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Abstract
Performance evaluation of the Rapid 1-2-3 Hema Express HIV test for the detection of antibodies to HIV in human serum and whole blood
G. Gibbs1, R. McCollum2, H. Haines3
Background: The purpose of this study was to determine the laboratory performance of the Rapid 1-2-3® Hema Express HIV lateral flow immunochromatography assay for the detection of antibodies to HIV in human serum and whole blood. This assay is self-loading, uses a range of sample sizes and is biohazard-contained.
Methods: Well-characterized ELISA and/or Western blot-confirmed HIV positive serum samples (n=258); negative serum samples (n=386); 2 low positive HIV panels (n=30); 2 mixed-titer positive HIV panels (n=25); 1 combination positive HIV 1/2 panel(n=15)and 3 HIV seroconversion panels (n=30) were obtained from commercial sources and evaluated in the assay. Either 20ml of serum or 10ml of serum mixed with 10ml fresh whole blood (spiked) was drawn onto the sample pad which was then inserted into a tube containing 400ml of run buffer. Assays were incubated at room temperature in a horizontal position and graded within 30 minutes. Subsets were observed for run times.
Results: With both serum and spiked whole blood samples the sensitivity, specificity, PPV, and NPV were 99.6%, 100%, 99.7% and 100%, respectively. For serum samples the run time was 4:32 ±1:12 min. For spiked whole blood samples the run time was 5:22 ±1:51 min. The results from the characterized performance panels were comparable with FDA-licensed rapid HIV assays and international standards.
Conclusions: The Rapid 1-2-3® Hema HIV Express Test meets or exceeds recognized performance requirements for rapid HIV assays. It has three major advantages It utilizes a sample pad capable of drawing whole blood from a finger stick directly onto the test strip eliminating the transfer of blood by other mechanisms. It accepts a sample range of 10-30ml, reducing sampling error. It is self-contained, eliminating external contamination and/or biohazard. These performance properties, and the ease of use of this test, make it well-suited for clinic and field use in HIV diagnostic screening.
AIDS 2008 - XVII International AIDS Conference
Abstract no.
CDB0033
Suggested Citation
"G.Gibbs, et al.
Performance evaluation of the Rapid 1-2-3 Hema Express HIV test for the detection of antibodies to HIV in human serum and whole blood.
:
AIDS 2008 - XVII International AIDS Conference:
Abstract no.
CDB0033"
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