Rapid confirmation of HIV infection.
OBJECTIVE
To investigate the utility of a prototype rapid confirmatory HIV assay which offers specific results in 5 min and has applications in a variety of important testing situations.


METHODS
The performance of the rapid confirmatory assay was assessed with 849 blood samples, including serum, plasma, venipuncture whole blood, and peripheral blood collected via fingerstick. Included were over 700 HIV Western blot (WB)-confirmed antibody positive sera, and others which were classified as negative or indeterminate by WB. The analytic sensitivity of the rapid confirmatory assay was assessed using 13 HIV-1 seroconversion panels, and all results were compared to those of an FDA-licensed WB reference test.


RESULTS
The rapid test exhibited 100% concordance with the reference test when testing HIV-1 WB-confirmed positive samples, and 92.3% concordance with samples having WB-inconclusive results. The sensitivity for confirming recent seroconversion was as good, or better than, the FDA-licensed HIV-1 WB in 10/13 panels. The rapid assay performed accurately with whole blood collected from fingerstick, and exhibited excellent precision and reproducibility.


CONCLUSIONS
We conclude that this rapid HIV confirmatory assay, the first of its kind, demonstrates proof of principle for the accurate confirmation of HIV-1 infection and offers important advantages in public health and clinical testing venues.
Constantine
Niel T
NT
Department of Pathology, University of Maryland School of Medicine, Baltimore, Maryland 21201, USA. constant@umbi.umd.edu
Ketema
Fassil
F
D015492:AIDS Serodiagnosis; D015153:Blotting, Western; D015483:HIV Antibodies / Q000097:blood*; D015488:HIV Antigens / Q000276:immunology*; D015658:HIV Infections / Q000175:diagnosis* / Q000821:virology; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D011933:Reagent Kits, Diagnostic; D012015:Reference Standards; D012680:Sensitivity and Specificity; D013997:Time Factors
D015483:HIV Antibodies; D015488:HIV Antigens; D011933:Reagent Kits, Diagnostic