The FDA has authorized Abbott to market the BinaxNOW COVID-19 Ag CARD, a kit for the rapid diagnosis of Covid-19 through a nasal swab, for emergency use (EUA).
The kit consists of nasal swabs, reagent and diagnostic cards. The healthcare professional opens the card which is the size of a credit card, adds the reagent, performs the nasal swab to the patient, inserts the swab into the card, closes it and in 15 minutes reads the result.
The test has a sensitivity of 97.1% and a specificity of 98.5%.
Together with BinaxNOW COVID-19 Ag CARD Abbott also introduced NAVICA, a new app for iPhone and Android devices that allows people to store, access and view BinaxNOW test results.
If the test is negative, the app displays a temporary digital pass encrypted with a QR code, similarly to an airline boarding pass. The pass will be renewed every time a person takes a new test and receives a negative result and will include the date of the last test result.
The NAVICA app can be downloaded for free in the United States from the App Store and Google Play Store. After downloading the app, just enter some basic information to activate the software. The whole process takes about two minutes.
The data that the NAVICA app transmits is encrypted. Users share first and last name, e-mail address, phone number, postal code and date of birth.
A very interesting aspect of this test is the price. Abbott said he will sell the tests for $5 each.
Abbott plans to produce over 50 million kits per month starting in October. At the present, marketing is limited to the US.
At this link you can download the technical document submitted to the FDA.