20-02-2008 - Diagnostic kits for avian influenza and bovine spongiform encephalopathy (BSE) obtain the green ligh
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Diagnostic kits for avian influenza and bovine spongiform encephalopathy (BSE) obtain the green light of the OIE Commission for Biological Standards
Paris , 13 February 2008 - The BioChek Avian Influenza Antibody and Prionics® Check Western diagnostic kits got a positive recommendation by the Commission for Biological Standards of the World Organisation for Animal Health (OIE).
Both kits still have to receive approval from the General Assembly of the 172 Member Countries national delegates in May at the OIE 76 th General Session, to obtain the final “Fitness for Purpose” stamp. In that case, they will be included to the OIE register of diagnostic kits and the laboratory authorised to stamp the OIE logo on any document or equipment associated with the test (including for example the commercial box containing the diagnostic kit). 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 biological standards Commission recommended the BioChek Avian Influenza Antibody test kit be included to the OIE register in “fit for the serological diagnosis in chickens of type A avian influenza (specific to IgG in the serum) and for the following purposes:
- Demonstrate historical freedom from infection in a defined population (country/zone/compartment/flock)
- Demonstrate re-establishment of freedom after outbreaks in a defined population (country/zone/compartment/flock)
- Confirmatory diagnosis of suspect or clinical cases
- Estimate prevalence of infection to facilitate risk analysis in non vaccinated populations (surveys/flock health schemes/disease control)
- Determine immune status in individual animals or populations (post-vaccination)”
The Commission recommended the Prionics® Check Western be included as “fit in cattle for:
- Confirmatory diagnosis of suspect or clinical cases (includes confirmation of positive screening test) in sensible animal populations
- Estimate prevalence of infection to facilitate risk analysis (surveys/herd health schemes/disease control, implementation of disease control measures) and to assist the demonstration of the efficiency of control policies.
- To confirm a non-negative test result obtained during active surveillance with a different type of test.”
Since 2007, the OIE studies the applications of diagnostic kits, or assays, submitted for approval at the annual General Assembly in May. It bases on recommendations given by experts and the OIE Biological Standards Commission to give its official and final vote. This new OIE procedure for validation and certification of assays was launched in May 2005.
The procedure was decided upon in order to palliate the confusion experienced by some Member Countries in face of the myriad diagnostic kits available on the world market for animal diseases, some of which have proven to be ineffective. Open to both public and private laboratories producing diagnostic kits the procedure is a critical element in animal diseases prevention and control for trade of animals and animal products or disease surveillance purposes worldwide.