NADAL® COVID-19 Ag Rapid Test (anteriornasal)

Description

NADAL® COVID-19 Ag Rapid Test.

Rapid test for the detection of SARS-CoV-2 viral nucleoprotein antigens in human naso- and oropharyngeal specimens.

– Listed by the German Federal Institute for Drugs and Medical Devices (BfArM) –

The NADAL® COVID-19 Antigen Rapid Test provides highly accurate results in minutes, costs only a fraction of a PCR test and saves laboratory capacity.

The NADAL® COVID-19 Antigen Rapid Test – a chromatographic immunoassay in lateral flow format – tests for protein fragments of the virus and thus for its direct, physical presence in the body. It is performed with the help of a swab taken from the oral or nasopharyngeal cavity. This is enriched in a buffer solution and then pipetted onto the test cassette. A qualitative result is available in less than 20 minutes.

Diagnostic sensitivity is 97.56% (ct value: 20 – 30), diagnostic specificity is >99.9%. This means that positive results of antigen tests are very accurate. However, since there is always a residual risk of a false-negative result, it is recommended to perform a PCR test to confirm negative results in case of doubt. Thus, between antibody, antigen and PCR tests, no exclusion procedure applies. Rather, their combined use is tactically smart. Because – to quote the U.S. Food and Drug Administration (FDA):

“Each category of diagnostic test has its own unique role in the fight against this virus.”

Features of the test:

• Reliable even with viral mutations.
• New Covid 19 Ag test from Germany.
• Anteriornasal
• Diagnostic sensitivity at 97.56 percent.
• Diagnostic specificity is over 99.9 percent.
• Quick result in only 15 minutes.
• Testing for nucleocapsid protein by throat swab.
• Comparable to PCR testing (early stage infection detection).
• All necessary utensils included in the test kit (incl. sterile swab).
• Manufacturer TÜV Rheinland certified.
• Approved as a lay test in Austria – Professional self-test for self-testing according to § 323c para. 18 of the Federal Tax Code.

The 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 the virus directly by testing for the presence of specific proteins of SARS-CoV-2. Thus, antigen detection closes a diagnostic gap. The nucleocapsid protein (N) is ideally suited for this detection because it is highly abundant in the virus and sufficiently specific for SARS-CoV-2. It is one of its 4 major structural proteins and is involved in replication, transcription and packaging of the viral genome.

The NADAL® COVID-19 Antigen Rapid Test is a chromatographic immunoassay in lateral flow format for the qualitative detection of SARS-CoV-2 viral nucleoproteins in human naso- and oropharyngeal specimens. The test is intended as an aid in the diagnosis of infection with SARS-CoV-2. It should be noted that the concentration of viral nucleoprotein antigens fluctuates during the course of the disease and may fall below the detection limit of the test. A possible infectivity of the test persons cannot be excluded due to negative test results.