20% of your COVID Results giving False Positives, says Recent Research. Here’s How to Find Reliable Rapid COVID tests?

Rapid antigen tests for the coronavirus are intended to provide certainty quickly and inexpensively as to whether one has been infected. Every week, millions of people in the world trust that the results displayed on the small test strips are correct.

In December, the Paul Ehrlich Institute (PEI), which is responsible for monitoring vaccines and medicinal products, published an analysis of 245 rapid antigen tests already approved in Germany. 199 passed the evaluation, 46 failed, which corresponds to around 19% [ see all data at this link ]. Now there is great excitement about these numbers.

The PEI inspects the quality of items that have previously been authorized on a regular basis. Rapid tests that can be purchased in Germany are repeatedly removed from the lists because they later turned out to be defective.

The paper, published in December, was a summary of all the rapid test investigations that the PEI carried out over the course of the year. These include self-tests that anybody may conduct at home, as well as those for professional usages, such as in test stations. A total of more than 600 rapid tests are approved in Germany, so far the PEI has only been able to independently check some of the products available.

Rapid tests were originally designed and approved to quickly deliver a result at low cost in the case of a very high viral load. Then a PCR test, which is significantly more exact, can offer assurance.

This also explains why, conversely, tests with an overall sensitivity of only 34% passed the study. With the very high viral load, they had a sensitivity of 80% and more – and only dropped significantly with the tougher criteria. So you have met the minimum requirements.

The most important place to go to find out what a rapid test is good for is the website of the Federal Institute for Drugs and Medical Devices (BfArM). There are continuously updated lists of the rapid tests and self-tests currently recognized in terms of test regulation.

However, these lists do not offer a complete overview of all the rapid tests available on the market either. Because fast testing is frequently allowed across the EU, this is the case.

This is how rapid tests are approved in Germany

There are often various products with similar-sounding names from the same manufacturer. Reference and AT numbers, which are assigned by the manufacturer or the BfArM and which are usually given on the packaging, can provide certainty here.

When traveling, it can be important that the rapid test is one of those that are recognized throughout the EU. The EU Commission has a separate list of fast tests from the BfArM. Additional details on test reports from other countries are also listed there.

As described above, neither the PEI nor the BfArM is responsible for approving rapid tests in the EU. If the PEI determines – as has now happened – that some tests do not meet its requirements, they will be removed from the BfArM list of reimbursable rapid tests. This does not automatically mean a sales ban, the dubious self-tests may continue to be offered in retail outlets. Every consumer must inform himself here.

PEI President Klaus Cichutek said in the ZDF morning show that countries, test centers, and discounters had based themselves on the checklists. They “offered the tests that we positively appraised,” according to Cichutek.

If a product even turns out to be potentially harmful to health, a product warning can be issued in various ways. This has often happened recently, especially with inferior FFP protective masks via the EU’s Rapex warning system. So far, there have only been a few recalls for quick tests.

Rapid antigen assays identify the coronavirus by reacting to certain components of the virus. Different tests can target different virus components, some even several.

Most tests available detect the so-called N-protein. According to the PEI, this is also the reason why most tests should also work with the Omicron variant without hesitation. “But the mutations in the omicron variant primarily affect the S protein,” writes the institute on its website.

Federal Health Minister Karl Lauterbach (SPD) announced on Sunday a positive list for rapid tests at Omicron. “The Paul-Ehrlich-Institut is currently examining what options there are for implementing this project. Statements are currently not possible either on the duration or on specific criteria for inclusion in a specific list for omicron tests,” says the institute.