User:Shawndouglas/sandbox/sublevel33 - Revision history

Shawndouglas at 20:37, 16 August 2023

2023-08-16T20:37:57Z

← Older revision		Revision as of 20:37, 16 August 2023
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	===7.~~3 Associations~~, ~~organizations, and interest groups===~~		<div class="nonumtoc">__TOC__</div>
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			\| text = This is sublevel33 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see [[User_talk:Shawndouglas\|my discussion page]] instead.<p></p>
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	* [https://asiacloudcomputing.org/about/ Asia Cloud Computing Association]: an "association that represents stakeholders of the cloud computing ecosystem in Asia"		==Sandbox begins below==
	* [https://www.cloudcta.co.uk/about/ Cloud Computing and Technology Association]: "the trade association for companies who deliver solutions on the cloud"
	* [http://www.cloudcomputingassn.org/ Cloud Computing Association]: "an independent membership organization dedicated to building a community of end-users and service providers of cloud-based solutions and products"
	* [https://cloudindustryforum.org/about/ Cloud Industry Forum]: a not-for-profit company that "champions and advocates the adoption and use of cloud-based services by businesses"
	* [https://cloudsecurityalliance.org/ Cloud Security Alliance]: an "organization dedicated to defining and raising awareness of best practices to help ensure a secure cloud computing environment"
	* [https://tc.computer.org/tccld/ IEEE Computer Society Technical Committee on Cloud Computing]: an IEEE community that "provides a forum for members to broaden professional contacts, facilitates information exchange, and stimulates the growth of research, education and industry in cloud computing"
	* [http://www.legalcloudcomputingassociation.org/ Legal Cloud Computing Association]: an association that "collaborates with Bar Associations and Law Societies to define industry-leading best practices"
	* [https://www.servicessociety.org/sigcloud SIG-CLOUD]: a special interest group of the Services Society that "promotes creative thinking, long-term visions, and innovative methodologies to respond to the emerging cloud computing technologies and applications"

	===~~7.4 Consultancy and support services~~===
	~~Note: This is intended to be a sampling of consultancies that provide cloud computing service assistance, most with some kind of experience working with labs. It's not intended to be a complete list.~~

	* [https://a-lign.com/ A-LIGN ASSURANCE]
	* [https://www.accenture.com/us-en/services/life-sciences/life-sciences-technology Accenture]
	* [https://astrixinc.com/insights/ Astrix]
	* [https://www.csolsinc.com/services/ CSols]
	* [https://edafio.com/services/ Edafio Technology Services]
	* [https://www.greenlightcomputers.co.uk/sectors/life-sciences/#cloud-based-solutions Greenlight Computers]
	* [https://www.kaliotek.com/life-sciences/ KalioTek]
	* [https://www.pwc.com/us/en/services/consulting/cloud-digital/cloud-transformation/pharmaceutical-life-sciences.html PWC]
	* [https://quantori.com/services/cloud-services Quantori]
	* [https://www.simtech.nl/ Simtech Consulting]
	* [https://synivate.com/services/ Synivate]
	* [https://www.tcgdigital.com/cloud/ TCG Digital]
	* [https://www.vertexlabs.info/solutions/ Vertex Laboratories]

Shawndouglas at 14:30, 28 July 2023

2023-07-28T14:30:31Z

← Older revision	Revision as of 14:30, 28 July 2023
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		===7.3 Associations, organizations, and interest groups===

		* [https://asiacloudcomputing.org/about/ Asia Cloud Computing Association]: an "association that represents stakeholders of the cloud computing ecosystem in Asia"
		* [https://www.cloudcta.co.uk/about/ Cloud Computing and Technology Association]: "the trade association for companies who deliver solutions on the cloud"
		* [http://www.cloudcomputingassn.org/ Cloud Computing Association]: "an independent membership organization dedicated to building a community of end-users and service providers of cloud-based solutions and products"
		* [https://cloudindustryforum.org/about/ Cloud Industry Forum]: a not-for-profit company that "champions and advocates the adoption and use of cloud-based services by businesses"
		* [https://cloudsecurityalliance.org/ Cloud Security Alliance]: an "organization dedicated to defining and raising awareness of best practices to help ensure a secure cloud computing environment"
		* [https://tc.computer.org/tccld/ IEEE Computer Society Technical Committee on Cloud Computing]: an IEEE community that "provides a forum for members to broaden professional contacts, facilitates information exchange, and stimulates the growth of research, education and industry in cloud computing"
		* [http://www.legalcloudcomputingassociation.org/ Legal Cloud Computing Association]: an association that "collaborates with Bar Associations and Law Societies to define industry-leading best practices"
		* [https://www.servicessociety.org/sigcloud SIG-CLOUD]: a special interest group of the Services Society that "promotes creative thinking, long-term visions, and innovative methodologies to respond to the emerging cloud computing technologies and applications"

