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Corona test - antigen test for self-use - description

Test name:
COVID-19 Antigen Rapid Test Cassette(Nasal Swab)
Rapid COVID-19 Antigen Test Cassette (Nasal Swab)
REF:
ICOVN-C81H
Trade name:
RightSign®, Sienna®, Exact Sign®

Manufacturer:
Hangzhou Biotest Biotech Co.Ltd (China)

Application:
• anterior nasal swab (nasal)
• Recognizes Omikron BA.4 and BA.5
• Test for self-application / self-application

Shelf life: 24 months
Testing body: CE1434 certified
BfArM test ID: AT1331/21
Paul Ehrlich Institute: evaluated positively
EU List/ RAT List: #1876 (Health Security Committee)

Performance data according to PEI v. 04/04/2022:
Sensitivity: Cq≤25 = 100% / Cq 25-30 = 95% / Cq ≥30 = 60%
Specificity: 99.20%

Packing unit = 1PU=5 pieces/box
1 carton= 675 pcs. (135 boxes/carton)

Contents:
5x test cassettes
5x extraction buffer tube with buffer solution
5x sterile nasal swabs
5x disposable pressure bags for disposal
1x user manual (multilingual)
1x Quick Start Guide


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