NADAL® COVID-19 Ag Rapid Test
Prepared for the second wave
The NADAL® COVID-19 Antigen Rapid Test delivers high-precision results in just a few minutes, costs just a fraction of what a PCR test does and conserves laboratory capacity.
The NADAL® COVID-19 Antigen Rapid Test – a chromatographic lateral flow immunoassay – checks for protein fragments from the virus and thus for its direct, physical presence in the body. It is performed using a swab from the oral cavity or the nasopharynx. This is extracted in a buffer solution and then pipetted onto the test cassette. A qualitative result is ready in less than 20 minutes.
The diagnostic sensitivity is 97.56 % (ct value: 20 – 30), and the diagnostic specificity is >99.9 %. That means that positive results from antigen tests are very precise. However, as there is always a residual risk of a false-negative result, when in doubt, a PCR test should be carried out to confirm negative results. The choice between antibody, antigen and PCR tests is not an either/or decision. Rather, the best tactic is a combined application. Because – to cite the U.S. Food and Drug Administration (FDA):
“Each category of diagnostic tests has its own unique role in the fight against this virus.”
– High specificity (> 99.9 %)
– Easy to use
– Fast and reliable test results in just 15 minutes
– Testing can be performed using naso- and oropharyngeal specimens
– Can be stored at room temperature
Highly sensitive with high viral loads: 97.56 % (ct-value: 20 – 30)
All test components – including sterile swabs – are included
No cross-reactivity with human pathogenic coronaviruses (like hCoV-229E, -HKU1, -NL63 and -OC43) nor influenza viruses (like influenza A/B)
Importance of the antigen test
While the NADAL® COVID-19 IgG/IgM Rapid Test* detects the virus indirectly, the NADAL® COVID-19 Antigen Rapid Test detects it directly by checking for the presence of specific proteins of the SARS-CoV-2 virus. Thus, antigen detection closes a diagnostic gap. The nucleocapsid protein (N) is ideal for virus detection because it is highly abundant in the virus and sufficiently specific for SARS-CoV-2. It is one of the 4 most important structural proteins of the virus and is involved in the replication, transcription and packaging of the viral genome.
The NADAL® COVID-19 Antigen Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of SARS-CoV-2 viral nucleoprotein antigens in human naso- and oropharyngeal samples. The test is intended to be used as an aid in the diagnosis of infections with SARS-CoV-2. It should be noted that the concentration of viral nucleoprotein antigens may vary during the course of the disease and may fall below the detection limit of the test. Possible infectiousness of test subjects cannot be excluded based on negative test results.
*According to the NOKLUS-study, amongst the top 3 worldwide in terms of diagnostic accuracy (see: www.noklus.no/media, 25.08.2020)