The FDA has authorized its first COVID-19 diagnostic for the purpose of broad-based screening. This would include people who haven’t shown any symptoms and those who don’t suspect having come in contact with someone suffering from COVID-19.
Previously, the agency’s testing green lights were only meant for people having early signs of an infection, like fever, high-risk individuals and front-line healthcare workers. Primarily to conserve testing resources and because most diagnostics hadn’t been proven accurate to screen large numbers of people, without unacceptable numbers of false positive and negative results.
The new regulatory expansion has been given to LabCorp’s coronavirus diagnostic test, first authorized by the FDA in mid-March. The agency has endorsed its use for batch testing and it allows up to five samples to be combined and analyzed in a go to stretch testing supplies and quicken the screening efforts.
Commissioner Stephen Hahn, M.D. said that FDA’s authorization of the first diagnostic test is used for anyone, irrespective of whether they show symptoms of COVID-19 or have other factors of exposure to risk. This is a step towards a type of broad screening that may enable the reopening of schools and workplaces.
In the last week, the FDA issued its first emergency authorization for pooled testing to Quest Diagnostic in order to prepare a new, long-term surveillance phase in the U.S. as its response to the pandemic. LabCorp and Quest together provide more than half of the country’s commercial lab testing services.
But the batch testing strategy is best for areas with a low prevalence of the virus. It reserves tests for individuals until after the first pass returns with a positive result.
COVID-19 infection rates are surging at present in many areas across the U.S. with many new infections per day.
Both Quest and LabCorp tests at present need a prescription, and LabCorp said negative results from pooled tests should not be considered as definitive because the method can make the test less sensitive. In fact, only swabs that are collected by a healthcare professional can be tested as a batch.