The FDA has backed the first COVID-19 diagnostic with a home collection option, at a time when the US is struggling to keep pace with the pandemic and suffering from a shortage of tests.
The regulator has reissued a previous Emergency Use Authorisation for the LabCorp (Laboratory Corporation of America) PCR test to permit testing of samples self-collected by patients at home using a special kit.
LabCorp’s test works by testing for the presence of the SARS-CoV-2 coronavirus in the body, as the US plays catch-up with its COVID-19 testing effort.
This allows for testing of samples collected from a patient’s nose using the designated kit, which contains nasal swabs and saline.
Once patients self-swab to collect their nasal sample, they mail their sample, in an insulated package, to a LabCorp lab for testing.
LabCorp intends to make its Pixel home test kit available to consumers in most states, with a doctor’s order, in the coming weeks.
The LabCorp home self-collection kit includes a specific Q-tip-style cotton swab for patients to use to collect their sample.
Due to concerns with sterility and cross-reactivity because of inherent genetic material in cotton swabs, other cotton swabs should not be used with this test at the present time.
The FDA said it is working with other developers to determine whether or not a Q-tip-style cotton swab can be used safely and effectively with other tests.
Last month a group of companies had to stop selling home test COVID kits directly to customers after the FDA clamped down on products that had not yet been authorised.
The shortage of tests in the US stems from a decision by US authorities to run with a test developed by the Centers for Disease Control (CDC) instead of using a protocol developed by the World Health Organization when the outbreak began to spread in January.
Unfortunately the CDC test was found to be inconclusive shortly after it reached labs.
Hopes that so-called herd immunity may pave the way for exits from lockdowns across the world were dealt a blow yesterday after the World Health Organization said only a tiny proportion of the global population had been infected so far.
It estimated that as few as 2% or 3% appear to have antibodies in the blood showing that they have been infected with COVID-19 and are possibly immune.