Establishment of a national network of validated and qualified laboratories for neutralizing anti-vaccinia antibodies titration.
A Proficiency Testing Study (PTS) was organized in France by the French Health Products Safety Agency (Afssaps) aiming at assessing the performance of laboratories in performing a neutralizing anti-vaccinia antibodies titration method by plaque reduction neutralization test (PRNT). The ultimate goal was to establish a national network of qualified and validated laboratories. Five laboratories were included in the PTS and four submitted their data. Three samples of human sera containing various immunoglobulin concentrations (a "high" serum: s-576, a "medium" serum: Ref-19584 and a "low" serum: s-483) were tested by PRNT as described in a procedure supplied by Afssaps and developed in each laboratory during preliminary assays. Data were sent to Afssaps which performed the statistical analysis. The overall performance of the four participating laboratories was satisfactory. This allowed the four participating laboratories to be validated and then to be qualified by the Ministry of Health. Finally a national network for anti-vaccinia immunoglobulins titration was established.
Poirier
Bertrand
B
Agence Française de Sécurité Sanitaire des Produits de Santé, 321 Avenue Jean Jaurès, 69007 Lyon, France. Bertrand.Poirier@afssaps.sante.fr
Leparc-Goffart
Isabelle
I
Crance
Jean-Marc
JM
Fleury
Hervé
H
Garin
Daniel
D
Gut
Jean-Pierre
JP
Tissier
Marie-Hélène
MH
Fuchs
Florence
F
D000914:Antibodies, Viral / Q000032:analysis* / Q000097:blood; D005069:Evaluation Studies as Topic; D005602:France; D006801:Humans; D007753:Laboratories / Q000592:standards; D009500:Neutralization Tests / Q000379:methods*; D012015:Reference Standards; D015203:Reproducibility of Results; D012900:Smallpox Vaccine / Q000032:analysis*; D014616:Vaccinia virus / Q000235:genetics / Q000276:immunology*
D000914:Antibodies, Viral; D012900:Smallpox Vaccine