How reliably do the corona antigen tests detect the coronavirus? The Paul Ehrlich Institute (PEI) has now got to the bottom of this question.
Germany – With the corona numbers rising, the demand for rapid tests is also increasing again. Because as the risk of infection increases, the tests become more important again in everyday life. The Paul Ehrlich Institute (PEI) has now examined their ability to detect the coronavirus, reports RUHR24. *
| Coronavirus | SARS-CoV-2 |
| Infectious disease | Covid-19 |
| Common symptoms | Cough, fever, runny nose, loss of smell and taste |
Corona antigen rapid tests – manufacturers are allowed to certify products themselves
From next week (November 15), one professionally performed test per week will again be available to every German citizen free of charge. * According to the PEI, a large number of rapid antigen tests with CE marking are currently available on the European market. These are used both for professional use by trained personnel and for testing at home.
The problem with this is that manufacturers of rapid tests are currently allowed to certify their tests themselves in accordance with an EU directive. According to the PEI, this will not change until May 2022. Then the tests have to be tested in an EU laboratory before they can be put on the market and this data has to be independently verified.
Federal institute checks corona rapid tests – 122 products in check
However, in order to ensure that only those rapid antigen tests are used that meet the minimum criteria defined by the Federal Ministry of Health, the PEI experts have now carried out their own check. The Federal Institute was supported by researchers from other institutions such as the Robert Koch Institute (news on the coronavirus in NRW * on RUHR24).
An important prerequisite for the reliability of these tests is sufficient sensitivity (sensitivity) of the rapid antigen tests, explains the PEI. Because this sensitivity expresses how well a test is able to detect the Sars-Cov-2 * coronavirus.
The experts therefore examined the rapid tests for their sensitivity. A total of 122 products were tested.
Corona rapid tests: false negative results – around a fifth do not meet the requirements
As the PEI explains in a current press release, the examiners come to mixed results in the test. 96 products were able to achieve the required values – in some cases even with very good results. Another 26 antigen tests – and thus around a fifth – do not pass the test ( Focus.de reported on it first).
The required sensitivity limit was 75 percent. In other words, for those tests that do not meet the minimum requirements, more than 25 percent of the tests that are negative after execution are false-negative.
Examples of antigen tests that are too often false negative include:
- Test name: dedicio Medical Test COVID-19 Ag plus test; Manufacturer: nal von minden GmbH
- Test name: Biokredit COVID-19 Ag; Manufacturer: Rapigen
- Test Name: SARS Cov-2 Antigen Rapid Test Cassette (Swab); Manufacturer: Spring Healthcare Services SP zoo
- The journal Eurosurveillance , in which the article on the test was published (online edition from November 4, 2021), offers a complete list.
This will have consequences for the rapid tests that failed in the test. The Federal Institute for Drugs and Medical Devices (BfArM) keeps a list of all antigen tests that, according to the manufacturer, meet the minimum criteria and that are reimbursable according to the Coronavirus Test Ordinance (TestV). The products that do not meet the requirements according to the current tests are removed from this list.
Paul Ehrlich Institute: most rapid tests reliably detect infection
On the other hand, these tests performed well:
- Test Name: SARS-CoV-2 Antigen Rapid Test Cassette; Manufacturer: Merlin Biomedical (Xiamen) Co., Ltd.
- Test Name: CLINITEST COVID-19 Rapid Antigen Test; Manufacturer: Siemens Healthineers
- Test name: SARS-CoV-2 antigen rapid test; Manufacturer: Xiamen Boson Biotech Co., Ltd.
- Test Name: Novel Coronavirus 2019-n CoV Antigen Test; Manufacturer: Beijing Hotgen Biotech Co., Ltd. (was sold for example at Aldi and Kaufland)
- The complete list can also be found at Eurosurveillance .
The good results relate to highly infectious people with a high viral load (and a corresponding so-called ct value below 25). In these groups of people, the antigen tests listed above even detected 100 percent of the virus – but if the viral load decreases, this value falls.
Overall, the experts come to the conclusion that most of the rapid antigen tests tested are suitable for the rapid identification of acute infections – but only as long as the viral load is high. * RUHR24 is part of the IPPEN.MEDIA editorial network.
List of rubric lists: © Holger John / dpa
