Evaluation of Commercial ELISA and In-House PCR Kits for Hepatitis C Diagnosis in Blood Transfusion Services in Katsina State

Hepatitis C virus (HCV) infection is a major cause of chronic liver disease globally, and transfusion-associated HCV transmission remains a risk in blood transfusion services with limited nucleic acid testing (NAT) capacity. In Katsina State, Northwest Nigeria, blood transfusion safety screening relies predominantly on ELISA-based antibody detection, which cannot identify seronegative viremic donors during the window period. This study evaluated the diagnostic performance of three commercially available anti-HCV ELISA kits compared with an in-house RT-PCR assay for HCV RNA detection in blood donor screening at Katsina State Blood Transfusion Service. Serum samples from 300 blood donors were tested with all four assay platforms. Sensitivity, specificity, and concordance indices were calculated. ELISA sensitivity ranged from 78.6% to 92.3% across the three kits, while in-house RT-PCR achieved 100% sensitivity at the NS5B gene target. Six samples were RT-PCR positive but ELISA negative, representing potential window period donations. False-reactive ELISA rates were observed for one kit at 8.3%, creating donor deferral challenges. These comparative findings demonstrate the diagnostic superiority of molecular testing for HCV blood safety screening and support the adoption of NAT as a mandatory adjunct to ELISA in state blood banks across Northwest Nigeria. Keywords: Hepatitis C, ELISA, RT-PCR, blood transfusion safety, Katsina State.