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FDA clears several novel tests under Emergency Use Authorization.
While the American Medical Association and other experts say that universal novel coronavirus disease (COVID-19) testing should be in place before businesses reopen across the country, the reality is that the tests are not readily available to many Americans.
Testing availability varies from state-to-state and some patients only have access to tests once they enter the ICU, Halee Fischer-Wright, MD, president and CEO of the Medical Group Management Association, told Medical Economics.
“California has been testing, New York doesn’t have enough tests, North Carolina is in between. We do see states that really aren’t doing testing unless people are being admitted to the ICU-it’s a real 'hodge podge' across the country,” Fischer-Wright said.
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“Widespread concerns remain about the availability of testing, which is why we have urged the federal government to use its full range of resources-including the Defense Production Act-to address production and distribution challenges, American Medical Association President Patrice Harris, MD, said in an article on AMA’s web site.
And, while many are concerned about how quickly the U.S. can reopen the economy, Harris believes the important question is, “How soon we can establish robust testing for the novel coronavirus in every part of the country, which, combined with contact tracing, is necessary to monitor community spread of the virus until there is a vaccine.”
“The hope is that in the future, antibody or serology testing could help guide recommendations for loosening current stay-at-home orders by providing insights as to how much of the U.S. population has been exposed to COVID-19, and whether individuals are susceptible to re-infection. Unanswered questions remain as to whether those who have recovered from COVID-19 have immunity to the virus, and how long that immunity lasts,” Harris said.
However, first it is “critically important that we dramatically expand our testing capacity, both diagnostic and antibody testing,” Harris said. “Only through that expansion will we have the data and information necessary for public health officials to determine when it is safe to resume a semi-normal way of life.
Diagnostic testing tells us who is currently infected, so these individuals can be safely isolated to prevent further spread, while contact tracing is conducted to quarantine those who were exposed.”
Despite testing availability concerns, the FDA has stepped up its approval of COVID-19 tests-including a novel at-home test. Here are the top tests recently cleared by the agency:
1 LabCorp received Emergency Use Authorization (EUA) from the FDA for its COVID-19 test to be utilized at home by patients who receive a physician’s order-the first of its kind. Nasal swab specimens can be collected at home using the Pixel by LabCorp™ COVID-19 test home collection kit - if recommended by a healthcare provider after completing a COVID-19 questionnaire.
“You could get a note from your doctor’s office, they FedEx you, you swab yourself, and then send it back to [your doctor] and they run it,” Fischer-Wright said. “We’re starting to see some creative ways to get those tests to the right place.:
The LabCorp testing kits will initially be made available to healthcare workers and first responders who may have been exposed to COVID-19 or may be symptomatic, the company said in a press release. However, LabCorp intends to make COVID-19 self-collection kits available to consumers in the coming weeks.
“Enabling individuals to self-administer sample collection will help prevent the risk of transmitting the virus to others and reduces the demand for personal protective equipment (PPE) as the tests do not require a clinician to perform the test collection,” LabCorp said.
LabCorp did not return requests for comment from Physicians Practice.
2. The first of its kind, FDA granted emergency use authorization (EUA) to Rutgers’ RUCDR Infinite Biologics and its collaborators for a new collection approach that utilizes saliva as the primary test biomaterial.
The new saliva collection method will allow for broader population screening than the current method of nose and throat swabs, Rutgers said in a Rutgers Today article.
“The impact of this approval is significant,” said Andrew Brooks, chief operating officer and director of technology development at RUCDR. “It means we no longer have to put healthcare professionals at risk for infection by performing nasopharyngeal or oropharyngeal collections. We can preserve precious personal protective equipment for use in patient care instead of testing.”
3. Abbott Laboratories received FDA EUA for the fastest available molecular point-of-care test to detect COVID-19. The Abbott ID Now COVID-19 test displays positive results in as little as five minutes and negative results in 13 minutes.
“What makes this test so different is where it can be used outside the four walls of a traditional hospital such as in the physicians' office or urgent care clinics,” Abbott says in a press release.
The test is a lightweight box (6.6 pounds and the size of a small toaster) that can sit in a variety of locations.
4. FDA recently granted EUA to another rapid-results test: the Cepheid Xpert Xpress SARS-CoV-2 test (Cepheid).
“The test we’re authorizing today will be able to provide Americans with results within hours, rather than days like the existing tests, and the company plans to roll it out by March 30, which is an incredibly rapid timeline for such an effort,” says HHS Secretary Alex Azar in a press release.
“There is now an option for testing at the point of care, which enables patient access to more immediate results,” FDA Commissioner Stephen Hahn, MD, added.
The point-of-care testing means that results are delivered to patients in the patient care settings such as hospitals, urgent care centers, and emergency rooms, instead of samples being sent to a lab, Hahn noted.