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YY/T 1260-2015: Diagnostic kit for IgM antibody to hepatitis E virus(ELISA)
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY/T 1260-2015	English	169	Add to Cart	3 days [Need to translate]	Diagnostic kit for IgM antibody to hepatitis E virus(ELISA)

YY/T 1260-2015: Diagnostic kit for IgM antibody to hepatitis E virus(ELISA)

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Diagnostic kit for IgM antibody to hepatitis E virus (ELISA) ICS 11.100 C44 People's Republic of China pharmaceutical industry standards HEV IgM antibody test kit (Enzyme-linked immunosorbent assay) Issued on. 2015-03-02 2016-01-01 implementation China Food and Drug Administration released

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This standard was proposed by the China Food and Drug Administration. This standard by the national medical clinical testing laboratory and diagnostic systems in vitro Standardization Technical Committee. This standard was drafted. Chinese Academy of Food and Drug test, MP Biomedical Asia Pacific Pte Ltd, Beijing Tso Bio-Pharmaceutical Co., Ltd., Shanghai Kehua Bio-Engineering Co., Ltd., Zhengzhou, the Biological Engineering Co., Ltd. Green Branch, Zhuhai Livzon Reagents Shares Limited. The main drafters of this standard. Zhou Cheng, blue Haiyun, Hu Weiping, Wu Bo, Chen Lin Jue, Li Xiaoxia, Dai Junying. HEV IgM antibody test kit (Enzyme-linked immunosorbent assay)

1 Scope

This standard specifies the HEV IgM antibody detection kit (ELISA) terms and definitions, classification, requirements, test Test methods, marking, labeling, instructions, packaging, transportation and storage. This standard applies to the application of the principle of capture enzyme-linked immunosorbent assay, using anti-human IgM (μ chain) monoclonal antibody coated microplate and enzyme Hutchison hepatitis E virus (HEV) and other antigen reagent composition kit, or the principle of indirect ELISA using hepatitis E disease Virus (HEV) antigen-coated microplate and enzyme-labeled anti-human IgM and other reagent composition kit for the detection of human serum or plasma samples The HEV IgM antibodies.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB/T 21415 in vitro diagnostic medical devices - Measurement of quantities in biological samples calibration and control materials assigned metrological traceability Derived

3 Requirements

3.1 Physical examination 3.1.1 Appearance. liquid component should be clear and transparent. 3.1.2 Kit components should be complete, complete, no liquid leakage. 3.2 Traceability The manufacturer shall provide a source of calibrators used according to GB/T 21415 and the relevant regulations, traceability and assignment method and corresponding indicators Uncertainty and so on. 3.3 Reference product meets the positive rate For examination by national reference or standardized by the National Reference reference product, 12 parts by detecting anti -HEVIgM positive reference product can not be False negative. 3.4 Reference product meets the negative rate With the national reference or standardized by the National Reference Reference products for examination, 20 parts of an anti -HEVIgM negative test results do not refer to products It was a false positive. 3.5 The minimum detection limit For examination by national reference or standardized by the National Reference Reference products, reference material verification of serial dilutions of positive end should be consistent ...