clauses required in Chapter 4.

d) Identification, labels and instructions for use. should comply with the corresponding provisions of GB/T 29791.2.

1 Scope

This document specifies the terms and definitions, technical requirements, Test methods, identification, labels and instructions for use, packaging, transportation, storage, etc.

This document applies to the intended use for auxiliary diagnosis and/or uterine infection of human papillomavirus (HPV)

Human papillomavirus nucleic acid (typing) detection kit for cervical cancer screening, applicable detection methods include PCR fluorescence method, PCR-reverse hybridization method, hybrid capture-chemiluminescence method, enzyme digestion signal amplification method, gene chip method, high-throughput sequencing, etc.

Note. This document is mainly for detection kits for the detection of HPV DNA. Among them, the use of cervical cancer screening includes clinical use for SARS of no clear significance Primary screening.

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document.

GB/T 191-2008 Graphical signs of packaging, storage and transportation

GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2: In vitro diagnostic reagents for professional use

3 Terms and Definitions

The following terms and definitions apply to this document.

4 Requirements

4.1 Requirements for Human Papillomavirus Nucleic Acid (Type) Detection Kit (PCR Fluorescence Method)