Differential Diagnosis of COVID-19 and Influenza Be prepared for the upcoming respiratory season with flexible testing options

The quality of treatment starts with diagnosis.

The CDC has advocated for testing that enables the differential diagnosis of Flu and COVID-19, especially in light of the upcoming 2020/2021 flu season which could see a second peak of COVID-19 disease.1 They have stated that 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 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/B. This ability can help inform diagnostic decision making and patient management along with PPE usage. Careful implementation of these tests will enhance the preparedness of healthcare systems around the globe.

The Simplexa™ COVID-19 Direct and Simplexa™ Flu A/B & RSV Direct Gen II kits can be run on the same disc at the same time for differential diagnosis of these pathogens from the same sample in a little over an hour. Additionally, DiaSorin Molecular continually monitors the major flu and COVID-19 databases and tests newly emerging isolates as well as current flu vaccine strains on an ongoing basis. This enables confidence in your results to handle new emerging strains.

DiaSorin Molecular has a comprehensive offering of respiratory tests that allow laboratories to make effective and efficient diagnoses during the pandemic and flu season. Simplexa™ kits are also available for the diagnosis of Bordetella pertussis/parapertussis and Group A Strep.

COVID-19 or Flu?

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REFERENCES: 1. GenomeWeb. (2020, June 4). CDC develops test for simultaneous detection of COVID-19, Flu. https://www.genomeweb.com/molecular-diagnostics/cdc-develops-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. MOL4150, Instructions For Use. 7. MOL2655, Instructions For Use.Simplexa, LIAISON MDX, and the associated logos are all trademarks or registered trademarks of DiaSorin Molecular LLC, or its affiliate, in the U.S. and/or other countries. ©2016 DiaSorin Molecular LLC. All rights reserved. Black Hole Quencher, CAL Fluor, Quasar dyes are trademarks of Biosearch Technologies, Inc. DiaSorin products incorporating the Black Hole Quencher, CAL Fluor, and Quasar dye technology are licensed and sold pursuant to an agreement with Biosearch Technologies, lnc., and these products are sold exclusively for clinical, diagnostic, or research and development purposes. Product availability subject to required regulatory approvals.

Rapid and reliable testing for COVID-19• Extensive sample and transport media types: Validated for nasal swab or

nasopharyngeal swab specimens in several transport media types. Also validated for nasal wash/aspirate and BAL specimens.

• Sample-to-answer workflow: No RNA extraction required and the kit contains ready to use, all-in-one reaction mix. Flexible system that allows testing of Flu and COVID-19 from the same sample on the same run or individually.

• Confidence in your results: Dual target assay design and validated on over 24.000 viral sequences from the NCBI and GSAID databases.

• Proven performance that you can count on6:

SAMPLE TYPE POSITIVE % AGREEMENT NEGATIVE % AGREEMENT

Nasal Swab 100.0% (30/30) 100.0% (30/30)

Nasopharyngeal Swab 100.0% (61/61) 100.0% (127/127)

Nasal Wash/Aspirate 96.7% (29/30) 100.0% (30/30)

BAL 100.0% (11/11) 100.0% (7/7)

Simplexa™ COVID-19 Direct Kit

Simplexa™ Flu A/B & RSV Direct Gen II Kit

Simple and easy Flu A/B & RSV testing• Specimen type: Validated for nasopharyngeal swab specimens in transport media

types including UTM, Remel M5, Remel M6, Copan ESwab™ (Liquid Amies).

• Sample-to-answer testing: No RNA extraction required and the kit contains ready to use, all-in-one reaction mix. Can run separately or at the same time as the Simplexa™ COVID-19 Direct kit.

• Broad strain coverage: Validated on over 100 strains including the 2020/2021 flu vaccine strains.

• Proven performance that you can count on7:

SAMPLE TYPE POSITIVE % AGREEMENT NEGATIVE % AGREEMENT

Influenza A 100.0% (55/55) 97.8% (181/185)

Influenza B 100.0% (58/58) 97.8% (178/182)

RSV 100.0% (52/52) 96.8% (182/188)

p: +39 0161 487526 p: +1 (562) 240-6500

e: cs.molecular@diasorin.comw: www.molecular.diasorin.com

FOR OUTSIDE THE US AND/OR CANADA ONLY