NEW YORK – Abbott said after the close of the market on Friday that the US Food and Drug Administration issued Emergency Use Authorization for the company's point-of-care test for detection of SARS-CoV-2.
According to the Abbott Park, Illinois-based firm, the test, which will run on its ID Now platform, can provide positive results in as little as five minutes and negative results in 13 minutes, and it can be used in a variety of healthcare settings, including doctors' offices, urgent care clinics, and hospital emergency departments.
The ID Now system leverages isothermal nucleic acid amplification for the qualitative detection of infectious diseases.
Abbott will make the ID Now COVID-19 test available next week for use in urgent care centers in the US, where the majority of ID Now instruments are placed.
The company received prior EUA for its Abbott RealTime SARS CoV-2 test for use on its m2000 platform. Abbott said that between the two platforms it expects to produce about 5 million tests per month.
"The COVID-19 pandemic will be fought on multiple fronts, and a portable molecular test that offers results in minutes adds to the broad range of diagnostic solutions needed to combat this virus," Abbott President and COO Robert Ford said in a statement. "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."