Paul Ehrlich Institute
New data: This is how well rapid tests identify Omikron – and this is how you find reliable tests
Rapid antigen tests detect the omicron variant of the coronavirus? The Paul Ehrlich Institute (PEI) investigated this question
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Rapid corona tests are practical, especially in times of high infection rates. The Paul-Ehrlich-Institut has examined whether the tests also work reliably at Omikron. The result is reassuring. However, consumers should still check which test they are using.
Two pink dashes – that’s all it takes to deliver bad news these days. At the moment the corona virus is lurking everywhere: in daycare centers, schools, open-plan offices. On Thursday, the Robert Koch Institute (RKI) reported more than 300,000 new infections within 24 hours for the first time since the pandemic began. The incidence is also high, over 1700.
Rapid antigen tests are important helpers in these times. But in the end there was a big question mark above them. It was unclear how well they work with the omicron variant of the corona virus. Individual reports, including from the US Food and Drug Administration FDA, had fueled the suspicion that the everyday helpers might have problems recognizing infections with just that widespread variant. But there was hardly any reliable data on the question. The uncertainty was great.
The Paul Ehrlich Institute (PEI) has now presented the long-awaited results of its own laboratory tests. They are reassuring: Based on a random sample, the institute’s experts found “no indication” of a reduced measurement accuracy of rapid antigen tests compared to Omikron, as they explained in a press presentation on Thursday. The institute had already suspected such a result, how from a communication from the end of December 2021. However, the current study supports this assessment once again.
In concrete terms, this means that, according to the PEI, whether there is an infection with the original variant, delta or omicron should not make a big difference in most tests. Quick tests that work with earlier variants do the same with Omikron. This also applies to the Omikron variant BA.2, which is currently on the rise in Germany. The measurement accuracy examined relates to the sensitivity of the tests. The more sensitive a test is, the more accurately it will correctly report infected people as positive (and the less likely it will be false negative).
However, consumers should take a closer look. According to the PEI, the results can be applied to most, but possibly not to all rapid tests.
Many rapid tests detect the virus in areas that are not mutated in Omicron
The results of the PEI relate to a random sample of 20 rapid tests that were positively assessed in advance with regard to their basic sensitivity. According to the PEI, the current results can be transferred to all those tests that – similar to the tests in the sample – target regions of the virus that are not mutated in Omicron compared to earlier variants. This should be the case for most tests. The only catch is that not all tests have precise information about which areas of the virus the antibodies in the tests bind to. The manufacturers requested further information on this.
428 answers came together. 385 tests target areas of the virus that don’t have a mutation. According to the PEI, you can use it to identify Omikron just as well as earlier variants. With 43 tests, i.e. a good ten percent, there is a question mark because either there are no precise manufacturer specifications or because the tests are aimed at regions of the virus that have mutated in Omicron. Here the manufacturers have to prove the sensitivity again separately or present more detailed information.
This is how consumers can find suitable tests
The Federal Institute for Drugs and Medical Devices (BfArM) maintains two lists of rapid tests – one for professional tests, one for self-tests. A column was added to both lists on Thursday (“Omicron detection according to the bridging test of the PEI”). A “yes” in the column means that, according to the assessment of the PEI, the test recognizes omicrons equally well.
Important to know: Consumers should not only pay attention to the omicron column, but also to the point “PEI evaluation”. A “yes” here means that the test demonstrably meets minimum criteria with regard to sensitivity and, for example, does not only refer to manufacturer information.
But even quick tests that meet all the criteria do not offer 100% security – this is well known. Rapid tests are less accurate than PCR tests and only work when the viral load is high. Especially in the early stages of the disease, they can weaken and “overlook” an infection. Experts therefore advise not to rely on a single test result, especially in the case of symptoms, but to take at least one further test, for example the following day.