FDA approves first COVID-19 home test
The molecular single-use test provides a positive or negative result in 30 minutes after swirling a nasal swab in a vial linked to a portable test unit. The Food and Drug Administration’s emergency authorization announced Tuesday would require a prescription to access the kit. The agency mandated health providers to report all home test results. Lucira Health, the California-based test manufacturer, said the kit would cost less than $50.
How effective is the test? It uses technology similar to the standard laboratory genetic tests. Lucira said it adapted its research on at-home flu tests to detect COVID-19 after the pandemic began. The FDA did not reveal any details on the regulators’ assessment of the test.
Dig deeper: Read Katie Gaultney’s WORLD Magazine report on rising coronavirus cases.
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