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YY/T 1824-2021: EB viral nucleic acids detection kit (fluorescent PCR)
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1824-2021 | English | 139 |
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EB viral nucleic acids detection kit (fluorescent PCR)
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YY/T 1824-2021
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Basic data | Standard ID | YY/T 1824-2021 (YY/T1824-2021) | | Description (Translated English) | EB viral nucleic acids detection kit (fluorescent PCR) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Word Count Estimation | 7,71 | | Issuing agency(ies) | State Drug Administration | YY/T 1824-2021: EB viral nucleic acids detection kit (fluorescent PCR)---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
EB viral nucleic acids detection kit (fluorescent PCR)
ICS 11:100:10
CCSC44
People's Republic of China Pharmaceutical Industry Standard
EB virus nucleic acid detection kit (fluorescence PCR method)
Published on 2021-12-06
2022-12-01 Implementation
Released by the State Drug Administration
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:
Please note that some content of this document may be patented: Publication of this document
Institutions do not assume responsibility for identifying patents:
This document is proposed by the State Drug Administration:
This document is under the jurisdiction of the National Standardization Technical Committee for Medical Clinical Laboratory and In Vitro Diagnostic Systems (SAC/TC136):
This document is drafted by: China National Institute for Food and Drug Control, Shengxiang Biotechnology Co:, Ltd:, Jiangsu Shuoshi Biotechnology Co:, Ltd:
Co:, Ltd:, Sun Yat-sen University Daan Gene Co:, Ltd:, Shanghai Fosun Long March Medical Science Co:, Ltd:, Beijing Zhuocheng Huisheng Biotechnology
Co:, Ltd:, Guangdong Yongnuo Medical Technology Co:, Ltd:
The main drafters of this document: Zhou Haiwei, Wu Kang, Liu Zhonghua, Jiang Xiwen, Xia Yi, Wang Lei, Luo Jingyan:
EB virus nucleic acid detection kit (fluorescence PCR method)
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:
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