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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" />
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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" />) Adding multiplex testing of SARS-CoV-2 plus other organisms to your laboratory will largely revolve around your lab's CLIA status and assessment of the available options.
==''Introduction to Quality and Quality Management Systems''==
{{ombox
| type      = content
| style    = width: 500px;
| text      = This book should not be considered complete until this message box has been removed. This is a work in progress.
}}
The goal of this short volume is to act as an introduction to the quality management system. It collects several articles related to quality, quality management, and associated systems.


Multiplexing provides a variety of benefits for laboratories and patients. In their 2015 paper on ELISA and multiplex technologies, Tighe ''et al'' find that multiplexed immunoassays have the potential to decrease diagnosis times and reduce assay costs. "At the same time, such multiplexing offers more comprehensive analysis whether for research purposes, differential diagnoses, or monitoring of therapeutic interventions."<ref name="TigheELISA15" /> They also note the potential for improved health surveillance of patients, catching early-onset diseases by looking for informative biomarkers.<ref name="TigheELISA15" /> From the perspective of diagnosing infections of SARS-CoV-2 or influenza, the CDC adds that multiplexing helps preserve testing supplies that may be in short supply, conduct more tests in a given time period, and paint a clearer picture of both viruses and their prevalence in a given population.<ref name="CDCInflu21">{{cite web |url=https://www.cdc.gov/coronavirus/2019-ncov/lab/multiplex.html |title=CDC’s Influenza SARS-CoV-2 Multiplex Assay and Required Supplies |author=Centers for Disease Control and Prevention |publisher=Centers for Disease Control and Prevention |date=13 July 2021 |accessdate=19 September 2021}}</ref>
;1. What is quality?
:''Key terms''
:[[Quality (business)|Quality]]
:[[Quality assurance]]
:[[Quality control]]
:''The rest''
:[[Data quality]]
:[[Information quality]]
:[[Nonconformity (quality)|Nonconformity]]
:[[Service quality]]
;2. Processes and improvement
:[[Business process]]
:[[Process capability]]
:[[Risk management]]
:[[Workflow]]
;3. Mechanisms for quality
:[[Acceptance testing]]
:[[Conformance testing]]
:[[Clinical quality management system]]
:[[Continual improvement process]]
:[[Corrective and preventive action]]
:[[Good manufacturing practice]]
:[[Malcolm Baldrige National Quality Improvement Act of 1987]]
:[[Quality management]]
:[[Quality management system]]
:[[Total quality management]]
;4. Quality standards
:[[ISO 9000]]
:[[ISO 13485]]
:[[ISO 14000|ISO 14001]]
:[[ISO 15189]]
:[[ISO/IEC 17025]]
:[[ISO/TS 16949]]
;5. Quality in software
:[[Software quality]]
:[[Software quality assurance]]
:[[Software quality management]]


==References==
<!--Place all category tags here-->
{{Reflist|colwidth=30em}}

Latest revision as of 19:46, 9 February 2022

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Introduction to Quality and Quality Management Systems

This book should not be considered complete until this message box has been removed. This is a work in progress.

The goal of this short volume is to act as an introduction to the quality management system. It collects several articles related to quality, quality management, and associated systems.

1. What is quality?
Key terms
Quality
Quality assurance
Quality control
The rest
Data quality
Information quality
Nonconformity
Service quality
2. Processes and improvement
Business process
Process capability
Risk management
Workflow
3. Mechanisms for quality
Acceptance testing
Conformance testing
Clinical quality management system
Continual improvement process
Corrective and preventive action
Good manufacturing practice
Malcolm Baldrige National Quality Improvement Act of 1987
Quality management
Quality management system
Total quality management
4. Quality standards
ISO 9000
ISO 13485
ISO 14001
ISO 15189
ISO/IEC 17025
ISO/TS 16949
5. Quality in software
Software quality
Software quality assurance
Software quality management


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