Test That Can Detect the Novel Coronavirus in 5 Minutes Receives FDA Approval

The US Food and Drug Administration (FDA) said that, for detection of the novel coronavirus (SARS-CoV-2), a test capable of giving positive results within minutes and negative results within 13 minutes had been granted emergency use authorization on March 28.

The test can provide rapid results in a wide range of healthcare settings, such as doctors' offices, urgent care clinics and hospital emergency departments.

The USA now has more coronavirus cases than other countries. Hospitals are struggling to meet the demand from thousands of people to be tested for this deadly virus.

Abbott Laboratories (the company's name) will make its COVID-19 tests available next week to healthcare providers in urgent care settings in the USA. Abbott aims to produce about 5 million tests per month. The test is authorized only for the detection of nucleic acids from SARS-CoV-2, not other viruses or pathogens (that is, a type of rapid antigen test).

In a statement, Abott said that it plans to begin distributing the test next week and increase production to 50,000 tests per day.

The portable test will be performed on the Abbott ID NOW platform. ID NOW is a rapid, instrument-based, isothermal system for the qualitative detection of infectious diseases. Isothermal nucleic acid amplification technology provides molecular results in just a few minutes, allowing clinicians to make evidence-based clinical decisions during a patient's visit.

This is the second FDA-approved test that can be used directly in doctors' offices and other community healthcare settings to give patients immediate results. An earlier test that provides results in 45 minutes, the Xpert Xpress PCR system, had already received approval.

As testing has expanded, there has been a marked increase in the number of confirmed COVID-19 cases in the USA.

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