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YY/T 1515-2017 PDF English

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YY/T 1515-2017: HIV-1 RNA quantitative assay
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YY/T 1515-2017150 Add to Cart Auto, 9 seconds. HIV-1 RNA quantitative assay Valid

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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/YYT1515-2017
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 ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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