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Guide to interference testing in clinical chemistry
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Basic data | Standard ID | WS/T 416-2013 (WS/T416-2013) | | Description (Translated English) | Guide to interference testing in clinical chemistry | | Sector / Industry | Health Industry Standard (Recommended) | | Classification of Chinese Standard | C50 | | Classification of International Standard | 11.020 | | Word Count Estimation | 21,285 | | Regulation (derived from) | State Health-Communication (2013) 3 | | Issuing agency(ies) | National Health and Family Planning Commission of the People's Republic of China | | Summary | This standard specifies the method for evaluating the impact of interfering substances in the detection system. This standard applies to in vitro diagnostic medical device manufacturers and clinical laboratories for clinical laboratory evaluation of quant | WS/T 416-2013: Guide to interference testing in clinical chemistry---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.
Guide to interference testing in clinical chemistry
ICS 11.020
C50
People's Republic of China health industry standards
Interfere with experimental guidelines
2013-07-16 released
2013-12-01 Implementation
People's Republic of China National Health and Family Planning Commission released
Directory
Preface Ⅰ
1 Scope 1
2 Terms and definitions 1
3 interfere with the experimental program 2
3.1 interfere with the test results 2
3.2 Interference standard and determination of measured and interfering test concentration 2
3.3 on the experimental operator requirements 4
3.4 on the detection system requirements 4
3.5 Laboratory Safety 4
3.6 interference screening experiments 4
3.7 interfere with dose effect evaluation experiment 7
4 Interference test report 10
Appendix A (informative) common biochemical project quality indicators 11
Appendix B (informative) Recommended concentrations of common test measured 12
Annex C (Informative) Recommended concentrations of common endogenous interferors
Appendix D (informative) interference screening test results record table 17
Appendix E (informative) Interference dose effect test results record table 18
References 19
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard is mainly drafted by. Clinical Laboratory of Ministry of Health, Peking University First Hospital, Beijing Union Medical College Hospital, Capital Medical University Affiliated
Beijing Tongren Hospital.
The main drafters of this standard. Wang Jing, Chen Wenxiang, Zhao Hai ship, Xie Jiehong, Wang Donghuan, Shen Ziyu, Wang Xuejing, Qiu Ling, Liu Xiangtao.
Interfere with experimental guidelines
1 Scope
This standard specifies the method of evaluation of interfering substances on the detection system.
This standard applies to in vitro diagnostic medical equipment manufacturers and clinical laboratories on the quantitative evaluation of clinical laboratory interference evaluation.
2 Terms and definitions
The following terms and definitions apply to this document.
2.1
Interference
In clinical chemistry, there is a clinically significant deviation in the concentration of the analyte from the characteristics of the sample or other components. This effect can be
Found in the detection system of non-specific, indicating poor response to the test object activity inhibition and so on.
2.2
Interferon interfering agent
Not the amount that is measured but has an effect on the measurement result.
[JJF1001-1998, Definition 4.8]
2.2.1
Endogenous interferents
Substances that appear in the sample due to pathology, such as bilirubin or hemoglobin, can interfere with the detection of other substances.
2.2.2
Exogenous interfering exogenousinterferent
Substances in the sample that interfere with the detection of other substances (such as drugs and their metabolites, sample preservatives, etc.) from the outside of the sample.
2.3
Interfere with standard interferencecriteria
The maximum permissible interference error that can occur between the concentration of the analyte and its true value can affect the physician's medical decision.
2.4
Measurand is measured
The specific amount to be measured.
[JJF1001-1998, Definition 4.7]
2.5
Specificity
The presence of interfering substances analysis system can correctly distinguish or detect the ability to be measured.
2.6
Total analysis error totalanalyticalerror
The difference between the measured value and the reference value.
[JCGM200..2008, Definition 2.16]
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