VIRAL-RNA IN THE RESOLUTION OF HUMAN-IMMUNODEFICIENCY-VIRUS TYPE-1 DIAGNOSTIC SEROLOGY

BACKGROUND: Assays for human immunodeficiency virus (HIV) antibody tes ting are characterized by very high levels of sensitivity and specific ity 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 d etermine whether viral RNA in such specimens is delectable in a quanti tative 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 t esting (i.e., reactive on enzyme immunoassay, nondiagnostic or nonreac tive 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 comme rcially available, quantitative, reverse transcriptase-polymerase chai n 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; spe cimen contamination during prior laboratory testing was suspected. CON CLUSION: Viral RNA was detected in specimens collected for serologic d iagnosis of HIV infection in which no special precautions had been tak en to preserve the nucleic acid. Such molecular methods potentially ad d a much needed tool to current HIV testing algorithms.