YY/T 1820-2021Specific antinuclear antibody IgG detecting kit (immunoblotting) (English PDF)
特异性抗核抗体IgG检测试剂盒（免疫印迹法）
This is a limited preview
Buy now to download the full PDF (20 pages)
Need quotation for your management?
Get a formal quotation for YY/T 1820-2021 in 30 minutes.
Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 6, 2021
Implementation date
May 1, 2023
Scope
YY/T 1820-2021 is the English-translated version of 特异性抗核抗体IgG检测试剂盒（免疫印迹法）.
YY/T 1820-2021 is the Chinese pharmaceutical industry standard for the kit that detects specific antinuclear antibodies of the IgG class by immunoblotting, the strip test used in the diagnosis of connective tissue disease.
It sets the requirements, the test methods, the labels and marks, the instructions for use and the rules for packaging, transport and storage, covering the appearance of the strips, the agreement with reference sera for each target antigen, the specificity, the repeatability between strips and lots, and the stability.
It applies to kits for the qualitative detection of autoantibodies against nuclear and cytoplasmic antigens in human serum or plasma, whether processed by hand or on an automated instrument. Issued on 6 December 2021, it has applied since 1 May 2023.
Found what you need?
Document preview — YY/T 1820-2021
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
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 and test methods of the specific antinuclear antibody IgG detection kit (immunoblotting method) (hereinafter referred to as the kit). law, labelling, labelling, instructions for use, packaging, transportation and storage.
This document is suitable for the qualitative detection of nuclear and cytoplasmic specific target antigens in human serum or plasma based on western blotting.
Anti-nuclear antibody specific autoantibody IgG kit, including manual operation method and instrument automatic operation method products.
This document does not apply to detection kits for total antinuclear antibodies.
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
The following terms and definitions apply to this document.
3.1 Specific antinuclear antibody
Antinuclear antibody (ANA), as an important biological marker of autoimmune disease, is the most widely used in clinical application.
The most basic group of autoantibodies. ANA is a general term for autoantibodies targeting various components of eukaryotic cells. ANA detection It is divided into the detection of ANA total antibodies and the detection of specific autoantibodies against the target antigen. Specific antinuclear antibodies are those directed against a specific target antigen antinuclear antibody-specific autoantibodies.
3.2 Detection limit
The measured value obtained by a given measurement procedure, for which, given the probability of misjudgment of the presence of a component in the claimed substance as alpha, the sound The misjudgment probability of the absence of this component is called beta.
Note 1. IUPAC (International Union of Pure and Applied Chemistry), also translated as International Theory (Chemistry)
Science) and the Union of Applied Chemistry. It is recommended that the default values of alpha and beta be equal to 0.05.
Note 2. It is used to describe a test procedure with a specific confidence level can be reported as the existence of the lowest measured value, is also used to refer to the minimum detectable concentration.
Note 3. It was also called "minimum detection limit", "minimum detection limit" and "detection limit". [Source: YY/T 1713-2020, 3.6, with modifications]
3.3 Cutoff
Used to identify a sample as a measure of the threshold for the presence or absence of a particular disease, condition, or measurand.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 20 pages — is available in the English PDF.
Referenced standards
Similar standards
How to Download YY/T 1820-2021
- 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 1820-2021
$105.00