Health
FDA approves CDC influenza and COVID-19 combination test to prepare for complex flu season
The FDA has issued a new emergency license to the Centers for Disease Control and Prevention for diagnostic tests for influenza and COVID-19. This is because the United States is preparing to enter this year’s flu season in the midst of a global pandemic.
This test is designed to help identify differences in patients who may have similar respiratory symptoms in one of the two disorders. This is the third FDA-approved diagnosis for this purpose, following the Qiagen and BioFire Diagnostics panel, which also covers additional viruses.
“With just one swab or sample, we can use combination tests to get answers to Americans faster,” says FDA Commissioner Stephen Hahn. statement.. “This efficiency helps a great deal to provide timely information to sick people with unknown respiratory disorders.”
In addition, using a single swab to test for multiple illnesses can reduce the demand for test supplies and reduce the risk of contacting healthcare professionals collecting samples.
Relation: Twist Bioscience announces research panel for screening COVID-19 and other respiratory viruses
The CDC multiplex assay is designed to detect only the genetic material of the novel coronavirus and influenza A and B viruses using both swab and sputum samples. However, negative results should not be used as the sole basis for eliminating infections, agency (PDF).
This test is designed to run on Thermo Fisher Applied Biosystems 7500 sequencing hardware. The CDC said the kit will be shipped to Public Health Laboratories once production and quality control are complete.
The first few weeks of coronavirus spread throughout the United States-currently counting approximately 2.9 million cases and 130,000 deaths-CDC’s first coronavirus diagnosis shows that one of the three reagents is a specific control It did not produce the correct result when tested against. The reagent was later removed from the testing procedure and CDC says the kit is still in use. The new test contains one primer mix and one probe mix.
The FDA says it encourages developers to pursue more combinatorial testing before the flu season begins in earnest this fall and winter, and updates its molecular diagnostic emergency use approval submission template. did.
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