Performance evaluation of HCV antibody detection by bi-directional lateral flow method / 中华检验医学杂志

ABSTRACT

Objective To analyze the clinical performance of hepatitis C virus antibody detection by bi-direetional lateral flow method and evaluate whether the bi-directional lateral flow method is suitable for clinical use.Methods Four hurdred and nineteen samples were collected and tested anti-HCV antibodies with hi-directional lateral flow and CMIA kits.These samples contain107 patients with confirmed hepatitis C virus infection,162 patients with other diseases than hepatitis C virus infection and 150 healthy controls.Two positive reference materials for ELISA were tested at the same time.The testing results were analyzed with statistical methods.Results Compared with RIBA,the sensitivity and specificity of bi- directional lateral flow method were 98.1% and 99.7% respectively,the agreement rate with CMIA was 99.0%.The reproducibility percentage of the+/-20% at the cutoff concentration were 97% and 99% respectively.No crossing reaction with hepatitis A/B/D/E virus infection and HIV-1/2 positive individuals were found in the tests.Conclusion The hi-directional lateral flow method for HCV detection shows good clinical performance and is suitable for clinical use.