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Rapid antigen test kit. Photo credit: Annie Spratt

Germany: Useless rapid antigen tests under the magnifying glass

The Paul Ehrlich Institute (PEI), the German medical regulatory body and research institution for vaccines and biomedicines, which is also a WHO Collaborating Centre for quality assurance, has found out that 92 percent of rapid antigen tests are worthless.

Published: January 20, 2022, 9:24 am

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    Berlin

    PEI evaluated 245 rapid antigen tests and the results were shocking: Only eight percent of them show valid results. This is according to an article published on January 16 by the website ScienceFiles.

    There is a list of rapid antigen tests maintained by the Federal Institute for Drugs and Medical Devices (BfArM). According to the article, 245 rapid antigen tests from a wide variety of manufacturers were included on this list. These tests have been a money tree for some since rapid tests are used extensively.

    The scientists examining the accuracy of the tests believe that in the face of the alleged pandemic, rapid antigen tests should be considered as a very important diagnostic tool. The article explained however that the Federal Institute for Drugs and Medical Devices apparently did not look too closely and obviously included many on its list of tests currently available on the market.

    In the 245 antigen tests evaluated at the Paul Ehrlich Institute, samples that had previously tested positive for SARS-CoV-2 using a PCR test were divided into three categories that differ in their virus load.

    Group 1 included specimens that had enough viral load to test positive for SARS-CoV-2 within less than 25 cycles. Group 2 included specimens that required between 26 and 30 cycles to obtain a positive test result. Group 3 contained samples that required more than 30 cycles to determine positively for SARS-CoV-2. The determination of SARS-CoV-2 was therefore easiest in group 1.

    For each rapid test, the accuracy with which it was able to correctly determine the samples in the respective groups, i.e. to detect SARS-CoV-2, was analyzed. The article reported that 46 of the 245 tests were more or less fraudulent because their sensitivity did not even reach 30 percent across the three groups, meaning at least 70 percent of such tests are wrong.

    Among them are bogus products like Absology Co. Ltd. ACAR-020, a rapid antigen test that has a sensitivity of 0 (zero) percent. This means that it is unable to correctly identify even one of the samples. The same applies to the “New Coronavirus Protein Detection Kit” from Beijing Savant Biotechnology. This test is also wrong 100 percent of the time. And the two tests are not the only complete failures.

    The Paul Ehrlich Institute describes an antigen rapid test as useful if it has a sensitivity of over 30 percent. According to the website ScienceFiles, this is highly problematic because a rapid antigen test with a sensitivity of 30 percent means that it will give incorrect results 70 percent of the time.

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