A one-stop shop for rapid diagnosis of Flu A, Flu B, RSV and SARS-CoV-2
July 2021
Never in the history of laboratory medicine has there been so much emphasis on diagnostic testing. “When I think about testing during the past year, the image that comes to mind is cars lined up for a couple of miles for drivers and passengers to get a nasal swab to know whether or not they’re infected with COVID-19,” said Dr. Fred Tenover, vice president of scientific affairs for Cepheid, a molecular diagnostics company based in Sunnyvale, Calif.
Cepheid received FDA emergency use authorization (EUA) for its 4-plex SARS-CoV-2, Flu A, Flu B and RSV combination test. This assay is offered in Cepheid’s GeneXpert Xpress System. It offers actionable detection and on-demand results with one sample collection. It optimizes the GeneXpert System module capacity by combining two Xpress tests into one.
It’s important for hospitals, urgent care and physician offices to detect and differentiate between flu, RSV and COVID-19, which all present with similar symptoms. Current flu and SARS-CoV-2 therapies need definitive diagnosis for each pathogen. This differentiation identifies potential cases of co-infection during respiratory season and provides risk assessment for patients and staff while resuming traditional healthcare procedures.
“We didn’t have a flu season this year probably due to social distancing and mask wearing and not seeing as much transmission,” Dr. Tenover said. “But as people start to congregate again and take the masks off, and kids start going back to school, the CDC is predicting that this next flu season could be a bad one. So, you really need to know that your test is going to pick up flu as well as COVID and the differentiation between the two.”
“The Cepheid test produces a fast and highly accurate answer,” Dr. Tenover continued. “It is standardized across all venues, including the central lab and near patient testing sites. The point-of-care (POC) assay is the same assay found in academic medical centers, the national reference laboratory and in mid-sized hospitals.”
This empowers patients with rapid results and assists hospitals, urgent care centers and physician offices to effectively manage limited resources. It provides labs with single-test confidence to accelerate workflows and support clinicians with on-demand, timely and accurate results.
“The value of the GeneXpert Xpress System comes in ease of use and a high degree of accuracy,” Dr. Tenover said. “Anyone can use this. It’s no more difficult than using a Keurig coffee maker.”
“SARS-CoV-2 is an RNA virus and RNA viruses always mutate. We expect them to. They have the ability to cause more infections, be more severe and in some cases, evade vaccines,” Dr. Tenover continued. “But all of these viruses are detected by the Cepheid assay. None of the emerging mutant strains are escaping detection.”