CENTRE
HOSPITALIER UNIVERSITAIRE ANGERS
Comparative evaluation of two commercial rapid tests able to detect
Hepatitis C Virus (HCV) antibody: Flavicheck HCV versus ImmunoComb®
HCV II
A.Pivert, H. LeGuillou-Guillemette, A. Ducancelle, F. Lunel-Fabiani
Laboratoire de Virologie, Département des Agents Infectieux et Pharmaco-toxicologie, Pôle de Biologie CHU Angers, 4 rue Larrey, 49933 Angers Cedex 9.
INTRODUCTION
PATIENTS
RESULTS
Rapid test for HCV antibody (HCV-Ab) detection are useful in emergency case like blood exposure, and in developing country. However, such tests have to be as sensitive as routine automated immunoassays. In this study, we have compared two rapid tests: Flavicheck HCV (Qualpro Diagnostics) and ImmunoComb® II HCV (Inverness Medical Innovations).
METHODS
During this comparative evaluation, 100 samples were tested. Using the VITROS® anti-HCV assay (Ortho Clinical Diagnostics), 7 samples were negative, 2samples were in the grey zone and 91 samples were reactive (conclusions as recommended by the manufacturer). Among the HCV-Ab positive samples, 15 patients had documented chronic HCV infection and presented a detectable HCV RNA and 4 patients had documented acute infection (sero-conversion).
Both tests were negative in 20 samples (20%: orange). Among them, 6 samples were VITROS® anti-HCV negative and 14 samples were VITROS® anti-HCV reactive (ratio<10). Both tests were positive in 47 samples
(47%: purple): 1 sample was negative with the reference assay,2 samples were VITROS®
anti-HCV weakly reactive (ratio<10) and 44 samples were VITROS® anti-HCV reactive (ratio>10).
Discrepant results were observed in 33 samples (33%: green): 20
samples were HCV RNA undetectable and 13 were
HCV RNA detectable. Among
them, 13 and 6 samples respectively were reactive using immunoblot.
This study shows that Flavicheck HCV has a major
lack of sensitivity. In view of such results, the French Agency (AFSSAPS) withdrew it from the French
market. Our results show that careful and accurate evaluation of rapid tests is needed before CE mark approval.
CONCLUSIONS
ImmunoComb® II HCV
Flavicheck HCV
ImmunoBlot assay were performed using Inno-LIA™ HCV Score
(Innogenetics) and RIBA™ HCV 3.0 SIA (Chiron™). Viral RNA was detected by in-house real time PCR or by RealTime HCV assay (Abbott Molecular Diagnostics).
6
14 6
7
13
7
44
2 1