		===7.4 Consultancy and support services===
		Note: This is intended to be a sampling of consultancies that provide cloud computing service assistance, most with some kind of experience working with labs. It's not intended to be a complete list.

		* [https://a-lign.com/ A-LIGN ASSURANCE]
		* [https://www.accenture.com/us-en/services/life-sciences/life-sciences-technology Accenture]
		* [https://astrixinc.com/insights/ Astrix]
		* [https://www.csolsinc.com/services/ CSols]
		* [https://edafio.com/services/ Edafio Technology Services]
		* [https://www.greenlightcomputers.co.uk/sectors/life-sciences/#cloud-based-solutions Greenlight Computers]
		* [https://www.kaliotek.com/life-sciences/ KalioTek]
		* [https://www.pwc.com/us/en/services/consulting/cloud-digital/cloud-transformation/pharmaceutical-life-sciences.html PWC]
		* [https://quantori.com/services/cloud-services Quantori]
		* [https://www.simtech.nl/ Simtech Consulting]
		* [https://synivate.com/services/ Synivate]
		* [https://www.tcgdigital.com/cloud/ TCG Digital]
		* [https://www.vertexlabs.info/solutions/ Vertex Laboratories]

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2021-09-06T13:13:32Z

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Shawndouglas: /* 2.2.3 The common cold */ Grammar

