Quality Management

To enable standardised measurement, it is necessary to standardise all assays at the outset and to ensure their ongoing quality assurance. This requires the timely preparation, distribution and implementation of protocols and SOPs, as well as an effective quality management system. Working in close collaboration with the COVIM laboratories, the scientific and technical coordination team (AP2) initiates the standardisation of the assays, designates the bodies responsible for implementing quality management, and continuously monitors the quality of the standardised measurements carried out by the COVIM platform.

When an assay is included in the COVIM platform’s assay portfolio, the relevant reference laboratories draw up the corresponding protocols and SOPs. These are subsequently distributed to the testing laboratories so that they can be implemented there. The reference laboratories may offer on-site training (at the reference laboratory or at the measuring laboratory) or online training for the standardisation process. The reference laboratories maintain reference samples which must be analysed by a measuring laboratory following the adoption of a protocol, in order to verify the initial standardisation. During the initial standardisation process, the reference laboratories maintain close contact with the scientific and technical coordination team (AP2). Following the initial standardisation of the assays, continuous quality control must be carried out. The reference laboratories are the bodies responsible for the quality assurance system for the respective assay. In this context, they prepare and distribute interlaboratory test samples to all measurement laboratories carrying out the relevant assays. Interlaboratory tests take place once a quarter in the first year and twice a year from the second year onwards. The results of the interlaboratory tests are reported to the scientific and technical coordination team (AP2). In addition, the reference laboratories prepare reference samples which can be used by the testing laboratories as positive and negative controls.