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YY/T 1828-2021: Anti-mullerian hormone(AMH) testing kit (chemiluminescence immunoassay)
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1828-2021 | English | 159 |
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Anti-mullerian hormone(AMH) testing kit (chemiluminescence immunoassay)
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YY/T 1828-2021
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Basic data | Standard ID | YY/T 1828-2021 (YY/T1828-2021) | | Description (Translated English) | Anti-mullerian hormone(AMH) testing kit (chemiluminescence immunoassay) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Word Count Estimation | 8,881 | | Issuing agency(ies) | State Drug Administration | YY/T 1828-2021: Anti-mullerian hormone(AMH) testing kit (chemiluminescence immunoassay)---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
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:
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