Evaluation of three commercially available hepatitis C virus antibody detection assays under the conditions of a clinical virology laboratory.
BACKGROUND
Most studies evaluating antibody detection assays are conducted on samples from healthy blood donors but not on samples of hospitalized patients which can show non-specific reactions.


OBJECTIVE
To compare the performance of three commercial automated assays for the detection of hepatitis C virus (HCV) antibodies, Monolisa anti-HCV Plus version 2, Axsym anti-HCV 3.0 and Vitros anti-HCV, on a population of hospitalized patients.


METHODS
The specificity of the assays was prospectively evaluated in 2020 routine serum samples. In order to assign the serostatus of each sample, those giving positive or discordant results were further tested by three immunoblots and by RT-PCR (Roche). Moreover, the sensitivity was evaluated on eight commercial HCV seroconversion panels.


RESULTS
The Monolisa, Axsym and Vitros assays showed specificities of 99.64%, 99.12% and 99.33%, respectively. Concerning the sensitivity, among 49 samples, the number of positive results was 21, 24 and 24 for the Monolisa, Axsym and Vitros kits, respectively. The differences were not statistically significant at an alpha risk of 5%.


CONCLUSIONS
All assays appeared to be reliable for routine screening, but there were a surprising number of indeterminate samples that could not be resolved by confirmatory tests.
Zachary
Pierre
P
Laboratoire de Virologie, Hôpitaux Universitaires de Strasbourg, 3 rue Koeberle, 67000 Strasbourg, France. pierre.zachary@viro-ulp.u-strasbg.fr
Ullmann
Murielle
M
Djeddi
Saadi
S
Meyer
Nicolas
N
Wendling
Marie-Josée
MJ
Schvoerer
Evelyne
E
Stoll-Keller
Françoise
F
Gut
Jean-Pierre
JP
D000465:Algorithms; D019411:Clinical Laboratory Techniques; D005260:Female; D016174:Hepacivirus / Q000276:immunology*; D006526:Hepatitis C / Q000175:diagnosis* / Q000276:immunology; D018937:Hepatitis C Antibodies / Q000097:blood*; D006760:Hospitalization; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D015151:Immunoblotting; D011247:Pregnancy; D012367:RNA, Viral / Q000097:blood; D011933:Reagent Kits, Diagnostic; D020133:Reverse Transcriptase Polymerase Chain Reaction; D012680:Sensitivity and Specificity
D018937:Hepatitis C Antibodies; D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic