Mr. Kronmueller, what exactly is behind the product name „Fast Track Diagnostics SARS-CoV-2 Assay1 Testkit“?
This is a molecular test developed by our subsidiary Fast Track Diagnostics. It detects infection with the novel corona virus. Molecular tests evaluate the organism at its most basic level: DNA and RNA. For our test, genetic material is isolated from a smear from a patient's nose/throat space. Viral RNA in this material is then converted into DNA by so-called reverse transcriptase. This is selectively propagated using a technique called polymerase chain reaction (PCR) if it contains specific genes of the SARS-CoV-2 virus. Once the DNA has been sufficiently propagated, it can be measured using fluorescence methods. PCR is used in biological and medical laboratories, for example for the detection of viral infections or hereditary diseases. Today, PCR is one of the most important methods of modern molecular biology.
Specifically, we use this test to look for the genetic material of the SARS-CoV-2 virus that causes the Covid-19 disease. The great advantage of molecular testing is its effectiveness at an early stage of infection and thus effective in urgent test situations.
The test has a 100% (91.8-100, 95% CI) diagnostic sensitivity and a 100% (88.7-100, 95% CI) diagnostic specificity2. What does this mean?
The specificity of a diagnostic test procedure indicates the likelihood that healthy people who do not suffer from the disease in question will also be recognized as healthy. Sensitivity indicates how many sufferers were actually identified as such during a test. The higher the sensitivity of a test, the safer it detects the disease.
The "100 percent" of both the sensitivity and the specificity of our test means that we have achieved the right result in all clinical tests in validation. This means that with a limited number of tests, we have not found a wrong result. The second number is the "Confidence Interval" (CI) in parentheses. The CI is a statistical measure that states that with 95 percent statistical probability we can say that the actual performance of the test is in the range of 91.8 to 100 percent.
Why are these parameters so important?
Both parameters give medical staff certainty as to whether a sick person is actually recognized as such and can be treated accordingly. On the other hand, with a very high percentage, it is possible to reduce the number of false positive results in healthy people, i.e. fewer people are wrongly identified as infected. So the higher both parameters are, the more reliable the correct results are achieved and thus the best possible treatment is initiated.
CE-marked for sale in the EU. This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21. U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Product availability may vary by country and is subject to regulatory requirements.
In method comparison studies, FTD SARS-CoV-2 has shown Positive Percent Agreement: 100% (91.8-100, 95% CI) and Negative Percent Agreement: 100% (88.7-100, 95% CI) when tested in Copan eSwab nasopharyngeal and oropharyngeal swabs.