GB/Z 157-2026In vitro diagnostic test systems - Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods (English PDF)

Foreword

This document is a standard or guiding technical document.

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

This document adopts the equivalent of ISO /T S5798.2022 "In vitro diagnostic testing systems - Nucleic acid amplification method for the detection of novel coronavirus (SARS-CoV-2)".

The document type of "Requirements and Recommendations for CoV-2" has been changed from an ISO technical specification to a national standardization guidance technical document of my country.

The following minimal editorial changes have been made to this document.

---6.3.2 Emergency Use Authorization. A note has been added clarifying that my country adopts an emergency approval mechanism for such situations;

---6.6.6 Determination of positive judgment value, Note 4 has been added to clarify the specific requirements related to registration review in my country.

Introduction

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the seventh known beta coronavirus to infect humans.

The disease caused by SARS-CoV-2 has been designated as Coronavirus Disease.2019 (COVID-19) by the World Health Organization (WHO).

Effective and efficient in vitro diagnostics are needed for the clinical management of SARS-CoV-2 infection and its spread. This requires the rational design, development, and establishment of... High-quality SARS-CoV-2 diagnostic methods based on nucleic acid amplification detection are crucial for ensuring COVID-19 infection control.

This document describes a testing system for detecting SARS-CoV-2 based on nucleic acid amplification, primarily used in in vitro diagnostic medical devices in medical laboratories.

The device, under normal use, can accurately detect SARS-CoV-2 nucleic acid in human specimens.

The primary purpose of this document is to provide guidance for in vitro diagnostic developers, manufacturers, customers, and other stakeholders in the design, development, and routine application of diagnostics.

The document provides requirements and recommendations for quality practices in SARS-CoV-2 nucleic acid amplification methods. It also covers laboratory-built diagnostics... This document describes the general technique for detecting SARS-CoV-2 using nucleic acid amplification.

The document addresses the impacts of pre-testing (specimen collection, processing, etc.), during testing, and post-testing; therefore, it provides guidelines for the design, development, implementation, and use of SARS-CoV-2.

Requirements and recommendations for all key aspects of the entire diagnostic workflow during CoV-2 nucleic acid amplification testing.

1 Scope

This document sets forth requirements and recommendations for the design, development, validation, verification, and implementation of nucleic acid amplification detection assays for SARS-CoV-2.

This document covers the pre-examination, examination, and post-examination procedures for human specimens.

This document is intended for medical laboratories. It is also intended for in vitro diagnostic developers and manufacturers, as well as those supporting SARS-CoV-2 research and... Used by diagnostic institutions and organizations. This document is not applicable to environmental samples.

2 Normative references

This document has no normative references.

3 Terms and Definitions

The following terms and definitions apply to this document.

The URLs for the terminology databases maintained by ISO and IEC for standardization are as follows. […]