Laboratories performing tests that can detect genetic material from the coronavirus SARS-CoV-2 must demonstrate in advance that they meet the quality requirements. RIVM supports them in that process.
- Once a laboratory starts performing certain tests, RIVM monitors whether quality remains consistently high (video, report 1, report 2, supplementary LCI guidelines). In these quality assessments, laboratories demonstrate how good their test methods are. This external quality assurance scheme includes COVID-19 testing for patient diagnostics and Track 1 of the COVID-19 testing strategy (testing to detect and control the virus). Test sites for Track 2 (testing to open society), and test sites offering testing to obtain travel certificates, may use materials from existing commercial and non-profit providers for quality assurance purposes.
- RIVM is also researching which antigen and antibody tests yield the most reliable results. To this end, RIVM is conducting its own research on different types of rapid antigen tests.
- RIVM is also compiling data from studies being conducted by other Dutch laboratories and aggregating the results. This enables laboratories to learn from each other and make well-informed choices about which rapid antigen tests to use.
- Manufacturers of rapid antigen tests who want to market them as self-tests need to request a CE certificate for home use. Approval is granted by a special Notified Body that reviews the application. Until 28 May 2021, market release was also possible if manufacturers received a temporary exemption from the Ministry of Health, Welfare and Sport (VWS). RIVM has been supporting the Ministry in that process.
- RIVM assesses whether the rapid antigen tests are suitable for consumer use. Similar to its monitoring of PCR tests, RIVM also checks antigen tests for Track 1 of the COVID-19 testing strategy (testing to detect and control the virus) by means of external quality assessment.
- Finally, RIVM is researching how well you are protected after an infection with the coronavirus SARS-CoV-2. It is not yet known how long antibodies against the virus remain present in the body. So far, it has been confirmed that a limited number of people have been infected for a second time.