Five minute Coronavirus test gets fast track US exemption
The Coronavirus test runs on Abbott’s portable ID NOW test system that is already used in a range of healthcare settings, from urgent care clinics to hospital emergency departments.
The molecular test, which provides a positive result for Covid-19 in five minutes and a negative result in 13 minutes, received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA). However the company highlights this is not FDA cleared or approved. It can be used by authorized laboratories and patient care settings, but only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
The test system uses a custom version of a technique called isothermal nucleic acid amplification to detect whether a patient is infected. This is faster than the more established polymerase chain reaction (PCR) that takes small amounts of the virus and amplifies it until there’s enough for detection. Up until now, PCR tests have taken over 24 hours, but automated lab systems are rolling out that can take 2.5 hours, A five minute test on a portable system dramatically increases testing capacity.
“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,” said Robert B. Ford, president and chief operating officer, Abbott. “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 says it will be making ID NOW Covid-19 tests available this week in the US where the majority of ID NOW instruments are in use today.
This comes a week after the company launched a test for hospitals and reference laboratories. The SARS-CoV-2 EUA Coronavirus test uses PCR instead and runs on the m2000 RealTime System that is used around the world. Abbott is scaling up production at its US site to reach capacity for 1 million PCR tests a month, and between the two platforms, Abbott expects to produce about 5 million tests per month by the end of April.
Another US medical equipment maker, Thermo Fisher, gained the same approval for its Covid-19 PCR test to run on its Applied Biosystems 7500 Fast Dx Real-time PCR system on 14th March. It is now making over 5m tests.
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