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WS/T 494-2017: Guideline for performance characteristics of immunological qualitative test
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| WS/T 494-2017 | English | 509 |
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Guideline for performance characteristics of immunological qualitative test
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WS/T 494-2017
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Basic data | Standard ID | WS/T 494-2017 (WS/T494-2017) | | Description (Translated English) | Guideline for performance characteristics of immunological qualitative test | | Sector / Industry | Health Industry Standard (Recommended) | | Classification of Chinese Standard | C50 | | Classification of International Standard | 11.020 | | Word Count Estimation | 22,230 | | Date of Issue | 2017-09-06 | | Date of Implementation | 2018-03-01 | | Regulation (derived from) | State-Health-Communication (2017) 14 | | Issuing agency(ies) | National Health and Family Planning Commission of the People's Republic of China | | Summary | This standard stipulates the clinical qualitative immunoassay method and clinical qualitative immunological test important routine quality control indicators. This standard applies to medical laboratories carrying out various clinical qualitative immunoassays. | WS/T 494-2017: Guideline for performance characteristics of immunological qualitative test---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.
Guideline for performance characteristics of immunological qualitative test
ICS 11.020
C50
People's Republic of China Health Industry Standard
Clinical qualitative immunoassay analysis of important routine items
Quality requirements
Published on.2017-09-06
2018-03-01 Implementation
The National Health and Family Planning Commission of the People's Republic of China released
Directory
Preface I
Introduction II
1 Scope 1
2 Terms and Definitions 1
3 Clinical Qualitative Immunoassay Method 4
3.1 Screening Test 4
3.2 Diagnostic Test 4
3.3 Confirmation Test 4
4 Clinical Qualitative Immunoassays Important Regular Items Analysis Quality Control Index 4
4.1 Content 4
4.2 Qualitative Determination of Precision 5
4.3 Qualitative immunoassay precision with results expressed as COI or S/CO ratio 5
4.4 Accuracy 7
4.5 Analytical sensitivity (ie, minimum detection limit) 16
4.6 Detection of Transformed Serum Plates 16
4.7 Analysis Specificity (Cross-Response) 16
4.8 Interference Factors 16
Reference 18
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard was drafted by. Beijing Hospital, Beijing Chaoyang Hospital, Capital Medical University, Chinese Academy of Medical Sciences Peking Union Medical College Hospital, Sichuan
Provincial Academy of Medical Sciences Sichuan Provincial People's Hospital.
The main drafters of this standard. Li Jinming, Zhang Rui, Wang Lunan, Zhang Kuo, Xie Jiehong, Wang Qingtao, Xu Yingchun, Huang Wenfang, Yuan Hong.
Introduction
There are many important routine test items for clinical qualitative immunoassays, with clear clinical significance and wide application. Clinical qualitative immunoassay results
Comparable accuracy is the basic need for medical and health work. Enhancing and ensuring the accuracy and comparability of test results is the quality of clinical testing and management.
Improve the important content of the work. Quality management must have clear quality control indicators, clinical qualitative immunoassay important routine test items
Analytical quality control indicators mainly include. precision, accuracy, analytical sensitivity (ie, the minimum detection limit), and the ability to detect transformed serum disks
Force, analysis of specificity (cross-reactivity) and interference factors.
Existing clinical qualitative immunoassay tests for important routine items have a large gap in detection performance, and even some commercial kits are
The quality control indicators, etc. are not given in the book. In addition, the most important performance indicators for these reagents should currently be achieved in some projects.
Low requirements lack corresponding standards and regulations. Therefore, it is difficult for clinical laboratories to fully evaluate the performance of the reagents used and also make the test results
The accuracy and comparability are hard to improve.
This standard will be used to determine the detection systems or reagents (including commercial and clinical) required for laboratories carrying out clinical qualitative immunoassays.
Laboratory-made reagents) interpret the interpretation and minimum requirements of analytical quality control indicators to ensure that clinical laboratories can evaluate correctly
Related qualitative immunological reagents.
Clinical qualitative immunoassay analysis of important routine items
Quality requirements
1 Scope
This standard stipulates the clinical qualitative immunoassay method and clinical qualitative immunological test important routine quality control indicators.
This standard applies to medical laboratories carrying out various clinical qualitative immunoassays.
2 Terms and definitions
The following terms and definitions apply to this document.
2.1
Accuracy
The closeness of the analyte to the actual result. The definition of accuracy in qualitative determination means that the sample is positive or negative
Determine the degree of agreement between the results and their true results. This is usually achieved through methodological comparisons.
2.2
Analytical sensitivity
Lower limit detectionlimits
The lowest concentration level of the test substance can be repeatedly detected. The lower limit of determination may vary for different types of specimens.
2.3
Analytical specificity analyticalspecificity
A test method only reacts to the test substance in the sample and does not react with other substances.
2.4
Analyte
The substances or ingredients tested in laboratory tests.
NOTE. Includes any element, ion, mixture, substance, factor, infectious substance, cell, organelle, (enzyme, hormone, or immunogen) activity, identity, presence, or absence,
Concentration, activity, intensity, or other features that need to be determined.
2.5
Bias bias
The difference between the test result and the true value.
2.6
5% detection concentration 5% ofdetectionconcentrat
C5
A 5% positive result will result when the analyte is tested at a concentration of C5. When using a sample with a concentration less than C5 for repeatability testing,
Continue to get a negative result.
2.7
Critical concentration concentration criticalconcentrat
C50
Analyte concentrations at or near the critical value will yield 50% positive results when multiple samples are repeatedly tested at this concentration.
50% of negative results.
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