DE
Listed by the Federal Institute for Drugs and Medical Devices (BfArM) as a self-test for self-testing under antigen tests for direct pathogen detection of the coronavirus SARS-CoV-2.
The RightSign®/Sienna® COVID-19 Antigen Rapid Test Cassette (Nasal Swab) is a nasal swab self-test for the detection of infection with the virus causing Covid-19. The test consists of antibodies that are able to recognise the antigens of the virus responsible for Covid-19. It allows rapid and efficient detection of infection with the coronavirus (SARS-CoV-2) within 10-15 minutes.
Test for coronavirus quickly and easily at home. The RightSign®/Sienna® antigen self-test is particularly easy to perform and therefore predestined for self-testing. All necessary test materials are included in the scope of delivery. A laboratory and other utensils are not required, which is why the test is also ideal for use at the so-called point-of-care.
- Reliable self-test
- Test result after only 10-15 minutes
- Can be carried out anywhere and at any time
BfArM test ID: AT1331/21
EU list/ RAT list: #1876 (Health-Security-Committee)
Paul-Ehrlich-Institut: positively evaluated
Performance data according to PEI v. 31.01.2022:
Sensitivity: Cq≤25 = 100% / Cq 25-30 = 95% / Cq ≥30 = 60%
Overall sensitivity: 90%
Clinical sensitivity: 93.2%
Clinical specificity: 99.2%
Accuracy: 97.5%
LOD:1000TCID/50ml
Recognition:
BA.4 & BA.5(Omicron), B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), P.1 (Gamma)
Name: COVID-19 Antigen Rapid Test Cassette (Nasal Swab)
Manufacturer's ref: ICOVN-C81H
Trade name: RightSign®, Sienna®, Exact Sign®
Manufacturer: Hangzhou Biotest Biotech Co Ltd.
Application: anterior nasal swab (Nasal)
Test for self-testing - CE1434
Scope of delivery 1pcs softbag:
1x Test cassettes
1x Extraction buffer tube with buffer solution
1x Sterile swabs
1x Disposable pressure bag for disposal
1x Instructions for use
1x Brief instructions
Packaging unit = 1VE=1pcs/softbag // 1 carton= 500pcs.
Scope of delivery box of 5:
5x Test cassettes
5x Extraction buffer tubes with buffer solution
5x Sterile swabs
5x Disposable pressure bags for disposal
1x Instructions for use
1x Brief instructions
Packaging unit = 1VE=5pcs./box // 1 carton= 675pcs. (135boxes/carton)
