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

From LIMSWiki
Jump to navigationJump to search
 
(106 intermediate revisions by the same user not shown)
Line 1: Line 1:
Another method some labs are taking to speed up turnaround time is using pooled testing. The general concept involves placing two or more test specimens together and testing the pool as one specimen. The most obvious advantage to this is that the process saves on reagents and other supplies, particularly when supply chains are disrupted, and it reduces the amount of time required to analyze large quantities of specimens.<ref name="CDCInterimPool21">{{cite web |url=https://www.cdc.gov/coronavirus/2019-ncov/lab/pooling-procedures.html |title=Interim Guidance for Use of Pooling Procedures in SARS-CoV-2 Diagnostic and Screening Testing |author=Centers for Disease Control and Prevention |publisher=Centers for Disease Control and Prevention |date=30 June 2021 |accessdate=19 September 2021}}</ref> This methodology is best used "in situations where disease prevalence is low, since each negative pool test eliminates the need to individually test those specimens and maximizes the number of individuals who can be tested over a given amount of time."<ref name="RohdeCOVID20">{{cite web |url=https://asm.org/Articles/2020/July/COVID-19-Pool-Testing-Is-It-Time-to-Jump-In |title=COVID-19 Pool Testing: Is It Time to Jump In? |author=Rohde, R. |publisher=American Society for Microbiology |date=20 July 2020 |accessdate=06 August 2020}}</ref> However, it's best left to situations where expectations are that less than 10 percent of the population being tested is affected by what's being tested for.<ref name="RohdeCOVID20" /><ref name="MashaPooled20">{{cite web |url=https://asiatimes.com/2020/08/pooled-virus-tests-help-stretched-health-services/ |title=Pooled virus tests help stretched health services |author=Masha, M.; Chau, S. |work=Asia Times |date=04 August 2020 |accessdate=06 August 2020}}</ref><ref name="CitronerHowPool20">{{cite web |url=https://www.healthline.com/health-news/how-pooled-testing-can-help-us-fight-spread-of-covid-19 |title=How Pooled Testing Can Help Us Fight Spread of COVID-19 |author=Citroner, G. |work=Healthline |date=03 August 2020 |accessdate=06 August 2020}}</ref>
{{Saved book
|title=Introduction to Quality and Quality Management Systems
|subtitle=
|cover-image=Time-Quality-Money.png
|cover-color=#fffccc
| setting-papersize = A4
| setting-showtoc = 1
| setting-columns = 1
}}


The downside of pooled testing comes with the issues of dilution, contamination, and populations with 10 or more percent infected. A target-positive specimen that commingles with other target-free specimens is itself diluted and in some cases may cause issues with the limit of detection for the assay. Additionally, if the pool tests positive, target-free specimens may become contaminated by a target-positive specimen. This may cause issues with any individual specimen assays that get ran. And the workflows involving pooling must be precise, as a technician working with multiple specimens at the same time increases the chance of lab errors.<ref name="RohdeCOVID20" /><ref name="MashaPooled20" /><ref name="CitronerHowPool20" /> Finally, at least in the U.S., a Food and Drug Administration (FDA) emergency use authorization (EUA) for a validated pooled testing method is required.<ref name="RohdeCOVID20" /> (Validation of pooled methods may differ in other countries.<ref name="MashaPooled20" />) The U.S. Centers for Disease Control and Prevention (CDC) has published [https://www.cdc.gov/coronavirus/2019-ncov/lab/pooling-procedures.html interim guidance] on pooled testing strategies for [[SARS-CoV-2]].
==''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.


On April 20, 2021, the FDA updated its policies to allow for pooled testing to be added to the use case scenarios for several existing test kits. "This means that tests with EUAs that are amended by this authorization may be used with pooled anterior nasal specimens from individuals without known or suspected COVID-19 when such individuals are tested as part of a testing program that includes testing at regular intervals, at least once per week."<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> However, affected kits can only be used in high-complexity CLIA labs, though "tests authorized for use in specific named or designated high-complexity laboratories can only be used in such laboratories."<ref name="FDAInVitroEUAs21" /> As of September 2021, four PCR test kit EUAs were amended to allow for pooled testing<ref name="FDAInVitroEUAs21" />:
;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]]


* Biomeme SARS-CoV-2 Real-Time RT-PCR Test
<!--Place all category tags here-->
* Clinical Enterprise SARS-SoV-2-RT-PCR Assay
* CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay (Version 3)
* Viracor SARS-CoV-2 assay
 
==References==
{{Reflist|colwidth=30em}}

Latest revision as of 19:46, 9 February 2022

Introduction to Quality and Quality Management Systems
Time-Quality-Money.png
This user book is a user-generated collection of LIMSWiki articles that can be easily saved, rendered electronically, and ordered as a printed book.
If you are the creator of this book and need help, see Help:Books.
Edit this book: Book Creator · Wikitext
Select format to download:

PDF (A4) · PDF (Letter)

Order a printed copy from these publishers: PediaPress
[ Start ] [ FAQ ] [ Basic help ] [ Advanced help ] [ Feedback ] [ Recent Changes ]


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


Retrieved from "https://www.limswiki.org/index.php?title=User:Shawndouglas/sandbox/sublevel1&oldid=46244"