FDA issues Emergency Use Authorisation for molecular COVID-19 test

The Food and Drug Administration (FDA) has issued Emergency Use Authorisation (EUA) for Abbott’s molecular point-of-care-test for the detection of COVID-19.

The company claims it is the fastest available molecular point-of-care test as it can deliver positive results in five minutes, and negative results within 13 minutes.

The test will run on the company's ID NOW platform, providing results in a range of healthcare.

The ID NOW platform weights 6.6lbs, is the size of a small toaster, and uses molecular technology. 

Robert B Ford, president and chief operation officer, Abbott, said: "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. 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."

Abbott is making ID NOW COVID-19 tests available to healthcare providers in urgent care settings in the U.S., where the majority of ID NOW instruments are in use today. The company is working with the Administration to deploy tests to areas where they can have the greatest impact. 

First introduced in 2014, ID NOW is a molecular point-of-care platform for Influenza A & B, Strep A and RSV testing in the U.S.

ID NOW is an instrument-based, isothermal system for the qualitative detection of infectious diseases. Its isothermal nucleic acid amplification technology provides molecular results within minutes, allowing clinicians to make evidence-based clinical decisions during a patient visit.

Lux Research analyst Nardev Ramanathan, commented on the development, saying: "The test has received Emergency Use Authorisation from the U.S. FDA and is extremely useful to expedite the testing process. The test, however, relies on large amounts of genomic material to be present, which doesn't happen in the early stages of the infection. Interested parties should also monitor for tech that can detect smaller amounts of genomic material (with a high degree of sensitivity and specificity), which is a biomarker for the earliest stages of infection. People are asymptomatic but still infectious then and need to be identified and isolated to better flatten the curve. Tests like the one developed in Singapore promise to do this, and in under five minutes as well, but none is commercially available at the time of writing."