Comparative field evaluation of HIV rapid diagnostic assays using serum, urine, and oral mucosal transudate specimens.
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.


METHODS
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.
Tribble
D R
DR
U.S. Naval Medical Research Unit No. 3, Cairo, Egypt.
Rodier
G R
GR
Saad
M D
MD
Binson
G
G
Marrot
F
F
Salah
S
S
Omar
C
C
Arthur
R R
RR
D000351:Africa, Eastern / Q000453:epidemiology; D015153:Blotting, Western; D005122:Exudates and Transudates / Q000737:chemistry / Q000821:virology; D015658:HIV Infections / Q000097:blood / Q000175:diagnosis* / Q000453:epidemiology / Q000652:urine / Q000821:virology; D006801:Humans; D015151:Immunoblotting; D007124:Immunoenzyme Techniques; D009061:Mouth Mucosa / Q000737:chemistry / Q000821:virology*; D012463:Saliva / Q000737:chemistry / Q000821:virology