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August 29, 2024 (Cleveland, OH)

FDA Authorizes Two New Combined COVID-19 and Influenza Tests as Covid Cases Rise



A summer surge in COVID has been hitting the country, with states in the south and west most impacted, but new vaccines and tests are on the way.

The Food and Drug Administration (FDA) recently announced emergency use authorizations for two new combined COVID-19 and influenza tests. The Nano-Check Influenza-COVID-19 Dual Test is now approved for use by laboratories to detect and differentiate influenza A and B and SARS-CoV-2 in nasal swab specimens. The second authorized test, the Flowflex Plus COVID-19 and Flu A/B Home Test, is approved for home use for people aged two and older.

This approval arrived as cases in Ohio climbed to 8,352, an increase of more than 1,000 over the previous week and the 12th straight week of rising numbers. Fortunately, updated mRNA COVID-19 vaccines from Moderna and Pfizer have been approved and are expected to be available in Ohio by mid-September. These vaccines target a subtype that was most common earlier this year, called KP.2, and are expected to provide cross-protection for offshoots, including KP.3.1.1.

The Centers for Disease Control and Prevention (CDC) reported an 18% test positivity rate for the week ending Aug. 17 across the United States. This rate is the highest it has been since January 2022. According to the CDC, levels of SARS-CoV-2 virus, which causes COVID-19, measured in wastewater are at “very high” levels nationally. These measurements indicate the actual confirmed cases are likely higher than the confirmed cases.

In June, the CDC recommended that everyone over six months old receive an updated COVID-19 vaccine and a flu shot. Unfortunately, there has been a lack of interest from the public in receiving updated vaccines as only about 22.5% of adults and 14% of children received last fall’s updated vaccines.

The U.S. Department of Health and Human Services (HHS) announced that American households would once again be eligible to order four COVID-19 tests beginning in September. The at-home tests are capable of detecting the new variants and can be ordered at HHS.gov beginning in late September. According to HHS, more than 900 million free COVID-19 tests have been sent to the American public since the pandemic began.

To prevent the virus from spreading to vulnerable populations, public health advises staying home when sick and testing for COVID. Because home rapid, or antigen, tests are less likely to detect the virus than the testing done by a healthcare provider and sent to a lab, a single negative rapid test at home cannot rule out infection. The CDC recommends performing two home tests 48 hours apart to be sure you don’t have COVID.

Learn more about the importance of COVID-19 vaccinations by visiting the Center for Disease Control and Prevention’s website.