Objective: To quantify the costs and effectiveness of different strategies for ruling out HIV infection in infants born to HIV-infected mothers in the United States.
Methods: The authors assessed 4 different testing strategies that incorporated serial HIV DNA polymerase chain reaction (PCR) testing with or without enzyme-linked immunosorbent assay (ELISA) antibody testing. Testing costs, false reassurance rates, and incremental cost-effectiveness ratios were compared for the 4 strategies.
Results: In HIV-exposed infants, HIV DNA PCR testing at birth, 1 month, and 4 months of age results in a false reassurance rate of 21 per million (at a 2% transmission rate). Adding an ELISA test lowers the false reassurance rate to 0.052 per million at a cost of $570,000 per additional case detected; adding another PCR lowers the false reassurance rate to 1.49 per million at a cost of $720,000 per additional case detected compared with the 3-PCR strategy. At a high transmission rate (20%), there would be substantially more erroneously negative results (false reassurance rate is 256 per million with PCR testing at birth, 1 month, and 4 months) and consequently more favorable cost-effectiveness ratios with additional testing: $47,000 per additional case detected by adding 1 ELISA test and $59,000 per additional case detected by adding another PCR test.
Conclusions: False-negative HIV results after serial testing in exposed infants are rare, and the incremental cost-effectiveness ratios of additional tests are substantial at low transmission rates. However, the false reassurance rate increases considerably with a 3-PCR strategy and additional testing becomes more cost-effective at greater transmission rates; therefore, additional testing may be warranted in infants at greater risk of infection.