MicroVal has approved the issuing of the extended certificate for Bruker Daltonics’s MALDI Biotyper for the confirmation of Salmonella spp. The extension study covers the validation of the addition of a fourth C8-esterase agar, which is CASE agar by Neogen.
Previously, the MALDI Biotyper was already validated by MicroVal for the confirmation of Salmonella spp. presumptive colonies isolated from XLD, BGA, 3 Chromogenic agars based on C8-esterase activity detection (RAPID’Salmonella, Brilliance Salmonella and ASAP) and nonselective (NA, TSA).
The MALDI Biotyper Complete Solution (MBT) uses a method based on mass spectrometry for rapid identification of organisms from microbial cultures. The extended validation study assesses the performance of the MBT as a confirmation method to replace the biochemical and serological confirmation procedures outlined in the ISO reference method for colonies isolated on CASE Agar.
The extended validation study has been performed by Campden BRI.
In 2018, MicroVal approved four validation studies against the draft version (DIS) of ISO 16140-6. The four resulting certificates for Bruker Daltonics’s MALDI Biotyper for four different target organisms (Cronobacter spp, Samonella spp, Campylobacter and Listeria spp. & Listeria Monocytogenes) were based on the results of parallel validation studies, performed by the MicroVal expert labs Q Laboratories and ADRIA.
In parallel, the Maldi-Tof system was approved according to AOAC-OMA by AOAC INTERNATIONAL. The MALDI Biotyper was awarded Method of the Year by AOAC International in 2018, and the work received the Best Publication Award in 2019.