Comparative evaluation of six rapid serological tests for HIV-1 antibody.
Six commercial rapid test kits for HIV-1 antibody were evaluated. Four laboratory technologists tested sera from four groups of U.S. military personnel or dependents: 202 subjects positive for HIV-1 antibody by Western blot, 200 seronegative voluntary blood donors, 199 seronegative obstetrics/gynecology patients, and 99 subjects with sera reactive by ELISA but negative by recombinant protein EIA and indeterminate by Western blot. The three tests using solid-phase immunoassay technology demonstrated the highest mean sensitivity (> 99%) and specificity (> 91%) for all groups tested, including sera indeterminate by Western blot. Two dot-immunoblot assays were less specific, possibly due to indistinct reaction end points, and a latex agglutination assay was also less specific because of difficulty distinguishing reactive results from the granular background. In an "ease-of-use" assessment, solid-phase capture immunoassays required less time and equipment and were easier to interpret than other testing methods. Solid-phase capture immunoassays for HIV-1 antibody may be suitable for use in emergency situations and in developing countries because they are highly sensitive and specific and are rapidly performed with minimal laboratory equipment.
Malone
J D
JD
Infectious Disease Division, National Naval Medical Center, Bethesda, MD 50014-5000.
Smith
E S
ES
Sheffield
J
J
Bigelow
D
D
Hyams
K C
KC
Beardsley
S G
SG
Lewis
R S
RS
Roberts
C R
CR
D015492:AIDS Serodiagnosis / Q000379:methods*; D015153:Blotting, Western; D004797:Enzyme-Linked Immunosorbent Assay; D005069:Evaluation Studies as Topic; D005260:Female; D015483:HIV Antibodies / Q000097:blood*; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D007118:Immunoassay / Q000379:methods; D007841:Latex Fixation Tests; D008297:Male; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity
D015483:HIV Antibodies; D011933:Reagent Kits, Diagnostic