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.
ABSTRACT
Objective To comparatively analyze the results of the PT derivative method and the Clauss method for detecting fi-brinogen(Fib) by the automated coagulation analyzer and to explore their accuracy and clinical value .Methods Fib was detected in 156 blood samples selected from the patients in this hospital from March to May 2013 ,25 normal control samples and 13 positive samples of D-dimer (DD) by the TP derivative method and the Clauss method .Results The Clauss method and the PT derivative method by Sysmex CA-1500 coagulation analyzer had good repetitive rate in measuring Fib for 25 times ;when Fib0 .05);when Fib in the range of 4 .1 -5 .0 g/L ,the detection results had statistically significant difference (P5 .0 g/L ,the detection results had statistically significant difference (P<0 .05);in 13 DD positive samples ,the detection results of the PT derivative method were significantly higher than those of the Clauss method with statistically significant difference (t=8 .530 , P<0 .05) .Conclusion The difference exists between the PT derivative method and the Clauss method for detecting Fib ,but the ac-curacy of the Clauss method is higher than its specificity ,the Clauss method should be the first choice for the clinical determination of plasma Fib .