Abstract:

Objective To investigate the consistency of 3 automated coagulation analyzers for coagulation items [prothrombin time（PT）,international normalized ratio（INR）,activated partial thromboplastin time（APTT）,fibrinogen（Fib）,thrombin time（TT）,D-dimer（DD）and fibrin/fibrinogen degradation product（FDP）] and the matrix effects of quality control materials. Methods A total of 100 samples were collected. Totally,PT,PT-INR,APTT,Fib,TT,DD and FDP were determined by 3 automated coagulation analyzers,including CA7000,Top700 and CP2000. Linear regression analysis was used to analyze the correlation of results. The relative deviation between any 2 analyzers was calculated. The matrix effect of 18 quality control materials for PT,Fib and DD was assessed with regression. Results There were good correlations among the 3 automated coagulation analyzers for PT,PT-INR and Fib （r²=0.91-0.99）. The deviations between any 2 analyzers were <15%,15% and 20%. The results of DD among the 3 automated coagulation analyzers had correlations （r²≥0.90）,CA7000 and CP2000 had good consistency,but the results of Top700 were lower than those of CA7000 and CP2000. Moderate correlations were observed for APTT and TT（r²=0.56-0.76）. Medical kits for FDP and matched calibrators were adopted to the 3 analyzers. There was a high correlation for FDP and DD （r²>0.99,r²=0.92-0.99）,and there was difference between any 2 analyzers. There was no compatibility for PT,Fib and DD on the 3 analyzers in 18 quality control materials. Conclusions The consistency of the results of the 3 automated coagulation analyzers is diverse. The matrix effects should be considered,which makes the deviation of quality control materials greater than that of patient.

Key words: Coagulation test, Correlation, Quality control material, Matrix effect