The Icon Medlab Rapid SARS- CoV-2 Antigen Test is approved for anterio-nasal sampling. The sample is taken with the swab provided. It can also be done in the anterio nasal areas, back nasal raven area and by oropharyngeal swab. The swab is very easily, shortly and free of pain to be carried out by everybody who has read the included instruction for use. (The Rapid SARS-CoV-2 Antigen Test kit cannot be used as the sole decision for the diagnosis or exclusion of a SARS-CoV-2- infection.)
The Icon Test proves pathogen-specific N-proteins (Nucleocapsid-N) and thus also identifies the new virus mutations. This is a mandatory criterion of the Federal Institute for Drugs and Medical Devices since the 15.01.2021.
All materials that are necessary for the test are already included in the test kit. The test result is available after 15 minutes already.
Please read the instructions carefully before applying the test.
• Icon Medlab Rapid SARS-CoV-2 Antigen Test (chromatographic immunoassay)
• Point of care test for the qualitative clinical evidence of the SARS-CoV-2 antigen
• Enables the evidence of acute SARS-CoV-2 infection
• Sensitive as against different mutations
• Listed at the Federal Institute for Drugs and Medical Devices (BfArM) in Germany
• Evaluated by the Paul-Ehrlich-Institute (PEI) in Germany
• Samples: anterio-nasal swab, nasopharyngeal swab and oropharyngeal swab
• Simple test
• Reliable results
• Test results after 15 minutes
• High test capacity through minimal time investment
• Sensitivity: 96,08%
• Specificity: 99,14%
• Accuracy: 98,59%
• No cross reaction with usual influenza viruses
• Storage at 4 to 30° C
• Test execution at room temperature
• Storage life: 18 months
• Test execution location-independant and no need of a lab
• No right of return
Do you have any questions about our product or want to order the SARS-CoV-2 Antigen Test directly?
Please send an inquiry to [email protected].
• Kit contains 20 Rapid SARS-CoV-2 Antigen test cards
• 20 sterile swabs
• 20 extraction tubes
• 20 extraction buffers filled in disposable squeezing vials
• Instruction for use
• EN ISO 13485:2016
• CoA, stability studies according to EC Directive 98/79/EC
• EC- Reg. MP: NL-CA002-2020-52869 GZ: CIBG-20203899
• CFDA Number: 20100174 – valid until the 05.11.2024
• Extraction buffer for every test increases
• Approved as anterio-nasal test
• Product number
• EAN Number: 4260717030004
• PZN Number: 17212657