YY/T 1515-2017 PDF English
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YY/T 1515-2017: HIV-1 RNA quantitative assay
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1515-2017YY 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 Assay1 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 Use3 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 product4 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 ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
