SARS-CoV-2 Antigen Rapid Test
Providing an aid in early diagnosis of individuals who are suspected of COVID-19 by their healthcare provider and who are asymptomatic.
Providing an aid in early diagnosis of individuals who are suspected of COVID-19 by their healthcare provider and who are asymptomatic.
Hangzhou, China, Apr. 8, 2021 – ACON, one
of the professional in-vitro diagnostic products manufacturers, announced today
that its Flowflex SARS-CoV-2 Antigen Rapid Test has been granted for Self-testing
by the Germany Federal Institute for Drugs and Medical Devices (Bundesinstitut
für Arzneimittel und Medizinprodukte, BfArM), and it has been included in the BfArM
Self-testing List according to §11 paragraph 1 of the German Medical Devices
Act (MPG) of antigen tests for self-administration by laypersons (self-tests)
for the detection of SARS-CoV-2.
Link: https://www.bfarm.de/DE/Medizinprodukte/Antigentests/_node.html
Moreover, on Apr. 1, 2021, the Netherlands Minister
of Medical Care and Sport granted ACON an exemption from the provisions in
article 3, paragraph 1 and article 7 of the Decree on in vitro diagnostic
medical devices (IVDs) with respect to making available and distributing the
Flowflex SARS-CoV-2 Antigen Rapid Test as a self-test for which no CE
certificate has (yet) been issued.
Link: https://www.rijksoverheid.nl/ministeries/ministerie-van-volksgezondheid-welzijn-en-sport/documenten/besluiten/2021/04/01/ontheffing-acon-biotech-flowflex-sars-cov-2-antigen-rapid-test
ACON Flowflex SARS-CoV-2 Antigen Rapid Test
is a lateral flow chromatographic immunoassay for the qualitative detection the
nucleocapsid protein antigen from SARS-CoV-2 in nasal, saliva and
nasopharyngeal swab specimens directly from individuals who are suspected of
COVID-19 by their healthcare provider within the first seven days of the onset
of symptoms. The SARS-CoV-2 Antigen Rapid Test can also test specimens from
asymptomatic individuals.
• Nasal, Saliva and Nasopharyngeal swab specimens
• Results in 15 minutes
• Excellent performance compared to molecular methods
• Room temperature storage
ACON Flowflex SARS-CoV-2 Antigen Rapid Test has a high sensitivity and specificity, with the accreditation by Paul-Ehrlich-Institut (PEI), the quality and performance are therefore highly reliable. At ACON, we continuously strive to develop high quality solutions for fighting against COVID-19, which is the corporate social responsibility as a long-established IVD enterprise.