The Food and Drug Administration on Wednesday authorized the first over-the-counter, at-home coronavirus test kit for consumers. Lapcorp’s Pixel COVID-19 Test Home Collection Kit is intended for use by anyone 18 years of age or older and allows people to self-collect a nasal swab sample at home and send it to Labcorp for testing. If the results are positive, or considered invalid, the client receives a call from the health care provider. Negative results are developed via email or portal online portal.
The kit is available for purchase either online or in-store.
The test requires no prescription.
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“This is the first kit for consumers to self-collect nasal samples for their home COVID-19,” said Jeff Schurren, director of the FDA’s Center for Devices and Radiological Health, in a press release. Was on the FDA website. “While many home storage kits can be suggested with a simple question naline questionnaire, this new authorized direct-to-consumer collection kit removes that step from the process, anyone collecting their samples and sending them to the lab for processing. . “
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The agency’s second self-test kit was approved about a month after the Emergency Use Author Theory (EU) was issued, but requires a prescription. Lucira COVID-19 All-in-One Test Kit is authorized for home use with self-collected nasal swabs for individuals 14 and older who have been infected with COVID-19 by their health care provider. It was also authorized for all age point-of-care settings, but samples of patients under 14 must be collected by a health care provider.
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Unlike Labcorp’s testing, Lucira doesn’t need an outside lab.
