ERP Micro December 2019

The MBT was used by 7 of the participants. All the isolates were correctly identified by the MBT. Only one misidentification was observed for the Proteus mirabilis strain by using another method than the MBT.  Other recognition The MALDI Biotyper has been validated according to the ISO/DIS 16140-part 6 (2017) by MicroVal. Four certificates and validate study reports are available on the MicroVal website: www.microval.org . The scopes are the following: 1. Certificate 2017LR72: Confirmation of Cronobacter spp. from ESIA, CCI and any non-selective nutrient-agars; 2. Certificate 2017LR73: Confirmation of Salmonella spp. from colonies isolated from XLD, BGA, chromogenics based on C8-esterase activity detection (Rapid’ Salmonella , Brilliance Salmonella and ASAP) and non-selective nutrient-agars; 3. Certificate 2017LR74: Confirmation of Campylobacter spp. from colonies isolates on mCCDA, Campy Cefex Agar, Chromogenic Agars (CampyFood Agar, Rapid’ Campylobacter ) and non- selective nutrient-agars (e.g. Columbia Blood agar); 4. Certificate 2017LR75: Confirmation of Listeria spp. and Listeria monocytogenes from colonies isolated on Ottaviani & Agosti Agar, Palcam, Oxford, Modified Oxford, Rapid’L.mono, and any non-selective nutrient-agars. Prior to the validation studies using a publicly available Draft Internal Standard (DIS), the General and Technical committees have considered the risk of possible modification that could impact on validation study design was limited. MicroVal uses only publicly available documents to ensure all the end-users can access the information: this is the case for DIS versions that are additionally submitted to a public vote. The technical differences between the DIS and Final Draft International Standard (FDIS) versions of the ISO 16140-part 6 are indicated in bold: - In case, some strains are unable to grow on the specified selective agar(s), a non-selective agar plate shall also be included in the method comparison study and the inter-laboratory study. - A total of 24 strains shall be tested per collaborator and all strains shall be tested with the reference confirmation procedure and the alternative confirmation method. These specific requirements of the FDIS were already included in the validation studies of the MALDI Biotyper: certificates 2017LR72, 2017LR73, 2017LR74 and 2017LR75. Therefore, there is no impact on the data interpretation of the studies that were done. The certified validation studies are therefore in full accordance with the FDIS version. At the ISO FDIS stage, only editorial comments can be considered during the voting. No technical changes can occur, those are the requirements of ISO. Quite recently the outcome of the FDIS vote was published and the standard was approved with a 100 % approval rate and only minor editorial comments. The MALDI Biotyper certification studies are fully in line with the final version of the ISO 16140-part 6 standard, expected to be published within two months. Once the ISO 16140-part 6 is published, the MicroVal certificates will be updated to refer to the final version.