User:Shawndouglas/Sandbox

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3.1.7 Multiplex testing

As the pandemic has progressed and test manufacturers have become more experienced with SARS-CoV-2 test development, multiplex testing has become an option. The multiplex assay—an immunoassay test able to measure multiple analytes in a single test—is certainly not new in itself. In 1989, R. Ekins developed the ambient analyte theory, which stated that miniaturizing an immunoassay can lead to an improved limit of detection (LOD). That work influenced the future development of microarray multiplex technology principles.[1] As of September 2021, eighteen in vitro molecular diagnostic tests are shown as receiving EUAs by the FDA, four of them even authorized for CLIA waived testing.

  1. Tighe, Patrick J.; Ryder, Richard R.; Todd, Ian; Fairclough, Lucy C. (1 April 2015). "ELISA in the multiplex era: Potentials and pitfalls" (in en). PROTEOMICS – Clinical Applications 9 (3-4): 406–422. doi:10.1002/prca.201400130. ISSN 1862-8346. PMC PMC6680274. PMID 25644123. https://onlinelibrary.wiley.com/doi/10.1002/prca.201400130.