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The COVID-19 Nasal Swab Test is approved by the European Commission as a self-test. A self-test means that anyone can take the test and that the rapid tests are for sale in supermarkets and pharmacies. A short nose swab and 15 minutes later you will know if someone is contagious with the corona virus.
This product is an immunoassay strip that uses highly sensitive monoclonal agents antibodies to detect the nucleocapsid protein (N protein) in SARS-CoV-2 viral particles. When a sample is added to the loading pad on a test card, it will migrate through the strip under capillary effect. If the N protein is present in the sample, it will bind with N protein antibody coated on the red colloidal gold particles on the strip to form a group of red complexes. These complexes are further accumulated by another N protein antibody coated on the test line (T line), resulting in a red band on the T line. As a control, a red band will always appear on the control line (C line), indicating that the correct volume of sample has been added to the test card.
Below is an instructional video that explains how this self-test is administered.
Just like Abbott, Roche, and Quidel, this test is registered in Europe and in possession of a valid CE and TüV certificate. This test also meets the minimum requirements of the RKI and PEI (the German RIVM) and is included in the BfArM list. The Federal Institute for Drugs and Medical Devices is an independent higher federal authority within the portfolio of the Federal Ministry of Health in Germany. The NewGene rapid test is registered in several countries including France, Italy, Portugal, Czech Republic, Belgium, Greece, Peru, and Argentina. And more countries (including Switzerland) are busy validating this easy quick test. CE certification for use as a consumer self-test has been requested.
Goffin Molecular Technologies is not liable for incorrect use, storage, results, and explanation of the rapid test and any resulting calamities.
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After completion, Goffin Molecular Technologies will contact you as soon as possible.