ACON, one of the professional in-vitro diagnostic products manufacturers, has announced that its Flowflex SARS-CoV-2 Antigen Rapid Test has been CE marked for self-testing. The CE certificate is issued by TUV SUD (CE0123) and validated from 14th May 2021 until 26th May 2024.
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SARS-CoV-2 Antigen tests play a critical role in the fight against COVID-19. There is emerging thinking that self-testing options could potentially support the COVID-19 response by reducing community spread, when linked to appropriate responses for isolation, contract tracing and care. In addition, modelling shows that if self-testing is performed frequently, and if patients are compliant with countermeasures, it could have a greater impact on transmission than one-time testing using more sensitive but slower laboratory-based diagnostics.
ACON Flowflex SARS-CoV-2 Antigen Rapid Test is a lateral flow test for the qualitative detection of the nucleocapsid antigen from SARS-CoV-2 in anterior nasal swab specimens directly from individuals suspected of COVID-19 within the first seven days of the onset of symptoms. The test can also test specimens from individuals without symptoms.
- Specimen: Anterior Nasal swab specimens
- Testing Time: 15-30 minutes
- Performance: Excellent performance compared to molecular methods
- Storage Temperature: 2-30 ℃
- Shelf life: 24 months
Before approved by CE for self-testing, ACON Flowflex SARS-CoV-2 Antigen Rapid Test was approved for self-testing (layperson use) in multiple European nations in recent months, like Germany, France, Austria, Netherlands, Portugal, Denmark and Czech, making Flowflex SARS-CoV-2 Antigen Rapid Test the most popular antigen test in the self-testing market.
Germany was the first country to grant special approval for self-testing (known as BfArM, Bundesinstitut für Arzneimittel und Medizinprodukte) in the world, according to Section 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. Starting at the end of February, the COVID-19 self-testing kits were selling like hot cakes in Germany. However, now there are 67 companies are listed in the self-testing list, which is confusing the market and users. There are good ones and not good ones in the list as well. With the open of CE review of the self-testing for whole European Union, we believe the gold and sand are showing.
Besides the approvals of its self-testing intended use, ACON Flowflex SARS-CoV-2 Antigen Rapid Test passed the comparative evaluation by Germany PEI (Paul-Ehrlich-Institut). And on May 10, ACON Flowflex SARS-CoV-2 Antigen Rapid Test is listed in the common list of COVID-19 rapid antigen tests by European Commission, and the Member States have agreed to mutually recognise its test results for public health measures. ACON Flowflex SARS-CoV-2 Antigen Rapid Test is one of the most reliable antigen tests in the world, and ACON becomes the world leader in Rapid Test industry, especially for SARS-CoV-2 Antigen Rapid Test.
Berapin Wu, the senior marketing manager of ACON, said: “We are proud to announce that our self-testing version of Flowflex SARS-CoV-2 Antigen Rapid Test is approved by CE, it will certainly contribute more to helping control the epidemic globally. It is an outstanding antigen rapid test with remarkable performance, which has a high sensitivity and specificity. ACON is focussing more on the Antigen Rapid Test currently and has expanded its production capacity to the top of the industry with the state-of-the-art facilities. Moreover, the capacity is still keeping expanding dramatically. At ACON, we continuously strive to develop and provide high quality tests in the fight against COVID-19, as a long-established IVD enterprise.”
References:
- Paltiel et al., 2021: https://www.medrxiv.org/content/10.1101/2021.02.06.21251270v1
- Hoehl et al., 2021: https://www.medrxiv.org/content/10.1101/2020.12.04.20243410v1
- Chin et al., 2021: https://www.medrxiv.org/content/10.1101/2020.04.30.20087015v4.full.pdf
- Larremore et al., 2020: https://pubmed.ncbi.nlm.nih.gov/33219112/
