5th International AIDS Society Conference on HIV Pathogenesis and Treatment Cape Town - July 19 - 22, 2009

HIGH RATES OF FALSE NEGATIVE RESULTS WITH ORAL FLUID AND BLOOD SPECIMENS USING DIFFERENT KITS OF RAPID TESTING FOR HIV DIAGNOSIS

IAS Conf HIV Pathog Treat 2009 Jul 19-22;5th: Abstract No. MOPDB104

J. Pavie, A. Rachline, B. Loze, L. Niedbalsky, W. Rozenbaum, F. Simon, J.-M. Molina
Saint-Louis Hospital, Paris, France

INTRODUCTION: Several kits are available for rapid HIV diagnosis. False positive results have been reported with oral fluid, but little information is available regarding rate of false negative results.

METHODS: 200 patients with HIV-1 (n=195) or 2 infection (n=5) using the reference EIA test (Abbott Ag/Ac HIV-1/2) were prospectively tested using blood and oral fluid with 6 different kits for rapid HIV diagnosis. All kits were CE approved: Determine HIV1-2 (Unipath/Inverness), INSTI HIV1/2 (Biolytical/Servibio), Vikia HIV ½ (BioMérieux), Determine 4th generation VIH1/2 Ag/Ac (Unipath/Inverness) and Oraquick Advance rapid HIV1/2 (Orasure/Orgentec). Reading was performed by trained personnel and 20 HIV negative subjects were enrolled to blind reading. Results were reported as positive, negative, uncertain, or nondiagnostic when kit controls reacted negative. Negative tests among HIV-infected patients were repeated using plasma.

RESULTS: All 20 HIV negative patients reacted negative. Among HIV-infected patients, median age was 42 years, 83 % were men, 59,5% white and from 31% Sub-Saharan Africa. Median CD4 count : 449 cells/mm³. Sixty-eight percent of patients were on HAART, 69% of whom had a plasma HIV RNA level < 50 cp/ml. Results are presented in Table 1.

All patients with negative tests using blood were positive using plasma. Two patients with primary HIV infection had negative tests with all kits using either blood or oral fluid.

CONCLUSION: There is variability among kits for rapid diagnosis of HIV infection using blood or oral fluid. This study should help to select the optimal tests for use.

2009-07-22
MOPDB104
Poster Discussion MOPDB1 - Update on Diagnosing and Monitoring

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