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

Possibly no more than 5% of HIV-infected people in developing countries know that they are infected with the virus. In much of the developing world HIV testing remains expensive and often hard to secure. Despite the need for accessible and affordable HIV testing services in Myanmar the only national-level testing currently offered by the government is for blood transfusions. However to increase access to HIV testing in Asia and other developing regions internal markets need to be created for private sector sales of valid and inexpensive HIV test kits. Findings are presented from the study in Myanmar of HIV test kits for rural hospitals lacking adequate laboratory facilities. 100 true HIV-positive and 100 true HIV-negative serum specimens were randomly allocated to 4 groups followed by a blind testing for HIV status. After 1 short training session laboratory technicians at 4 township hospitals 20-50 km from Yangon were sent 800 sera labeled only by identification number and divided into 4 groups of 200 specimens each half being HIV-positive and half HIV-negative. Testing was then conducted in the field using the Sero-Strip HIV 1/2 rapid test. The tests validity was determined on the basis of 399 true HIV-positive and 401 true HIV-negative sera. All true positives were correctly identified as were all but 2 of the true negatives. The test was therefore 100% sensitive and 99.5% specific. This research was completed by in-country scientists who are best suited to evaluate the validity of HIV tests conducted in local environments.