OBJECTIVETo detect hepatitis C virus (HCV) antibody in saliva and find its clinical significance.

METHODSSera and saliva samples from eighty-six patients were parallely detected HCV antibodies (anti-HCV) with EIA using a modified protocol.

RESULTSTwenty-nine of 86 patients were positive for anti-HCV in sera samples; and, 27/29 were also anti-HCV positive with saliva samples. For the 57 anti-HCV negative sera, the saliva samples were all negative. Comparing with the results of sera, the sensitivity (93.1%, 27/29) and specificity (100%, 57/57) of salivary detection for anti-HCV could be accepted.

CONCLUSIONIf the results of sera are considered as "golden standard", these results suggest that tests on saliva can be useful in HCV clinical diagnosis and epidemiological studies for estimating the prevalence of HCV in populations.

Antibodies, Viral ; blood ; immunology ; Clinical Laboratory Techniques ; methods ; Hepacivirus ; immunology ; Hepatitis C ; diagnosis ; virology ; Humans ; Immunoenzyme Techniques ; Saliva ; immunology ; virology ; Sensitivity and Specificity

BACKGROUND: A reliable rapid assay for hepatitis C virus (HCV) may be helpful in various clinical settings. We evaluated the performance of the OraQuick HCV Rapid Antibody Test (OraSure Technologies Inc., Bethlehem, PA, USA). METHODS: Clinical sensitivity and specificity were evaluated with oral fluids and sera from 137 patients diagnosed with hepatitis C and 300 healthy blood donors in a multi-center collaborative study. The stored sera of 200 proven HCV-infected patients and 200 healthy subjects were also evaluated. Analytical sensitivity was estimated with 4 commercial seroconversion panels and 7 Korean reference panels. The performance of 4 laboratory-based tests (3 chemiluminescence assays and 1 enzyme immunoassay) and 4 rapid test kits was compared. We also assessed the interference due to bilirubin, hemoglobin, lipid, rheumatoid factor, multipara, and several viral infections. RESULTS: The clinical sensitivity and specificity of the OraQuick HCV test using oral fluid were 97.8% (95% confidence interval [CI], 93.2-99.4%) and 100% (95% CI, 98.4-100%), respectively. The clinical sensitivity using serum samples was 100%. Using the 4 seroconversion panels, the OraQuick HCV test showed results comparable to those of the laboratory-based assays; its analytical sensitivity was higher than that of the other rapid test kits. There was no cross-reactivity with common interfering factors. CONCLUSIONS: The clinical performance of the OraQuick HCV Test is comparable to that of laboratory-based tests with both serum and oral fluid. This supports the supplementary use of rapid HCV testing using oral fluid in various medical and non-medical settings.
Cross Reactions ; Hepacivirus/*immunology ; Hepatitis C/blood/*diagnosis ; Hepatitis C Antibodies/*blood ; Humans ; Immunoassay ; Reagent Kits, Diagnostic ; Saliva/immunology/virology ; Sensitivity and Specificity

BACKGROUND: A reliable rapid assay for hepatitis C virus (HCV) may be helpful in various clinical settings. We evaluated the performance of the OraQuick HCV Rapid Antibody Test (OraSure Technologies Inc., Bethlehem, PA, USA). METHODS: Clinical sensitivity and specificity were evaluated with oral fluids and sera from 137 patients diagnosed with hepatitis C and 300 healthy blood donors in a multi-center collaborative study. The stored sera of 200 proven HCV-infected patients and 200 healthy subjects were also evaluated. Analytical sensitivity was estimated with 4 commercial seroconversion panels and 7 Korean reference panels. The performance of 4 laboratory-based tests (3 chemiluminescence assays and 1 enzyme immunoassay) and 4 rapid test kits was compared. We also assessed the interference due to bilirubin, hemoglobin, lipid, rheumatoid factor, multipara, and several viral infections. RESULTS: The clinical sensitivity and specificity of the OraQuick HCV test using oral fluid were 97.8% (95% confidence interval [CI], 93.2-99.4%) and 100% (95% CI, 98.4-100%), respectively. The clinical sensitivity using serum samples was 100%. Using the 4 seroconversion panels, the OraQuick HCV test showed results comparable to those of the laboratory-based assays; its analytical sensitivity was higher than that of the other rapid test kits. There was no cross-reactivity with common interfering factors. CONCLUSIONS: The clinical performance of the OraQuick HCV Test is comparable to that of laboratory-based tests with both serum and oral fluid. This supports the supplementary use of rapid HCV testing using oral fluid in various medical and non-medical settings.
Cross Reactions ; Hepacivirus/*immunology ; Hepatitis C/blood/*diagnosis ; Hepatitis C Antibodies/*blood ; Humans ; Immunoassay ; Reagent Kits, Diagnostic ; Saliva/immunology/virology ; Sensitivity and Specificity