Session 80Poster Presentations Diagnostic Tests for HIV Session Day and Time: Tuesday 1:30 - 3:30 pm Room: Hall A
661 Performance Characteristics of a Novel, Point-of-Care Rapid HIV-1/2 Test with Application in the Developing World A. Burgess-Cassler*1, L. A. Salvo2, P. D. Slowey2, B. O'Farrell3, E. Banaga3 1Raptecon LLC, Vancouver, WA; 2Hema Diagnostic Systems, LLC, Miami Beach, FL; and 3BioDot, Inc, Irvine, CA
Background:The objective of this study was to define preclinical performance parameters for a novel, rapid HIV-1/2 antibody screening assay (RAPID 1-2-3 HEMA HIV, Hema Diagnostic Systems, LLC). The strip-based lateral flow assay was run in a test tube. The strip will eventually be integrated into a proprietary housing device. The final product will include a system for isolation of whole blood specimens offering added protection to the individual performing the test. This combination of simple, reliable strip and superior mechanical design will be offered as the RAPID 1-2-3 HEMA HIV assay.
Methods:The Rapid 1-2-3 HEMA HIV strip test was validated using a number of banked specimens (normal human sera, sera from HIV infected individuals, and uninfected sera containing potentially interfering substances), as well as several commercial panels (seroconversion, performance, verification). Some testing was performed on mock whole blood specimens in parallel to demonstrate equivalence between sample matrices.
The protocol involved addition of a small volume of specimen to test buffer and immersion of the strip into this homogenous mixture. Results (qualitative) were read visually at minimum and maximum time points of 20 and 60 minutes, respectively.
Results: The assay results demonstrated that 1) the strip test is equivalent in sensitivity and specificity to FDA-licensed EIAs; 2) specificity is not affected by potential interferents; 3) HIV-1 and HIV-2 are both recognized; 4) sensitivity for seroconversion and low titer specimens is comparable to FDA-licensed EIAs; 5) whole blood and serum give comparable results; and 6) results do not change significantly during the recommended read period.
Conclusions: Hema Diagnostic System’s Rapid 1-2-3 HEMA HIV test has been shown to be as sensitive and specific as licensed EIAs. These data, combined with the its demonstrated ruggedness suggest it holds great promise as a viable diagnostic tool for HIV screening programs throughout the world.
