FDA Authorize First Non-Prescription COVID Test Also Capable Of Testing Flu Or RSV
The US Food and Drug Administration (FDA) recently authorised the Labcorp Seasonal Respiratory Virus (acronym: RT-PCR DTC) Test for usage without a prescription by those with symptoms of a respiratory viral infection with a similar consistency to COVID-19. This is the first non-prescription straight-to-consumer multi-analyte Covid test which has been authorised by the FDA, and allows the individual to collect a nasal swab themselves from home, before sending the sample to Labcorp, so it can be tested.
This test can identifya multitude of respiratory viruses simultaneously, detecting both Influenza A and Influenza B, more commonly known as the flu, along with respiratory syncytial virus, more ubiquitously known as RSV, and also SARS-CoV-2, which is the virus that acts as a catalyst to Covid-19.
The results are then delivered via an online portal, as well as follow-up contact from a healthcare practician in the event of either positive or invalid results.
“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, M.D., J.D., director of FDA’s Center for Devices and Radiological Health.
“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.”
The home sampling collection kit can be bought either online or in-store without having to provide a prescription. These samples are viable for self-collection by those aged 18 or older, or collected by those aged 14 and above with adult supervision. The kit is also available for use of those as young as 2, as long as it is collected and administered by an adult.
All of this means consumers can determine more easily whether or not they may be infected with RSV, flu, or COVID, which in turn can allow them to determine whether or not quarantining in self-isolation is necessary. It also aids in assisting decisions following a discussion with a healthcare professional.
The FDA is an agency contained within the US Department of Health and Human Services. It’s role is to protect the public by regulating the safety and security, as well as effectiveness, of drugs designed for human and veterinary consumption.