Abstract: Objective To evaluate the analysis performance and consistency of Roche Cobas e601 and Abbott Architect i2000 chemiluminescence immunoassay systems in the detection of Anti-HCV. Methods Verification experiments were taken to measure the precision, the detection limit and the masculine coincidence rate for two analyzers in the detection of anti-HCV based on the method recommended by CLSI. 120 reactive samples and 30 non-reactive samples were detected by two analyzers respectively. Kappa statistic was used to measure the agreement between the results. Results The precision of two analyzers was good. The detection limit of the two analyzers was 0.3 NCU and the masculine coincidence rate was 100%.The total coincidence rate of the two analysis system for the detection of anti-HCV was 70.67%. The coincidence rate for non-reactive, e601 S /CO≥15.0 and i2000 S/CO≥6.0 sample was 100%. The coincidence rate of e601 S/CO 1.01~ 5.0 and i2000 S/CO 1.01~ 2.0 samples were 0 and 44.4% respectively. The degree of consistency in the Kappa coefficient section was weak (K = 0.35, P < 0.05). Conclusion The analysis performance of the two analysis systems for detection of anti-HCV is good, which is suitable for the routine inspection of clinical specimens.
ZHAO Qiao-mei,ZHANG jing,LIU Ying-li,SHI-Yu,WANG Hai-bin,XU Cheng
. Performance Verification of Different Chemiluminescence Analysis System in the Detection of Anti-HCV[J]. Labeled Immunoassays and Clinical Medicine, 2015
, 22(4)
: 345
.
DOI: 10.11748/bjmy.issn.1006-1703.2015.04.026