YY/T 1526-2017: Detection kit for human immunodeficiency virus 1 type(HIV-1) p24 antigen and antibodies to human immunodeficiency virus(chemiluminescence immuno-assay)

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Scope

This Standard specifies the requirements, test methods, mark, label and use
instructions, package, transportation and storage of detection kit for antigen and
antibodies to human immunodeficiency virus (chemiluminescence immuno-assay).
This Standard is applicable to the kit perform qualitative detection of human
immunodeficiency virus 1 (HIV-1), p24 antigen and (HIV-1 p24) and HIV (including HIV-
1 and HIV-2) antibodies in the human serum and/or plasma through the light source
(including chemiluminescence analysis, immunofluorescence analysis, time-resolved
immunofluorescence analysis) excited by special substance based on the sandwich
method; namely, detection kit for antigen and antibodies to human immunodeficiency
virus.

Basic Data

Standard ID	YY/T 1526-2017 (YY/T1526-2017)
Description (Translated English)	Detection kit for human immunodeficiency virus 1 type(HIV-1) p24 antigen and antibodies to human immunodeficiency virus(chemiluminescence immuno-assay)
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C44
Classification of International Standard	11.100
Word Count Estimation	10,157
Date of Issue	2017-05-02
Date of Implementation	2018-04-01
Issuing agency(ies)	State Food and Drug Administration