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COVID-19: DIAGNOSTICS & TESTING

FIND is the Foundation for Innovative New Diagnostics, a global non-profit organization driving innovation in the development and delivery of diagnostics to combat major diseases affecting the world’s poorest populations.

FIND is a WHO Collaborating Centre of Laboratory Strengthening and Diagnostic Technology Evaluation

Effective diagnostics are the eyes and ears of a global pandemic response

Tests are critical to help limit the spread of the disease. There is no time to waste in the fight against COVID-19.

SARS-COV-2 DIAGNOSTIC PIPELINE

SARS-CoV-2-Evaluation Reports

The Paul Ehrlich Institute also carries out a comparative evaluation of rapid antigen tests in the laboratory. If it turns out that a test passes this evaluation, it will be included in the list “Comparative evaluation of the sensitivity of SARS-CoV-2 rapid antigen tests” of the Paul Ehrlich Institute. If a test does not meet this evaluation, it is deleted from the BfArM’s list.

RAPID ANTIGEN TESTS FOR THE DIAGNOSIS OF A SARS-COV-2 INFECTION

WELCOME! ON THIS WEBPAGE WE TRY TO SUMMARIZE THE RESULTS OF MANUFACTURER INDEPENDENT EVALUATIONS OF ANTIGEN DETECTING RAPID DIAGNOSTIC TESTS (AG-RDTS) FOR SARS-COV-2.

Displayed tests for the novel coronavirus (SARS-CoV-2) in Germany

Table of SARS-CoV-2 tests displayed in Germany

Please note: The list only contains tests that have already been registered by the responsible authorities. In addition, there may be open reports that are still being processed by the responsible authorities and are therefore not included in this list. Furthermore, our databases contain formal information and no technical or content-related information on the tests. Due to the common European legal basis, tests that are registered in another European member state are also allowed on the German market. These are not included in the database.

To search within the table, simply use the key combination CTRL + F. For more information and more convenient search and filter options, you can purchase a flat rate for research in public databases.

* The manufacturer or his authorized representative or importer is obliged to notify in accordance with Section 5 of the Medical Devices Act (MPG).

Antigen-Tests SARS-CoV-2 use by laypeople

Tests for personal use by laypeople approved in Germany

The BfArM has issued the first special approvals in accordance with Section 11 (1) of the Medical Devices Act (MPG) for antigen tests for self-use by laypeople (self-tests) for the detection of SARS-CoV-2. Further information on the legal basis and the requirements checked can be found further down on this page under the menu item “Notes on the special approval of antigen tests by the BfArM”.

COVID-19 test types

The test procedures at a glance

The following test procedures are currently established:

PCR tests

They are used for direct pathogen detection; the samples are analyzed in laboratories. They are considered the so-called “gold standard”. These are the most accurate tests at the moment.

Rapid PCR tests

These tests use the same method as PCR tests, but in a much simplified manner. Therefore, they are a little less precise. They can be carried out independently of laboratories and can therefore be used flexibly.

Antigen tests

If pathogens can also be detected directly, certain test criteria must be met in order to be meaningful. Works with a test cartridge, similar to a pregnancy test. To be carried out by trained personnel.

Corona antigen self-test

The self-test can be carried out by laboratories or private individuals. It is identical to the antigen test, except that the material can also be removed and applied yourself.

a) with blood drop collection and application to a test cartridge
b) gargle test and application to a test cartridge
c) nasopharyngeal swab apply to a test cartridge (insertion through the noses deep into the pharynx)
d) nose and / or throat swab (insertion through the nose only about 2.5 cm and in the oral cavity / NASAL-SWAP)
e) spit test and apply to a test cartridge
f) Combinations of nasal and throat swabs

For the user, tests d) + e) + f) ​​are the most comfortable

Antibody tests

They mainly detect an infection that has passed if the body has already made antibodies against the pathogen. Antibody tests say nothing about whether the affected person is still infectious, how long ago the infection was or whether there is adequate immune protection against a renewed infection. These tests are also available as quick tests

Important test criteria: sensitivity and specificity

Important test criteria: Sensitivity and specificity Tests that have a high specificity and a high sensitivity are particularly meaningful. But what exactly do these criteria mean?

The specificity describes the accuracy of a test, whether all healthy people tested are also recognized as healthy. The sensitivity provides information on whether all sick people are recognized as sick.

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Sensitivity

An infected person is really infected and receives a positive test result. In a test with 98% sensitivity, 98 out of 100 infected people are detected, two are not detected. They get a negative test result even though they are infected. These false test results are known as “false negatives”.

coronavirus
Specificity

A healthy (uninfected) person is also recognized as healthy and receives a negative test result. In a test with 95% specificity, 95 out of 100 healthy people are recognized as healthy. 5 out of 100 test positive even though they are not infected. These false results are called “false positives”.

A test with high sensitivity but relatively low specificity can accordingly also produce false-positive results.

However, it is not only the test-specific criteria that are important. The pretest probability also plays a role. It indicates how high the estimated risk of infection is for the person concerned. The pretest probability results on the one hand from the environment of the person concerned (work environment, many contacts and so on) and the prevalence (= number of infected people in the general population). If the pretest probability is high, for example because you have had contact with an infected person or the prevalence in the region is high, a positive result makes the actual presence of an infection much more likely.

Another sticking point is the point in time when a sick person is tested: Especially at the beginning and when an infection subsides, the Viurslast is still (or again) low, which can lead to false-negative results.

Correct sampling or transport are further influences that can lead to false-negative test results if used improperly. Therefore, if there is justified suspicion (the person tested has symptoms, is the contact person, etc.), a second PCR test should be carried out if necessary. A positive test result in the antigen test must also be confirmed by a PCR test.

The 3 Types of COVID-19 Tests