Detection of HIV DNA in peripheral blood by the polymerase chain reaction: a study of clinical applicability and performance.

We evaluated the applicability and performance of the polymerase chain reaction (PCR) in a clinical setting in two independent studies. In a study of its applicability, the specificity and sensitivity of PCR for detection of HIV DNA were 100% (225 out of 225 seronegative, low-risk individuals tested negative) and 94% (67 out of 71 seropositive individuals tested positive), respectively. In a second study evaluating the performance of PCR, seven out of 474 (1.5%) antibody-negative specimens were found to be positive, 149 out of 151 (99%) antibody-positive specimens were positive, and 12 out of 13 (92%) antibody-indeterminate specimens were negative for HIV DNA. The results from these studies show that PCR in a clinical environment is specific and sensitive. PCR is also useful in the detection of HIV infection in the absence of HIV-specific antibody and the resolution of equivocal antibody results.