Performance of an In-house Multiplex PCR and Comparison of Amplicor HIV-1 Test For Diagnosis of HIV-1 Infection in Thailand

Abstract

This study compared laboratory performance of an in-house HIV-1 DNA-PCR to an Amplicor HIV-1 test in the detection of HIV-1 DNA in 255 blood specimens from 35 infant born to HIV infected mothers, 40 individuals at risk undergoing HIV testing and 180 blood donors. The specimens were collected during December 2003 - July 2004. The in-house multiplex PCR simultanously detected both HIV-1 DNA and human DNA at chromosome 5. The latter PCR product was used as a marker indicating the quality of blood specimens for PCR testing. This in-house multiplex PCR has limit of detection of 5 copies 8E5 per reaction with 100 percent detection [95% confidence interval (CI); 78.2-100]. Both PCR gave 100 percent concordant results, as compared to HIV-infection status of 255 samples (chi-square test, p= 1.00).

The in-house multiplex PCR has comparable sensitivity and specificity to the Amplicor HIV-1 test in detecting HIV infection status.

The test has been implemented to support HIV-1 diagnostic services in Thailand for 8,000-12,000 under-18-month infants born to infected mothers and further field assessment should be carried out in order to verify the effectiveness of the test.