COVID-19 or Flu?

Be prepared for the upcoming respiratory season with Simplexa™ Direct kits

Differential Diagnosis of COVID-19 and Influenza

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.


REFERENCES: 1. GenomeWeb. (2020, June 4). CDC develops test for simultaneous detection of 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 COVID-19 Direct Kit - 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 50,000 viral sequences from the NCBI and GSAID databases.

Proven performance that you can count on

Simplexa® COVID-19 Direct Clinical Agreement Study
Sample TypeSample Type Positive % Agreement Negative % Agreement
Sample TypeNasal Swab Positive % Agreement100% (30/30) Negative % Agreement100% (30/30)
Sample TypeNasopharyngeal Swab Positive % Agreement100% (52/52) Negative % Agreement100% (56/56)
Sample TypeNasal Wash/Aspirate Positive % Agreement96.7% (29/30) Negative % Agreement100% (30/30)
Sample TypeBronchoalveolar lavage (BAL) Positive % Agreement100% (11/11) Negative % Agreement100% (7/7)

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This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARSCoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

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

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 on

Simplexa® Flu A/B & RSV Direct Gen II Clinical Agreement Summary
Positive % Agreement Negative % Agreement
SpecimenInfluenza A Sensitivity100.0% (55/55) Specificity97.8% (181/185)
SpecimenInfluenza B Sensitivity100.0% (58/58) Specificity99.9% (178/182)
SpecimenRSV Sensitivity100.0% (52/52) Specificity96.8% (182/188)

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