The EU Common List is, after the BfArM list as well as after the latest list of the Paul Ehrlich Institute, the latest guideline for the recognition as well as reimbursability of the costs of corona testing procedures by pharmacies. It serves a uniform quality assurance.
Paul Ehrlich Institute – previous requirements for Covid tests
The Paul Ehrlich Institute (PEI) replaced the list of the Federal Office for Drugs and Medical Devices. It previously decided on the billability of rapid antigen tests by pharmacies. Contrary to what was decided by the new test regulation, overall sensitivity and documentation requirements played a subordinate role. Previously, pooling and saliva tests were also permitted. They belong to the group of in vitro diagnostics for which reimbursement is no longer envisaged in future.
In this way, the new test regulation should help to ensure that as few false-positive and false-negative results as possible are produced in test centres and distort the statistics. The bypassing of positive Covid cases, but also the prevention of unnecessary further diagnostic measures in negative cases can thus be significantly reduced.
EU Common List: Specifications for overall sensitivity
The EU Common List provides for tests with an overall sensitivity of at least 80 per cent for symptomatic patients. For independent studies with randomly selected subjects with a Ct of less than 25, an overall sensitivity of at least 90 percent is even prescribed. This also applies to retrospective in vitro studies.
The EU Common List was jointly agreed by the EU member states. The tests on the list are divided into two categories:
• Category A: antigen tests evaluated by prospective clinical trials
• Category B: tests evaluated by retrospective in vitro studies
EU Common List: What changes for Covid tests and studies?
The EU Common List is the linchpin of the new test regulation. Qualitative evidence is now no longer required for reimbursement. Minimum criteria and evaluation are no longer taken into account, as manufacturers must have the test certificate of an approved body. The European guideline of the Medical Device Coordination Group (MDCG) is relevant for testing. It refers to the SARS-CoV2 tests and the valid specifications.
The new criteria for independent studies to validate tests are:
• Conduct of the validation study by an independent laboratory
• Conduct the validation study in at least one laboratory of the 27 member states of the EU
• Participation of at least one public institution of an EU Member State
• Prospective clinical field study design of the validation study
• Evaluation of performance also possible through retrospective in vitro study design
Although the use of an in vitro diagnostic product was also required in the past, the listing of the tests in the BfArM list will no longer be necessary for the entitlement to remuneration. The EU Common List now contains only CE-marked Covid tests. The results must have come from a throat, nasal or pharyngeal swab. Tests based on sputum, blood, saliva or stool are no longer included in the EU Common List. Also excluded are pooled antigen tests and rapid antigen tests for stand-alone use.
What is the sensitivity of Covid tests?
Sensitivity refers to the ability of a Covid test to correctly diagnose the disease in affected individuals. With a test sensitivity of 80 per cent, just as many patients with infection are identified (true-positive), while 20 per cent of guests remain undetected (false-negative).
What is the specificity of Covid tests?
Clinical test specificity refers to the ability of corona tests to rule out disease. With test specificity, the proportion of correctly excluded diseases is 80 per cent (true-negative); the proportion falsely identified as ill (false-positive) is 20 per cent.
With the entry into force of the new test regulation, the EU Common List replaces previous lists of the Paul Ehrlich Institute and the BfArM and ensures a standardisation of diagnostic quality. Exclusively listed tests will in future be reimbursable for pharmacies up to an amount of 9.50 euros. The guidelines for assessing the validity of tests are admittedly somewhat arbitrary, as stool or blood-based tests have high sensitivity as well as specificity.
You can find out about the currently listed antigen rapid tests at the following link: https://health.ec.europa.eu/system/files/2022-07/covid-19_eu-common-list-antigen-tests_en.pdf