Rapid COVID-19 Antigen Test (for current infection)

Essential information about the COVID-19 Rapid Antigen Test

This COVID-19 rapid antigen test is a very sensitive and specific in vitro diagnostic medical device for detecting coronavirus SARS-CoV-2. It is clinically validated and certified for professional use.

The test can help you to determine if an individual is currently infected with the coronavirus SARS-CoV-2.

Frequently asked questions about the COVID-19 antigen test

What does the testing kit include?

Testing kit includes all the tools needed to perform 20 analysis.

20 testing devices
20 sterile swabs
20 extraction tubes
20 nozzles with filter
20 ampoules with extraction buffer
Workstation
Instructions for use

What are the performance characteristics of this coronavirus test?

Clinical performance evaluation study compared results of this test against 603 confirmed cases with PCR.

Diagnostic sensitivity: 97.09%
Diagnostic specificity: 99.99%
Overall agreement: 99.17%

Can individuals buy the test?

No. Only legal entities can buy the test.

Who can use the rapid COVID-19 antigen tests?

These tests are for professional use only. This means that only medical healthcare professionals can carry out the analysis.

Rapid antigen test for current infection with SARS-CoV-2

These rapid tests detect SARS-CoV-2 antigen. Therefore they are beneficial in screening of current infection with the coronavirus SARS-CoV-2. It is best to carry out the analysis in a time of high viral load, as ECDC summarized:

Rapid antigen tests perform best in high viral load cases, in pre-symptomatic and early symptomatic cases, up to five days from symptom onset.¹

If you may need to know if a person was infected in the past, please have a look at the COVID-19 Antibody Test.

¹ European Centre for Disease Prevention and Control. Options for the use of rapid antigen tests for COVID-19 in the EU/EEA and the UK. 19 November 2020. ECDC: Stockholm; 2020.

Did you know? Based on research data, patients develop symptoms of COVID-19 typically within 5-6 days after the initial exposure to the virus. The SARS-CoV-2 load is at its peak at the time of symptom onset or in the first week of illness.²

² Cevik Muge, Kuppalli Krutika, Kindrachuk Jason, Peiris Malik. Virology, transmission, and pathogenesis of SARS-CoV-2 BMJ 2020; 371:m3862

Accuracy and reliability of the COVID-19 antigen test

Clinical performance evaluation study compared results of this test against 603 confirmed cases with PCR.

Diagnostic sensitivity: 97.09%
Diagnostic specificity: 99.99%
Overall agreement: 99.17%

This rapid antigen test is manufactured according to the ISO 13485 and CE certified for professional use. It complies with the European directive 98/79/EC on the in vitro diagnostic medical devices in every aspect.

It is very easy-to-use. Specialized laboratory personnel or equipment is not required.

Fast 3-step testing procedure

Using these tests is simple but pay special attention to the proper specimen collection.

Collect a specimen.
Mix specimen with the extraction buffer.
Apply the extract on the testing device.

Then wait 15 minutes to read the result.

The possibilities of utilizing these rapid antigen tests are various. For instance, tests can be easily included in a testing routine anywhere outside the hospital setting because they do not require any special instruments.