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, March 23, 2021 – ACON, one of the professional in-vitro diagnostic products manufacturers, announced today that its Flowflex SARS-CoV-2 Antigen Rapid Test has passed the comparative evaluation by Germany PEI (Paul-Ehrlich-Institut), and it has been included in the list “Comparative evaluation of the sensitivity of rapid SARS-CoV-2 antigen tests” of the PEI (Paul-Ehrlich-Institut).*
In November, 2020, ACON Flowflex SARS-CoV-2 Antigen Rapid Test was listed in the BfArM antigen tests list, which fulfils all the minimum criteria for antigen tests laid down by the Paul-Ehrlich-Institut in consultation with the Robert Koch-Institut (RKI), as well as for refunding pursuant to the Coronavirus 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 tests in the fight against COVID-19, which is the corporate social responsibility as a long-established IVD enterprise.
About Paul-Ehrlich-Institut (PEI)
The Paul-Ehrlich-Institut (PEI), the Federal Institute for Vaccines and Biomedicines, in Langen near Frankfurt/Main is a senior federal authority reporting to the Federal Ministry of Health (Bundesministerium für Gesundheit, BMG). It is responsible for the research, assessment, and marketing authorisation of biomedicines for human use and immunological veterinary medicinal products. Its remit also includes the authorisation of clinical trials and pharmacovigilance, i.e. recording and evaluation of potential adverse effects.
The Germany Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) and the Paul-Ehrlich-Institut are the authorities that provide information on SARS-CoV-2 test systems. The information materials complement each other. The legal framework for this, among other things, is the Coronavirus Test Regulation (Coronavirus-Testverordnung, TestV).