YY/T 1515-2017Human immunodeficiency virus type 1 (HIV-1) RNA quantitative detection kit (English PDF)
人类免疫缺陷病毒（I型）核酸定量检测试剂盒
This is a limited preview
Buy now to download the full PDF (23 pages)
Need quotation for your management?
Get a formal quotation for YY/T 1515-2017 in 30 minutes.
Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
May 2, 2017
Implementation date
April 1, 2018
Scope
YY/T 1515-2017 is the English-translated version of 人类免疫缺陷病毒（I型）核酸定量检测试剂盒.
YY/T 1515-2017 is the Chinese pharmaceutical industry standard for the kit that measures HIV-1 RNA quantitatively by nucleic acid amplification, the viral load test.
It sets the requirements, the test methods, the marks, labels and instructions for use and the rules for packaging, transport and storage, covering the detection limit and the linear range in international units, the accuracy against reference materials, the specificity and the coverage of the subtypes, the precision, the internal control and the stability. Issued on 2 May 2017, it has applied since 1 April 2018.
Found what you need?
Document preview — YY/T 1515-2017
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope4
- 2 Normative References4
- 3 Requirements4
- 4 Test Methods6
- 5 Mark, Label and Use Instructions7
- 6 Package, Transportation and Storage7
- Bibliography8
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
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
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 23 pages — is available in the English PDF.
Referenced standards
Similar standards
How to Download YY/T 1515-2017
- 1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
- 2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
- 3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
- 4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.
Related Standards
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
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
YY/T 0479-2026 — Medical diagnostic X-ray tube assemblies and X-ray source assemblies - Determination of maximum symmetric radiation field
Secure payment via Stripe
Payments accepted
YY/T 1515-2017
$125.00