YY/T 1247-2014: Hepatitis B virus surface antigen (HBsAg) detection reagent (kit) (chemiluminescent immunoassay)

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Scope

This Standard specifies the technical requirements, test method, marks, labels,
instructions, packaging, transportation, and storage of the hepatitis B virus surface
antigen (HBsAg) detection reagent (kit) (chemiluminescent immunoassay).
This standard is applicable to the reagent (kit) that utilizes the chemiluminescent analysis
technique, and adopts the double antibody sandwich method to qualitatively or
quantitatively measure the hepatitis B virus surface antigen (hereinafter referred as
“HBsAg”) reagent (kit) in human’s serum and plasma. It includes chemiluminiscence,
electrochemiluminescence and time-resolved fluorescence etc.
This Standard does not apply to.
a) The calibrator of surface antigen of hepatitis B virus that is marketed independently,
and the quality control materials of surface antigen of hepatitis B virus;
b) Biochip in the principle of chemiluminescent immunoassay.
2  Normative references
The articles contained in the following documents have become part of this Document
when they are quoted herein. For the dated documents so quoted, all the modifications
(Including all corrections) or revisions made thereafter shall be applicable to this
document.
GB/T 21415 In vitro diagnostic medical devices - Measurement of quantities in
biological samples - Metrological traceability of values assigned to calibrators and
control materials

Basic Data

Standard ID	YY/T 1247-2014 (YY/T1247-2014)
Description (Translated English)	Hepatitis B virus surface antigen (HBsAg) detection reagent (kit) (chemiluminescent immunoassay)
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C44
Classification of International Standard	11.100
Word Count Estimation	11,171
Date of Issue	6/17/2014
Date of Implementation	7/1/2015
Quoted Standard	GB/T 21415
Regulation (derived from)	China Food and Drug Administration in 2014 Bulletin No. 30
Issuing agency(ies)	State Food and Drug Administration
Summary	This Standard applies to the use of chemiluminescence analysis, using the principle of double-antibody sandwich qualitative or quantitative determination of human serum, plasma reagent hepatitis B virus surface antigen (box), including chemiluminescence,