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

Stephen R. Lee, Keith W. Kardos, Eugene R Schiff, Cheryl A. Berne, Karam Mounzer, Alpha T. Banks, Harvey A. Tatum, Timothy J. Friel, Michael P. DeMicco, William M. Lee, Scott E. Eder, Alexander Monto, Graham D. Yearwood, Geraldine B. Guillon, Lisa A. Kurtz, Mark Fischl, Jay Lynn Unangst, Laura Kriebel, Gary Feiss, Michele Roehler

Research output: Contribution to journalArticle

61 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)27-31
Number of pages5
JournalJournal of Virological Methods
Volume172
Issue number1-2
DOIs
StatePublished - Mar 1 2011

Fingerprint

Virus Diseases
Hepacivirus
Hepatitis C Antibodies
Oral Health
Hepatitis C
Infection
Point-of-Care Systems
Food
Serum
Hepatitis
Signs and Symptoms

Keywords

  • HCV
  • Oral fluid
  • Rapid test

ASJC Scopus subject areas

  • Virology

Cite this

Evaluation of a new, rapid test for detecting HCV infection, suitable for use with blood or oral fluid. / Lee, Stephen R.; Kardos, Keith W.; Schiff, Eugene R; 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.

In: Journal of Virological Methods, Vol. 172, No. 1-2, 01.03.2011, p. 27-31.

Research output: Contribution to journalArticle

Lee, SR, Kardos, KW, Schiff, ER, Berne, CA, Mounzer, K, Banks, AT, Tatum, HA, Friel, TJ, DeMicco, MP, Lee, WM, Eder, SE, Monto, A, Yearwood, GD, Guillon, GB, Kurtz, LA, Fischl, M, Unangst, JL, Kriebel, L, Feiss, G & Roehler, M 2011, 'Evaluation of a new, rapid test for detecting HCV infection, suitable for use with blood or oral fluid', Journal of Virological Methods, vol. 172, no. 1-2, pp. 27-31. https://doi.org/10.1016/j.jviromet.2010.12.009
Lee, Stephen R. ; Kardos, Keith W. ; Schiff, Eugene R ; 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. / Evaluation of a new, rapid test for detecting HCV infection, suitable for use with blood or oral fluid. In: Journal of Virological Methods. 2011 ; Vol. 172, No. 1-2. pp. 27-31.
@article{e16751f2210744d19aee7bf28417b699,
title = "Evaluation of a new, rapid test for detecting HCV infection, suitable for use with blood or oral fluid",
abstract = "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{\circledR} 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{\circledR} 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{\circledR} 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.",
keywords = "HCV, Oral fluid, Rapid test",
author = "Lee, {Stephen R.} and Kardos, {Keith W.} and Schiff, {Eugene R} and Berne, {Cheryl A.} and Karam Mounzer and Banks, {Alpha T.} and Tatum, {Harvey A.} and Friel, {Timothy J.} and DeMicco, {Michael P.} and Lee, {William M.} and Eder, {Scott E.} and Alexander Monto and Yearwood, {Graham D.} and Guillon, {Geraldine B.} and Kurtz, {Lisa A.} and Mark Fischl and Unangst, {Jay Lynn} and Laura Kriebel and Gary Feiss and Michele Roehler",
year = "2011",
month = "3",
day = "1",
doi = "10.1016/j.jviromet.2010.12.009",
language = "English",
volume = "172",
pages = "27--31",
journal = "Journal of Virological Methods",
issn = "0166-0934",
publisher = "Elsevier",
number = "1-2",

}

TY - JOUR

T1 - Evaluation of a new, rapid test for detecting HCV infection, suitable for use with blood or oral fluid

AU - Lee, Stephen R.

AU - Kardos, Keith W.

AU - Schiff, Eugene R

AU - Berne, Cheryl A.

AU - Mounzer, Karam

AU - Banks, Alpha T.

AU - Tatum, Harvey A.

AU - Friel, Timothy J.

AU - DeMicco, Michael P.

AU - Lee, William M.

AU - Eder, Scott E.

AU - Monto, Alexander

AU - Yearwood, Graham D.

AU - Guillon, Geraldine B.

AU - Kurtz, Lisa A.

AU - Fischl, Mark

AU - Unangst, Jay Lynn

AU - Kriebel, Laura

AU - Feiss, Gary

AU - Roehler, Michele

PY - 2011/3/1

Y1 - 2011/3/1

N2 - 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.

AB - 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.

KW - HCV

KW - Oral fluid

KW - Rapid test

UR - http://www.scopus.com/inward/record.url?scp=79451474583&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=79451474583&partnerID=8YFLogxK

U2 - 10.1016/j.jviromet.2010.12.009

DO - 10.1016/j.jviromet.2010.12.009

M3 - Article

VL - 172

SP - 27

EP - 31

JO - Journal of Virological Methods

JF - Journal of Virological Methods

SN - 0166-0934

IS - 1-2

ER -