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

An evaluation of three new rapid diagnostic test kits for human immunodeficiency virus types 1 and 2 (HIV-1/2), hepatitis B surface antigen (HBsAg), and syphilis involved a two-phase comparison of rapid diagnostic assays using prospectively collected from hospitals and clinics in Ho Chi Minh City, Vietnam. After specificity and sensitivity testing, three new rapid diagnostic test kits were tested in parallel with six commonly used diagnostic test kits. The DetermineHIV-1/2 test had fewer indeterminate or equivocal results than the CapillusHIV-1/HIV-2 or HIV Blot 2.2� tests. However, the DetermineHIV-1/2 test yielded one false-positive result when compared with the SerodiaHIV, HIV Blot 2.2� , and microparticle enzyme immunoassay (IMx� ) HIV tests. The SerodiaHBsAg test yielded more false-negative results when compared with the DetermineHBsAg diagnostic test kit. The results of the syphilis diagnostic tests evaluated in this clinical trial consistently agreed with those of the rapid plasma reagin test for syphilis. The DetermineSyphilis Treponema pallidum (TP) test had three false-positive results compared with the SerodiaTP and the SerodiaTP●particle agglutination (PA) tests, which had two false-positive results that were confirmed as negative by an ELISA. Application of these serologic tests within this comparative evaluation framework, using the World Health Organization alternative testing strategies, proved to be an effective way to determine serostatus related to HIV, hepatitis B, and syphilis. In many developing areas worldwide, field and clinic lab- oratory capabilities may be insufficient for the detection of infectious agents for definitive clinical diagnostic purposes. The absence of simple, rapid diagnostic testing methods for sexually transmitted diseases (STDs) and hepatitis has sig- nificantly hampered public health efforts to retard the spread of these diseases. The inability to provide tests for quick recognition of human immunodeficiency virus (HIV), hep- atitis B, and syphilis has allowed infected individuals to un- knowingly spread the disease through sexual contacts, blood donations, and intravenous needle sharing. In cities through- out Asia, current laboratory evaluation of blood specimens may preclude case follow-up and counseling due to a long time lag between initial sample collection and conventional test completion. High-risk populations typically seek treat- ment during clinic visits in association with acute episodes and are not likely to return a second time for test results. Diagnostic technology is adapting itself for application in developing countries. Advancements in the laboratory di- agnosis of HIV/acquired immunodeficiency syndrome (AIDS), hepatitis B, and syphilis have considered the fol- lowing conditions, including: 1) speed of results; 2) test va- lidity and accuracy; 3) minimal specimen requirement; 4) variable type of specimen, including whole blood; 5) ease of test kit use, with few requirements for specialized labo- ratory equipment; and 6) stable reagents, requiring no re- frigeration. These criteria for the nine diagnostic tests eval- uated are listed in Tables 1, 2, and 3.