Evaluation of a new, rapid test for detecting HCV infection, suitable for use with blood or oral fluid

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...

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Bibliographic Details
Published in:	Journal of virological methods Vol. 172; no. 1; pp. 27 - 31
Main Authors:	Lee, Stephen R., Kardos, Keith W., Schiff, Eugene, Berne, Cheryl A., Mounzer, Karam, Banks, Alpha T., Tatum, Harvey A., Friel, Timothy J., DeMicco, Michael P., Lee, William M., Eder, Scott E., Monto, Alexander, Yearwood, Graham D., Guillon, Geraldine B., Kurtz, Lisa A., Fischl, Mark, Unangst, Jay Lynn, Kriebel, Laura, Feiss, Gary, Roehler, Michele
Format:	Journal Article
Language:	English
Published:	Kidlington Elsevier B.V 01-03-2011 Elsevier
Subjects:	Adolescent Adult Aged Aged, 80 and over antibodies Antibodies - blood Biological and medical sciences blood serum Body Fluids - virology Child Female food consumption Fundamental and applied biological sciences. Psychology HCV Hepacivirus - immunology Hepacivirus - physiology hepatitis C Hepatitis C - blood Hepatitis C - diagnosis Hepatitis C virus Humans Immunoenzyme Techniques - standards Male Microbiology Middle Aged Oral fluid people Polymerase Chain Reaction Prospective Studies Rapid test Reagent Kits, Diagnostic - standards Reproducibility of Results risk Risk Factors Sensitivity and Specificity seroconversion Techniques used in virology Virology Young Adult Europe RIBA Rapid test HIV RNA CI IgG Oral fluid HCV EIA NS4 PCR NS3 Hepatic disease Method Blood Infection Virus Viral disease Digestive diseases Flaviviridae Detection Hepatitis C virus Hepacivirus Viral hepatitis C
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Summary:	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. 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. 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.
Bibliography:	http://dx.doi.org/10.1016/j.jviromet.2010.12.009 ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Article-2 ObjectType-Feature-1
ISSN:	0166-0934 1879-0984
DOI:	10.1016/j.jviromet.2010.12.009