• with BfArM approval
• high specificity >99,9%
• high sensitivity forhigh virus load 97,56%
• easy to use – throat swab
• meets the requirements of the german Federal Institute for Drugs and Medical Devices
• all test components – including sterileswabs – are included
• o cross reactivity with human pathogensCorona viruses (like hCoV-229E, -HKU1, -NL63or -OC43)or influenza viruses (like influenza A/B)
The COVID 19 antigen rapid test is a chromatographic immunoassay in lateral flow format for qualitative detection of viral SARS-CoV-2 nucleoproteins in human naso- and oropharyngeal samples. The test is intended as an aid in the diagnosis of SARS-CoV-2 infections. It should be noted that the concentration of viral nucleoprotein antigens fluctuates during the course of the disease and falls below the detection limit of the test can fall. A possible infectivity of the test persons cannot be excluded due to negative test results.
The nal von Minden NADAL® COVID-19 Ag test fulfils the criteria for antigen tests established by the Paul-Ehrlich-Institute (PEI) in coordination with the Robert Koch Institute (RKI) and is available on the Whitelist of the Federal Institute for Drugs and Medical Devices.
Components of the test package:
NADAL® COVID-19 Ag per test cassette* (20 pcs.) Additional material supplied according to 93/42/EEC:
• 20 sterile swabs
• 20 extraction tubes incl. dropper attachments
• 2 buffer bottles “Buffer” (7 mL each)**
• 1 reagent holder
• 1 instruction manual
*Contains preservative sodium azide: <0.1%.
**Buffer contains the following preservative:
Sodium azide: <0.1 mg/mL.
According to Regulation (EC) No 1272/2008 CLP no Hazard labelling required. The concentrations are below the exemption limits.
Shelf life and storage
The test kits should be stored at 2-30°C until the stated expiry date. The test kits are stable until the expiration date indicated on the foil pouch. The test cassette must remain in the sealed foil pouch until use. Please do not freeze the test kits. Do not use the tests after the expiry date indicated on the packaging. Make sure that the components of the test kit are protected from contamination. Do not use the components of the test kit if there are signs of microbial contamination or precipitation. Biological contamination of dosing devices, containers or reagents can lead to incorrect results.
Warning and note
Currently, the tests in Germany can only be used for professional in vitro diagnostic use by medical professionals.
The NADAL® COVID-19 Ag Test was evaluated with clinical samples whose status was confirmed by RT-PCR (Ct range positive: 20-37). The sensitivity was calculated for the range of high to medium viral load (Ct 20-30) and high to very low viral load (Ct 20-37).
Diagnostic sensitivity (Ct 20-30): 97.6% (93.1% – 99.2%)*
Overall compliance (Ct 20-30): 98.9% (96.9% – 99.6%)*
Diagnostic specificity: >99.9% (97.7% – 100%)*
The detection limit of the NADAL® COVID-19 Ag test is 2 x 102.4 TCID50/mL and was determined using a SARS-CoV-2 control with a known virus titre. The detection limit of the NADAL® COVID-19 Ag test is 0.4 ng/mL for recombinant SARS-CoV-2 nucleoproteins.