Source: Abstract #SAT-206 Field evaluation of Xpert® HCV Viral Load point-of-care test for detection of hepatitis C virus infection by venipuncture-collected and finger-stick capillary whole-blood samples—J. Grebely, et al.
Study Aims and Results: Improving HCV testing, diagnosis and linkage to care is a continuing challenge. Current point-of-care testing allows for easy and quick delivery of HCV antibody results. Developing a similar HCV RNA point-of-care test will allow for the diagnosis of active infection at the same time. This study evaluates the Xpert® HCV Viral Load assay using samples collected by venipuncture and finger stick capillary whole-blood. The needed samples were collected from people in a study where they were observed receiving services in Australia. Xpert® HCV Viral Load assay’s reliability and accuracy was compared to the current “gold standard”, Abbott Real Time HCV Viral Load assay. There were 150 participants in the study. The median age was 44 years, 87% were male and 65% reported a history of injection drug use. There were 45 HCV RNA positive people. The reliability and accuracy of the Xpert® HCV Viral Load assay for HCV RNA detection in blood draw samples was 100% and 99.1%. In the one instance where the Abbott Real Time HCV RNA was undetectable and the Xpert® HCV RNA was detectable HCV RNA was confirmed with a RT-PCR HCV RNA assay. This confirmation determined the Xpert® was false positive. The reliability and accuracy of the Xpert assay for HCV RNA detection in finger stick samples was 95.5% and 98.1%.
Conclusion: The study showed that the Xpert® HCV Viral Load assay had comparatively reliable results to the Abbott Real Time HCV RNA Viral Load assay in terms of reliability and accuracy
Editorial Comments: The reliability of the Xpert® HCV Viral Load assay when compared to the Abbott Real Time HCV RNA Viral Load assay is promising. The inability to provide on-site HCV RNA confirmation for the existing OraQuick HCV Antibody point-of-care test has shown to be unable to improve the HCV Treatment Cascade issues of client confirmation. Providing an HCV antibody result is important but if we are unable to confirm active infection providing a positive antibody assay runs the potential of increasing anxiety without providing concrete answers. The Xpert® HCV Viral Load assay looks to be a promising step towards improving that.
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