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M94A2733.TXT
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1994-10-25
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Document 2733
DOCN M94A2733
TI Performance of a new commercial test to measure HIV p24 antigen
utilizing acid dissociation.
DT 9412
AU Sherlock CH; Karakas L; Craib KJ; University of British Columbia, St
Paul's Hospital, BC Centre for; Excellence in HIV/AIDS, Vancouver,
Canada.
SO Int Conf AIDS. 1994 Aug 7-12;10(1):237 (abstract no. PB0376). Unique
Identifier : AIDSLINE ICA10/94369842
AB OBJECTIVE: To assess the performance of a new HIV p24 antigen ELISA
(Coulter Corporation) and to compare this with the test of record in
North America (Abbott HIVAG-1). METHODS: 500 banked frozen sera were
selected from patients who were HIV antibody (ab) and HIVAG-1 positive.
200 sera were selected from HIVAb negative patients with no risks for
HIV infection. All sera were tested by Coulter HIV-1 p24 antigen assay
(C-p24) both before and after acid dissociation by the Coulter ICD Prep
Kit (ICD). All repeat positives were neutralized with Coulter's p24
neutralization assay (C-neut). Those that did not neutralize were called
negative. All Coulter tests were quantified in pg/ml; only 56 sera were
quantified by HIVAG-1. RESULTS: Of 500 HIVAG-1 positive sera, 423 (85%)
repeated C-p24 positive; of these, 405 were C-neut positive. After ICD,
497 (99.4%) repeated positive; all were C-neut positive. 2 of the 3 ICD
C-neut negatives were also C-p24 negative; 1 was low positive. Of the
200 HIV Ab negative sera, all were negative by both C-p24 and after ICD.
If Coulter ICD is taken as the test of reference, the C-p24 is 82%
sensitive and 99.5% specific. If HIVAG-1 is the test of reference, the
sensitivity of C-p24 is 81% and of ICD is 99.4%. The correlation
coefficient (r) between both C-p24 runs was 0.97, also for both ICD
runs. The correlation coefficient between C-p24 and HIVAG-1 on 56
quantified sera was 0.86 but the C-p24 concentrations were significantly
higher than the HIVAG-1 concentrations (ratio 1.4;p < .001, paired t
test). The ratio of mean ICD concentrations to mean C-p24 concentrations
was 5.8. DISCUSSION AND CONCLUSIONS: There would be little merit in
using C-p24 since its sensitivity is low compared with its own ICD
performance and with HIVAG-1. Coulter ICD results show excellent
sensitivity, specificity and reproducibility with mean p24
concentrations 5.8 times those with C-p24.
DE Antigen-Antibody Complex/IMMUNOLOGY Comparative Study Enzyme-Linked
Immunosorbent Assay/*METHODS Human HIV Core Protein p24/*BLOOD HIV
Seronegativity/IMMUNOLOGY HIV Seropositivity/*DIAGNOSIS/IMMUNOLOGY
HIV-1/*IMMUNOLOGY Predictive Value of Tests Reproducibility of Results
MEETING ABSTRACT
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).