Evaluation of an indigenously manufactured rapid immunochromatographic test for detection of HBsAg

A 'rapid' one step immunochromatographic, visually read, antigen capture assay--the "HEPACARD" (J Mitra & Co. Ltd., New Delhi, India) used for rapid screening of HBsAg was evaluated. Thousand consecutive sera sent to our laboratory for the purpose of HBsAg screening were tested by this device and by a third generation enzyme immunoassay (EIA) (Auszyme Monoclonal, Abbott Laboratories, Chicago, Illinois) or an automated Axsym microparticle enzyme immunoassay (MEIA) (Axsym HBsAg V2, Abbott Laboratories, Abbott Park, Chicago, Illinois, ISA). Hepacard showed a sensitivity of 79% (CU: 57.3-92%) and specificity of 98.9% (CI: 97.9-99.4%) when compared to the findings by the third generation EIA assays. This study suggested that this particular rapid HBsAg test results have to be confirmed by either an EIA or MEIA where the facility exists. The test may be used only in a small hospital setting where the facilities for enzyme immuno assays do not exist.