International Council for Standardization in Haematology (ICSH) laboratory guidance for the verification of haemostasis analyser‐reagent test systems. Part 2: Specialist tests and calibrated assays
نویسندگان
چکیده
Before a new method is used for clinical testing, it essential that evaluated suitability its intended purpose. This document gives guidance the performance, verification and implementation processes required by regulatory accreditation bodies. It covers planning of specialist haemostatic tests, including factor assays, D-dimers, direct anticoagulants thrombophilia testing.
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ژورنال
عنوان ژورنال: International Journal of Laboratory Hematology
سال: 2021
ISSN: ['1751-553X', '1751-5521']
DOI: https://doi.org/10.1111/ijlh.13550