Validation of a Commercially Available Indirect Elisa Using a Nucleocapside Recombinant Protein for Detection of Schmallenberg Virus Antibodies

Abstract

A newly developed Enzym Like Immuno Sorbant Assay (ELISA) based on the recombinant nucleocapsid protein (N) of Schmallenberg virus (SBV) was evaluated and validated for the detection of SBV-specific IgG antibodies in ruminant sera by three European Reference Laboratories. Validation data sets derived from sheep, goat and bovine sera collected in France and Germany (n = 1515) in 2011 and 2012 were categorized according to the results of a virus neutralization test (VNT) or an indirect immuno-flurorescence assay (IFA). The specificity was evaluated with 1364 sera from sheep, goat and bovine collected in France and Belgium before 2009. Overall agreement between VNT and ELISA was 98.9% and 98.3% between VNT and IFA, indicating a very good concordance between the different techniques. Although cross-reactions with other Orthobunyavirus from the Simbu serogroup viruses might occur, it is a highly sensitive, specific and robust ELISA-test validated to detect anti-SBV antibodies. This test can be applied for SBV sero-diagnostics and disease-surveillance studies in ruminant species in Europe.

European interlaboratory comparison of Schmallenberg virus (SBV) real-time RT-PCR detection in experimental and field samples

“…1,[4][5][6]10,14,16,23,30 In order to improve overall test performance and to establish confidence in the reliability of laboratory test procedures, interlaboratory testing is recommended.…”

Anticipation et adaptation des politiques publiques : le rôle d’une agence de sécurité sanitaire

“…De même, le tissu relationnel avec les laboratoires d'analyse via notre rôle de LNR est un élément de la relation de confiance qui nous lie à ces opérateurs essentiels de la sécurité sanitaire. Leur participation volontaire à nos réseaux de surveillance (Résapath, réseau Salmonella…) (Anses 2016b(Anses , 2016c en est un témoignage. L'anticipation ou tout au moins la connaissance en temps réel de la situation sanitaire est un élément essentiel et nécessaire à l'adaptation des politiques publiques.…”

Serological survey of Schmallenberg virus in red deer (Cervus elaphus), France, 2010-2012

“…The sera were first screened using an SBV indirect ELISA test (i-ELISA) yet validated in cattle, sheep and goats (ELISA ID Screen ® Schmallenberg virus Indirect, bicupule, ID Vet, France) (6). The results were expressed as S/P values using the cut-off recommended for domestic species (S/P = (OD sample/OD positive control)*100): S/P<60%: negative; S/P>70%: positive and S/P between 60% and 70%: doubtful).…”

“…The antigen used in both c-ELISA and i-ELISA is the same N recombinant protein. A subset of samples were also submitted to a seroneutralization test according to a protocol previously described (SNT) (6).…”