Difference between revisions of "User:Shawndouglas/sandbox/sublevel1"

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As of September 2021, the U.S. Food and Drug Administration (FDA) has issued 260 EAUs for all types of molecular ''in vitro'' diagnostic test kits. Two hundred and eight of those 260 are only authorized to be used in CLIA-certified high-complexity laboratories, and 19 are rated for both moderate- and high-complexity. When looking at the makeup of the EUAs, a huge majority of those tests use some form of RT-PCR methods, with most using real-time or qualitative versions of RT-PCR (qRT-PCR). CLIA-waived RT-PCR tests are still rare, however. Eight PCR-based kits from five manufacturers have an additional authorization for point-of-care (POC) use (and thus CLIA-waived use) when used with their authorized POC devices<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>:
{{Saved book
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|subtitle=
|cover-image=Time-Quality-Money.png
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* BioFire Diagnostics' BioFire Respiratory Panel 2.1-EZ
==''Introduction to Quality and Quality Management Systems''==
* Cepheid's Xpert Omni SARS-CoV-2
{{ombox
* Cepheid's Xpert Xpress SARS-CoV-2
| type      = content
* Cepheid's Xpert Xpress SARS-CoV-2/Flu/RSV
| style    = width: 500px;
* Mesa Biotech's Accula SARS-Cov-2 Test
| text      = This book should not be considered complete until this message box has been removed. This is a work in progress.
* Roche Molecular Systems' cobas SARS-CoV-2
}}
* Roche Molecular Systems' cobas SARS-CoV-2 & Influenza A/B
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.
* Visby Medical's COVID-19 Point of Care Test


Of course, there are many more test kits than those approved in the United States. The Foundation for Innovative New Diagnostics (FIND) is currently "collating an overview of all SARS-CoV-2 tests commercially available or in development for the diagnosis of COVID-19."<ref name="FINDSARS20">{{cite web |url=https://www.finddx.org/covid-19/pipeline/ |title=SARS-CoV-2 Diagnostic Pipeline |author=Foundation for Innovative New Diagnostics |publisher=Foundation for Innovative New Diagnostics |date=n.d. |accessdate=18 November 2020}}</ref> As of September 2021, their site shows nearly 280 commercialized manual NAAT tests around the world (most being RT-PCR), with 30 in development. The AdVeritasDx test and controls database is also useful.<ref name="AVDTheSARS">{{cite web |url=https://adveritasdx.com/ |title=The SARS-CoV-2 Test & Controls Database |author=AdVeritasDx |date=2020 |accessdate=18 November 2020}}</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

Introduction to Quality and Quality Management Systems
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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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