Meridian Unmasking the complexities Multiplexing WHITEPAPER

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Conclusion

Multiplex assays that combine the detection of several targets at once have several advantages including their high-throughput potential, ability to provide more results per sample, and lower reagent consumption (i.e., miniaturization). All of these benefits translate to a lower price-per-data point compared to traditional singleplex assays. Given many respiratory disease symptoms overlap, it is not possible to reliably differentiate an infection with one of these viruses on clinical grounds alone. Multiplex testing addresses the higher demand for screening between infections due to SARS-CoV-2, influenza A/B and RSV during what is expected to be higher than normal flu season. Molecular multiplex testing offers high sensitivity and specificity, detecting infected individuals early in the course of the disease and

enabling adequate time for the appropriate treatment. However, molecular tests require sophisticated equipment, experienced technicians and generally have a turn-around time of 1-5 days. In contrast, immunoassay rapid antigen assays are easy to use and can provide a result in 10-15 minutes, but they are considered to have a lower performance and are less sensitive. Each testing type, molecular or immunoassay, has advantages and disadvantages and they can be used independently from one another or in a testing algorithm that leverages the advantages of both. By employing multiplexing assays for the flu, COVID and RSV, patients will be able to be treated faster and more effectively, regardless of the testing type employed.

References 1 Jong-Yoon Jong. “Multiplex molecular diagnostics: shifting the paradigm.” Medica Laboratory Observer. Feb 17, 2013. Accessed Sept 12, 2023: https://www.mlo-online.com/home/article/13005002/multiplex- molecular-diagnostics-shifting-the-paradigm 2 The University of Sydney. “How COVID-19 created dramatic changes in a ‘winter virus’”. May 31, 2022. Accessed Sept 12, 2023: https://www.sydney.edu.au/news-opinion/news/2022/05/31/how-covid19- created-dramatic-changes--in-a-winter-virus.html 3 Budd, J., Miller, B.S., Weckman, N.E. et al. (2023) Lateral flow test engineering and lessons learned from COVID-19. Nat Rev Bioeng 1, 13–31. https://doi.org/10.1038/s44222-022-00007-3 4 Use of SARS-CoV-2 antigen-detection rapid diagnostic tests for COVID-19 self-testing.4 ), WHO https:// www.who.int/publications-detail-redirect/WHO-2019-nCoV-Ag-RDTs-Self_testing-2022.1 (2022). World Health Organization interim guidance on recommending COVID-19 self-testing using SARS-CoV-2 antigen tests; the web annexes include useful information on implementation 5 World Health Organization. “The ACT-Accelerator: two years of impact”. April 26, 2022. Accessed Sept 12, 2023: https://www.who.int/publications/m/item/the-act-accelerator--two-years-of-impact (2022). 6 Gasperino, D. et al. (2018) Improving Lateral Flow Assay Performance Using Computational Modeling. Annu. Rev. Anal. Chem. 11:219–44. https://doi.org/10.1146/annurev-anchem-061417-125737 7 Centers for Disease Control and Prevention. “Rapid Diagnostic Testing for Influenza: Information for Clinical Laboratory Directors”. https://www.cdc.gov/flu/professionals/diagnosis/rapidlab.htm. Accessed October 26, 2021 8 Centers for Disease Control and Prevention. “RSV in Infants and Young Children”. https://www.cdc.gov/ rsv/high-risk/infants-young-children.html. Accessed October 26, 2021. 9 Meng, J., Stobart, C. C., Hotard, A. L. & Moore, M. L. (2014). An overview of respiratory syncytial virus. PLoS Pathog. 24;10(4):e1004016. doi: 10.1371/journal.ppat.1004016.

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