Evaluation of Two Commonly Used Commercial Immunochromatographic and ELISA Screening Kits for the Detection of Anti-HCV Antibodies among Patients in North Central Nigeria

Abstract

Background: Hepatitis C Virus infection presents a major public health threat globally. The advent of different immunoassays for the detection of specific markers for the diagnosis of the infection since the discovery of the virus is a positive development, but their varied degrees of sensitivity and specificity is a matter of public health concern. Aim: To evaluate the efficiency of two commercial rapid test kits for the detection of anti- HCV antibodies against a third generation Enzyme Immunoassay (EIA) used as a gold standard. Methodology: A total of 500 patient plasma samples screened by ELISA (Autobio Diagnostics, China) were subjected to further screening using two rapid test (immuno chromatographic) strips supplied by Global Diagnostics (USA) and Wondfo Biotech Diagnostic Products (China). Results: Of the 500 samples, anti HCV was detected in 79(15.80%) by ELISA, 59(11.80%) by Wondfo strip, whereas only 45(9.00%) by Global strip method. This gave Wondfo Kit a sensitivity of 75.0%, specificity of 99.0%, overall accuracy of 95.2%, positive predictive value of 93.6%, negative predictive value of 95.4% positive likelihood ratio of 75.0, negative likelihood ratio of 0.25 and Kappa value of 0.803, while Global Kit had a sensitivity of 57.0%, specificity of 100.0%, overall accuracy of 93.2%, positive predictive value of 100%, negative predictive value of 92.5%, positive likelihood ratio of 0.57, negative likelihood ratio of 0.43 and Kappa value of 0.672. Conclusion: The result pattern reveals a marked or significant variation in sensitivity of the test kits. It is therefore recommended that third generation ELISA should be used for blood donors screening, to reduce transmission of hepatitis C virus through blood transfusion. Where the use of ELISA is practically unavailable in health facilities like in remote rural areas or poorest developing countries, the used of rapid strips can be adopted provided their performance are validated before its adoption. We recommend the use of PCR for detection of HCV RNA as a supplement to ELISA in laboratories or blood banks that can afford it.