2020-05-20T16:31:24Z

2.2.3 The common cold: Grammar

← Older revision		Revision as of 16:31, 20 May 2020
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	Approximately 10 to 15 percent of cases of what we call the "common cold" are associated with an endemic coronavirus, of which are two distinct groups: HCoV-229E and HCoV-OC43.<ref name="WatTheCommon04">{{cite journal \|title=The common cold: A review of the literature \|journal=European Journal of Internal Medicine \|author=Wat, D. \|volume=15 \|issue=2 \|pages=79–88 \|year=2004 \|doi=10.1016/j.ejim.2004.01.006 \|pmid=15172021}}</ref> Disease symptoms associated with these coronaviruses—typically in the form of respiratory infection and the symptoms that come with it—by themselves are typically mild<ref name="LoeffelholzLab20" />, and laboratory testing isn't necessarily indicated for those immunocompetent individuals capable of self-limiting.<ref name="BabadyMulti18">{{cite journal \|title=Multicenter Evaluation of the ePlex Respiratory Pathogen Panel for the Detection of Viral and Bacterial Respiratory Tract Pathogens in Nasopharyngeal Swabs \|journal=Journal of Clinical Microbiology \|author=Babady, N.E.; England, M.R.; Jurcic Smith, K.L. et al. \|volume=56 \|issue=2 \|at=e01658-17 \|year=2018 \|doi=10.1128/JCM.01658-17 \|pmid=29212701 \|pmc=PMC5786739}}</ref> However, symptom overlap with pharyngitis and bronchitis, as well as the complication of pharyngitis and sinusitis also potentially having bacterial origin, can complicate clinical diagnosis. Additionally, as more antivirals that target a specific virus are created, and as concerns of unnecessarily using antibiotics to treat viral diseases grows<ref name="JenisonRapid16">{{cite web \|url=https://www.statnews.com/2016/11/30/antibiotic-resistance-molecular-diagnostics/ \|title=Rapid lab tests can help reduce antibiotic resistance \|author=Jenison, R. \|work=STAT \|date=30 November 2016 \|accessdate=03 April 2020}}</ref><ref name="RoyRapid18">{{cite web \|url=https://www.healio.com/infectious-disease/antimicrobials/news/online/%7B226c31f3-1d8e-4ffe-82b1-654cb37303c4%7D/rapid-test-for-viral-infections-reduces-unnecessary-antibiotic-prescribing \|title=Rapid test for viral infections reduces unnecessary antibiotic prescribing \|author=Roy, K. \|work=Healio \|date=26 September 2018 \|accessdate=03 April 2020}}</ref>, laboratory methods of respiratory virus diagnosis—particularly for those who are immunocompromised—have value.<ref name="WatTheCommon04" /><ref name="BabadyMulti18" />		Approximately 10 to 15 percent of cases of what we call the "common cold" are associated with an endemic coronavirus, of which are two distinct groups: HCoV-229E and HCoV-OC43.<ref name="WatTheCommon04">{{cite journal \|title=The common cold: A review of the literature \|journal=European Journal of Internal Medicine \|author=Wat, D. \|volume=15 \|issue=2 \|pages=79–88 \|year=2004 \|doi=10.1016/j.ejim.2004.01.006 \|pmid=15172021}}</ref> Disease symptoms associated with these coronaviruses—typically in the form of respiratory infection and the symptoms that come with it—by themselves are typically mild<ref name="LoeffelholzLab20" />, and laboratory testing isn't necessarily indicated for those immunocompetent individuals capable of self-limiting.<ref name="BabadyMulti18">{{cite journal \|title=Multicenter Evaluation of the ePlex Respiratory Pathogen Panel for the Detection of Viral and Bacterial Respiratory Tract Pathogens in Nasopharyngeal Swabs \|journal=Journal of Clinical Microbiology \|author=Babady, N.E.; England, M.R.; Jurcic Smith, K.L. et al. \|volume=56 \|issue=2 \|at=e01658-17 \|year=2018 \|doi=10.1128/JCM.01658-17 \|pmid=29212701 \|pmc=PMC5786739}}</ref> However, symptom overlap with pharyngitis and bronchitis, as well as the complication of pharyngitis and sinusitis also potentially having bacterial origin, can complicate clinical diagnosis. Additionally, as more antivirals that target a specific virus are created, and as concerns of unnecessarily using antibiotics to treat viral diseases grows<ref