Local evaluation of a rapid HIV assay for use in developing countries.

We present a research scheme for evaluating inexpensive HIV rapid tests in a developing country setting and assess the field validity of the Sero Strip HIV 1/2 rapid test. The research design features the random allocation of 100 true HIV-positive and 100 true HIV-negative serum specimens to 4 groups, followed by blind testing for HIV status. After one short training session, laboratory technicians at 4 township hospitals (25-35 beds) located 20-50 km from Yangon, Myanmar were sent 800 sera labelled with only an identification number and divided into four groups of 200 specimens each, half being HIV-positive and half HIV-negative. Testing was done in the field with the Sero-Strip HIV 1/2. Determination of the test's validity was based on 399 true HIV positive and 401 true HIV negative sera. All true positives were correctly identified, as were all but two of the true negatives. The sensitivity (% of true positives that test positive) was 100%, and the specificity (% of true negatives that test negative) was 99.5%. The research was completed by in-country scientists who are best suited to evaluate the validity of HIV tests conducted in local environments.