Comparative evaluation of ELISA & CLIA screening assays in the effective detection of HIV infection in blood donor samples

Abstract

Background: Since the set-up of the first blood bank in India in 1939, by the Bengal Red Cross Society, screening for transfusion transmissible infections in donated blood has been improvising steadily in the country. Currently it is either done by rapid diagnostic tests (RDTs) or the more common enzyme linked immunosorbent assay (ELISA) or the latest available sensitive assay namely, chemiluminescence immunoassay (CLIA). Aim: The prime objective of this analytical study was to assess the degree of performance of the readily available CLIA against two different ELISA testing methods for the serological screening of HIV. Methods: We have included 850 samples obtained from serial blood donors who donated blood dating from March 2021 to March 2022. All the collected blood samples were screened by two different ELISA testing methods & CLIA analyzer. The results were then computed and evaluated. Results: Out of 850 samples, 98 were ultimately confirmed to be HIV positive by qPCR testing. As far as sensitivity is considered, both CLIA and ELISA methods hadn’t shown much disparity.