name="JenisonRapid16">{{cite web \|url=https://www.statnews.com/2016/11/30/antibiotic-resistance-molecular-diagnostics/ \|title=Rapid lab tests can help reduce antibiotic resistance \|author=Jenison, R. \|work=STAT \|date=30 November 2016 \|accessdate=03 April 2020}}</ref><ref name="RoyRapid18">{{cite web \|url=https://www.healio.com/infectious-disease/antimicrobials/news/online/%7B226c31f3-1d8e-4ffe-82b1-654cb37303c4%7D/rapid-test-for-viral-infections-reduces-unnecessary-antibiotic-prescribing \|title=Rapid test for viral infections reduces unnecessary antibiotic prescribing \|author=Roy, K. \|work=Healio \|date=26 September 2018 \|accessdate=03 April 2020}}</ref>, laboratory methods of respiratory virus diagnosis—particularly for those who are immunocompromised—have value.<ref name="WatTheCommon04" /><ref name="BabadyMulti18" />

	RT-PCR, a molecular method, has been used for well over a decade for detecting coronaviruses.<ref name="WatTheCommon04" /><ref name="MahonyDetect08">{{cite journal \|title=Detection of Respiratory Viruses by Molecular Methods \|journal=Clinical Microbiology Reviews \|author=Mahoney, J.B. \|volume=21 \|issue=4 \|pages=716–47 \|year=2008 \|doi=10.1128/CMR.00037-07 \|pmid=18854489 \|pmc=PMC2570148}}</ref> However, as molecular methods of analysis have expanded over the years, more rapid solutions for testing have been developed. For example, the GenMark ePlex rapid multiplex molecular diagnostics instrument and the ePlex Respiratory Pathogen Panel were evaluated in a multicenter trial by Babady ''et al.'' in 2017.<ref name="BabadyMulti18" /> The panel is capable of testing for the presence of 15 viral types—including the -229E, -OC43, and two other coronaviruses—and two bacterial types in nasopharyngeal swab specimens, with results in typically less than two hours.<ref name="BabadyMulti18" /> The ~~costs~~ associated with these sorts of tests, compared to their benefits, likely limits ubiquitous use at the first sign of a cold<ref name="BabadyMulti18" />, but as molecular diagnostic technologies become more compact and easy-to-use, testing for infection by endemic human coronaviruses may become slightly more commonplace. However, as the authors point out, with no treatment for these endemic coronaviruses, any additional utility beyond diagnosing an illness as viral rather than bacterial would primarily be found in epidemiological studies of the associated genotyping data.<ref name="BabadyMulti18" />		RT-PCR, a molecular method, has been used for well over a decade for detecting coronaviruses.<ref name="WatTheCommon04" /><ref name="MahonyDetect08">{{cite journal \|title=Detection of Respiratory Viruses by Molecular Methods \|journal=Clinical Microbiology Reviews \|author=Mahoney, J.B. \|volume=21 \|issue=4 \|pages=716–47 \|year=2008 \|doi=10.1128/CMR.00037-07 \|pmid=18854489 \|pmc=PMC2570148}}</ref> However, as molecular methods of analysis have expanded over the years, more rapid solutions for testing have been developed. For example, the GenMark ePlex rapid multiplex molecular diagnostics instrument and the ePlex Respiratory Pathogen Panel were evaluated in a multicenter trial by Babady ''et al.'' in 2017.<ref name="BabadyMulti18" /> The panel is capable of testing for the presence of 15 viral types—including the -229E, -OC43, and two other coronaviruses—and two bacterial types in nasopharyngeal swab specimens, with results in typically less than two hours.<ref name="BabadyMulti18" /> The cost associated with these sorts of tests, compared to their benefits, likely limits ubiquitous use at the first sign of a cold<ref name="BabadyMulti18" />, but as molecular diagnostic technologies become more compact and easy-to-use, testing for infection by endemic human coronaviruses may become slightly more commonplace. However, as the authors point out, with no treatment for these endemic coronaviruses, any additional utility beyond diagnosing an illness as viral rather than bacterial would primarily be found in epidemiological studies of the associated genotyping data.<ref name="BabadyMulti18" />


