At-Home COVID-19 Test Kit Receives Emergency Approval

A California company says it has received emergency use authorization from the U.S. Food and Drug Administration for consumers to use its COVID-19 test kit at home, which takes 30 minutes and costs $55.

Signage for U.S. Food and Drug Administration
(TNS) — A California company says it has received emergency use authorization from the U.S. Food and Drug Administration for consumers to use its COVID-19 test kit at home.

Lucira Health, a medical technology company, said the over-the-counter test kit can deliver accurate results in 30 minutes or less at home.

The cost of the test is $55.

Lucira said, “Each single-use test kit contains everything needed to conduct one COVID-19 test. It can detect a positive result in as few as 11 minutes or confirm a negative result within 30 minutes. It was designed and tested extensively for individuals to use independently and does not require a physician’s prescription or telehealth/supervised assistance.”

The Check It test kit has a “swab, stir and detect” process that Lucira during trials “100% of users successfully performed the test in about 2 minutes.”

“Molecular tests are more sensitive than antigen tests because they amplify critical parts of the viral target. The targeted, molecular amplification that Lucira CHECK IT and PCR tests employ makes them demonstrably more sensitive and reliable than ‘rapid’ antigen tests, which can miss active COVID-19 infections,” Lucira said.

The test kit includes the test device, two AA batteries, a sample vial, swab and instructions.

To use the test, consumers must swab both nostrils. The swab is stirred in a sample vile, which is then pressed into the unit to start the test.

“The ‘ready’ light will blink until a ‘positive’ or ‘negative’ green light is illuminated within 30 minutes,” Lucira said.

The same prescription test kit is still available for sale to health care providers.

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