Clungene COVID-19 Antigen Self-Test with Certificate – Box of 5

Back to normality with the digital certificate

identyME is the first product based on international standards that makes certified home testing easy and safe for everyone.

This offer includes identyME QR code sticker and CLONGEN COVID-19 antigen test (layman).

With identyME, you can create COVID-19 test certificates from the comfort of your home or a location of your choice and do not need to go to a testing station. Simply register the test using the free www.identyme.app application. And after 15 minutes, you will receive a valid certificate that you can use to attend events, restaurants and travel. Accredited by the Austrian Ministry of Health, identyME can be used across borders in the entire EU region *.

The smart certification system for digitised COVID-19 tests.

• Easily and conveniently decentralised from anywhere
• Complete documentation of every test
• 100% GDPR compliant
• Digital certificate within minutes
• Use for e.g. travel, hospitality and events
• At least 24h-valid within the EU *
• Flexibly integrable into other systems

Antigen lay test for COVID-19

.
The COVID-19 Antigen Rapid Test from Hangzhou Clongene Biotech Co, Ltd. is a lateral flow immunoassay method for the qualitative detection of SARS-CoV-2 nucleocapsid antigens using an anterior nasal swab.

The ANTIGEN lay test simplifies sampling considerably, as the swab can be taken in the nasal vestibule (short nose, “nasal drill test”) at a depth of only 1.5 cm in the nose..

To do this, a sample is taken from the front of the nose and applied to a test cassette. The test works according to the lateral flow principle and indicates within 15 minutes whether COVID-19 antigens could be detected in the sample. After 30 minutes, the displayed result is invalid.

Packaged individually in a 5-pack (box) with individual buffer solution for each test.

• High accuracy, specificity and sensitivity
• Sample material: nasopharyngeal swab
• Reliably rule out Sars-CoV-2 infection with high accuracy
• CE certified and reimbursable test listed at the Federal Institute for Drugs and Medical Devices according to the Coronavirus Test Ordinance (TestV): List of Antigen Tests – Test ID: AT373/21,
• File number of the special approval of the BfArM, for self-administration by laypersons (self-tests): 5640-S-168/21.
• Easy handling everything from one set
• Quick result easy to read in 15 minutes
• Store at room temperature

The COVID-19 antigen rapid test fulfils the minimum criteria of the RKI and PEI for SARS-CoV-2 antigen tests in the sense of § 1 para. 1 sentence 1 TestVO and is listed on the BfArM list under the number AT282/21 of the “Antigen tests for direct pathogen detection of the coronavirus SARS-CoV-2”.

Clinical evaluation

• Sensitivity: 91.4 %
• Specificity: 99.4 %

Scope of delivery:

• identyME QR code with instructions
• Coronavirus antigen test cassettes
• Sterile swabs
• Sampling tubes with cap and included extraction buffer
• Packaging insert

How to handle the test result

Please follow the instructions for handling your test result!

• POSITIVE: COVID-19 infection is currently suspected. Please contact your doctor/family physician or local health department immediately. Please comply with local guidelines for self-isolation and have a PCR confirmation test performed.
• NEGATIVE: Please continue to comply with all applicable rules regarding contact with others as well as applicable protective measures – even if the test is negative, an infection may be present! In case of suspicion, repeat the test after 1-2 days, as the coronavirus cannot be detected accurately in all phases of an infection.
• INVALID: Possibly caused by incorrect test performance – Please repeat the test. If test results remain invalid, contact physician or COVID-19 testing centre.

Return excluded.