Category: EN – newsitem

On 29 October 2018, MicroVal organised a successful workshop on the validation and verification of alternative microbiological confirmation methods.

Recently MicroVal approved on the issuing of the first validation certificates for confirmation methods worldwide, for the Bruker Maldi-Tof. These have been issued based on the results of four parallel validation studies for four different target organisms (Cronobacter spp, Samonella spp, Campylobacter and Listeria spp. & Listeria Monocytogenes).

The objectives of the workshop were to inform and exchange on verification and validation of microbiological methods, especially focussing on alternative confirmation methods. The current developments of the relevant standards on validation of alternative microbiological confirmation methods (ISO/DIS 16140-6), on in-house method validation (ISO/DIS 16140- 4) and  verification (ISO/DIS 16140-3) were also discussed.

It was a successful workshop with a full auditorium and lively participation. MicroVal aims to organize more workshops in the future.

An important part of the MicroVal validation process is the presentation and discussion of study results in the MicroVal Technical Committee (MVTC).

The MVTC comprises of more than 15 members, including representatives of test kit manufactures, expert labs, end users and government. Decisions in the MVTC  regarding, for instance, validation are based on consensus amongst members, with the ISO 16140 and the MicroVal rules as a solid foundation. The combined knowledge and experience of the members allows for flexibility and innovation, at the same time providing trust and accountability.

MicroVal is the first validation platform to approve the issue of certificates according to ISO 16140-6 for confirmation methods.

The Maldi Biotyper has been approved according to the new ISO 16140-part 6 standard. Four certificates have been issued, based on the results of parallel validation studies for four different target organisms (Cronobacter spp, Samonella spp, Campylobacter and Listeria spp. & Listeria Monocytogenes). In parallel, the Maldi-Tof solution was approved according to AOAC-OMA by AOAC International. During the AOAC annual meeting in Toronto the MALDI Biotyper was awarded Method of the Year.