Document 2742
 DOCN  M94A2742
 TI    Comparison of the sensitivity and specificity of acid dissociated and
       regular HIV p24 antigen assays.
 DT    9412
 AU    Hofheinz D; Toedter G; Coulter Immunology, Hialeah, FL 33010.
 SO    Int Conf AIDS. 1994 Aug 7-12;10(1):235 (abstract no. PB0371). Unique
       Identifier : AIDSLINE ICA10/94369833
 AB    OBJECTIVE: To compare individual results obtained with regular HIV-1 p24
       (Abbott and Coulter), with those of acid dissociated HIV p24 (ICD-Prep).
       METHODS: Serum or plasma from 778 HIV seropositive individuals and 258
       HIV seronegative individuals collected retrospectively. All samples were
       assayed following the Coulter HIV-1 p24 Antigen Assay with and without
       the ICD-Prep procedure. Additionally, 499 HIV seropositive, HIV antigen
       positive (Abbott, HIVAG-1) samples were run using the Coulter HIV p24
       ICD-Prep procedure. All positive samples were repeated and neutralized
       following manufactures recommended procedures. RESULTS: Of the 778
       seropositive samples tested, 484 (62.2%) were positive by both Coulter
       HIV p24 and ICD HIV p24. 175 (22.5%) were positive by ICD only, and 1
       (0.1%) was positive by regular HIV p24 only. The remaining 118 (15.2%)
       were negative by both procedures. With the ICD-Prep procedure, 496 of
       499 (99.4%) HIVAG-1 positive samples were positive. DISCUSSION AND
       CONCLUSION: When performed in a blinded study, 484 of 485 (99.8%) of
       samples positive by regular HIV p24 are positive also by the ICD-Prep
       method. When run on 499 known antigen positive samples, 99.4% (496) were
       ICD positive. The four regular positive by ICD were all low positive. We
       conclude that with the sensitivity and specificity of the ICD-Prep
       procedure, it is not necessary to run the regular HIV p24 assay on sera.
 DE    AIDS Serodiagnosis/METHODS  Comparative Study  Human  HIV Core Protein
       p24/*BLOOD  HIV Seronegativity  HIV Seropositivity/*DIAGNOSIS/IMMUNOLOGY
       HIV-1/*IMMUNOLOGY  Predictive Value of Tests  Retrospective Studies
       MEETING ABSTRACT

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