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

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.