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

• Published in: The Journal of infectious diseases Vol. 217; no. 12; pp. 1889 - 1896
• Main Authors: Lamoury, Francois M J, Bajis, Sahar, Hajarizadeh, Behzad, Marshall, Alison D, Martinello, Marianne, Ivanova, Elena, Catlett, Beth, Mowat, Yasmin, Marks, Philippa, Amin, Janaki, Smith, Julie, Ezard, Nadine, Cock, Victoria, Hayllar, Jeremy, Persing, David H, Kleman, Marika, Cunningham, Philip, Dore, Gregory J, Applegate, Tanya L, Grebely, Jason
• Format: Journal Article
• Language: English
• Published: United States 25.05.2018
• Subjects: 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; Australia
• ISSN: 0022-1899; 1537-6613
• DOI: 10.1093/infdis/jiy114

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.