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YY/T 1589-2018 English PDF

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YY/T 1589-2018: Estradiol testing kit(Chemiluminescent immunoassay)
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YY/T 1589-2018English139 Add to Cart 3 days [Need to translate] Estradiol testing kit(Chemiluminescent immunoassay) Valid YY/T 1589-2018

PDF similar to YY/T 1589-2018


Standard similar to YY/T 1589-2018

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Basic data

Standard ID YY/T 1589-2018 (YY/T1589-2018)
Description (Translated English) Estradiol testing kit(Chemiluminescent immunoassay)
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Word Count Estimation 7,764
Date of Issue 2018-04-11
Date of Implementation 2019-05-01
Regulation (derived from) China Drug Administration Announcement No. 4 of 2018
Issuing agency(ies) State Drug Administration

YY/T 1589-2018: Estradiol testing kit(Chemiluminescent 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.
(Estradiol Assay Kit (Chemiluminescence Immunoassay)) ICS 11.100 C44 People's Republic of China Pharmaceutical Industry Standard Estradiol assay kit (Chemiluminescence immunoassay) Estradioltestingkit (Chemiluminescentimmunoassay) Published on.2018-04-11 2019-05-01 implementation State Drug Administration issued

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. Publication of this document The organization is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the National Medical Clinical Laboratory and the In vitro Diagnostic System Standardization Technical Committee (SAC/TC136). This standard was drafted. Beijing Medical Device Inspection Institute, Sichuan Mike Biotechnology Co., Ltd., Roche Diagnostics (Shanghai) Ltd., Beckman Coulter Trading (China) Co., Ltd. The main drafters of this standard. Yan Juan, Yang Zhong, Zou Yingxi, Tian Junxi, Cai Xiaorong, Zhang Hong. Estradiol assay kit (Chemiluminescence immunoassay)

1 Scope

This standard specifies the requirements, test methods, labels and instructions for use of estradiol assay kits (chemiluminescence immunoassay), packages Requirements for loading, transportation and storage. This standard applies to kits for the determination of estradiol by chemiluminescence immunoassay. Including microplates, tubes, magnetic particles, microbeads A chemiluminescence immunoassay kit for testing with a plastic bead or the like.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 191 packaging storage and transportation icon GB/T 21415 in vitro diagnostic medical device biological sample medium quantity measurement calibrator and control substance evaluation Source GB/T 29791.2 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 2. Professional in vitro diagnostic reagents

3 requirements

3.1 Appearance and physical inspection The kit should be complete in components, the inner and outer packaging should be complete, the label should be clear, and the liquid reagent should be leak-free. 3.2 Linear Within the linear range given by the manufacturer (the lower limit of the linear range is not higher than 20 ng/L and the upper limit is not less than 1000 ng/L), the correlation coefficient (r) should be Not less than 0.9900. 3.3 Detection limit Should not be higher than 15ng/L. 3.4 Accuracy Accuracy should meet one of the following requirements. a) Relative Deviation. Using a Certified Reference Material (CRM) or other recognized reference material that can be used to evaluate routine methods as a sample For line testing, the relative deviation of the measured results should not exceed ±15%. b) Recovery test. The recovery rate should be in the range of [85%~115%]. 3.5 repeatability Samples with concentration (35±7) ng/L and (200±40) ng/L were tested 10 times for each replicate, and the coefficient of variation (CV) should be no more than 10%.

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