AEGiS-11IAC: Multi-center evaluation of an HIV-1/2 rapid assay in 9 countries and using seroconversion panels.

11th International AIDS Conference


Vancouver, British Columbia — July 7-12, 1996

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Multi-center evaluation of an HIV-1/2 rapid assay in 9 countries and using seroconversion panels.

Int Conf AIDS 1996 Jul 7-12; 11:218 (abstract no. Tu.A.151)
Constantine NT, Mohamed AH, Zhang X, Sangare A, Holm-Hansen C; University of Maryland School of Medicine, Baltimore, MD, USA. Fax: 410-328-3726.

OBJECTIVE: To evaluate the accuracy of a new HIV 1/2 rapid assay with sera from 9 countries, and using 4 HIV seroconversion panels.

METHODS: A total of 1,472 sera were included and originated from: Tanzania (171), Cote d'lvoire (20), Peru (283), Egypt (200), Uganda (107), Vietnam (40), Indonesia (43), Ecuador (8), and the U.S. (600). The total number of positives were 339, and included 16 HIV-2, and 4 HIV-1/2 dual reactors. Testing was performed using the RED-DOT HIV-1 &2 rapid assay (Catalina, USA) and results were compared to those of routine ELISAs and Western blots. Also, the ability of the rapid assay to detect early infection was assessed using 48 samples from 4 HIV seroconversion panels (Serologicals, USA).

RESULTS: All confirmed positive samples, including the HIV-2 positives were detected by the RED-DOT HIV-1 &2, yielding a sensitivity of 100%. The number of false positive results ranged from 0-5 per study, resulting in specificities of 97.7-100%. The overall specificity was 99% (1133/1144). When testing the seroconversion panels, the RED-DOT HIV-1 &2 assay detected infection at the same time, or earlier, than four ELISAs and a Western blot.

CONCLUSIONS: In this multi-center evaluation, the RED-DOT HIV-1 &2 rapid assay exhibited a 100% sensitivity and an acceptable specificity. It is capable of detecting HIV-2 positive samples, and is equivalent to other screening assays for detecting early HIV infection.

Keywords: AEGIS, HIV-2, HIV-1, HIV Infections, HIV Seropositivity, Evaluation Studies, Blotting, Western, Enzyme-Linked Immunosorbent Assay, Sensitivity and Specificity, Reproducibility of Results, Tanzania, Uganda, Vietnam, Peru, Indonesia, Ecuador, Egypt, United States, nursing, utilization, ICA11

960707
TuA151

Copyright © 1996 - International AIDS Society (IAS). Reproduction of this abstract (other than one copy for personal reference) must be cleared through the IAS.