First diagnostic kit for animal diseases and zoonoses passes the OIE Commission for Biological Standards recommendation, awaits green light of the International Committee
The Platellia Rabies II diagnostic kit of Bio-Rad laboratory is the first to gain a positive recommendation by the World Organisation for Animal Health (OIE) Commission for Biological Standards according to the new OIE procedure for validation and certification of diagnostic assays launched in May 2005.
After getting the Standards Commission scientific and technical clearance, this rabies diagnostic kit has one last step to pass to get its “Fitness for Purpose” stamp, which “determines immune status in individual animals for dogs and cats (for regulation of international movement or trade) and in populations for foxes (for monitoring wildlife vaccination programmes)”. At the annual general session in May the OIE International Committee (General Assembly of the 167 Member Countries representatives) will study the application submitted to the OIE, recommendations given by experts and the Standards Commission and finally give its official vote.
In case of approval, the diagnostic kit of Bio-Rad will be included to the OIE register and the laboratory authorised to stamp the OIE logo on any document or equipment associated with the test. The validation and certification status is to be renewed every five years, a procedure designed to ensure the OIE official certification answers high quality requirements.
The procedure was decided upon in order to palliate the confusion experienced by some Member Countries in face of the myriad diagnostic kits available for animal diseases. Open to both public and private laboratories producing diagnostic kits the procedure is a critical element in animal diseases prevention and control for trade or surveillance purposes.
Three other applications are under study for certifying different laboratories diagnostic kits for white spot syndrome virus (WSSV), bovine spongiform encephalopathy (BSE) and avian influenza (AI).