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Diagnostic kit for IgG antibody to hepatitis E virus(ELISA)
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Basic data
| Standard ID | YY/T 1259-2015 (YY/T1259-2015) |
| Description (Translated English) | Diagnostic kit for IgG antibody to hepatitis E virus(ELISA) |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C44 |
| Classification of International Standard | 11.100 |
| Word Count Estimation | 8,832 |
| Date of Issue | 2015-03-02 |
| Date of Implementation | 2016-01-01 |
| Quoted Standard | GB/T 21415 |
| Regulation (derived from) | The State Food and Drug Administration Announcement 2015 No. 8 |
| Issuing agency(ies) | State Food and Drug Administration |
| Summary | This Standard specifies the HEV IgG antibody detection kit (ELISA) terms and definitions, classification, requirements, test methods, marking, labeling, instructions, packaging, transportation and storage. This Standard applies to the principle of indirect ELISA using hepatitis E virus (HEV) consisting of antigen-coated microplate and enzyme-labeled anti-human IgG and other reagent kit for the detection in human serum or plasma samples HEV IgG antibodies. |
YY/T 1259-2015: Diagnostic kit for IgG antibody to hepatitis E virus(ELISA)
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Diagnostic kit for IgG antibody to hepatitis E virus (ELISA)
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
HEV IgG antibody test kit
(Enzyme-linked immunosorbent assay)
(ELISA)
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, Zhang Xuedong, Dai Junying.
HEV IgG antibody test kit
(Enzyme-linked immunosorbent assay)
1 Scope
This standard specifies the HEV IgG antibody test kit (ELISA) terms and definitions, classification, requirements, test
Test methods, marking, labeling, instructions, packaging, transportation and storage.
This standard applies to the principle of indirect ELISA using the hepatitis E virus (HEV) antigen-coated microplate and enzyme-labeled
And other anti-human IgG reagent composition kit for the detection of human serum or plasma samples HEV IgG 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 assignment method and corresponding indicators, as well as
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, 10 parts by detecting anti -HEVIgG positive reference material, false negative
Of no more than 1 part.
3.4 Reference product meets the negative rate
For examination by national reference or standardized by the National Reference Reference products, in 30 parts of anti -HEVIgG negative reference materials, false positive
Of no more than 1 part.
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
Reference materials detection requirements.
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