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Verification of analytical performance of quantitative kits by clinical laboratory
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Basic data
| Standard ID | WS/T 420-2013 (WS/T420-2013) |
| Description (Translated English) | Verification of analytical performance of quantitative kits by clinical laboratory |
| Sector / Industry | Health Industry Standard (Recommended) |
| Classification of Chinese Standard | C50 |
| Classification of International Standard | 11.020 |
| Word Count Estimation | 41,416 |
| Quoted Standard | GB/T 22576-2008; ISO 18113-2009; CLIA 88 |
| 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 clinical laboratory kit for goods quantitative analysis method to verify performance. This standard applies to clinical laboratory validation of goods quantitative analysis of the performance of the kit. For some commodities qu |
WS/T 420-2013: Verification of analytical performance of quantitative kits by clinical laboratory
---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.
Verification of analytical performance of quantitative kits by clinical laboratory
ICS 11.020
C50
People's Republic of China health industry standards
Clinical Laboratory on Commodity Quantitation Kit
Analyze performance verification
2013-07-16 released
2013-12-01 Implementation
People's Republic of China National Health and Family Planning Commission released
Directory
Preface Ⅰ
Introduction Ⅱ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 symbol 3
5 commodity quantitative kit analysis performance requirements and regulations 3
6 Quantitative product analysis kit performance verification program General 4
7 precision verification 5
Verification of accuracy
9 linear (measurement interval) verification 19
Appendix A (informative) Precision Verification Example 24
Appendix B (informative) Verification of correctness of comparison of patient samples with other test methods/kits Example 28
Appendix C (informative) with the reference substance to verify the accuracy of Example 31
Appendix D (Informative) Linear Verification Example 34
Appendix E (informative) Chi-Square distribution determined by the percentage point 36
References 37
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard was drafted by the Ministry of Health Clinical Laboratory Center, Beijing Aerospace General Hospital, Ministry of Health Beijing Hospital.
The main drafters of this standard. Yang Zhenhua, Chen Wenxiang, Shen Ziyu, Chen Baorong, Tan Aiguo, Wang Zhiguo, Li Xiaopeng, Zhang Chuanbao, Wang Jing.
Introduction
According to "Medical institutions clinical laboratory management approach" (hereinafter referred to as "management approach") requirements, clinical laboratory testing methods used,
Equipment, etc. should ensure that the test results are accurate and reliable, the clinical laboratory should check the purchased commodity quantitative kit to ensure that the selected
The kit meets the clinical laboratory requirements of clinical performance, analytical performance, economic performance and other requirements. Among them, the analytical performance is this
One of the important aspects of these requirements. This standard is based on the above requirements and development.
Clinical laboratory validation and evaluation of the kit is different from the clinical laboratory on the self-developed test methods or equipment and the national food
The verification method or instrument approved by the SFDA will be fully validated,
Just verify that the regulatory agency, such as SFDA or FDA approved major performance, often referred to as verification or verification
(demonstration).
Laboratory medicine contains many kinds of sub-disciplines, some sub-disciplinary methods for quantitative testing due to various reasons, such as blood cell count test method due to
The lack of a stable test sample can not be measured continuously for several days as recommended in this document. In this case, it can be modified appropriately according to the actual situation.
Clinical Laboratory on Commodity Quantitation Kit
Analyze performance verification
1 Scope
This standard specifies the clinical laboratory for quantitative analysis of the performance of reagents to verify the method.
This standard applies to clinical laboratories on the quantitative analysis of commercial reagents kit performance verification. For some product quantitation kits may not finish
All applicable, can be modified on the basis of this standard.
This standard does not apply to the analysis of commodity quantitative kit for a comprehensive and systematic evaluation. If the clinical laboratory for the goods set
Volume of the kit operation steps, dosage, calculation and other major changes, only validated is not enough, then you should use a more comprehensive and complex
The confirmation method.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 22576-2008 medical laboratory quality and ability of the specific requirements
ISO 18113-2009 clinical laboratory testing and in vitro diagnostic test system information provided by the manufacturers of in-vitro diagnostic medical devices
(Clinical laboratory testing and invitrodiagnostictestsystems-Invitrodiagnostic medical services-
Informationsuppliedbythemanufacturer)
CLIA88 Clinical Laboratory Improvement Amendments (Clinical Laboratory Impression Amendments)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Referencequalityvalue
Referencevalue
The value used as a basis for comparison with the same amount of value.
Note 1. The reference value can be the true value being measured, in which case it is unknown; it can also be a fixed value, in which case it is known.
Note 2. Reference values with measurement uncertainty are usually provided by the following reference objects.
a) a substance, such as a certified reference substance;
b) a device, such as a steady-state laser;
c) a reference measurement procedure;
d) Comparison with measurement standards.
3.2
Measurement offset measurementbias
Offset bias
System measurement error estimate.
[JJF1001-2011, 5.5]
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