Research on Hepatitis C Virus Detailed by Scientists at OraSure Technologies, Inc.

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New research, 'Evaluation of a new, rapid test for detecting HCV infection, suitable for use with blood or oral fluid,' is the subject of a report. "The availability of a highly accurate, rapid, point-of-care test for hepatitis C virus (HCV) may be useful in addressing the problem of under-diagnosis of HCV, by increasing opportunities for testing outside of traditional clinical settings. A new HCV rapid test device (OraQuick?? HCV Rapid Antibody Test), approved recently in Europe for use with venous blood, fingerstick blood, serum, plasma, or oral fluid was evaluated in a multi-center study and performance compared to established laboratory-based tests for detection of HCV," scientists writing in the Journal of Virological Methods report (see also Hepatitis C Virus).

"The HCV rapid test was evaluated in prospective testing of subjects with signs and/or symptoms of hepatitis, or who were at risk for hepatitis C using all 5 specimen types. Performance was assessed relative to HCV serostatus established by laboratory methods (EIA, RIBA and PCR) approved in Europe for diagnosis of hepatitis C infection. Sensitivity to antibody in early infection was also compared to EIA in 27 seroconversion panels. In addition, the reliability of the oral fluid sample for accurate detection of anti-HCV was assessed by studying the impact of various potentially interfering conditions of oral health, use of oral care products and consumption of food and drink. In this large study of at-risk and symptomatic persons, the overall specificities of the OraQuick?? HCV Rapid Antibody Test were equivalent (99.6-99.9%) for all 5 specimen types and the 95% CIs substantially overlapped. Overall sensitivities were virtually identical for venous blood, fingerstick blood, serum and plasma (99.7-99.9%). Observed sensitivity was slightly lower for oral fluid at 98.1% though the upper CI (99.0%) was equal to the lower CI for venous blood and fingerstick blood. Most of the HCV positive subjects which gave nonreactive results in oral fluid had serological and virological results consistent with resolved infection. Sensitivity for anti-HCV in early seroconversion was virtually identical between the HCV rapid test and EIA. Detection of anti-HCV in oral fluid appeared generally robust to conditions of oral health, consumption of food and drink and use of oral care products. The OraQuick?? HCV Rapid Antibody Test demonstrated clinical performance that was equivalent to current laboratory-based EIA," wrote S.R. Lee and colleagues, OraSure Technologies, Inc.

The researchers concluded: "This new, HCV rapid test appears suitable as an aid in the diagnosis of HCV infection and may increase testing opportunities due to its simplicity and flexibility to use multiple specimen types, including fingerstick blood and oral fluid."

Lee and colleagues published their study in the Journal of Virological Methods (Evaluation of a new, rapid test for detecting HCV infection, suitable for use with blood or oral fluid. Journal of Virological Methods, 2011;172(1-2):27-31).

Additional information can be obtained by contacting S.R. Lee, OraSure Technologies, Inc., 220 East First Street, Bethlehem, PA 18015 USA.

Keywords: City:Bethlehem, State:PA, Country:United States, Antibodies, Blood Proteins, Digestive System Diseases, Flaviviridae Infections, Gastroenterology, Globulins, HCV, Hepatitis C Virus, Hepatitis Viruses, Hepatology, Human Hepatitis, Immunoglobulins, Immunology, Infectious Disease, Liver Diseases, RNA Viruses, Viral, Virology.

This article was prepared by Lab Business Week editors from staff and other reports. Copyright 2011, Lab Business Week via NewsRx.com.

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