Simplexa^™
COVID-19 & Flu A/B Direct Kit

The CDC has advocated for testing that enables the differential diagnosis of Flu and COVID-19, especially in light of the upcoming flu season which could see community circulation of both viruses.¹ Determining if influenza or SARS-CoV-2 is causing the infection is important for clinical treatment, infection control, 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 the season 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 on the horizon, it is critical that laboratories are able to rapidly diagnose and differentiate between major respiratory pathogens such as SARS-CoV-2 and influenza A and influenza B using an accurate test. Rapid diagnosis leads to better diagnostic decision making and patient management. Careful implementation of these tests will enhance the preparedness of healthcare systems around the globe.

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.

A real-time PCR assay that enables the differential diagnosis of COVID-19, influenza A, and influenza B from the same sample in the same well. Broad strain coverage and validated on over 80 flu strains and current circulating variants of SARS-CoV-2.