Clinical evaluation of a hepatitis C antibody rapid immunoassay on self-collected oral fluid specimens

• Published in: Diagnostic microbiology and infectious disease 2019-10, Vol.95 (2), p.149-151
• Main Authors: Kimble, Mabel Michille, Stafylis, Chrysovalantis, Treut, Peter, Saab, Sammy, Klausner, Jeffrey D.
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Female; Hepacivirus - immunology; Hepacivirus - isolation & purification; Hepatitis C; Hepatitis C - diagnosis; Hepatitis C - virology; Hepatitis C Antibodies - analysis; Humans; Immunoassay; Immunoassay - methods; Male; Middle Aged; Oral fluid; Point of care test; Rapid test; Reagent Kits, Diagnostic; Reproducibility of Results; Saliva - immunology; Saliva - virology; Self Care; Sensitivity and Specificity; Specimen Handling; Young Adult
• ISSN: 0732-8893; 1879-0070
• DOI: 10.1016/j.diagmicrobio.2019.05.010

We evaluated the performance of the OraQuick® HCV Rapid Antibody Test (Orasure Technologies, Inc., Bethlehem, PA) on oral fluid specimens when used by patients for self-testing. Participants used a set of instructions, self-collected their specimens, and interpreted their result. A researcher interpreted the test simultaneously and independently. Participants' true antibody status was determined by reviewing medical records or by a venipuncture blood sample. Sensitivity, specificity, and κ statistic were calculated. The sample included 95 participants (48 male and 47 female). Sensitivity and specificity on self-collected oral fluid samples were 88.4%% (95% CI, 74.9–96.1) and 100% (95% CI, 93–100), respectively, when patients interpreted the test results. Sensitivity and specificity were 97.7% (95% CI, 88–99.9) and 98% (95% CI, 89.6–100), respectively, when trained staff interpreted the result. κ statistic was 0.89 (95% CI 0.80–0.98). The rapid HCV test kit showed good performance when used for self-testing of oral fluid specimens.