Evaluation of the Performance of Two Rapid Immunochromatographic Tests for Detection of Hepatitis B Surface Antigen and Anti HCV Antibodies Using Elisa Tested Samples

摘要

Study Design: An experimental study conducted at the King Edward Medical University, Lahore during the period between November 2009 and January 2010. Four rapid immunochromatographic assays - ONE STEP HBsAg One Check, One step HBsAg test Accurate; Rapid anti HCV test One Check and Hepatitis C virus one step device Accurate were evaluated for detection of hepatitis B surface antigen and anti HCV. A collection of ELISA tested samples (57 tested for Hepatitis B by ELISA, 68 tested for Anti HCV antibodies by ELISA) were stored at -20°C and subsequently tested with rapid ICT tests (devices) (Accurate and One Check brands). Sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy of these tests were calculated using ELISA as the gold standard. Aims: The study was aimed to evaluate the performance of two commercially available rapid immuno-chromatographic testing (ICT) kits for HBsAg and anti HCV antibodies. Materials and Methods: Elisa tested samples for HBV (n = 57) and HCV (n = 68) were allotted random numbers to the positive and negative specimens. The medical officers allotting the numbers and the one performing the tests were double blind. Results: Among the 38 ELISA HBV positive sera, 20 were positive by Hepatitis B surface antigen one check and 19 were positive by accurate. Among the 53 ELISA Anti HCV positive sera 24 were positive by one check, 32 were positive by accu-rate and 4 were weakly positive by accurate. The sensitivity for rapid Hepatitis B surface antigen was found to be 53% and 50 % for one check and accurate respectively. The sensitivity of rapid HCV devices was found to be 66% and 45% for Accurate and One Check kits respectively. The negative predictive value for rapid HBsAg devices was 51% and 49% for One Check and Accurate kits respectively. The positive predictive values for HCV were 96% and 97% with One Check and Accu-rate respectively; for HBV, these were 100% and 95% with Accurate and One Check respectively. Conclusion: These results suggest that the rapid immuno-chromatographic kits for HBsAg and HCV have only limited efficacy and should be backed by superior methods like ELISA and PCR where possible.