Boson Antigen Self-test (CE)

Specjalna oferta dla naszych polskich klientów:

W tej chwili mamy do 5 milionów testów Bosona, które możemy wysłać w ciągu 3 dni. Są one pakowane zgodnie z polskim prawem i posiadają odpowiedni certyfikat CE, aby mogły być sprzedawane w supermarketach i online do samodzielnego testowania. Minimalna ilość zamówienia to 500.000 testów w pojedynczym opakowaniu. W celu uzyskania dalszych informacji prosimy o kontakt. Ta oferta jest dostępna tylko w tym tygodniu.

The Corona antigen self-test is performed via a swab in the anterior nasal region. The result is available after approximately 15 minutes – all currently known mutations of the virus are detected. The product consists of test cassettes, swabs, vial with extraction solution, tube with dropper cap and instructions for private use. It is the first test that has obtained CE certification for self-testing at home.

SKU: Boson0021x1 Category: Tags: ,

Product Description

The Corona antigen self-test is performed via a swab in the anterior nasal region. The result is available after approximately 15 minutes – all currently known mutations of the virus are detected. The product consists of test cassettes, swabs, vial with extraction solution, tube with dropper cap and instructions for private use.

THE FIRST RAPID SELF-TEST TO DETECT THE SARS-COV-2 VIRUS THAT HAS OBTAINED CE CERTIFICATION FOR HOME TESTING

Test principle

Colloidal gold immunochromatography assay based on the lateral flow principle with nasal swab for sampling.

Study

02-2021

 (N=926)

Sensitivity96,77%
Specifity99,20%
Samplinganterior-nasal swab
Sample SizeN total = 230102 PCR-positive128 PCR-negative

 

Cross Reactivity

None of the samples that were analyzed show any cross-reactivity or interference with other pathogens or chemical substances present in the blood or plasma or other chemical substances.

Mutation Detection

Confirmed by recognition of the N protein (see PEI validation)

Details:

  • Nasal swab
  • This test is listed by the BAG for the nasopharyngeal and nasal smear!
  • BfArM listed 5640-S-007/21, approved “laientest”
  • AT Approved for home and self-applying according to §323c ABS 18 BAO
  • In vitro immunochromatographic test
  • Fast, qualitative detection of SARS-CoV-2 antigens
  • Reduces the risk of infection for the specialist staff
  • Suitable for children, the elderly or people with disabilities
  • Can also be used in the first 7 days after the onset of symptoms
  • Suitable for point-of-care supply
  • Mutants have no influence on the test result
  • Sensitivity: 96.34%
  • Specificity: 99.16%
  • Storage temperature 4–30 ° C
  • Result in 15min

Click belowe to download CE certification and Declaration of Conformity:

CE Certification Selftest

Declaration of Conformity

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