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Comparative field evaluation of HIV rapid diagnostic assays using serum, urine, and oral mucosal transudate specimens
D R Tribble1, G R Rodier, M D Saad
1U.S. Naval Medical Research Unit No. 3, Cairo, Egypt.
Background:
Comparative field utility of selected HIV-1 assays using homologous collections of serum, urine and oral mucosal transudate (OMT) was determined in adult populations from a tuberculosis hospital and STD clinic in Djibouti, East Africa.
Study Design:
Enzyme immunoassay with confirmatory Western blot was performed on all serum specimens for comparison with rapid, instrument-free assays (SUDS HIV-1, Murex: TestPack HIV-1/2. Abbott; and COMBAIDS HIV 1 + 2, SPAN Diagnostics) using various specimen sources. Delayed (48 h post-collection) testing was also performed on urine. Sensitivity and specificity for the rapid assays, in descending order, were as follows: serum SUDS HIV-1 assay (100%, 98.3%), serum COMBAIDS HIV-1/2 assay (98.4%, 99.6%), and OMT SUDS HIV-1 assay (98.4%, 94.5%).
Results:
The OMT EIA optical density cutoff value was modified resulting in an improved specificity from 89.1 to 99.6%, however, sensitivity decreased from 100 to 98.5%. Urine EIA and rapid assays demonstrated unacceptable test performance for use as a screening test.