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| 1 minute read

Faster COVID-19 Tests Approved

Today, as has been happening all this past week, several large commercial diagnostic labs have launched what they say are super-fast COVID-19 tests that the labs can each rapidly scale-up to tens of thousands of results per day by April 1st.

The tests are expected to take between 5 minutes (announced today, by Abbott Labs) and 45 minutes (announced 6 days ago, by Cepheid) both of which beat the 3 hours (announced 8 days earlier, by Roche).

The U.S. is presently conducting approximately 80,000 tests per day and experts say it needs to be performing approximately 160,000 per day.

Some of the new tests are so fast, and are so much less invasive, they can be self-administered in any clinical setting, using medical devices the size of a toaster, instead of the complex sampling methods that had to be shipped to designated labs. Some are even amenable to a drive-up setting, letting personal protective equipment (PPE) remain in the clinical setting for healthcare workers treating COVID-19 inpatients. 

The new diagnostic tests have each been fast-tracked through the U.S. Department of Health and Human Services Food and Drug Administration (FDA) in their emergency approval process, which finally kicked into high gear just about a week ago, in what some viewed as a late response to the pandemic crisis and national state of emergency. 

There are also 29 different private companies currently working on a serology test, which is a test to look for COVID-19 antibodies, present in people who have had the virus and recovered. Those tests are also getting emergency approval and also have not been through rigorous validation procedures. Their results cannot be guaranteed and are coming with serious warnings. The hope is that serology testing could provide valuable population health information to health departments, enable recovered individuals to know they are recovered, let doctors learn for certain whether patients can catch it again or not, and if not, to go back to work. 

Perhaps most importantly, antibody treatments are being tried on coronavirus patients under “compassionate use” exceptions to FDA’s usual slow approval process, along with experimental anti-malarial drug cocktails. Viral antibody treatments for other viruses have historically been helpful in shortening the duration and severity of the illness in the newly infected, and other countries have said they believe the anti-malaria drug is helpful, though largely manufactured in India, the drug is no longer being exported from that country. 

At this point it is all hands on deck to battle this novel coronavirus. 

“[C]ompanies producing medical devices with even faster testing capabilities are racing to receive approval from the FDA.”