Cepheid’s Xpert Xpress CoV-2/Flu/RSV plus test detects and differentiates between three distinct respiratory illnesses with four targets
November 2021 – Repertoire Magazine
Americans masked up, socially distanced, and washed their hands to slow the transmission of the SARS-CoV-2 virus last year. One of the unexpected results was the almost non-existence of flu during last year’s respiratory season. That’s unlikely to be the case this year.
Between September 2020 and April 2021, there were slightly more than 2,000 lab-confirmed cases of influenza in the U.S., according to the CDC.1 The U.S. sees more than 200,000 lab-confirmed flu cases in a typical respiratory season. This is a small portion of the total number of cases, which chart into the millions.2
But as more people head back to work and school, the flu will likely return. And the lack of exposure to the flu last year could make people more susceptible to it, along with co-infections between flu, COVID-19, and RSV.
Children’s hospitals activated surge plans in response to an increase of children presenting with RSV, which usually hits during the winter. RSV presents like many other respiratory illnesses as a fever, cough, and runny nose and can cause respiratory distress like other respiratory illnesses. Public health experts say the increase in RSV is an indirect result of the pandemic as pediatricians didn’t see typical instances of RSV last respiratory season.3
“We anticipated there would be a significant respiratory season and co-infections this year,” said Cisco Merrill, National Sales Director, Alternate Site for Sunnyvale, Calif.-based Cepheid, a molecular diagnostics company. “We had to find a way to test for all those illnesses at the same time. We increased production to get our tests to more clinics to help filter out patients who weren’t acute and to help unburden the health systems.”
Respiratory tract infections require an accurate diagnosis to ensure that patients receive appropriate treatment. Cepheid’s Xpert® Xpress CoV-2/Flu/RSV plus (4-plex plus) – a PCR test – provides actionable, rapid respiratory results to meet the challenges of the pandemic and other respiratory illnesses. It rapidly detects SARS-CoV-2, Flu A, Flu B, and RSV and identifies potential cases of co-infections.
The test provides actionable detection of SARS-CoV-2 in 25 minutes with results for all four pathogens in 36 minutes. It also tests for three distinct gene targets for SARS-CoV-2: N2, E, and RdRP, offering broad coverage for detecting the virus, inclusive of variants.4 Cepheid’s 4-plex plus provides a rapid result that aids physicians in determining appropriate treatment in a single-cartridge, easy-to-use workflow, helping hospitals, clinics, and physician offices to manage limited resources.
PCR tests like Cepheid’s 4-plex plus take more time to deliver results than antigen tests do but, according to the FDA, antigen tests may not detect all active infections as they do not work the same way as PCR tests. They are not as sensitive as molecular PCR tests, which leads to a higher chance of false negatives; negative results from an antigen test may need to be confirmed with a PCR test prior to making treatment decisions.5
“Getting it right the first time and not infecting others is significantly important,” Merrill said. “Our test makes it much more likely you’ll get the right result.”
“We position that to our distribution partners and our physicians. We’re a little bit longer in time than antigen tests, but it’s still under an hour and you’re much more likely to get the right result,” Merrill emphasized. “Meet and treat in one visit. One swab. One test.”
Not only does Cepheid’s 4-plex plus check for three distinct respiratory illnesses with four targets, it also uses one swab to test for all four.4
“That helps unburden the health system from a supply constraint perspective,” Merrill added. “There was a significant swab shortage last year. Even if there were enough assays, there weren’t enough swabs to test. The 4-plex plus design provides one swab for four tests and helps aid swab supply.”
Using only one swab and one test along with diagnosing in one encounter can be a competitive differential.
The specificity for Cepheid’s 4-plex plus is over 99%.4
“Having that confidence to tell patients what they definitively have and what treatment plan can be started is an advantage for physicians and non-acute facilities,” Merrill said. “PCR testing is the ultimate in quality and people are asking for it by name. They might not know what PCR stands for but, like an MRI, they know they need to get one.”
1 CDC: Weekly U.S. Influenza Surveillance Report (FluView)
2 CDC. Estimated Influenza Illnesses, Medical visits, Hospitalizations, and Deaths in the United States — 2019–2020 Influenza Season.
Reviewed June 2, 2021. Accessed September 29, 2021. https://www.cdc.gov/flu/about/burden/2019-2020.html?web=1&wdLOR=c8E88FEDA-013B-400E-B982-42900B491873
3 The Washington Post: Children’s hospitals seeing early increase in seasonal respiratory illness. September 15, 2021.
4 Xpert® Xpress CoV-2/Flu/RSV plus Package Insert 302-6991, Rev. A. September 2021.
5 FDA. Coronavirus Update: FDA Authorizes First Antigen Test to Help in the Rapid Detection of the Virus that Causes COVID-19 in Patients. Press Release. May 9, 2020. Accessed September 29, 2021. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-antigen-test-help-rapid-detection-virus-causes