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Omicron detection independently confirmed - Testsealabs Antigen Test Kits

March 12, 2022

With a change in the course of infection, new virus variants keep appearing, which must continue to be reliably detected by rapid antigen tests and PCR tests. As part of two laboratory studies, the detection of virus variants using the Testsealabs COVID-19 antigen rapid test was examined. The sensitivity of samples of the delta variant (B.1.617.2) and samples of the omicron variant (B.1.1.529) was determined. The Omicron subvariant BA.2 was also examined.  

       

For each virus variant, 31 samples from patients who had shown COVID symptoms within the last seven days were examined. The result of the quick test was compared with the result of a PCR test as a reference method.

Diagnostic Sensitivity - Delta Variant (B.1.617.2)

All samples with positive real-time RT-PCR results tested positive by antigen test (diagnostic sensitivity 100% (31/31; 95% CI: 89.0-100%)). Even samples with a high Ct value of ~35-37 were detected by the antigen test with a weak positive result.

 

Diagnostic Sensitivity - Omicron Variant (B.1.1.529)

All samples with real-time RT-PCR Ct values up to 34 tested positive with the antigen test. The sensitivity of the Testselabs Rapid Covid-19 Antigen Test was 96.9% (31/32; 95% CI: 84.3-99.4%) for all samples (Ct value up to 38).

 

The Testsealabs Rapid Antigen Test was able to successfully detect all samples with high and medium viral loads. Even with samples with high Ct values and low viral load, detection was still possible in most cases. This applies to both the delta and the omicron variant, with the novel omicron subvariant BA.2 also being examined.

 

Omicron evaluation by the PEI

The Testsealabs antigen rapid test is also suitable for detecting the omicron variant according to the assessment of the Paul Ehrlich Institute. The corresponding information can be found in the BfArM's antigen rapid test database.

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