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FIRST NON-PRESCRIPTION TEST AUTHORIZED BY USFDA FOR COVID-19, FLU, AND RSV

Author: Medical Team (Alniche Life Sciences)

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FIRST NON-PRESCRIPTION TEST AUTHORIZED BY USFDA FOR COVID-19, FLU, AND RSV

                                            

This is the first Emergency Use authorization (EUA) granted by USFDA to a direct-to-consumer (non-prescription) multi-analyte COVID-19 test, which allows a person to obtain a nose swab sample at home and send it for testing. The test can detect many respiratory viruses at once, including influenza A and B, respiratory syncytial virus, and SARS-CoV-2 virus including the variants Delta and omicron. The results of the test are supplied via an internet portal, with a health care provider following up on any positive or incorrect test results.

Test results will be available on average between 1-2 days after the test maker company, Labcorp, receives the completed collection kit. Since the records of the test result are published online, it thereby aids the respective government in the maintenance of the database for monitoring of COVID-19 cases.

"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, MD, JD, director of the FDA's Center for Devices and Radiological Health.

Adults 18 years and older can self-collect the samples; individuals 14 years and older can self-collect with adult supervision, whereas children 2 years and older can get themselves tested through with adult assistance. Since the kit utilizes a short nasal swab, it is more comfortable and easier for individuals and parents to collect samples at home.  Consumers may use this test to determine which virus they are afflicted with and then make educated decisions about quarantine and other elements of healthcare.

Dr. Brian Caveney, chief medical officer and president, Labcorp Diagnostics commented, “In time for flu season, the single test helps doctors and individuals make more informed treatment decisions given that symptoms of COVID-19 and flu are similar.”

In the home collection kit, the Roche cobas® SARS-CoV-2 & influenza A/B Test for cobas® 6800/8800 Systems is employed. The test utilizes the Nucleic acid amplification (NAA) methodology for the detection of the virus. Only trained clinical laboratory workers who have been particularly informed and trained in real-time PCR and in vitro diagnostic methods should use the cobas SARS-CoV-2 and influenza A/B Test.

As per Labcorp, for those who are uninsured the cost of the test will be $169. However, those who meet clinical standards, such as having symptoms, being exposed to someone who has COVID-19, or being asked to be tested by a health care physician, will receive the kit free of charge.

Adults 18 and up, as well as parents and guardians of children aged 2 to 17, can get the combined collection kit online through Pixel by Labcorp beginning in early October, 2022. Furthermore, clinicians may request the collection kit for children as young as two years old immediately from their electronic medical record system.

References-

  1. Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test Available without a Prescription That Also Detects Flu and RSV. FDA. News release.  May 16, 2022. https://www.fda.gov/news-events/press-announcements/ coronavirus-covid-19-update-fda-authorizes-first-covid-19-test-available-without-prescription-also
  2. LabCorp Receives Emergency Use Authorization for at Home Collection Kit for Combined COVID-19 And Flu Detection. LabCorp. News Release.https://ir.labcorp.com/news-releases/news-release-details/labcorp-receives-emergency-use-authorization-home-collection-kit

 

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