Performance Evaluation of Blood Donor Screening Assays for Serological Detection of Hepatitis B Surface Antigen and Antibodies to Hepatitis C Virus

Abstract

Background and Objectives: Screening for transfusion transmissible infections in donated blood can be done by either rapid diagnostic tests (RDTs) or enzyme-linked immunosorbent assay (ELISA) or any other available sensitive immunoassay such as chemiluminescence immunoassay (CLIA). The aim of this assay was to evaluate performance of two commercially available RDTs and CLIA against ELISA for serological screening of hepatitis B surface antigen (HBsAg) and anti hepatitis C virus (HCV). In addition, we also tested the seropositive samples by RDTs, CLIA, and/or ELISA by molecular assays (transcription-mediated amplification, transcription-mediated amplification, and quantitative polymerase chain reaction). Methods: In this prospective study, 1000 consecutive blood donors were screened from September 2017 to March 2018. All blood samples collected during the study period were tested by RDTs, CLIA, and ELISA, and the results obtained were compared. Results: On considering ELISA as a reference standard, low analytical sensitivity was noted for both RDTs (64.29%) and CLIA (71.43%) for HBsAg detection. Similar results were also noted for both RDTs (25%) and CLIA (75%). The positive predictive value of CLIA was found to be lower (HBsAg 31.25%; anti-HCV 50%) as compared to RDTs (HBsAg 90%–100%; anti-HCV 100%). High false positivity was noted with CLIA, while RDTs missed seropositive samples. The viral load for HBsAg and anti-HCV seropositive samples ranged from 29.7 IU/ml to 3.4 × 104 IU/ml and 7.56 × 106 IU/ml, respectively. Conclusions: Performance of CLIA as screening assay was better compared to RDTs. CLIA seems to be a suitable screening assay for emergency situations and predonation apheresis donor screening. RDTs may be used as supplemental assay prior to donor notification.