	===2.3 Organizational and agency guidance on COVID-19 testing===		===2.3 Organizational and agency guidance on COVID-19 testing===

Shawndouglas at 19:33, 1 May 2020

2020-05-01T19:33:28Z

← Older revision		Revision as of 19:33, 1 May 2020
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	====2.4.1 Background on the laboratory testing environment====		====2.4.1 Background on the laboratory testing environment====
	Before continuing, it should be noted that many elements of the prior-mentioned COVID-19 testing guidance have governmental public health laboratories in mind. However, as the scale of the epidemic has grown, the need for commercial laboratories and assay developers to get involved with increasing analytical testing throughput—through a more rigorous public-private partnership—has become abundantly clear.<ref name="MadrigalPrivate20">{{cite web \|url=https://www.theatlantic.com/health/archive/2020/03/next-covid-19-testing-crisis/609193/ \|title=Private Labs Are Fueling a New Coronavirus Testing Crisis \|author=Madrigal, A.C.; Meyer, R. \|work=The Atlantic \|date=31 March 2020 \|accessdate=07 April 2020}}</ref><ref name="HaleFDAOpens20">{{cite web \|url=https://www.fiercebiotech.com/medtech/fda-opens-gates-to-commercial-coronavirus-testing-without-agency-review \|title=FDA opens the gates to commercial coronavirus testing without agency review \|author=Hale, C. \|work=FierceBiotech \|date=17 March 2020 \|accessdate=07 April 2020}}</ref><ref name="ApplebyWhyIt20">{{cite web \|url=https://www.npr.org/sections/health-shots/2020/03/28/822869504/why-it-takes-so-long-to-get-most-covid-19-test-results \|title=Why It Takes So Long To Get Most COVID-19 Test Results \|author=Appleby, J. \|work=NPR - Health Shots \|date=28 March 2020 \|accessdate=07 April 2020}}</ref><ref name="Ryan-MosleyWhySome20">{{cite web \|url=https://www.technologyreview.com/s/615444/covid-19-test-results-faster-commercial-labs-delays-coronavirus/ \|title=Why some covid-19 tests in the US take more than a week \|author=Ryan-Mosley, T. \|work=MIT Technology Review \|date=05 April 2020 \|accessdate=07 April 2020}}</ref> Even so, at least in the United States, turnaround times have been slow due to a variety of factors, from lack of in-house laboratory resources to handle high test volumes and a slower-than-expected ramping up of test kit production<ref name="MadrigalPrivate20" /><ref name="ApplebyWhyIt20" /><ref name="Ryan-MosleyWhySome20" />, to actually getting diagnostic assays that are more rapid (yet still accurate) in their diagnosis, simpler to use, and useable at the point of care.<ref name="Nguyen2019_20">{{cite journal \|title=2019 novel coronavirus disease (COVID-19): Paving the road for rapid detection and point-of-care diagnostics \|journal=Micromachines \|author=Nguyen, T.; Bang, D.D.; Wolff, A. \|volume=11 \|issue=3 \|at=306 \|year=2020 \|doi=10.3390/mi11030306 \|pmid=32183357}}</ref><ref name="YangPoint20">{{cite journal \|title=Point-of-care RNA-based diagnostic device for COVID-19 \|journal=Diagnostics \|author=Yang, T.; Wang, Y.-C.; Shen, C.-F.; Cheng, C.-M. \|volume=10 \|issue=3 \|at=165 \|year=2020 \|doi=10.3390/diagnostics10030165}}</ref> The good news is examples of these rapid point-of-care molecular test kits are now becoming available around the globe, including the United States as part of the U.S. Food and Drug Administration's EUA process.		Before continuing, it should be noted that many elements of the prior-mentioned COVID-19 testing guidance have governmental public health laboratories in mind. However, as the scale of the epidemic has grown, the need for commercial laboratories and assay developers to get involved with efforts towards increasing analytical testing throughput—through a more rigorous public-private partnership—has become abundantly clear.<ref name="MadrigalPrivate20">{{cite web \|url=https://www.theatlantic.com/health/archive/2020/03/next-covid-19-testing-crisis/609193/ \|title=Private Labs Are Fueling a New Coronavirus Testing Crisis \|author=Madrigal, A.C.; Meyer, R. \|work=The Atlantic \|date=31 March 2020 \|accessdate=07 April 2020}}</ref><ref name="HaleFDAOpens20">{{cite web \|url=https://www.fiercebiotech.com/medtech/fda-opens-gates-to-commercial-coronavirus-testing-without-agency-review \|title=FDA opens the gates to commercial coronavirus testing without agency review \|author=Hale, C. \|work=FierceBiotech \|date=17 March 2020 \|accessdate=07 April 2020}}</ref><ref name="ApplebyWhyIt20">{{cite web \|url=https://www.npr.org/sections/health-shots/2020/03/28/822869504/why-it-takes-so-long-to-get-most-covid-19-test-results \|title=Why It Takes So Long To Get Most COVID-19 Test Results \|author=Appleby, J. \|work=NPR - Health Shots \|date=28 March 2020 \|accessdate=07 April 2020}}</ref><ref name="Ryan-MosleyWhySome20">{{cite web \|url=https://www.technologyreview.com/s/615444/covid-19-test-results-faster-commercial-labs-delays-coronavirus/ \|title=Why some covid-19 tests in the US take more than a week \|author=Ryan-Mosley, T. \|work=MIT Technology Review \|date=05 April 2020 \|accessdate=07 April 2020}}</ref> Even so, at least in the United States, turnaround times have been slow due to a variety of factors, from lack of in-house laboratory resources to handle high test volumes and a slower-than-expected ramping up of test kit production<ref name="MadrigalPrivate20" /><ref name="ApplebyWhyIt20" /><ref name="Ryan-MosleyWhySome20" />, to actually getting diagnostic assays that are more rapid (yet still accurate) in their diagnosis, simpler to use, and useable at the point of care.<ref name="Nguyen2019_20">{{cite journal \|title=2019 novel coronavirus disease (COVID-19): Paving the road for rapid detection and point-of-care diagnostics \|journal=Micromachines \|author=Nguyen, T.; Bang, D.D.; Wolff, A. \|volume=11 \|issue=3 \|at=306 \|year=2020 \|doi=10.3390/mi11030306 \|pmid=32183357}}</ref><ref name="YangPoint20">{{cite journal \|title=Point-of-care RNA-based diagnostic device for COVID-19 \|journal=Diagnostics \|author=Yang, T.; Wang, Y.-C.; Shen, C.-F.; Cheng, C.-M. \|volume=10 \|issue=3 \|at=165 \|year=2020 \|doi=10.3390/diagnostics10030165}}</ref> The good news is examples of these rapid point-of-care molecular test kits are now becoming available around the globe, including the United States as part of the U.S. Food and Drug Administration's EUA process.

