Accuracy of rapid oral HCV diagnostic test among a Saudi sample.

OBJECTIVES: The objective of this study was to investigate the accuracy of the OraQuick® rapid diagnostic test in the detection of hepatitis C virus (HCV) antibodies in oral fluid among a Saudi population sample. DESIGN: A case-control cross-sectional study was conducted on 60 HCV-positive patients and 100 HCV-negative control subjects. PATIENTS AND METHODS: The HCV-positive patients were recruited from the Clinics of Infectious Diseases of King Abdulaziz University (KAU) Hospital, Jeddah, while the control group was collected from KAU, Faculty of Dentistry, including staff and students. The OraQuick® HCV rapid antibody test (OraSure Technologies, Inc. USA) utilized the oral fluid swab. Sensitivity and specificity for the test were calculated and correlated to the patients' viral load. RESULTS: Out of the 60 PCR + ve patients, 53 (88.33 %) revealed a positive OraQuick test, whereas 7 (11.67 %) patients showed negative test, revealing 88.33 % sensitivity and 100 % specificity for detection of salivary HCV antibodies. Only PCR level was valuable in predicting the outcome of OraQuick test. CONCLUSION: Using oral fluid for the detection of HCV antibodies could be a useful tool for epidemiological purposes and for field collection of samples in developing countries or in nonclinical settings by persons with minimal training. CLINICAL RELEVANCE: Millions of pilgrims visit Saudi Arabia during every year, many of whom are from countries where HCV infection is endemic; therefore, it will be very helpful to use a noninvasive, quick, simple, specific, and sensitive method for detection of HCV antibodies using oral fluid.