Evaluation of the Xpert HCV Viral Load Finger-Stick Point-of-Care Assay.

Abstract

Point-of-care hepatitis C virus (HCV) RNA testing is advantageous, enabling diagnosis of active infection in a single visit. This study evaluated the sensitivity and specificity of the Xpert HCV Viral Load Finger-Stick assay (Xpert HCV VL FS) for HCV RNA detection (finger-stick) and the Xpert HCV Viral Load assay (plasma) compared with the Abbott RealTime HCV Viral Load assay by venepuncture. Plasma and finger-stick capillary whole-blood samples were collected from participants in an observational cohort in Australia. Of 223 participants enrolled, HCV RNA was detected in 40% of participants (85 of 210) with available Xpert HCV Viral Load testing. Participants receiving HCV therapy were excluded from subsequent analyses (n = 16). Sensitivity of the Xpert HCV Viral Load assay for HCV RNA quantification in plasma collected by venepuncture was 100.0% (95% confidence interval [CI] 96.9%-100.0%) and specificity was 100.0% (95% CI, 94.4%-100.0%). Sensitivity of the Xpert HCV VL FS assay for HCV RNA quantification in samples collected by finger-stick was 100.0% (95% CI, 93.9%-100.0%) and specificity was 100.0% (95% CI, 96.6%-100.0%). The Xpert HCV VL FS test can accurately detect active infection from a finger-stick sample in 1 hour allowing single-visit HCV diagnosis.

• Authors: Francois M J Lamoury, Sahar Bajis, Behzad Hajarizadeh, Alison D Marshall, Marianne Martinello, Elena Ivanova, Beth Catlett, Yasmin Mowat, Philippa Marks, Janaki Amin, Julie Smith, Nadine Ezard, Victoria Cock, Jeremy Hayllar, David H Persing, Marika Kleman, Philip Cunningham, Gregory J Dore, Tanya L Applegate, Jason Grebely, LiveRLife Study Group
• Journal: The Journal of infectious diseases (J Infect Dis) Vol. 217 Issue 12 Pg. 1889-1896 (05 25 2018) ISSN: 1537-6613 [Electronic] United States
• PMID: 29534185 (Publication Type: Journal Article, Observational Study, Research Support, Non-U.S. Gov't)

Chemical References

• RNA, Viral

Topics

• Adult
• Australia
• Biological Assay (methods)
• Blood Specimen Collection (methods)
• Cohort Studies
• Female
• Hepacivirus (genetics)
• Hepatitis C (virology)
• Humans
• Male
• Middle Aged
• Point-of-Care Systems
• Point-of-Care Testing
• RNA, Viral (genetics)
• Sensitivity and Specificity
• Serologic Tests (methods)
• Viral Load (methods)