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


OBJECTIVE
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.


METHODS
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.
Lee
S R
SR
OraSure Technologies, Inc., 220 East First Street, Bethlehem, PA 18015, United States. slee@orasure.com
Yearwood
G D
GD
Guillon
G B
GB
Kurtz
L A
LA
Fischl
M
M
Friel
T
T
Berne
C A
CA
Kardos
K W
KW
D006526:Hepatitis C / Q000175:diagnosis*; D018937:Hepatitis C Antibodies / Q000032:analysis / Q000097:blood; D018936:Hepatitis C Antigens; D006801:Humans; D055767:Immobilized Proteins; D007124:Immunoenzyme Techniques / Q000379:methods*; D019095:Point-of-Care Systems; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity
D018937:Hepatitis C Antibodies; D018936:Hepatitis C Antigens; D055767:Immobilized Proteins; D011933:Reagent Kits, Diagnostic