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YY/T 1735-2021: Hepatitis c virus antibody (Anti-hcv) detection reagent (kit) (Chemiluminescent immunoassay)
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY/T 1735-2021	English	149	Add to Cart	3 days [Need to translate]	Hepatitis c virus antibody (Anti-hcv) detection reagent (kit) (Chemiluminescent immunoassay)

YY/T 1735-2021: Hepatitis c virus antibody (Anti-hcv) detection reagent (kit) (Chemiluminescent immunoassay)

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Hepatitis c virus antibody (Anti-hcv) detection reagent (kit) (Chemiluminescent immunoassay) ICS 11.100 C44 People's Republic of China Pharmaceutical Industry Standards Hepatitis C virus antibody detection kit (kit) (Chemiluminescence Immunoassay) Released on 2021-03-09 2022-04-01 implementation Issued by the National Medical Products Administration

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC136). Drafting organizations of this standard. China Institute for Food and Drug Control, Beijing Institute of Medical Device Inspection, Beijing Kemei Biotechnology Co., Ltd., Zhengzhou Antu Biological Engineering Co., Ltd., Suzhou Xinbo Biological Technology Co., Ltd., Xiamen Wantai Kairui Biological Technology Co., Ltd., Mike Biological Co., Ltd., Abbott Trading (Shanghai) Co., Ltd., Roche Diagnostic Products (Shanghai) Co., Ltd., Siemens Medical Diagnostic Products (Part 1) Sea) Co., Ltd., Fuji Rubio Co., Ltd. The main drafters of this standard. Gu Jinlian, Wang Ruixia, Wang Jianmei, Wang Xinming, Tu Xianju, Xu Feihai, Wang Baoning, Wang Xuefeng, Cai Xiaorong, Xing Chunlian, White jade. Hepatitis C virus antibody detection kit (kit) (Chemiluminescence Immunoassay)

1 Scope

This standard specifies the requirements, test methods, labels, and labels of hepatitis C virus antibody detection reagents (kits) (chemiluminescence immunoassay). Signs, instructions for use, packaging, transportation and storage, etc. This standard is applicable to the qualitative detection of C in human serum and plasma using the principle of chemiluminescence analysis using indirect method or double antigen sandwich method. Hepatitis B virus antibody detection kit (kit). Including chemiluminescence, electrochemiluminescence and time-resolved fluorescence methods. This standard does not apply to. a) Hepatitis C virus antibody calibrators and hepatitis C virus antibody quality control products that are intended to be sold separately; b) A biochip based on the principle of chemiluminescence immunoassay.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document. GB/T 191 Packaging, storage and transportation pictorial signs 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 requirements

3.1 Appearance The appearance should meet the following requirements. a) Each component of the reagent (kit) should be complete and complete, and there should be no leakage of liquid; b) Chinese packaging labels should be clear and free from wear. 3.2 Compliance rate of positive reference products Use the national reference material or the positive reference material standardized by the national reference material for verification, and the conformity rate of the positive reference material should meet the corresponding requirements. Please refer to Appendix A for information on national reference materials for hepatitis C virus antibodies. The following clauses are similar. 3.3 Compliance rate of negative reference products Use the national reference material or the negative reference material standardized by the national reference material for verification, and the compliance rate of the negative reference material should meet the corresponding requirements. 3.4 The lowest detection limit Use the national reference product or the lowest detection limit reference product standardized by the national reference product for verification, and the minimum detection limit should meet the corresponding requirements. 3.5 Repeatability Use a national reference product or a precision reference product standardized by a national reference product for verification, and perform parallel testing for 10 times. The coefficient of variation (CV) should be ...