Kauneustori
Rapid antigen test for COVID-19 (SARS-CoV-2) Corona
Rapid antigen test for COVID-19 (SARS-CoV-2) Corona
Noutomyymälä Espoo
Sinikalliontie 3
02630 Espoo
Finland
The SARS-CoV-2 antigen rapid test is a one-step in vitro test based on immunochromatography.
The rapid test has been developed for quick, easy and reliable antigen determination of the SARS-CoV-2 virus from a sample taken from the front of the nose of a person suspected of having COVID-19 within seven days of the onset of symptoms. The result of the sample is ready in about 15 minutes. The test is well suited for home use. The product is CE-marked and contains clear instructions for use in Finnish. More information about corona home tests and procedures after the corona test on THL's website.
Purpose
The Healthwing SARS-CoV-2 Antigen Rapid Test is a one-step in vitro test based on immunochromatography. It is designed for rapid qualitative
For the determination of the antigen of the SARS-CoV-2 virus, the first seven
within a day of the onset of symptoms. The SARS-CoV-2 antigen rapid test should not be used as the sole basis for diagnosing SARS-CoV-2 infection or
to exclusion. Adults must assist with tests performed by children under the age of 14.
Contents of the package
Supplies 1 test/pack 5 tests/pack 20 tests/pack
SARS-CoV-2 antigen rapid test card (sealed foil bag) 1 5 20
Sterile cotton swab 1 5 20
Extraction tube 1 5 20
Extraction solution 1 5 20
Instructions for use (this appendix) 1 1 1
Pipe holder 1 (package) 1 1
PERFORMANCE (SENSITIVITY AND TARGETING)
The SARS-CoV-2 antigen rapid test card was compared with a confirmed clinical diagnosis. 156 samples were tested in the study.
Sensitivity 96.77%
Targeting 99.20%
Accuracy 98.72%
The feasibility study produced the following results:
- 99.10% of non-professional users completed the test successfully by themselves
- 97.87% of the different results were interpreted correctly
