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YY/T 1458-2016: Antibodies to thyroid peroxidase quantitative test reagent(chemiluminescent immunoassay)
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1458-2016 | English | 159 |
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Antibodies to thyroid peroxidase quantitative test reagent(chemiluminescent immunoassay)
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YY/T 1458-2016
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Basic data | Standard ID | YY/T 1458-2016 (YY/T1458-2016) | | Description (Translated English) | Antibodies to thyroid peroxidase quantitative test reagent(chemiluminescent immunoassay) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 8,817 | | Date of Issue | 2016-01-26 | | Date of Implementation | 2017-01-01 | | Regulation (derived from) | China Food and Drug Administration Bulletin 2016 No.25 | | Issuing agency(ies) | State Food and Drug Administration | YY/T 1458-2016: Antibodies to thyroid peroxidase quantitative test reagent(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.
Antibodies to thyroid peroxidase quantitative test reagent (chemiluminescent immunoassay)
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Anti - thyroid Peroxidase Antibody Quantitative Detection Reagent
(Box) (chemiluminescence immunoassay)
Antibodiestothyroidperoxidase quantitativetestreagent
2016-01-26 release
2017-01-01 Implementation
State Food and Drug Administration issued
Foreword
This standard is 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. The issuer of this document does not assume responsibility for the identification of these patents.
This standard is proposed by the State Food and Drug Administration.
This standard by the National Medical Laboratory Laboratory and in vitro diagnostic system Standardization Technical Committee (SAC/TC136) centralized.
The drafting of this standard. Beijing Medical Device Testing Institute, Beijing Branch US Biotechnology Co., Ltd., Capital Medical University, Beijing days
(Shanghai) Co., Ltd., Roche Diagnostic Products (Shanghai) Co., Ltd.
The main drafters of this standard. Wang Ruixia, Cheng Yinghao, Kang Xixiong, Wang Xuefeng, Mu Shiyu.
Anti - thyroid Peroxidase Antibody Quantitative Detection Reagent
(Box) (chemiluminescence immunoassay)
1 Scope
This standard specifies the anti-thyroid peroxidase antibody quantitative detection reagent (box) (chemiluminescence immunoassay method) requirements, test methods,
Identification, labeling, instruction manual, packaging, shipping and storage.
This standard is suitable for quantitative determination of human anti-thyroid peroxidase antibody reagent (box) by chemiluminescence immunoassay [
Referred to as "Anti-TPO reagent (box)"]. Anti-TPO reagent (box) according to the different principles of chemiluminescence can be divided into enzymatic and non-enzymatic
Optical immunoassay reagent (box), according to the different operating procedures can be divided into manual operation and instrument automatic operation method.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 21415-2008 In Vitro Diagnostic Medical Devices Quantitative Measurement of Biological Samples Metering of Calibration and Control Substance
The origin of traceability
YY/T 0466.1 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General requirements
3 request
3.1 appearance
Should be based on the characteristics of the product packaging requirements of the appropriate appearance requirements, the general composition of the components of the kit should be, traits, inner and outer packaging, labels
And so on.
a) kit components should be complete, both inside and outside the packaging should be complete, clear label;
b) liquid reagents no leakage, freeze-dried components were loose body, after the liquid solution evenly (no visible particles, no precipitation).
3.2 traceability
Should be based on GB/T 21415-2008 and the relevant provisions of the TPO calibrator used to provide the source, the assignment process and measurement uncertainty
And so on.
3.3 Accuracy
Accuracy should meet one of the following requirements.
a) Relative deviation.
With a reference material (CRM) or other recognized reference material that can be used to evaluate conventional methods as a sample,
The relative deviation of the measurement results should not exceed ± 10%.
b) Comparison test.
Anti-TPO reagent (box) and the specified analysis system for comparison test.
1) The correlation coefficient (r) should be not less than 0.950 and the slope should be within [0.9,1.1].
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