(RTTNews) - Abbott Laboratories said Wednesday that it has received an Emergency Use Authorization from the U.S. Food and Drug Administration for a COVID-19 portable antigen test that will deliver results within 15 minutes. It will be priced at $5.
The company's BinaxNOW COVID-19 Ag Card is about the size of a credit card and requires no additional equipment to operate. It uses lateral flow technology with demonstrated sensitivity of 97.1% and specificity of 98.5% in clinical study.
The device will be an important tool to manage risk by quickly identifying infectious people so they don't spread the disease to others, the company said in a statement.
The company said it will ship tens of millions of tests in September, ramping to 50 million tests a month at the beginning of October.
Abbott also said it will offer a mobile app at no charge that will allow people to display their results obtained through a healthcare provider when entering facilities requiring proof of testing. The app is supported by Apple and Android digital wallets and will be available from public app stores in the U.S.
If test results are negative, the app will display a digital health pass via a QR code, similar to an airline boarding pass. If test results are positive, people will receive a message to quarantine and talk to their doctor, the company said.
The company noted that the digital health pass is stored in the app temporarily and expires after the time period specified by organizations that accept the app.
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