The Federal Office of Public Health (FOPH) has mandated the Swiss Society of Microbiology (SSM) to evaluate and compare available SARS-CoV-2 antigen tests with a specific and standardized protocol. The Coordination Commission of Clinical Microbiology (CCCM) of the SSM has developed these testing and acceptance criteria for SARS-CoV-2 antigen tests. The criteria are based on previous validation experience, expert opinion, literature and guidelines from other institutions and societies namely the World Health Organization and FIND. The criteria may be adapted for specific use cases of antigen tests.

A key reason for a separate validation process is the current lack of experience with SARS-CoV-2 specific antigen tests. A high quality of diagnostic tests has to be ensured, especially in the public health crises we currently face. The members of the CCCM consider that the clinical and analytical performance may substantially differ between companies depending on pre-to post-analytical aspects, namely the quality of the sample collection, handling of the assay, variable analytical chemistry such as different antigen and antibodies used, and different patient/testing cohorts, etc.. Indeed, a broad range of different published assays and assay performances can be found in the scientific literature.

For this reason, the FOPH mandated the SSM to develop a validation protocol and validation criteria in order to evaluate and compare available SARS-CoV-2 antigen test with a specific and standardized protocol. Such an approach will help us to generate important evidence on tests performance and a better comparison of tests across the field. Pure evidence from the literature or foreign quality criteria e.g. “CE labels” cannot be used in this specific situation. The CCCM will report the test results of the validation to the FOPH. The FOPH will publish a white list of validated and approved antigen tests over the course of the next weeks. The white list will contain antigen tests, which can be used in Switzerland for the FOPH defined indications and allow for re-imbursement by the Swiss confederation.

Briefly, we require a laboratory validation with a direct comparison to previously clinically validated assays such as Roche or Abbott. In addition, a low limit of detection must be reached for these tests.

Interested diagnostic companies can contact the SSM (This email address is being protected from spambots. You need JavaScript enabled to view it.) and we will evaluate the documentation around their test and coordinate the validation within the SSM diagnostic lab network.

In addition, the SSM supports the current usage of SARS-CoV-2 antigen tests. These antigen tests represent an important addition to the current SARS-CoV-2 available tests (RT-PCR, serology and virus sequencing). A detailed statement on antigen test recommendation of the CCCM can be found here:

  This statement includes aspects of test indication, safety precautions in sample collection, quality control, and reporting.