	As the demand for expanded diagnostic testing grows in the face of a pandemic, it's important to compare the U.S. laboratory testing environments of public health and large commercial testing labs with those of small, in-office clinical labs. In the U.S., all but research-based laboratory testing of human specimens is regulated under the [[Clinical Laboratory Improvement Amendments]] (CLIA), including public health laboratories. CLIA is meant to ensure quality laboratory testing in the country. Seven different criteria are used to gauge and assign one of three complexity levels to laboratory devices and [[assay]]s: high, moderate, and waived.<ref name="CDCTestCom">{{cite web \|url=https://www.cdc.gov/clia/test-complexities.html \|title=Clinical Laboratory Improvement Amendments (CLIA): Test complexities \|author=Centers for Disease Control and Prevention \|date=06 August 2018 \|accessdate=09 April 2020}}</ref><ref name="FDAIVDReg">{{cite web \|url=https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clia-categorizations \|title=CLIA Categorizations \|publisher=U.S. Food and Drug Administration \|date=25 February 2020 \|accessdate=09 April 2020}}</ref> Additionally, CLIA mandates clinical laboratories handling specimens originating from the U.S. and its territories to apply for a CLIA certificate that is appropriate for the type of testing it performs. Labs using complex devices and assays would have to apply for a high complexity certificate, and so on. Waived tests are recognized as simple to perform with a low risk of erroneous results and include among others urinalysis for pregnancy and drugs of abuse, blood glucose and cholesterol tests, and fertility analysis.		As the demand for expanded diagnostic testing grows in the face of a pandemic, it's important to compare the U.S. laboratory testing environments of public health and large commercial testing labs with those of small, in-office clinical labs. In the U.S., all but research-based laboratory testing of human specimens is regulated under the [[Clinical Laboratory Improvement Amendments]] (CLIA), including public health laboratories. CLIA is meant to ensure quality laboratory testing in the country. Seven different criteria are used to gauge and assign one of three complexity levels to laboratory devices and [[assay]]s: high, moderate, and waived.<ref name="CDCTestCom">{{cite web \|url=https://www.cdc.gov/clia/test-complexities.html \|title=Clinical Laboratory Improvement Amendments (CLIA): Test complexities \|author=Centers for Disease Control and Prevention \|date=06 August 2018 \|accessdate=09 April 2020}}</ref><ref name="FDAIVDReg">{{cite web \|url=https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clia-categorizations \|title=CLIA Categorizations \|publisher=U.S. Food and Drug Administration \|date=25 February 2020 \|accessdate=09 April 2020}}</ref> Additionally, CLIA mandates clinical laboratories handling specimens originating from the U.S. and its territories to apply for a CLIA certificate that is appropriate for the type of testing it performs. Labs using complex devices and assays would have to apply for a high complexity certificate, and so on. Waived tests are recognized as simple to perform with a low risk of erroneous results and include among others urinalysis for pregnancy and drugs of abuse, blood glucose and cholesterol tests, and fertility analysis.
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	As of April 28, the U.S. Food and Drug Administration (FDA) has 42 EAUs for molecular ''in vitro'' diagnostic test kits. Forty-one of those 42 test kits use some form of RT-PCR methods, with most using real-time versions of RT-PCR (rRT-PCR). Thirty of those 41 are only authorized to be used in CLIA-certified high-complexity laboratories, with nine being rated for both moderate- and high-complexity. Two RT-PCR kits—Mesa Biotech's Accula SARS-Cov-2 Test and Cepheid's Xpert Xpress SARS-CoV-2 Test—have an additional authorization for point-of-care (POC) use (and thus CLIA-waived use) when used with their authorized POC devices.<ref name="FDAEmerg20" />		As of April 28, the U.S. Food and Drug Administration (FDA) has 42 EAUs for molecular ''in vitro'' diagnostic test kits. Forty-one of those 42 test kits use some form of RT-PCR methods, with most using real-time versions of RT-PCR (rRT-PCR). Thirty of those 41 are only authorized to be used in CLIA-certified high-complexity laboratories, with nine being rated for both moderate- and high-complexity. Two RT-PCR kits—Mesa Biotech's Accula SARS-Cov-2 Test and Cepheid's Xpert Xpress SARS-CoV-2 Test—have an additional authorization for point-of-care (POC) use (and thus CLIA-waived use) when used with their authorized POC devices.<ref name="FDAEmerg20" />

	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=10 April 2020}}</ref> As of April 28, their site shows more than 180 commercialized manual NAAT tests around the world (most being RT-PCR), with more than 20 in development.		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=10 April 2020}}</ref> As of April 28, their site shows more than 180 commercialized manual NAAT tests around the world (most being RT-PCR), with more than 20 in development. 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=01 May 2020}}</ref>

