YY/T 1824-2021EB viral nucleic acids detection kit (fluorescent PCR) (English PDF)
EB病毒核酸检测试剂盒（荧光PCR法）
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 6, 2021
Implementation date
December 1, 2022
Scope
YY/T 1824-2021 is the English-translated version of EB病毒核酸检测试剂盒（荧光PCR法）.
YY/T 1824-2021 is the Chinese pharmaceutical industry standard for the kit that detects Epstein-Barr virus nucleic acid by fluorescent PCR.
It sets the requirements, the test methods, the labels and instructions for use and the rules for packaging, transport and storage, covering the appearance, the detection limit, the specificity against other herpesviruses, the accuracy against reference materials, the linearity where the result is quantitative, the repeatability and the stability, together with the internal control that guards against inhibition.
It applies to kits for the qualitative or quantitative detection of EBV nucleic acid in human whole blood, serum and plasma. Issued on 6 December 2021, it has applied since 1 December 2022.
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Document preview — YY/T 1824-2021
National Standard of the People's Republic of China
- Classification
- C 44
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Requirements
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.
1 Scope
This document specifies the requirements, test methods, standard Sign and instructions for use, packaging, transportation and storage.
This document is suitable for the qualitative/quantitative detection of EBV nucleic acid in human whole blood, serum/plasma based on the principle of fluorescence PCR. kit.
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 Graphical signs of packaging, storage and transportation
GB/T 29791.1 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 1. Terms, definitions and general Require
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 terms and definitions defined in GB/T 29791.1 apply to this document.
4 Requirements
4.1 Appearance
The appearance should meet the following requirements.
a) The components of the kit should be complete and complete, and the liquid should not leak;
b) Chinese packaging labels should be clear and undamaged.
4.2 Nucleic acid extraction function
The nucleic acid extraction function should meet the following requirements.
a) For kits containing nucleic acid extraction components, the manufacturer shall make appropriate requirements for nucleic acid extraction and verify the nucleic acid extraction function;
b) Kits for which samples need to be extracted but do not contain nucleic acid extraction components shall be described or specified by the manufacturer of the extraction kits, and test kits shall be provided. certificate or confirmation;
c) For kits that directly perform amplification without sample extraction, the manufacturer should be able to provide sufficient evidence to prove its anti-interference ability.
4.3 Internal standard and/or control
Manufacturers should establish appropriate quality control procedures for the test results of the kits, and should combine them in the reaction system according to the process characteristics of their products.
The internal standard and (or) control should be set up, and the internal standard and (or) control should be treated the same as the sample.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 22 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 191Graphical symbols marking for handling and storage of packages
- GB/T 29791.1In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 1: Terms, definitions and general requirements
- GB/T 29791.2In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use
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Related Standards
GB/T 191-2025 — Graphical symbols marking for handling and storage of packages
GB/T 29791.1-2013 — In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 1: Terms, definitions and general requirements
GB/T 29791.2-2013 — In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use
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YY/T 1824-2021
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