YY/T 1515-2017: HIV-1 RNA quantitative assay

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Scope

This Standard specifies the requirements, test methods, mark, label and use
instructions, package, transportation, storage, etc. of the HIV-1 RNA quantitative assay.
This Standard is applicable to the HIV-1 RNA reagent based on the nucleic acid
amplification methods (including real-time fluorescent PCR method, NASBA method
based on the nucleotide-amplification, and branched DNA, namely, bDNA method),
and used for quantitatively testing the human serum and/or plasma; it is abbreviated
as HIV-1 RNA quantitative assay.

Basic Data

Standard ID	YY/T 1515-2017 (YY/T1515-2017)
Description (Translated English)	HIV-1 RNA quantitative assay
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C44
Classification of International Standard	11.100
Word Count Estimation	10,116
Date of Issue	2017-05-02
Date of Implementation	2018-04-01
Issuing agency(ies)	State Food and Drug Administration