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YY/T 1828-2021: Anti-mullerian hormone(AMH) testing kit (chemiluminescence immunoassay)
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY/T 1828-2021	English	159	Add to Cart	3 days [Need to translate]	Anti-mullerian hormone(AMH) testing kit (chemiluminescence immunoassay)

YY/T 1828-2021: Anti-mullerian hormone(AMH) testing kit (chemiluminescence immunoassay)

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Anti-mullerian hormone(AMH) testing kit (chemiluminescence immunoassay) ICS 11:100:10 CCSC44 People's Republic of China Pharmaceutical Industry Standard Anti-Mullerian Hormone Assay Kit (chemiluminescence immunoassay) Published on 2021-12-06 2023-05-01 Implementation Released by the State Drug Administration directory Preface III 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Requirement 1 5 Test method 2 6 Labels and Instructions for Use 3 7 Packaging, transportation and storage 3 Reference 4

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: Please note that some content of this document may be patented: The issuing agency of this document assumes no responsibility for identifying patents: This document is proposed by the State Drug Administration: This document is under the jurisdiction of the National Standardization Technical Committee for Medical Clinical Laboratory and In Vitro Diagnostic Systems (SAC/TC136): This document is drafted by: Beijing Tongren Hospital Affiliated to Capital Medical University, Beijing Medical Device Inspection Institute, Beijing Medical Device Technology Evaluation Center, Beckman Coulter Trading (China) Co:, Ltd:, Shenzhen Mindray Biomedical Electronics Co:, Ltd: The main drafters of this document: Liu Xiangyi, Sun Li, Sun Rong, Fan Danqing, Li Ke: Anti-Mullerian Hormone Assay Kit (chemiluminescence immunoassay)

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: ...