By Bede E. Ezeugo

An essential point, according to the decisions of the german federal ministers, to allow more openings again is an expanded test strategy. Hence, the federal-state resolved that starting from  8th March, every german resident will be entitled to a free rapid test for corona per week. There has since been an upsurge in the demand and supply of these test kits within Germany and other European countries. While many players are already in the market, there is still opportunity for new entrants. Are you a manufacturer, supplier or distributor of SARS-CoV-2 antigen tests, who is targeting german and european markets?

Although, there’s currently no established international minimum analytical sensitivity standard for SARS-CoV-2 antigen available. However, a parallel diagnostic examination using PCR and antigen test involving at least 100 persons is mandatory according to the ยง 1 Paragraph 1 Clause 1 TestVO: Rapid antigen tests (of german authorities) and Paul Ehrlich Institut.

  • Sensitivity, Specificity, Cross Reactivity and Interference: To determine sensitivity, a parallel test ( with PCR and antigen test) of 100 people with Covid-19 symptoms within seven days of the onset of symptoms should be carried out.  An analytical correspondence of the antigen-positive / PCR-positive with the Ct values of the PCR is requested, and the PCR test used must also be shown. More than 80% of selected PCR-positive samples must also be positive in the SARS-CoV-2 antigen rapid test. The mean qPCR Ct value for the antigen positive samples should be determined. A further evaluation should determine the detection rate of the antigen test (e.g. detection rate> 90%) in relation to the ct value, though the Ct values for a given concentration of target RNA between PCR tests vary. To determine specificity, the examination of at least 100 asymptomatic people without a specific risk of exposure should be carried out using SARS-CoV-2 rapid antigen test; Clarification of any reactive samples should be done using PCR. Specificity criterion of rapid antigen test should be > 97%. For cross reactivity determination, analysis should be done using samples with a high concentration of related human coronaviruses (e.g. human coronavirus 229E, human coronavirus OC43, human coronavirus NL63, MERS coronavirus). Mention of the examined markers and information on any cross-reactivities should be indicated in the package leaflet. To ascertain diagnostic interference, a examination of pathogen-positive samples, in which the pathogen can cause analogous symptoms (e.g. influenza A, B; RSV) or could interfere with the test principle (e.g. protein A-positive Staphylococcus aureus in nasal swabs as sample matrix ) should be carried out. Mention of the examined markers and information on any interference should be indicated in the package insert/leaflet.
  • Test Design: The applicant must provide information on the specific SARS-CoV-2 proteins (antigens) target. Corresponding information on the effect of the test should also be provided in the package insert, according to the specifications of the IVD guideline. If the relevant antigen test detects the SARS-CoV-2 surface protein (“spike”), It must be demonstrated that mutations in SARS-CoV-2 that lead to a variation in the spike antigen (e.g. “UK variant”) can be reliably detected.
  • Availability of the test in Germany: The applicant must guarantee to offer the test to users in Germany in a number appropriate to the infection rate, and the ability to provide tests for any comparative evaluation.
  • Comparative Evaluation: The performance data can be obtained from a comparative evaluation by various institutions in Germany (including the Robert Koch Institute; Paul Ehrlich Institute; Consiliar Laboratory for Coronaviruses; Institute for Microbiology of the Bundeswehr) with the help of a joint sample panels and checked against other tests. Whether corresponding to the state of art and minimum criteria are evaluated.

Do you have questions regarding Bfarm marketing and distribution of your SARS-CoV-2 antigen test kits in Germany and other EU countries? Do you need a partner and EU responsible person to kick start your entry strategy? Kindly contact us on: