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| LFAs are currently rare, but due to their advantages of being quick and useable at the point of care, some healthcare professionals have suggested that as a format for antigen and antibody (serology) testing, they could positively change the testing landscape.<ref name="SheridanFast20">{{cite web |url=https://www.nature.com/articles/d41587-020-00010-2 |title=Fast, portable tests come online to curb coronavirus pandemic |author=Sheridan, C. |work=Nature Biotechnology - News |date=23 March 2020 |accessdate=08 April 2020 |doi=10.1038/d41587-020-00010-2}}</ref><ref name="BistriceanCOVID20">{{cite web |url=https://medium.com/@lablynx/covid-19-testing-for-the-physician-office-laboratory-pol-covidlims-com-bf1615e071ab |title=COVID-19 Testing for the Physician Office Laboratory (POL) - CovidLiMS.com |work=Medium |author=Bistricean, C. |date=01 April 2020 |accessdate=10 April 2020}}</ref><ref name="DickensCorona20">{{cite web |url=https://reaction.life/coronavirus-testing-how-it-works-questions-answered/ |title=Coronavirus testing: How it works – Questions answered |work=Reaction |author=Dickens, J.F. |date=03 April 2020 |accessdate=10 April 2020}}</ref> As of September 2021, 25 of 88 serology tests that have received EUAs by the FDA are explicitly labeled as being LFAs, with 12 of those 25 being approved for POC/CLIA-waived use.<ref name="FDAInVitroEUASero21">{{cite web |url=https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-serology-and-other-adaptive-immune-response-tests-sars-cov-2 |title=In Vitro Diagnostics EUAs - Serology and Other Adaptive Immune Response Tests for SARS-CoV-2 |publisher=U.S. Food and Drug Administration |date=03 September 2021 |accessdate=07 September 2021}}</ref> An article by Sheridan in ''Nature Biotechnology'' highlights a handful of others developed around the world (see their Table 1).<ref name="SheridanFast20" /> FIND shows more than 400 commercialized rapid diagnostic immunoassay tests around the world, though it's not clear how many of them actually LFAs (from their list, only 14 are explicitly stated as being LFA).<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> While LFAs have increasingly been approved around the world in 2021<ref name="FDAInVitroEUASero21" /><ref name="FINDSARS20" />, it remains a question whether or not we continue to see more of them, at least in the United States.<ref name="BistriceanCOVID20" />
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| Also of note are [[Variants of PCR#Isothermal amplification methods|isothermal amplification]] methods. Abbott's ID NOW and Cue Health's Cue COVID-19 and Cue COVID-19 Test for Home and OTC tests (the latter being the first isothermal amplification test approved for home use) are described by the FDA as using "isothermal nucleic acid amplification technology for the qualitative detection of SARS-CoV-2 viral nucleic acids."<ref name="HintonCue20">{{cite web |url=https://www.fda.gov/media/136522/download |format=PDF |title=ID NOW COVID-19 |author=Hinton, D.M. |publisher=U.S. Food and Drug Administration |date=27 March 2020 |accessdate=10 April 2020}}</ref><ref name="HintonIDNOW20">{{cite web |url=https://www.fda.gov/media/138823/download |format=PDF |title=Cue COVID-19 Test |author=Hinton, D.M. |publisher=U.S. Food and Drug Administration |date=10 June 2020 |accessdate=08 July 2020}}}}</ref><ref name="HintonCueOTC21">{{cite web |url=https://www.fda.gov/media/146467/download |format=PDF |title=Cue COVID-19 Test for Home and Over The Counter (OTC) Use |author=Hinton, D.M. |publisher=U.S. Food and Drug Administration |date=05 March 2021 |accessdate=07 September 2021}}</ref> Isothermal amplification tends to be an easier process to manage due to being able to keep amplification at a constant temperature.<ref name="ZanoliIsotherm13">{{cite journal |title=Isothermal Amplification Methods for the Detection of Nucleic Acids in Microfluidic Devices |journal=Biosensors |author=Zanoli, L.M.; Spoto, G. |volume=3 |issue=1 |pages=18–43 |year=2013 |doi=10.3390/bios3010018 |pmid=25587397 |pmc=PMC4263587}}</ref> In fact, Abbott has stated its EUAed ID NOW COVID-19 test can be completed within five minutes.<ref name="AbbottDetect20">{{cite web |url=https://www.abbott.com/corpnewsroom/product-and-innovation/detect-covid-19-in-as-little-as-5-minutes.html |title=Detect COVID-19 in as Little as 5 Minutes |publisher=Abbott |date=27 March 2020 |accessdate=10 April 2020}}</ref> However, May 2020 findings by New York University put the test's accuracy into question. On July 1, 2020, an FDA spokesperson allegedly indicated receipt of 126 reports of "adverse events" concerning the test.<ref name="DevineCorona20">{{cite web |url=https://www.cnn.com/2020/07/03/politics/coronavirus-white-house-test-abbott/index.html |title=Coronavirus test used by White House has questionable accuracy |author=Devine, C. |work=CNN Politics |date=03 July 2020 |accessdate=08 July 2020}}</ref> In 2020, some 393 complaints were reported to the FDA, with 1,492 complains being reported in 2021 (through July 31) according to an FDA MAUDE (Manufacturer and User Facility Device Experience) search.<ref name="FDAMAUDE">{{cite web |url=https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Search.cfm |title=MAUDE - Manufacturer and User Facility Device Experience |publisher=U.S. Food and Drug Administration |accessdate=07 September 2021 |quote=Search for "ID NOW COVID-19" in Brand Name}}</ref> The FDA was reportedly investigating the data and working with Abbott to have additional studies performed on the test's accuracy in 2020.<ref name="PerroneFDA20">{{cite web |url=https://apnews.com/c8ab010e8e02dfe7beb34a5e5df11279 |title=FDA probes accuracy issue with Abbott’s rapid virus test |author=Perrone, M. |work=Associated Press |date=14 May 2020 |accessdate=19 May 2020}}</ref> In October 2020, Abbott released additional study data showing overall sensitivity of 93.3% and specificity of 98.4%, emphasizing the ID NOW's best use with samples taken within seven days of symptom onset.<ref name="TaylorAbbot20">{{cite web |url=https://www.medtechdive.com/news/abbott-on-defense-id-now-coronavirus-test-postmarket-study/586579/ |title=Abbott, on defense, details embattled rapid COVID-19 test results |author=Taylor, N.P. |work=MedTechDive |date=07 October 2020 |accessdate=18 November 2020}}</ref> On August 27, 2021, the FDA re-issued its EUA for the ID NOW with updated ''in silico'' inclusivity analysis results (among other things)<ref name="HintonIDNOWAug21">{{cite web |url=https://www.fda.gov/media/136522/download |format=PDF |title=ID NOW COVID-19 |author=Hinton, D.M. |publisher=U.S. Food and Drug Administration |date=27 August 2021 |accessdate=07 September 2021}}</ref>, but it's not clear if the FDA is continuing to work with Abbott on the test's accuracy claims.
| | ==''Introduction to Quality and Quality Management Systems''== |
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| | 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. |
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| Specific isothermal amplification techniques called [[loop-mediated isothermal amplification]] (LAMP) and reverse transcription LAMP (RT-LAMP) are beginning to emerge as options for COVID-19 testing. For example, Talis Biomedical is developing the Talis One COVID-19 system for point-of-care testing. It has received National Institutes of Health's Rapid Acceleration of Diagnostics (RADx) funding<ref name="NIHDelivering20">{{cite web |url=https://www.nih.gov/news-events/news-releases/nih-delivering-new-covid-19-testing-technologies-meet-us-demand |title=NIH delivering new COVID-19 testing technologies to meet U.S. demand |author=National Institutes of Health |publisher=National Institutes of Health |work=News Releases |date=31 July 2020 |accessdate=12 August 2020}}</ref> and, should it receive its EUA (as of August 2021, it was still awaiting FDA authorization<ref name="O'ConnorDespite21">{{cite web |url=https://www.360dx.com/business-news/despite-mdx-product-delays-talis-biomedical-expecting-meaningful-revenue-ramp-2022 |archiveurl=https://web.archive.org/web/20210811210316/https://www.360dx.com/business-news/despite-mdx-product-delays-talis-biomedical-expecting-meaningful-revenue-ramp-2022 |title=Despite MDx Product Delays, Talis Biomedical Expecting 'Meaningful Revenue Ramp in 2022' |author=O'Connor, L. |work=360 Dx |date=11 August 2021 |archivedate=11 August 2021 |accessdate=07 September 2021}}</ref>), is expected to be among the first U.S.-approved RT-LAMP tests for COVID-19.<ref name="TalisOne">{{cite web |url=https://talis.bio/technology/ |title=The Talis Advantage |publisher=Talis Biomedical |accessdate=13 August 2020}}</ref> In November 2020, the first LAMP-based, prescription "collect and test" at-home kit—the Lucira COVID-19 All-In-One Test Kit—was approved by the FDA for emergency use.<ref name="RomoFDAApproves20">{{cite web |url=https://www.npr.org/sections/coronavirus-live-updates/2020/11/17/936055284/fda-approves-first-at-home-coronavirus-test |title=FDA Approves 1st At-Home Coronavirus Test |author=Romo, V. |work=NPR |date=17 November 2020 |accessdate=18 November 2020}}</ref> Globally, examining FIND's list of nearly 280 commercialized manual NAAT tests around the world, five of them are explicitly shown to be some form of LAMP test. Multiple preprints on ''medRxiv'' and ''bioRxiv'', as well as published papers, suggest that RT-LAMP could provide rapid results for SARS-CoV-2 testing.<ref name="Schmid-BurgkLAMP20">{{cite journal |title=LAMP-Seq: Population-Scale COVID-19 Diagnostics Using Combinatorial Barcoding |journal=bioRxiv |author=Schmid-Burgk, J.L.; Li, D.; Feldman, D. et al. |year=2020 |doi=10.1101/2020.04.06.025635}}</ref><ref name="LambRapid20">{{cite journal |title=Rapid Detection of Novel Coronavirus (COVID-19) by Reverse Transcription-Loop-Mediated Isothermal Amplification |journal=medRxiv |author=Lamb, L.E.; Barolone, S.N.; Ward, E. et al. |year=2020 |doi=10.1101/2020.02.19.20025155}}</ref><ref name="KellnerARapid20">{{cite journal |title=A rapid, highly sensitive and open-access SARS-CoV-2 detection assay for laboratory and home testing |journal=bioRxiv |author=Kellner, M.J.; Ross, J.J.; Schnabl, J. et al. |year=2020 |doi=10.1101/2020.06.23.166397}}</ref><ref name="YuRapid20">{{cite journal |title=Rapid Detection of COVID-19 Coronavirus Using a Reverse Transcriptional Loop-Mediated Isothermal Amplification (RT-LAMP) Diagnostic Platform |journal=Clinical Chemistry |author=Yu, L.; Wu, S.; Hao, X. et al. |volume=66 |issue=7 |pages=975–77 |year=2020 |doi=10.1093/clinchem/hvaa102 |pmid=32315390 |pmc=PMC7188121}}</ref><ref name="ParkDevelop20">{{cite journal |title=Development of Reverse Transcription Loop-Mediated Isothermal Amplification Assays Targeting Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) |journal=Journal of Molecular Diagnostics |author=Park, G.-S.; Ku, K.; Baek, S.-H. et al. |volume=22 |issue=6 |pages=729–35 |year=2020 |doi=10.1016/j.jmoldx.2020.03.006 |pmid=32276051 |pmc=PMC7144851}}</ref> However, it's apparent that adoption of LAMP as a COVID-19 test technique has been slow at best overall.
| | ;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]] |
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| ==References==
| | <!--Place all category tags here--> |
| {{Reflist|colwidth=30em}}
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