YY/T 1831-2021Treponema pallidum antibodies detection kit (immunochromatographic method) (English PDF)
梅毒螺旋体抗体检测试剂盒（免疫层析法）
This is a limited preview
Buy now to download the full PDF (18 pages)
Need quotation for your management?
Get a formal quotation for YY/T 1831-2021 in 30 minutes.
Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 6, 2021
Implementation date
May 1, 2023
Scope
YY/T 1831-2021 is the English-translated version of 梅毒螺旋体抗体检测试剂盒（免疫层析法）.
YY/T 1831-2021 is the Chinese pharmaceutical industry standard for kits that detect antibody to Treponema pallidum by immunochromatography, the rapid strip test for syphilis.
It sets the requirements, the test methods, the identification, labels and instructions for use, and the rules for packaging, transport and storage, covering the appearance of the strip, the agreement with national reference panels for negative and positive results, the detection limit, the specificity against potentially cross-reacting sera, the repeatability and the stability.
It applies to kits for the qualitative determination of the antibody in human serum, plasma or whole blood, whether the label is colloidal gold or latex. Issued on 6 December 2021, it has applied since 1 May 2023.
Found what you need?
Document preview — YY/T 1831-2021
National Standard of the People's Republic of China
- Classification
- C 44
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Requirements
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1. Structure and Drafting Rules of Standardization Documents" drafted.
1 Scope
This document specifies the requirements, test methods, identification, labeling and instructions for use of Treponema pallidum antibody detection kits (immunochromatography). Books, packaging, transportation and storage.
This document is suitable for the qualitative determination of Treponema pallidum antibodies in human serum, plasma or whole blood based on the principle of immunochromatography.
Treponema pallidum antibody detection kits such as body gold method and latex method.
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 Graphical signs of packaging, storage and transportation
GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2. In vitro diagnostic reagents for professional use
3 Terms and Definitions
There are no terms and definitions that need to be defined in this document.
4 Requirements
4.1 Appearance
The appearance should meet the following requirements.
a) The components of the kit should be complete and complete, and the liquid should not leak;
b) Chinese packaging labels should be clear and free of wear.
4.2 Physical inspection
Physical inspection should meet the following requirements.
a) The width of the film strip should be greater than or equal to 2.5mm;
b) The liquid moving speed should be greater than or equal to 10mm/min.
4.3 Conformance rate of negative reference products
Use the national negative reference product for testing, the positive reaction should not be more than 2 copies, and the conformity rate (-/-) of the negative reference product should be greater than or equal to 18/ 20; Or use a standardized negative reference substance for testing, and the results should meet the corresponding requirements.
Note: See Appendix A for the national negative reference product information involved in this document.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.
Referenced standards
Similar standards
How to Download YY/T 1831-2021
- 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 191-2025 — Graphical symbols marking for handling and storage of packages
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
Secure payment via Stripe
Payments accepted
YY/T 1831-2021
$105.00