NADAL COVID-19 Antigen Rapid Test

Intended use: The NADAL COVID-19 Ag Test is a lateral flow chromatographic immunoassay for the qualitative detection of SARSCoV-2 viral nucleoprotein antigens in human nasal, nasopharyngeal or oropharyngeal specimens. This test is intended for use as an aid in the diagnosis of infections with SARS-CoV-2. Possible infectiousness of test subjects cannot be ruled out based on negative test results. The test procedure is not automated and requires no special training or qualification. The NADAL COVID-19 Ag Test is designed for professional use only. Benefits at a glance: Optimised testing process Nasal, nasopharyngeal and oropharyngeal swab samples now also possible Pre-filled buffer tubes High specificity and sensitivity Fast and reliable results in just 15 minutes Storage at room temperature All test components – including sterile swabs – are included No cross-reactivity with seasonal coronaviruses (such as hCoV-229E, -NL63 or -OC43) or influenza viruses (such as influenza A/B) Reliable detection of all known variants of SARS-CoV-2 Category A.1 on the EU common list of COVID-19 antigen rapid tests Test principle: Anti-SARS-CoV-2 antibodies are immobilised in the test line region (T) of the membrane. A specimen is added to an extraction tube containing buffer in order to release SARSCoV-2 antigens. During the test, extracted antigens bind to anti-SARS-CoV-2 antibodies conjugated to coloured particles and precoated onto the sample pad of the test cassette. The mixture then migrates along the membrane chromatographically by capillary action and interacts with the reagents on the membrane. The complexes are then captured by antiSARS-CoV-2 antibodies in the test line region (T). Excess coloured particles are captured in the control line region (C). The presence of a coloured line in the test line region (T) indicates a positive result. The absence of a coloured line in the test line region (T) indicates a negative result. Specimen collection and test procedure: Contents: ① Test cassettes (individually packaged) ② Sterile swabs (individually packaged) ③ Extraction tubes pre-filled with buffer (400 μL each) ④ Package insert Performance characteristics: Sensitivity - 97.56% Specificity > 99.9% CE-IVD certificated