Abbott’s $5, 15-Minute BinaxNOW COVID-19 Antigen Test Receives FDA Emergency Use Authorization Amid Global Surge to Over 24 Million Cases
Aug 27, 2020 15:28
CST Updated
15:28
Abbott
Diagnostic and pharmaceutical product manufacturers
FDA
U.S. Food and Drug Administration
August 27, 2020 News /Bio ValleyBIOON/ -- Currently, the COVID-19 pandemic is still spreading rapidly worldwide. According to Baidu's "Real-time Epidemic Situation of Novel Coronavirus Pneumonia"Big DataReport》, as of 15:00 on August 26, 2020,Global Cumulative Confirmed Cases Exceed 24.33 Million, with over 829,000 deaths. Among them,The cumulative number of confirmed cases in the United States has exceeded 6 million., with 183,000 deaths. Rapid identification of COVID-19-infected individuals is crucial for epidemic prevention and control.
Recently,Abbott(Abbott) announced that the U.S. Food and Drug Administration (FDA) has been conducted on the company's developedBinaxNOW COVID-19 Ag CardGranted Emergency Use Authorization (EUA). This test card can detect the novel coronavirus (SARS-CoV-2) from nasal swabs of patients suspected of having COVID-19.Nucleocapsid Protein AntigenPerform qualitative testing.
This test card usesAbbott's mature lateral flow technology requires no instruments or equipment, delivering results in just 15 minutes.. Submitted toFDAIn the data, a clinical study conducted by Abbott in collaboration with several top research universities in the United States showed that among patients suspected by healthcare providers of being infected with COVID-19,Within the first 7 days prior to symptom onset,BinaxNOW COVID-19 Ag Card testSensitivity was 97.1% (positive agreement rate), and specificity was 98.5% (negative agreement rate).
The selling price of this test card is$5,PossessingHighly portable (approximately the size of a credit card)and affordability. As no equipment is required, this test card will become an important tool for managing risk during the COVID-19 pandemic,It can serve as the first line of defense to rapidly identify infected individuals and isolate them, thereby preventing transmission of the disease to others.
Abbott will also launch a companion app for iPhone and Android devicesMobile Application (app）NAVICA，This is the first app of its kind, and it will be offered free of charge. In crowded settings, when organizations such as workplaces and schools request it, the app will allow individuals with negative test results to display a temporary digital health pass that shows their BinaxNOW test result to organizational staff. The pass, along with the date of the test result, will be updated each time the individual is tested through a healthcare provider. Organizations will be able to view and verify the information displayed on mobile devices, facilitating entry into facilities in conjunction with other measures such as hand hygiene, social distancing, enhanced cleaning, and mask-wearing.
Abbott plans to distribute tens of millions of test cards in September, reaching a monthly capacity of 50 million test cards by early October. Since April this year, the company has invested hundreds of millions of dollars in two new factories in the United States for large-scale production of BinaxNOW.
Robert B. Ford, President and Chief Executive Officer of Abbott, stated: “We intentionally designed the BinaxNOW test and the NAVICA app to provide a comprehensive testing solution that helps Americans feel more confident about their health and daily lives. Together, BinaxNOW and the NAVICA app offer an affordable, easy-to-use, and scalable testing option, along with a complementary digital health tool that helps us return to a greater sense of normalcy in our everyday lives.”
Dr. Joseph Petrosino, Chair of Molecular Virology and Microbiology at Baylor College of Medicine, stated, “The large-scale rollout of this test card and app will enable tens of millions of people to access rapid and reliable testing. Laboratory-based tests offer excellent sensitivity, but it may take several days or even longer to obtain results. In contrast, rapid antigen tests provide immediate results, allowing infectious individuals to leave public spaces and enter isolation, thereby preventing further viral transmission.” (Bioon.com)