Evaluation of the performance of four rapid tests for detection of hepatitis B surface antigen in Antananarivo, Madagascar.

ABSTRACT

Four rapid immunochromatographic assays--Determine HBsAg, Virucheck HBsAg, Cypress HBsAg Dipstick and Hexagon HBsAg--for human hepatitis B surface antigen (HBsAg) detection in human serum were evaluated. A collection of reference serum samples (91 HBsAg positive and 109 HBsAg negative) stored at -80 degrees C was used. Sensitivity and positive predictive value (PPV) exceeded 95%, and specificity and negative predictive value (NPV) exceeded 96% for all tests. The Determine HBsAg test performed best in this study, with a sensitivity of 97.8%, a specificity and PPV of 100%, a NPV of 98.2% and an accuracy rate of 99.0%. However, the differences between the tests were not significant. Other factors should therefore also be taken into account by the Ministry of Health in its decision to recommend a particular test price, availability, delivery time and feasibility of whole-blood testing. The Determine test appears to be the most suitable for Madagascar, based on all these criteria. The use of this test, despite its lower sensitivity, could prevent blood-borne transmission of hepatitis B virus (HBV) in areas with limited resources.