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====3.1.7 Multiplex testing====
====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.<ref name="TigheELISA15">{{Cite journal |last=Tighe |first=Patrick J. |last2=Ryder |first2=Richard R. |last3=Todd |first3=Ian |last4=Fairclough |first4=Lucy C. |date=2015-04 |title=ELISA in the multiplex era: Potentials and pitfalls |url=https://onlinelibrary.wiley.com/doi/10.1002/prca.201400130 |journal=PROTEOMICS – Clinical Applications |language=en |volume=9 |issue=3-4 |pages=406–422 |doi=10.1002/prca.201400130 |issn=1862-8346 |pmc=PMC6680274 |pmid=25644123}}</ref> 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.
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.<ref name="TigheELISA15">{{Cite journal |last=Tighe |first=Patrick J. |last2=Ryder |first2=Richard R. |last3=Todd |first3=Ian |last4=Fairclough |first4=Lucy C. |date=2015-04 |title=ELISA in the multiplex era: Potentials and pitfalls |url=https://onlinelibrary.wiley.com/doi/10.1002/prca.201400130 |journal=PROTEOMICS – Clinical Applications |language=en |volume=9 |issue=3-4 |pages=406–422 |doi=10.1002/prca.201400130 |issn=1862-8346 |pmc=PMC6680274 |pmid=25644123}}</ref> By 2013, development of multiplex protein immunoassays was becoming increasingly prominent.<ref name="TigheELISA15" />
 
As of September 2021, eighteen "multi-analyte" ''in vitro'' molecular diagnostic tests are shown as receiving EUAs by the FDA, four of them even authorized for CLIA waived testing.<ref name="FDAInVitroEUAs21">{{cite web |url=https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2 |title=In Vitro Diagnostics EUAs - Molecular Diagnostic Tests for SARS-CoV-2 |publisher=U.S. Food and Drug Administration |date=07 September 2021 |accessdate=07 September 2021}}</ref> Common additional targets for analysis among the various kits include influenza A, influenza B, and respiratory syncytial virus (RSV).<ref name="FDAInVitroEUAs21" /> However, several multiplex test kits cover an even broader array of respiratory-affecting organism types and subtypes such as adenovirus and a few other coronavirus types, to name a few. Kits include the ePlex Respiratory Pathogen Panel 2<ref name="HintonePlex20">{{cite web |url=https://www.fda.gov/media/142902/download |format=PDF |title=ePlex Respiratory Pathogen Panel 2 (ePlex RP2 Panel) |author=Hinton, D.M. |publisher=U.S. Food and Drug Administration |date=07 October 2020 |accessdate=19 September 2021}}</ref>, the NxTAG Respiratory Pathogen Panel + SARS-CoV-2<ref name="HintonNxTAG21">{{cite web |url=https://www.fda.gov/media/146492/download |format=PDF |title=NxTAG Respiratory Pathogen Panel + SARS-CoV-2 |author=Hinton, D.M. |publisher=U.S. Food and Drug Administration |date=03 March 2021 |accessdate=19 September 2021}}</ref>, the QIAstat-Dx Respiratory SARS-CoV-2 Panel<ref name="HintonQIAstat21">{{cite web |url=https://www.fda.gov/media/136569/download |format=PDF |title=QIAstat-Dx Respiratory SARS-CoV-2 Panel |author=Hinton, D.M. |publisher=U.S. Food and Drug Administration |date=29 July 2021 |accessdate=19 September 2021}}</ref>, and the BioFire Respiratory Panel 2.1-EZ.<ref name="HintonBioFireRes21">{{cite web |url=https://www.fda.gov/media/142693/download |format=PDF |title=BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ) |author=Hinton, D.M. |publisher=U.S. Food and Drug Administration |date=30 August 2021 |accessdate=19 September 2021}}</ref> (Of the four, the BioFire panel is approved for CLIA waived testing.<ref name="FDAInVitroEUAs21" />)
 
Multiplexing provides a variety of benefits for laboratories and patients.

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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] By 2013, development of multiplex protein immunoassays was becoming increasingly prominent.[1]

As of September 2021, eighteen "multi-analyte" in vitro molecular diagnostic tests are shown as receiving EUAs by the FDA, four of them even authorized for CLIA waived testing.[2] Common additional targets for analysis among the various kits include influenza A, influenza B, and respiratory syncytial virus (RSV).[2] However, several multiplex test kits cover an even broader array of respiratory-affecting organism types and subtypes such as adenovirus and a few other coronavirus types, to name a few. Kits include the ePlex Respiratory Pathogen Panel 2[3], the NxTAG Respiratory Pathogen Panel + SARS-CoV-2[4], the QIAstat-Dx Respiratory SARS-CoV-2 Panel[5], and the BioFire Respiratory Panel 2.1-EZ.[6] (Of the four, the BioFire panel is approved for CLIA waived testing.[2])

Multiplexing provides a variety of benefits for laboratories and patients.

  1. ↑ 1.0 1.1 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. 
  2. ↑ 2.0 2.1 2.2 "In Vitro Diagnostics EUAs - Molecular Diagnostic Tests for SARS-CoV-2". U.S. Food and Drug Administration. 7 September 2021. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2. Retrieved 07 September 2021. 
  3. ↑ Hinton, D.M. (7 October 2020). "ePlex Respiratory Pathogen Panel 2 (ePlex RP2 Panel)" (PDF). U.S. Food and Drug Administration. https://www.fda.gov/media/142902/download. Retrieved 19 September 2021. 
  4. ↑ Hinton, D.M. (3 March 2021). "NxTAG Respiratory Pathogen Panel + SARS-CoV-2" (PDF). U.S. Food and Drug Administration. https://www.fda.gov/media/146492/download. Retrieved 19 September 2021. 
  5. ↑ Hinton, D.M. (29 July 2021). "QIAstat-Dx Respiratory SARS-CoV-2 Panel" (PDF). U.S. Food and Drug Administration. https://www.fda.gov/media/136569/download. Retrieved 19 September 2021. 
  6. ↑ Hinton, D.M. (30 August 2021). "BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ)" (PDF). U.S. Food and Drug Administration. https://www.fda.gov/media/142693/download. Retrieved 19 September 2021. 
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