Validation of the Roche AMPLICOR HIV DNA test version 1.5 for early infant diagnosis of HIV in Papua New Guinea.

Human immunodeficiency virus (HIV) is a significant public health issue in Papua New Guinea (PNG). After heterosexual transmission (90%), the second most common route of transmission is vertically from mother to child (3.5%). Before the introduction of molecular methods of HIV testing in PNG, diagnosing exposed infants was problematic because there were no reliable assays available for accurate early infant HIV detection. This study aimed to validate and assess a global gold standard for virological early infant HIV diagnosis in PNG: the AMPLICOR HIV DNA v1.5 assay (Roche) using dried blood spot (DBS) specimens. The assay was validated in three ways: by testing well-characterized DBS and kit controls and by blinded retesting of 42 patient specimens. The assay was further investigated by comparison with a serological assay. The results indicated that the assay was robust and highly reproducible using DBS and kit controls, with 100% sensitivity and specificity. Of the 42 infant DBS specimens that were retested blindly, 100% of the test results were concordant with diagnostic results. Among the 42 infant specimens tested with the Amplicor HIV DNA v1.5 assay we found that 33% of infants (n = 14) were HIV PCR positive and 67% (n = 28) negative. The earliest point of HIV detection established for this study was three months of age. This pilot study indicates that HIV-infected infants in PNG can be effectively diagnosed using virological testing and can thus be started earlier on treatment than was previously possible with serological testing.