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Estradiol testing kit(Chemiluminescent immunoassay)
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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 | 7,734 |
| 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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