FDA approves first home testing kits for coronavirus

FDA approves first COVID-19 at-home collection kit

Stephen Hahn, the commissioner of the Food and Drug Administration, joined President Donald Trump and Vice President Mike Pence at Friday’s coronavirus task force briefing.

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It was at the briefing that Trump announced the FDA has approved the first at-home testing kit for COVID-19.

The test, developed by Lab Corp, received an Emergency Use Authorization by the FDA April 21. It allows nasal swab specimens to be collected at home using an at-home collection kit.

Stephen Hahn, commissioner of the U.S. Food and Drug Administration, speaks about the coronavirus in the James Brady Press Briefing Room of the White House, Friday, April 24, 2020, in Washington. (AP Photo/Alex Brandon)
Stephen Hahn, commissioner of the U.S. Food and Drug Administration, speaks about the coronavirus in the James Brady Press Briefing Room of the White House, Friday, April 24, 2020, in Washington. (AP Photo/Alex Brandon)

Credit: Alex Brandon

Credit: Alex Brandon

“This is a test where, under certain circumstances, with a doctor’s supervision, a test can be mailed to a patient and the patient can then perform the self-swab and then mail back and get the results after that time -- all under the guidance of a licensed physician,” Hahn said.

The news comes after the FDA issued a warning against using malaria drug hydroxychloroquine to treat COVID-19.

"The FDA is aware of reports of serious heart rhythm problems in patients with COVID-19 treated with hydroxychloroquine or chloroquine, often in combination with azithromycin and other QT prolonging medicines," the agency said in a statement Friday. "We are also aware of increased use of these medicines through outpatient prescriptions. Therefore, we would like to remind health care professionals and patients of the known risks associated with both hydroxychloroquine and chloroquine. We will continue to investigate risks associated with the use of hydroxychloroquine and chloroquine for COVID-19 and communicate publicly when we have more information."

FILE - This Tuesday, April 7, 2020 file photo shows a bottle of hydroxychloroquine tablets in Texas City, Texas. On Friday, April 24, 2020, the U.S. Food and Drug Administration warned doctors against prescribing the malaria drug to treat COVID-19 outside of hospitals or research settings. (AP Photo/David J. Phillip)
FILE - This Tuesday, April 7, 2020 file photo shows a bottle of hydroxychloroquine tablets in Texas City, Texas. On Friday, April 24, 2020, the U.S. Food and Drug Administration warned doctors against prescribing the malaria drug to treat COVID-19 outside of hospitals or research settings. (AP Photo/David J. Phillip)

Credit: David J. Phillip

Credit: David J. Phillip

The FDA said  hydroxychloroquine and chloroquine “have not been shown to be safe and effective for treating or preventing COVID-19” and they are being studied in clinical trials for COVID-19.

“We authorized their temporary use during the COVID-19 pandemic for treatment of the virus in hospitalized patients when clinical trials are not available, or participation is not feasible, through an Emergency Use Authorization,” the FDA said.

The agency added that the hydroxychloroquine or chloroquine can cause abnormal heart rhythms and a dangerously rapid heart rate. It can also lead to an increased risk of these heart problems for those with other health issues, such as heart disease and kidney disease.