Differential diagnosis of flu and COVID-19, especially during flu season is key to
infection control, patient management, and reducing the burden on healthcare costs. Determining if influenza or SARS-CoV-2 is causing the infection is important for appropriate clinical intervention, isolation, and community mitigation efforts.1 In addition to the threat from single infections, co-infections with multiple
respiratory viruses in the same patient have been reported which present unique
diagnostic challenges.2-5 To complicate these infections even further, variants of
SARS-CoV-2 and emerging strains of influenza can lead to the reduced efficacy of vaccinations and pose a risk for missed detection by current molecular tests.
With these challenges and especially since both COVID-19 and influenza have overlapping symptoms, it is critical that laboratories are able to rapidly diagnose with an accurate test.6 Rapid diagnosis leads to better diagnostic decision making and patient outcomes. Careful implementation of appropriate molecular tests will enhance the preparedness of healthcare systems around the globe especially during peak surge seasons.
The Simplexa® COVID-19 & Flu A/B Direct kit allows for the in vitro qualitative
detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A virus, and influenza B virus from nasopharyngeal swabs (NPS). The assay provides broad strain coverage for both the SARS-CoV-2 and
influenza viruses to provide confidence in the results.
1. GenomeWeb. (2020, June 4). CDC develops test for simultaneous detection of COVID-19, Flu. https://www.genomeweb.com/molecular-diagnostics/cdcdevelops-test-simultaneous-detection-covid-19-flu.
2. Singer, B. D. (2020). COVID-19 and the next influenza season. Science Advances. DOI 10.1126/sciadv.abd0086.
3. Bordi, L., Nicastri, E., Scorzolini, L., Di Caro, A., Capobianchi, M. R., Castilletti, C., & Lalle, E. (2020). Differential diagnosis of illness in patients under investigation for the novel coronavirus (SARS-CoV-2), Italy, February 2020. Journal of European Surveillance, 25(8), 2-5.
4. Wu, X., Cai, Y., Huang, X., Yu, X., Zhao, L., Wang, F., Li, Q., Gu, S., Xu, T., Li, Y., Lu, B., & Zhan, Q. (2020). Co-infection with SARS-CoV-2 and Influenza A Virus in Patient with Pneumonia, China. Emerging Infectious Diseases, 26(6), 1324-1326.
5. Carolina, A. Ferreira, A. F., Romao, T. T., Macedo, Y. S., Pupe, C., & Nascimento, O. J. M. (2020). COVID-19 and herpes zoster co-infection presenting with trigeminal neuropathy. European Journal of Neurology. DOI: 10.1111/ene.14361.
6.Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases (NCIRD). (2022). Similarities and Differences between Flu and COVID-19. https://www.cdc.gov/flu/symptoms/flu-vs-covid19.htm
Why to choose it
A real-time PCR assay that enables the differential detection of SARS-CoV-2, influenza A and influenza B viruses from the same sample in the same reaction. Broad strain coverage and validated on over 80 flu strains and against over 2.3M SARS-CoV-2 sequences including circulating variants.
Confidence In Your Results
The Simplexa® COVID-19 & Flu A/B Direct kit provides broad strain coverage and is validated on over 80 flu strains as well as analyzed against over 2.3M
SARS-CoV-2 sequences in the GISAID database with 100% detection prediction.
Sensitive detection of all targets without competitive interference observed within the multiplex assay.
Direct from nasopharyngeal specimens with no RNA extraction required.
One Test One Sample
A real-time PCR assay enabling differential detection of SARS-CoV-2, influenza A and influenza B from the same sample in the same reaction.
Performance You Can Trust
Simplexa® COVID-19 & Flu A/B Direct Clinical Agreement Study
|Sample TypeVirus||Positive %
|Sample TypeSARS-CoV-21||Positive % Agreement98.5%
|Negative % Agreement97.4%
|Sample TypeInfluenza A2||Positive % Agreement97.6%
|Negative % Agreement100%
|Sample TypeInfluenza B2||Positive % Agreement98.2%
|Negative % Agreement100%
1Data from prospective study.
2Data from retrospective study.
For details on clinical study see MOL4250 instructions for use.
Simplexa® COVID-19 & Flu A/B Direct Kit*
|Code MOL4250||Reactions 24|
Simplexa® COVID-19 & Flu A/B Positive Control Pack
|Code MOL4260||Reactions 10|
*Direct Amplification Discs are included with kit.