Performance of an antigen-antibody combined assay for hepatitis C virus testing without venipuncture.
BACKGROUND
Hepatitis C virus (HCV) is underdiagnosed and therefore increasing the opportunities for HCV testing without venipuncture may be useful.


OBJECTIVE
We evaluated the analytical performance of a modified, commercially available, combined HCV antigen-antibody assay (cEIA) (Monolisa(®) HCV-Ag-Ab-ULTRA) and a commercially available point-of-care (POC) device (OraQuick(®) HCV) on fingerstick blood (FSB) and oral mucosal transudate (OMT).


METHODS
FSB, OMT and serum samples were collected from 113 cases of HCV-antibody-positive patients and 88 HCV-antibody-negative controls. The HCV-antibody-positive group included 63 patients with quantifiable HCV-RNA (56%) and 17 HIV/HCV co-infected patients (15%). FSB and OMT specimens were collected as dried blood spots (DBSs) or with the OraSure collection system, before testing with cEIA.


RESULTS
With FSB specimens, the cEIA and the POC device exhibited 100% specificity and 98.2% and 97.4% sensitivity, respectively. The specificity of the cEIA in FSB sharply decreased if stored 3days at room temperature. With OMT specimens, the cEIA sensitivity (71.7%) and specificity (94.3%) were significantly lower than the performance of OraQuick(®) HCV (sensitivity, 94.6%; specificity, 100%). The optical densities obtained with the cEIA in FSB and OMT were lower in HIV/HCV co-infected patients compared with HCV monoinfected patients.


CONCLUSIONS
The cEIA using FSB specimens collected on DBSs preserved in appropriate storage conditions was a reliable alternative, equivalent to the POC assay, for HCV testing without venipuncture. The cEIA was not adapted for HCV testing on OMT.
Laboratoire de Virologie, Département des Agents Infectieux, Pôle Biologie, Centre Hospitalier Universitaire Grenoble, BP 217, 38043 Grenoble Cedex 9, France. Slarrat@chu-grenoble.fr
Sylvie
S
Larrat
Cécile
C
Bourdon
Monique
M
Baccard
Cécile
C
Garnaud
Sophie
S
Mathieu
Jean-Louis
JL
Quesada
Anne
A
Signori-Schmuck
Raphaele
R
Germi
Myriam
M
Blanc
Pascale
P
Leclercq
Marie-Noelle
MN
Hilleret
Vincent
V
Leroy
Jean-Pierre
JP
Zarski
Patrice
P
Morand
D000328:Adult; D000368:Aged; D000956:Antigens, Viral / Q000097:blood*; D001769:Blood / Q000276:immunology / Q000821:virology; D019411:Clinical Laboratory Techniques / Q000379:methods*; D005260:Female; D006526:Hepatitis C / Q000175:diagnosis*; D018937:Hepatitis C Antibodies / Q000097:blood*; D006801:Humans; D007118:Immunoassay / Q000379:methods; D008297:Male; D008875:Middle Aged; D018962:Phlebotomy; D019095:Point-of-Care Systems; D012463:Saliva / Q000276:immunology / Q000821:virology; D012680:Sensitivity and Specificity; D055815:Young Adult
D000956:Antigens, Viral; D018937:Hepatitis C Antibodies