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WS/T 477-2015 PDF English

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WS/T 477-2015: Quantitative D-dimer assay
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WS/T 477-2015English209 Add to Cart 3 days [Need to translate] Quantitative D-dimer assay

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Basic data

Standard ID WS/T 477-2015 (WS/T477-2015)
Description (Translated English) Quantitative D-dimer assay
Sector / Industry Health Industry Standard (Recommended)
Classification of Chinese Standard C50
Classification of International Standard 11.02
Word Count Estimation 9,965
Date of Issue 2015-11-06
Date of Implementation 2016-05-01
Quoted Standard WS/T 359-2011
Regulation (derived from) State-Health-Communication 2015 No.15
Issuing agency(ies) National Health and Family Planning Commission of the People's Republic of China
Summary This Standard defines the quality control requirements D- dimer testing. This Standard applies to conduct clinical laboratory D- dimer testing.

WS/T 477-2015: Quantitative D-dimer assay

---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.
Quantitative D-dimer assay ICS 11.020 C50 People's Republic of China health industry standards D-dimer quantitative detection Posted on.2015-11-06 2016-05-01 implementation People's Republic of China National Health and Family Planning Commission released

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard was drafted. Beijing Hospital, Shanghai Jiao Tong University School of Medicine Ruijin Hospital, Chinese Academy of Medical Sciences Beijing Union Medical College Hospital, Sichuan Provincial People's Hospital. Drafters of this standard. Peng Mingting, Xie Bo, Zhou Wenbin, Li Chenbin, Gu Xiaolin, Wang Xuefeng, Su Wei, Zhao Yongqiang, Li Yan Xin. D-dimer quantitative detection

1 Scope

This standard specifies the D-dimer test quality control requirements. This standard applies to carry out D-dimer testing of clinical laboratories.

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. Guide to the collection and treatment of blood samples for plasma coagulation experiments Medical institutions clinical laboratory management approach Ministry of Health.2006

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Venous thromboembolism; VTE Thrombosis (clot) Clogging of the vein causes embolism, including deep vein thrombosis and pulmonary thromboembolism. 3.2 Pretest probability; PTP In a clear diagnosis, to determine the patient in a certain clinical status of the early probability. 3.3 Negativepredictivevalue; NPV The proportion of true negatives in all negative results. 3.4 Sensitivity The actual prevalence of test results for the positive proportion. 3.5 Detection system measurementsystem A set of devices for detecting or assessing the presence or absence of a particular substance in a clinical specimen, or for quantifying the substance in a specimen. Detection The system includes all instrumentation, reagents, calibration aids (as applicable), other items required to complete the test, and operating instructions.

4 specimen collection and processing requirements

4.1 specimen collection 4.1.1 According to the principle and requirements of detection methods, plasma or whole blood samples for D-dimer detection. 4.1.2 When using plasma samples, collect samples according to the requirements of WS/T 359-2011, it is recommended to use 109mmol/L sodium citrate anticoagulant Of the venous blood separated from the plasma, anticoagulant and blood ratio of 1. 9. Some D-dimer detection methods such as not affected by anticoagulants can be ...

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