Protocol for Evaluation of the Automated Coagulation Analyzer / 现代检验医学杂志

ABSTRACT

When the device is installed,it needs to be verified by some special tests to evaluate its performance and to determine whether the device is in accordance with the requirements of the relevant inspection specifications.The projects of the automated coagulation analyzer are particularity different from other tests,especially the biochemistry tests.So the clinical laboratory should establish and implement the matching performance validation protocol.This article refers to the CLSI related documents to summarize a feasible and applicable evaluation protocol,helping for evaluating automated coagulation analyzer.