HOTGEN Coronavirus (2019-nCoV) Antigen Test for Nonprofessionals 1 Box

Antigenic lay test for COVID-19

Hotgen’s Coronavirus (2019-nCoV) antigen test is an in vitro immunochromatographic test for the determination of coronavirus antigen using a nasal swab.

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

The coronavirus (2019-nCoV) antigen 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”.

Individually packed with individual buffer solution for each individual test.

For use as a self-test from 18 years of age. For children under 18 years of age, either a parent or guardian performs the test or the test is performed under their supervision.

• High accuracy, specificity and sensitivity
• Sample material: Nasopharyngeal swab
• Identification of acute infection
• CE certification CE 0123
• CE certified and reimbursable test listed at the Federal Institute for Drugs and Medical Devices according to the Coronavirus Test Regulation (TestV): List of Antigen Tests – Test ID: AT1236/21
• Listed and validated: Paul Ehrlich Institute
• Easy handling all in one kit
• Rapid result in 15 minutes
• Results are easy to read
• Storage at room temperature
• Test for professional use only

Clinical evaluation

• Sensitivity: 95.37%
• Specificity: 99.13%

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.