The US Federal Food and Drug Administration (FDA) announced the authorization of the first covid-19 diagnostic test to be done at home instead of moving to a medical center.
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In a statement, the FDA announced that the covid-19 RT-PCR test manufactured by the Laboratory Corporation of America (LabCorp) will consist of kits that can be used by patients at home to collect samples and send them for analysis.
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“Throughout this pandemic, we have been facilitating the development of tests to guarantee patients access to accurate diagnoses,” said the FDA commissioner, Stephen Hahn. “Specifically, for tests that include collecting samples at home, we work with LabCorp to ensure that data from samples collected at home are as safe and accurate as data from a doctor’s office, hospital or other testing site, “he added.
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The kits will be offered through the company’s Pixel platform and will initially be available to healthcare workers and emergency personnel who may have been exposed to the virus.
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How will they work?
This LabCorp molecular test test allows you to analyze a sample collected from the patient’s nose using a kit containing nasal swabs and saline.
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Once patients take a swab to collect their nasal specimen, they should place it in the solution and then mail it, in a sealed package, to a LabCorp laboratory for analysis.
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The lab said it will seek to make home kits available to patients in most states’ Pixel ‘by LabCorp covid-19 Test.
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<iframe class = "_ 3ndsl" height = "0" srcdoc = "
We received approval from @US_FDA to perform # COVID19 tests using an at-home collection kit. These kits reduce the need of #PPE used by healthcare workers. Initially, kits will be made available to frontline healthcare workers and first responders. https://t.co/X4XQmHDxRN pic.twitter.com/vKsKucclif
– LabCorp (@LabCorp) April 21, 2020
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They indicated that it may be requested with a medical order in the next few weeks.
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The home kit includes a specific cotton swab for patients to use to collect their sample.
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Not any swab, not any test
Not all swabs are the same for a test.
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So due to sterility and cross reactivity due to the genetic material inherent in cotton swabs, Other cotton swabs should not be used with this test at this time.
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FDA clarifies that “this authorization only applies to the specific test” of LabCorp and that “It is not a general authorization for home collection of patient samples using other swabs, other media, or tests, performed entirely at home.”
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The priority, health workers
The laboratory notes in a statement that the FDA’s Emergency Use Authorization (USA) allows progress in test delivery if recommended by a healthcare provider after completing a questionnaire linked to the coronavirus.
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They emphasize that this development is part of the “effort” to “increase the supply and availability of tests for healthcare workers” who have symptoms consistent with covid-19. Those workers are the priority.
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