Format

Send to

Choose Destination
J Clin Virol. 2017 Apr;89:46-50. doi: 10.1016/j.jcv.2017.02.009. Epub 2017 Feb 24.

Evaluation of two VIDAS ®prototypes for detecting anti-HEV IgG.

Author information

1
CHU Toulouse, Hôpital Purpan, Laboratoire de virologie, National Reference Center for Hepatitis E, F-31300, France; INSERM, U1043, Centre de Physiopathologie de Toulouse Purpan, Toulouse, F-31300, France. Electronic address: abravanel.f@chu-toulouse.fr.
2
R&D Immunoassay Department, Biomérieux SA, Chemin de l'Orme, Marcy l'étoile, France.
3
CHU Toulouse, Hôpital Purpan, Laboratoire de virologie, National Reference Center for Hepatitis E, F-31300, France; INSERM, U1043, Centre de Physiopathologie de Toulouse Purpan, Toulouse, F-31300, France.
4
CHU Toulouse, Hôpital Purpan, Laboratoire de virologie, National Reference Center for Hepatitis E, F-31300, France.

Abstract

BACKGROUND:

High performance anti-hepatitis E virus (HEV) IgG assays are crucial for epidemiology.

OBJECTIVE:

To evaluate the performance of 2 prototypes developed for the VIDAS® automatic system for detecting anti-HEV IgG, one based on the ORF2 antigen (ORF2 prototype) and the other on the ORF2 and ORF3 antigens (ORF2/3 prototype), with reference to the Wantai anti-HEV IgG assay.

STUDY DESIGN:

The sensitivity of each assay was determined by testing 113 blood samples, 63 from immunocompetent and 50 from immunocompromised patients, with a proven HEV infection defined by detecting HEV RNA. Their specificity was assessed with 103 blood samples that the Wantai assay indicated was negative for anti-HEV IgM and IgG, and negative for HEV-RNA. Cross reactivity was assessed using samples that were positive for hepatitis A virus IgG (n=16), hepatitis C virus antibodies (n=15), hepatitis B virus antigen and anti-HBc antibodies (n=16), rheumatoid factor (n=14), and negative for anti-HEV IgG with the Wantai assay.

RESULTS:

The sensitivities in immunocompetent patients were: 95.2% (ORF2), 96.8% (ORF2/3), and 93.6% (Wantai); in immunocompromised patients they were: 66% (ORF2), 72% (ORF2/3), and 68% (Wantai). Both VIDAS prototypes detected low concentrations of anti-HEV IgG. The overall specificity was 100% (ORF2 prototype) and 98.1% (ORF2/3 prototype). Both VIDAS prototypes cross-reacted in five samples (9.6%), mainly those containing HCV antibodies or rheumatoid factor.

CONCLUSION:

Both VIDAS® prototypes performed very well and appear to be suitable for routine detection of anti-HEV IgG.

KEYWORDS:

Anti-HEV IgG; Hepatitis E Virus; Prototypes; VIDAS

PMID:
28249234
DOI:
10.1016/j.jcv.2017.02.009
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center