Document 2665 DOCN M94A2665 TI Potential applications of an HIV-1 PCR procedure in a diagnostic testing laboratory algorithm--results of a prospective study. DT 9412 AU Fearon M; Galli R; Major C; Read S; Gomez P; Ontario Ministry of Health Laboratory, Toronto, Canada. SO Int Conf AIDS. 1994 Aug 7-12;10(1):252 (abstract no. PB0438). Unique Identifier : AIDSLINE ICA10/94369910 AB OBJECTIVE: To evaluate the potential of the Roche Amplicor HIV-1 PCR kit for use as a supplemental laboratory procedure in a diagnostic testing algorithm. METHODS: Fresh whole blood specimens were collected in acid-citrate-dextrose (ACD) tubes from: 387 patients at risk for infection; 44 patients with previous indeterminate serology; and 42 infants born to seropositive mothers. Lymphocyte pellets were prepared from each sample for PCR testing, according to established protocols, and remaining plasma portions were tested for HIV-1 and HIV-2 antibodies using a peptide EIA (Detect HIV, BioChem Pharma) and in-house Western Blot (WB). In addition, whole blood virus culture and p24Ag testing were carried out on selected specimens. RESULTS: Of the 387 specimens from patients at risk for HIV infection, specific HIV-1 DNA was detected by the Amplicor PCR kit in 69 specimens. Plasma fractions were reactive for HIV-1 antibodies on all 69 samples as well. The remaining 318 patients were negative for HIV antibodies, with no proviral DNA detected. Of the 44 patients with previous indeterminate serology, 2 were positive by PCR and serology on the follow-up sample (ie. seroconversion), 1 of which was also culture positive. There was 100% concordance between PCR and culture for the 42 samples from infants born to seropositive mothers (11 + by PCR and culture, 31 negative by both). CONCLUSIONS: There were no observed false positive or negative PCR results amongst the 473 specimens in this study. The Amplicor PCR kit has potential for use as a supplemental test in a diagnostic testing algorithm to resolve indeterminate WB, to provide evidence of vertical transmission of HIV, and possibly for determination of early infection in seronegative high-risk individuals. DE Adult *Algorithms AIDS Serodiagnosis/*METHODS Blotting, Western Female Human HIV Seropositivity/*DIAGNOSIS/IMMUNOLOGY *HIV-1/IMMUNOLOGY HIV-2/IMMUNOLOGY Immunoenzyme Techniques Infant, Newborn Male Polymerase Chain Reaction/*METHODS Predictive Value of Tests Pregnancy Prospective Studies MEETING ABSTRACT SOURCE: National Library of Medicine. NOTICE: This material may be protected by Copyright Law (Title 17, U.S.Code).