EUA (US Emergency Use Authorization) & FDA (Food and Drug Administration) for the fastest available molecular Lab-In-A-Box that checks for novel coronavirus detection (COVID-19), producing positive results in as little as five minutes and negative results in 13 minutes.
The key is the use of molecular testing that targets a small portion of the RNA of the SARS-CoV-2 virus and amplifies the segment until there is enough to detect it. Certain methods of testing can take hours or days to yield viable results.
Testing was one of the early issues facing the U.S. in coping with the coronavirus pandemic, the country has lagged behind other nations internationally in terms of per capita monitoring, which experts believe has hindered its ability to monitor and control the spread of the virus and its related respiratory disease properly.
Abbott said it was partnering with the U.S. government to apply assessments to locations where they may have the biggest effect, including emergency rooms.
“With rapid testing on ID NOW, healthcare providers can perform molecular point-of-care testing outside the traditional four walls of a hospital in outbreak hotspots. Because of its small size, it can be used in more non-traditional places where people can have their results in a matter of minutes, bringing an alternate testing technology to combat the novel coronavirus.”said Robert B. Ford, president, and chief operating officer, Abbott.
The FDA issued an emergency permit for use against COVID-19 to the molecular system and Abbott said it is currently ramping up production with plans to produce 50,000 tests a day beginning next week.
The FDA also said the device can be used to check swabs directly taken straight to the machine from the patient’s nose or throat as well as stabilized nasal, nasopharyngeal, or throat swabs in viral transport media.
Among those unaware, the US has outstripped China and Italy with the largest number of confirmed cases of coronavirus reaching over 257,379 and over 6,558 deaths.