YY/T 1515-2017 English PDF (YYT1515-2017)

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YY/T 1515-2017: HIV-1 RNA quantitative assay
YY/T 1515-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.100
C 44
HIV-1 RNA Quantitative Assay
ISSUED ON. MAY 02, 2017
IMPLEMENTED ON. APRIL 01, 2018
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative References ... 4
3 Requirements ... 4
4 Test Methods ... 6
5 Mark, Label and Use Instructions ... 7
6 Package, Transportation and Storage ... 7
Bibliography ... 8
HIV-1 RNA Quantitative Assay
1 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.
2 Normative References
The following documents are essential to the application of this document. For the
dated documents, only the versions with the dates indicated are applicable to this
document; for the undated documents, only the latest version (including all the
amendments) are applicable to this document.
GB/T 191-2008 Packaging – Pictorial Marking for Handling of Goods
GB/T 29791.2-2013 In Vitro Diagnostic Medical Devices - Information Supplied by
the Manufacturer (Labelling) - Part 2. In Vitro Diagnostic Reagents for Professional
Use
3 Requirements
3.1 Appearance
The appearance shall meet the following requirements.
a) The components of the kit shall be complete, intact, and free of liquid-leakage;
b) Chinese packaging labels shall be clear and without wearing.
3.2 HIV-1 RNA positive reference compliance rate
Test with a national HIV-1 RNA positive reference or a standardized HIV-1 RNA positive
reference; the results shall be consistent with the corresponding reference product
4 Test Methods
4.1 Appearance
Take visual examination with normal or corrected visual acuity under natural light, the
results shall meet the requirements of 3.1.
4.2 HIV-1 RNA positive reference compliance rate
Test with a national HIV-1 RNA positive reference or a standardized HIV-1 RNA positive
reference; operate as per the product instruction; the results shall meet the
requirements of 3.2.
4.3 HIV-1 RNA negative reference compliance rate
Test with a national HIV-1 RNA negative reference or a standardized HIV-1 RNA
negative reference; operate as per the product instruction; the results shall meet the
requirements of 3.3.
4.4 HIV-1 RNA quantitative reference
Test with a national HIV-1 RNA quantitative reference or a standardized HIV-1 RNA
quantitative reference; operate as per the product instruction; the results shall meet
the requirements of 3.4.
4.5 HIV-1 RNA sensitivity reference
Test with a national HIV-1 RNA sensitivity reference or a standardized HIV-1 RNA
sensitivity reference; operate as per the product instruction; the results shall meet the
requirements of 3.5.
4.6 HIV-1 RNA linear reference
Test with a national HIV-1 RNA linear reference or a standardized HIV-1 RNA linear
reference; operate as per the product instruction; the results shall meet the
requirements of 3.6.
4.7 Stability
The following methods can be selected.
a) Shelf life stability. take the reagent (kit) for a certain period of time before the
expiration of valid date; operate as per the product instructions; the results shall
meet the requirements of 3.7.2.
b) Thermal stability. place the reagent (kit) for certain time under certain