COVID-19 Roundup: First Rapid At-Home Test Requires Prescription; COVID's Long-Term Impact on Kids; and CDC's Thanksgiving Guidance

FDA Approves First At-Home COVID-19 Test, But Prescription is Required

The U.S. Food and Drug Administration (FDA) said it has issued an emergency use authorization for the first at-home COVID-19 test that provides results in 30 minutes or less.

“While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home,” states FDA Commissioner Stephen M. Hahn, M.D., in a statement.

The Lucira COVID-19 All-In-One Test Kit, the FDA explains, examines self-collected nasal swab samples in individuals age 14 and older who are suspected of having the coronavirus by their healthcare provider. The test is currently authorized for prescription use only. It is expected to cost $50 or less, according to the test kit manufacturer, California-based Lucira Health. The kits are expected to be available nationwide through healthcare providers by early spring 2021.

The test is also authorized for use in “point-of-care (POC) settings,” such as doctor’s offices, hospitals, urgent care centers and emergency rooms, for all ages, the FDA states. But samples must be collected by a healthcare provider when it is used at these healthcare setting to test individuals younger than 14 years old.

The FDA: “The test works by swirling the self-collected sample swab in a vial that is then placed in the test unit. In 30 minutes or less, the results can be read directly from the test unit’s light-up display that shows whether a person is positive or negative …”

Pediatricians: More Research, Data Needed on COVID-19’s Long-Term Impact on Kids

The nation’s largest associations representing pediatricians and children’s hospitals are urging U.S. health authorities to collect data on the longer-term impact of COVID-19 on children, “including how the virus may harm children’s physical health after the acute illness has resolved.”

Since the start of the COVID-19 pandemic, more than 1 million infants, children and adolescents have been diagnosed with the coronavirus, according to data released earlier this week by the American Academy of Pediatrics (AAP) and Children’s Hospital Association (CHA). The two groups track data reported by state health departments.

As of Nov. 12, a total of 1,039,464 children have tested positive for COVID-19 since the onset of the pandemic, the data shows. In the one-week period ending Nov. 12th, there were 111,946 new COVID-19 in children, “which is substantially larger than any previous week in the pandemic, the AAP and CHA said in a statement.

Severe illness from COVID-19 remains rare in children. But the AAP is calling on government officials to enact “a new, national strategy to reduce the spread of the virus and address myriad harms resulting from the pandemic.” More data is also needed on the “emotional and mental health effects the pandemic is having on children and adolescents,” the AAP says.

“As a pediatrician who has practiced medicine for over three decades, I find this number staggering and tragic. We haven’t seen a virus flash through our communities in this way since before we had vaccines for measles and polio,” said AAP President Sally Goza, M.D., in a statement.

CDC: Celebrate Thanksgiving Only ‘With People You Live With’ and Avoid Travel

With coronavirus cases surging across the nation, the U.S. Centers for Disease Control and Prevention (CDC) recommended against traveling for the upcoming holiday and urged Americans to gather for Thanksgiving only with members of their households.

“More than 1 million COVID-19 cases were reported in the United States over the last 7 days,” the CDC stated in a report released Thursday. “The safest way to celebrate Thanksgiving is to celebrate at home with the people you live with.”

Gatherings with family and friends “who do not live with you can increase the chances of getting or spreading COVID-19 or the flu,” the CDC added. Additionally, travel may increase your chance of getting and spreading COVID-19, the agency added.

Celebrating virtually, or with members of your household, is the safest choice this Thanksgiving, the agency said.

If you choose to attend a gathering outside your household, the CDC recommends the following steps:

• Bring your own food, drinks, plates, cups, and utensils.
• Wear a mask and safely store your mask while eating and drinking.
• Avoid going in and out of the areas where food is being prepared or handled, such as in the kitchen.
• Use single-use options, like salad dressing and condiment packets, and disposable items like food containers, plates, and utensils.