Verification Assessment in Three Hematology Analyzers / 医疗卫生装备

ABSTRACT

Objective To evaluate the veracity and consistency of the results obtained from three automated hematology an-alyzers. Methods The reproducibility tests were used to assess the precision,the verification tests were exerted to evaluate the accuracy and consistency of test parameters(WBC,RBC,Hb,Hct and Plt) of the three hematology analyzers. According to the 1/2 standard of American Clinical Laboratory Improvement Amendment (CLIA,88),the relative bias of the reference analyzer and other assessed analyzers were determined. Results The results obtained from the three analyzers showed ex-cellent precision and stability,the coefficients of variation (CV) were all less than 5%; compared with the results of LH750,the results of Gens 5diff and ACT-5diff showed excellent correlation,all coefficients of correlation(?) exceeded 0.975. The results of both RBC and Hct obtained from Gens 5diff and ACT-5diff exceeded allowable error; the results of WBC,Hb and Plt were in the allowable error range. Conclusion In the condition of the excellent precision and stability,system errors existed in the analyzer can be found by verification on time. Through being adjusted and calibrated,the hematology ana-lyzers can meet the requirements and these results are consistent.