YY/T 1247-2014 English PDF (YYT1247-2014)

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YY/T 1247-2014: Hepatitis B virus surface antigen (HBsAg) detection reagent (kit) (chemiluminescent immunoassay)
YY/T 1247-2014
Hepatitis B virus surface antigen (HBsAg) detection reagent (kit) (chemiluminescent immunoassay)
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Hepatitis B virus surface antigen assay reagent (kit)
(Chemiluminescent immunoassay)
HepatitisBvirussurfaceantigen (HBsAg) detectionreagent (kit)
Issued on. 2014-06-17
2015-07-01 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 laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) centralized.
This standard was drafted. Chinese Academy of Food and Drug test, Beijing Medical Device Testing, Biotechnology Co., Ltd. Beijing Branch of the United States,
Roche Diagnostics (Shanghai) Co., Ltd., Beijing Tak source of Biomedical Engineering Co., Abbott Trading (Shanghai) Co., Ltd.
The main drafters of this standard. Zhou Cheng, Wangrui Xia, Du Haiou, Cheng Yinghao, Cai Xiaorong, Wang Yunfeng, Wang Xuefeng.
Hepatitis B virus surface antigen assay reagent (kit)
(Chemiluminescent immunoassay)
1 Scope
This standard specifies the hepatitis B virus surface antigen assay reagent (kit) (chemiluminescent immunoassay) technical requirements, test methods,
Logos, labels, brochures, packaging, transportation and storage.
This standard applies to the use of chemiluminescence analysis, using the principle of double antibody sandwich qualitative or quantitative determination of human serum, plasma beta
Reagents hepatitis virus surface antigen (hereinafter referred to as "HBsAg") (the box). Including chemiluminescence, ECL, and time-resolved fluorescence
method.
This standard does not apply to.
a) intended for individual sales of hepatitis B virus surface antigen calibrators and control materials hepatitis B virus surface antigen;
b) by CLIA for the principle of biochips.
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
3 Requirements
3.1 Quantitative assay reagent (kit)
3.1.1 Appearance
Shall meet the following requirements.
a) a liquid component should be clear and transparent;
b) reagent (box) of each component should be complete, complete, no liquid leakage; Chinese packaging labels should be clear, no damage.
3.1.2 Traceability
Manufacturers should provide a source of calibrators used according to GB/T 21415 and the relevant provisions, assignment methods, and uncertainty and so on.
3.1.3 Accuracy
With HBsAg national reference or standardized by the National Reference Reference products as samples for testing, the relative deviation of measurement results
It should be within ± 20% range.
3.1.4 The positive rate in line with the reference product
Or by using the National Reference National Reference standardized positive reference material for testing, with no negative.
Note. This standard of "positive reference material compliance rate" means for the hook effect (HookEffective) indicators evaluate the product exists. Hook effect is Free
Since the detection of Phytophthora antigen, antibody concentration ratio caused improper test results were false negative phenomenon.