Vol.43  「FDA Approves Labcorp’s non-prescription COVID-Flu-RSV Home Test」

Last Updated 10 June 2022. Cellspect Co., Ltd.

On the 16th, U.S. time, the U.S. Food and Drug Administration (FDA) granted Labcorp an Emergency Use Authorization (EUA) for its respiratory virus detection kit, which is the first non-prescription (OTC) that can simultaneously detect SARS-CoV-2, influenza and Respiratory syncytial virus (RSV).

 

“While the FDA has now authorized many COVID-19 tests without a prescription, this is the first test authorized for flu and RSV, along with COVID-19, where an individual can self-identify their need for a test, order it, collect their sample and send it to the lab for testing, without consulting a health care professional,” said Jeff Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH). “The rapid advances being made in consumer access to diagnostic tests, including the ability to collect your sample at home for flu and RSV without a prescription, brings us one step closer to tests for these viruses that could be performed entirely at home.”

 

This home sample collection kit can be purchased online or in a store without a prescription. The samples can be self-collected by individuals ages 18 years and older, self-collected by individuals 14 years and older with adult supervision, or collected with adult assistance for individuals 2 years and older. This will enable consumers to more easily determine whether they may be infected with COVID-19, flu, or RSV, which can aid in determining if self-isolation (quarantine) is appropriate and to assist with health care decisions after discussion with a health care professional. According to the company, the new test detects known COVID-19 variants, including Delta and Omicron.

 

On the same day, LabCorp also released the "Labcorp OnDemand" home testing kit, which can measure HbA1c in small blood samples. HbA1c reflects the average blood glucose concentration in the human body for 8-12 weeks, and is the main indicator for monitoring and screening diabetic patients or pre-diabetic patients. This test kit makes diabetes screening and management easier.

 

LabCorp has been making breakthroughs in home testing. It's COVID-19 home test was the first FDA-approved non-prescription COVID-19 test. With the increasing awareness of the prevention of infectious diseases, the mode of disease prevention has gradually changed. Demand for home testing kits is expected to increase greatly. It is believed that these practical and convenient home testing kits will enable better development of disease prevention in the future.

 References:​​

  1. May 16, 2022, “Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test Available without a Prescription That Also Detects Flu and RSV”. FDA News Release

  2. Kathleen Doheny, May 18, 2022, “FDA Approves First COVID-Flu-RSV Home Test”. WebMD.

  3. May 16, 2022. “Labcorp Launches First-of-its-kind At-home Collection Device for Diabetes Risk Testing” businesswire

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