Inter-laboratory validation of foot-and-mouth disease diagnostic capability in Germany

With only one exception, all laboratories reliably detected viral RNA with two real-time RT-PCR assays down to a dilution of 10(−4) of the original material. The LFD pen-side test was evaluated at 8 of 20 laboratories, and FMDV antigen was detected by all participants down to a dilution of 1:81. Serological diagnosis was also very consistent at most participating institutions. Very few false-negative results were returned for the diluted positive sera, and testing of a large cohort of negative samples demonstrated a high specificity of over 99% for the two commercial ELISA kits used (PrioCHECK® FMDV NS and ID Screen® FMD NSP). In conclusion, the proficiency test demonstrated the reliable and robust FMDV diagnostic capability of the German regional veterinary diagnostic laboratories. Furthermore, the suitability of the commercially available ELISA systems for the detection of FMDV-specific antibodies was confirmed. Proficiency tests are an important quality assurance measure for transboundary diseases like FMDV where diagnostic capacity in free countries has to be available at the highest possible standard.