Evaluation of rapid diagnostic tests for the detection of human immunodeficiency virus types 1 and 2, hepatitis B surface antigen, and syphilis in HoChi Minh City, Vietnam

An evaluation of three new rapid diagnostic test kits for human immunodefic iency virus types 1 and 2 (HIV-1/2), hepatitis B surface antigen (HBsAg), a nd syphilis involved a two-phase comparison of rapid diagnostic assays usin g prospectively collected from hospitals and clinics in Ho Chi Minh City, V ietnam. After specificity and sensitivity testing, three new rapid diagnost ic test kits were tested in parallel with six commonly used diagnostic test kits. The Determine(TM) HIV-1/2 test had fewer indeterminate or equivocal results than the Capillus(R) HIV-1/HIV-2 or HIV Blot 2.2(TM) tests. However , the Determine(TM) HIV-1/2 test yielded one false-positive result when com pared with the Serodia(R) HIV, HIV Blot 2.2(TM), and microparticle enzyme i mmunoassay (IMx(R)) HIV tests. The Serodia(R) HBsAg test yielded more false -negative results when compared with the Determine(TM) HBsAg diagnostic tes t kit. The results of the syphilis diagnostic tests evaluated in this clini cal trial consistently agreed with those of the rapid plasma reagin test fo r syphilis. The Determine(TM) Syphilis Treponema pallidum (TP) test had thr ee false-positive results compared with the Serodia(R) TP and the Serodia(R ) TP.particle agglutination (PA) tests, which had two false-positive result s that were confirmed as negative by an ELISA. Application of these serolog ic tests within this comparative evaluation framework, using the World Heal th Organization alternative testing strategies, proved to be an effective w ay to determine serostatus related to HIV, hepatitis B, and syphilis.