YY/T 1828-2021Anti-Mullerian hormone testing kit (chemiluminescent immunoassay) (English PDF)
抗缪勒管激素测定试剂盒（化学发光免疫分析法）
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 6, 2021
Implementation date
May 1, 2023
Scope
YY/T 1828-2021 is the English-translated version of 抗缪勒管激素测定试剂盒（化学发光免疫分析法）.
YY/T 1828-2021 is the Chinese pharmaceutical industry standard for the kit that measures anti-Müllerian hormone by chemiluminescence immunoassay, the marker of ovarian reserve.
It sets the technical requirements, the test methods, the labels and instructions for use and the rules for packaging, transport and storage, covering the appearance of the kit, the traceability of the calibrator, accuracy, linearity, the detection limit, precision, the hook effect at high concentrations and stability. Issued on 6 December 2021, it has applied since 1 May 2023.
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Document preview — YY/T 1828-2021
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
- Preface
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Requirement
- 5 Test method
- 6 Labels and Instructions for Use
- 7 Packaging, transportation and storage
- Reference
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 technical requirements of the anti-Mullerian hormone assay kit (chemiluminescence immunoassay) (hereinafter referred to as the AMH kit). requirements, test methods, labels and instructions for use, packaging, transportation and storage.
This document applies to the kit for the determination of anti-Mullerian hormone based on the principle of chemiluminescence immunoassay.
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 the liquid should not leak;
b) Packaging labels should be clear, non-abrasive and easily identifiable.
4.2 Detection limit
The detection limit should not be greater than 0.02ng/mL.
4.3 Accuracy
Recovery should be in the range of [85%, 115%].
4.4 Repeatability
Within the linear range of the kit, test high and low levels of quality control substances or clinical samples, and repeat the test using the same batch of kits At least 10 times, the coefficient of variation (CV) of the test results should not be greater than 8%.
4.5 Batch-to-batch difference
Within the linear range of the kit, three batches of kits were used to detect high and low levels of quality control substances or clinical samples, respectively.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 pages — is available in the English PDF.
Referenced standards
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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
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YY/T 1828-2021
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