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WS/T 505-2017: Guideline for evaluation of qualitative test performance
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Guideline for evaluation of qualitative test performance
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WS/T 505-2017
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Basic data | Standard ID | WS/T 505-2017 (WS/T505-2017) | | Description (Translated English) | Guideline for evaluation of qualitative test performance | | Sector / Industry | Health Industry Standard (Recommended) | | Classification of Chinese Standard | C50 | | Classification of International Standard | 11.100 | | Word Count Estimation | 29,215 | | Date of Issue | 2017-09-06 | | Date of Implementation | 2018-03-01 | | Quoted Standard | NCCLS GP10-A | | Adopted Standard | NCCLS EP12-A Vol.22 No.14, NEQ; NCCLS EP12-A2 Vol.28 No.3, NEQ | | 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 specifies the evaluation method for qualitative measurement performance. The qualitative tests described in this standard are limited to methods with only two test results (eg, positive/negative, responding/non-responsive). For semi-quantitative methods where the results are reported as negative, +1, +2, +3, +4, or titer, the precision and methodological comparison tests covered by this standard can only be used for their critical values. This standard is applicable to laboratories carrying out various types of qualitative tests, as well as manufacturers, regulatory agencies and laboratory inspectors who need to study or describe the detection performance of qualitative diagnostic kits. | WS/T 505-2017: Guideline for evaluation of qualitative test performance---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 evaluation of qualitative test performance
ICS 11.100
C50
People's Republic of China Health Industry Standard
Qualitative measurement performance evaluation guide
Published on.2017-09-06
2018-03-01 implementation
National Health and Family Planning Commission of the People's Republic of China
Content
Foreword III
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 qualitative determination method 4
5 Timing of performance verification 4
6 Preparation for performance verification 5
7 Sample collection and processing 5
8 Repetitive study 6
9 Methodology Comparison 10
10 Data Analysis 12
11 Example 19
Appendix A (informative) -20%~ 20% concentration range includes example C5~C95 interval 20
Appendix B (informative appendix) Example 21 for comparative evaluation using diagnostic accuracy criteria
Appendix C (informative appendix) Real diagnosis unknown comparison evaluation example 24
Reference 25
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard is formulated in accordance with the National Clinical Laboratory Standardization Committee (NCCLS) EP12-AVol.22No.14UserPro-
tocolforEvaluationofQualitativeTestPerformance;ApprovedGuideline and EP12-A2Vol.28No.3
UserProtocolforEvaluationofQualitativeTestPerformance;ApprovedGuideline-SecondEdition.
This standard was drafted. National Health and Family Planning Commission Clinical Testing Center, Guangdong Provincial Hospital of Traditional Chinese Medicine, Beijing Chaoyang Hospital affiliated to Capital Medical University.
The main drafters of this standard. Li Jinming, Zhang Kuo, Chen Qubo, Wang Lunan, Zhang Rui, Xie Jiehong, Wang Qingtao.
Introduction
Qualitative measurement is one of the most commonly used methods in clinical laboratories. It is widely used as a screening, diagnosis and treatment method for various diseases, but it is
In the work, often because different manufacturers reagents, different methods and even different laboratories use the same reagents or methods to get different results, shadow
The clinical application of the results of the qualitative test. In order to ensure the consistency and comparability of daily test results, the clinical laboratory will be the corresponding qualitative test.
Before the reagents, methods or detection systems are used for routine testing, performance verification or methodological comparison evaluation of the reagents, methods or detection systems is required.
Because each laboratory has different emphasis in experimental design, data analysis or interpretation of results, there are many methodological evaluations for qualitative determination.
Diverse. In order to ensure that the laboratory's qualitative measurement performance verification or evaluation has rules to ensure the quality of laboratory qualitative testing,
standard.
Qualitative measurement performance evaluation guide
1 Scope
This standard specifies the evaluation method for qualitative measurement performance. The qualitative measurements described in this standard are limited to only two test results (eg.
Positive/negative, reactive/non-reactive) methods. Semi-quantitative for negative results, 1, 2, 3, 4 or titers
The precision and methodological comparison tests covered by this standard can only be used for their critical values.
This standard is applicable to laboratories carrying out various types of qualitative testing, as well as research or description of the diagnostic performance of qualitative diagnostic kits.
Manufacturers, regulators and laboratory inspectors.
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.
NCCLSGP10-A uses the receiver operating characteristic curve to evaluate the clinical accuracy of laboratory testing (Assessmentofthe
ClinicalAccuracyofLaboratory Tests Using Receiver Operating Charateristics(ROC)plots.
ApprovedGuideline,.1995)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Bias bias
When two methods or two instruments perform the comparison experiment, the measured observation average value (measurement under repeated conditions) and the reference side of the measured method
The difference between the measured values obtained by the method or the reference instrument.
3.2
C5~C95 interval C5~C95interval
Analyte concentration near the critical value, it can be considered that the analyte detection result outside this concentration range is always negative (concentration \u003cC5)或始
Finally positive (concentration > C95).
Note 1. The existence of imprecision makes the detection results within this interval not always consistent.
Note 2. The letter C is an abbreviation of concentration, and the subscript (5, 50 or 95) indicates the percentage of positive results.
Note 3. C5 is the analyte concentration when only 5% of the tested samples can be judged as positive, and C95 is the analyte when 95% of the tested samples can be judged as positive.
concentration.
3.3
50% concentration C50
Analyte concentration close to the critical value, repeated detection of a single sample of this concentration will yield 50% positive results and 50% negative
Sexual results.
3.4
Accuracy
The proximity between the measured result of the analyte and the actual result.
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