International Council for Standardization in Haematology (ICSH) laboratory guidance for the evaluation of haemostasis analyser‐reagent test systems. Part 1: Instrument‐specific issues and commonly used coagulation screening tests-Reference-Cited by-同舟云学术

International Council for Standardization in Haematology (ICSH) laboratory guidance for the evaluation of haemostasis analyser‐reagent test systems. Part 1: Instrument‐specific issues and commonly used coagulation screening tests

Published:2020-11-29 Issue:2 Volume:43 Page:169-183
ISSN:1751-5521
Container-title:International Journal of Laboratory Hematology
language:en
Short-container-title:Int J Lab Hem

Author:

Gardiner Chris¹^ORCID,Coleman Robyn²^ORCID,Maat Moniek P. M.³^ORCID,Dorgalaleh Akbar⁴^ORCID,Echenagucia Marión⁵^ORCID,Gosselin Robert C.⁶^ORCID,Ieko Masahiro⁷^ORCID,Kitchen Steve⁸^ORCID

Affiliation:

1. Haemostasis Research Unit University College London London UK

2. Department of Haematology Sullivan Nicolaides Pathology Bowen Hills QLD Australia

3. Department of Haematology Erasmus Medical Centre Rotterdam The Netherlands

4. Department of Hematology and Blood Transfusion School of Allied Medicine Iran University of Medical Sciences Tehran Iran

5. Centro Nacional de Hemofilia Banco Municipal de Sangre del Distrito Capital Caracas Venezuela

6. Thrombosis and Hemostasis Center University of CaliforniaDavis Health System Sacramento CA USA

7. Health Sciences University of Hokkaido Ishikari‐Tobetsu Japan

8. Sheffield Haemophilia and Thrombosis Centre Royal Hallamshire Hospital Sheffield UK

Publisher

Wiley

Subject

Biochemistry, medical,Clinical Biochemistry,Hematology,General Medicine

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/ijlh.13411

Reference45 articles.

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4. PMDA.Current situation of regulations and premarket review in future of companion diagnostics in Japan approval reviews of IVD products: devices and reagents.2019.https://www.pmda.go.jp/files/000153694.pdf. Accessed July 1 2020.

5. National Association of Testing Authorities Australia (NATA).Validation and verification of quantitative and qualitative test methods.2018.

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