Viral RNA in the resolution of human immunodeficiency virus type 1 diagnostic serology

BACKGROUND: Assays for human immunodeficiency virus (HIV) antibody testing are characterized by very high levels of sensitivity and specificity. Nonetheless, serologic testing of HIV-infected individuals before they produce multispecific HIV antibodies will not detect and confirm those individuals as positive for HIV. This study was carried out to determine whether viral RNA in such specimens is detectable in a quantitative RNA polymerase chain reaction assay. STUDY DESIGN AND METHODS: Study specimens were identified through the United States military HIV testing program. Thirty-five individuals were studied whose HIV type 1 (HIV-1) infection status was serologically inconclusive at initial testing (i.e., reactive on enzyme immunoassay, nondiagnostic or nonreactive on Western blot), but who were documented to be infected (n = 15) or uninfected (n = 20) through the testing of subsequently collected (follow-up) sera. HIV-1 RNA was detected in sera by the use of a commercially available, quantitative, reverse transcriptase-polymerase chain reaction assay. RESULTS: Specimens from 15 individuals subsequently confirmed to be positive for HIV antibody were all positive for HIV-1 RNA. Specimens from 19 of 20 individuals subsequently confirmed to be negative for HIV antibody were negative for HIV-1 RNA. In the one HIV-1 RNA-positive serum from this group, the RNA copy number was low; specimen contamination during prior laboratory testing was suspected. CONCLUSION: Viral RNA was detected in specimens collected for serologic diagnosis of HIV infection in which no special precautions had been taken to preserve the nucleic acid. Such molecular methods potentially add a much needed tool to current HIV testing algorithms.