OIE Procedure for Validation and Certification of Diagnostic Assays

sheet Name of the diagnostic kit: Platelia Rabies II Manufacturer: Bio-Rad OIE Approval number: 20070101 Date of Registration: May 2007 Disease: Rabies Pathogen Agent: Rabies virus Type of Assay: The PLATELIA RABIES II kit is an in vitro diagnostic indirect ELISA test. Purpose of Assay: Certified by the OIE in May 2007 as fit for purpose to determine immune status post-vaccination in individual dogs or cats (for regulation of international movement or trade) and in fox populations (for monitoring wildlife vaccination programmes). Species and Specimen: Dog, cat and fox serum 1. Information on the kit Please refer to the kit insert available on the OIE Registry web page or contact manufacturer at [email protected]. The quantitative results are expressed as ELISA Units per ml (EU/ml) which are equivalent to International Units as measured by virus neutralisation tests. 2. Summary of validation studies STAGE 1 Validation Calibration against the OIE international standard and determination of analytical sensitivity and specificity, repeatability (intra-assay, inter-assay and inter-lot) were completed during the BioRad internal validation with the following results. Analytical sensitivity lower limit of detection, 0.125 EU/ml Analytical specificity not pertinent for this kit as there is no evidence from the literature of serological cross reactions to the rabies glycoprotein from closely related infections in the target species. Intra-assay repeatability negative samples, 5.37 %CV positive range of samples, 1.67-4.04 %CV Inter-assay repeatability negative samples, 12.5 %CV positive range of samples, 3.9-6.3 %CV Inter-lot repeatability negative samples, 4.29-33.54 %CV (across species) positive samples, 3.05-4.90 %CV (across species) Abstract sheet – Bio-Rad Platelia Rabies IIsheet – Bio-Rad Platelia Rabies II