Evaluation of a rapid, point-of-care test device for the diagnosis of hepatitis C infection

Abstract Background Despite considerable evolution in the quality of laboratory-based testing for detection of HCV, the availability of rapid, point-of-care tests may increase diagnoses by increasing opportunities for testing outside of traditional laboratory settings. Objectives We evaluated the pe...

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Veröffentlicht in:Journal of clinical virology 2010-05, Vol.48 (1), p.15-17
Hauptverfasser: Lee, S.R, Yearwood, G.D, Guillon, G.B, Kurtz, L.A, Fischl, M, Friel, T, Berne, C.A, Kardos, K.W
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container_end_page 17
container_issue 1
container_start_page 15
container_title Journal of clinical virology
container_volume 48
creator Lee, S.R
Yearwood, G.D
Guillon, G.B
Kurtz, L.A
Fischl, M
Friel, T
Berne, C.A
Kardos, K.W
description Abstract Background Despite considerable evolution in the quality of laboratory-based testing for detection of HCV, the availability of rapid, point-of-care tests may increase diagnoses by increasing opportunities for testing outside of traditional laboratory settings. Objectives We evaluated the performance of a new, rapid HCV test that can be used with venous blood, finger stick blood, serum, plasma, or oral fluid and compared it to FDA-approved laboratory methods. Study design HCV positive subjects as well as subjects at low risk for HCV were tested with the rapid test using all 5 specimen types and results compared to FDA-approved laboratory methods. In addition, performance was assessed in commercially available seroconversion panels. Results Sensitivity and specificity of the rapid test was equivalent to laboratory EIA and performance was comparable across all 5 specimen types. Conclusions The OraQuick® HCV Rapid Antibody Test appears suitable as an aid in the diagnosis of HCV infection.
doi_str_mv 10.1016/j.jcv.2010.02.018
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Objectives We evaluated the performance of a new, rapid HCV test that can be used with venous blood, finger stick blood, serum, plasma, or oral fluid and compared it to FDA-approved laboratory methods. Study design HCV positive subjects as well as subjects at low risk for HCV were tested with the rapid test using all 5 specimen types and results compared to FDA-approved laboratory methods. In addition, performance was assessed in commercially available seroconversion panels. Results Sensitivity and specificity of the rapid test was equivalent to laboratory EIA and performance was comparable across all 5 specimen types. 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Psychology ; HCV ; Hepatitis C - diagnosis ; Hepatitis C Antibodies - analysis ; Hepatitis C Antibodies - blood ; Hepatitis C Antigens ; Hepatitis C virus ; Human viral diseases ; Humans ; Immobilized Proteins ; Immunoenzyme Techniques - methods ; Infectious Disease ; Infectious diseases ; Medical sciences ; Microbiology ; Miscellaneous ; Point-of-Care Systems ; Rapid ; Reagent Kits, Diagnostic ; Sensitivity and Specificity ; Viral diseases ; Viral hepatitis ; Virology</subject><ispartof>Journal of clinical virology, 2010-05, Vol.48 (1), p.15-17</ispartof><rights>Elsevier B.V.</rights><rights>2010 Elsevier B.V.</rights><rights>2015 INIST-CNRS</rights><rights>Copyright 2010 Elsevier B.V. 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subjects Allergy and Immunology
Antibodies
Biological and medical sciences
Diagnosis
Fundamental and applied biological sciences. Psychology
HCV
Hepatitis C - diagnosis
Hepatitis C Antibodies - analysis
Hepatitis C Antibodies - blood
Hepatitis C Antigens
Hepatitis C virus
Human viral diseases
Humans
Immobilized Proteins
Immunoenzyme Techniques - methods
Infectious Disease
Infectious diseases
Medical sciences
Microbiology
Miscellaneous
Point-of-Care Systems
Rapid
Reagent Kits, Diagnostic
Sensitivity and Specificity
Viral diseases
Viral hepatitis
Virology
title Evaluation of a rapid, point-of-care test device for the diagnosis of hepatitis C infection
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