	====2.4.3 LFA- and LAMP-based====		====2.4.3 LFA- and LAMP-based====
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	Reports of reagent shortages appeared in March and April from various sources<ref name="HerperShortage20">{{cite web \|url=https://www.statnews.com/2020/03/10/shortage-crucial-chemicals-us-coronavirus-testing/ \|title=Shortage of crucial chemicals creates new obstacle to U.S. coronavirus testing \|work=STAT \|author=Herper, M.; Branswell, H. \|date=10 March 2020 \|accessdate=10 April 2020}}</ref><ref name="HaleQiagen20">{{cite web \|url=https://www.fiercebiotech.com/medtech/qiagen-aims-to-more-than-quadruple-its-covid-19-reagent-production-6-weeks \|title=Qiagen aims to more than quadruple its COVID-19 reagent production in 6 weeks \|work=Fierce Biotech \|author=Hale, C. \|date=18 March 2020 \|accessdate=10 April 2020}}</ref><ref name="MehtaMystery20">{{cite web \|url=https://www.chemistryworld.com/mystery-surrounds-uk-claim-of-covid-19-test-reagent-shortage/4011457.article \|title=Mystery surrounds UK claim of Covid-19 test reagent ‘shortage’ \|work=Chemistry World \|author=Mehta, A. \|date=03 April 2020 \|accessdate=10 April 2020}}</ref><ref name="RocheIrish20">{{cite web \|url=https://www.irishtimes.com/news/science/irish-scientists-develop-reagent-in-effort-to-ease-covid-19-testing-delays-1.4223897 \|title=Irish scientists develop reagent in effort to ease Covid-19 testing delays \|work=The Irish Times \|author=Roche, B. \|date=08 April 2020 \|accessdate=10 April 2020}}</ref>, though whether the shortage is a real supply issue or "a consequence of restrictive policies on where and how testing could be completed" is argued by some.<ref name="NoltingLocal20" /><ref name="MehtaMystery20" /> Others have taken matters into their own hands in regards to reagent component shortages. Noting Irish laboratories' difficulties sourcing lysis buffer (for isolating molecules of interest and keeping them stable), Cork Institute of Technology's Dr. Brigid Lucey worked with several other virologists and microbiologists, as well as pharmaceutical company Eli Lilly, to produce a custom-formulated yet high-quality lysis buffer for not only Irish laboratories but also other countries can take advantage of. "We are happy to share what we found with other countries and it’s important our scientists retain their skills to make this kind of formulation because we may need to do this again in the future if we get other pandemics," she said.<ref name="RocheIrish20" />		Reports of reagent shortages appeared in March and April from various sources<ref name="HerperShortage20">{{cite web \|url=https://www.statnews.com/2020/03/10/shortage-crucial-chemicals-us-coronavirus-testing/ \|title=Shortage of crucial chemicals creates new obstacle to U.S. coronavirus testing \|work=STAT \|author=Herper, M.; Branswell, H. \|date=10 March 2020 \|accessdate=10 April 2020}}</ref><ref name="HaleQiagen20">{{cite web \|url=https://www.fiercebiotech.com/medtech/qiagen-aims-to-more-than-quadruple-its-covid-19-reagent-production-6-weeks \|title=Qiagen aims to more than quadruple its COVID-19 reagent production in 6 weeks \|work=Fierce Biotech \|author=Hale, C. \|date=18 March 2020 \|accessdate=10 April 2020}}</ref><ref name="MehtaMystery20">{{cite web \|url=https://www.chemistryworld.com/mystery-surrounds-uk-claim-of-covid-19-test-reagent-shortage/4011457.article \|title=Mystery surrounds UK claim of Covid-19 test reagent ‘shortage’ \|work=Chemistry World \|author=Mehta, A. \|date=03 April 2020 \|accessdate=10 April 2020}}</ref><ref name="RocheIrish20">{{cite web \|url=https://www.irishtimes.com/news/science/irish-scientists-develop-reagent-in-effort-to-ease-covid-19-testing-delays-1.4223897 \|title=Irish scientists develop reagent in effort to ease Covid-19 testing delays \|work=The Irish Times \|author=Roche, B. \|date=08 April 2020 \|accessdate=10 April 2020}}</ref>, though whether the shortage is a real supply issue or "a consequence of restrictive policies on where and how testing could be completed" is argued by some.<ref name="NoltingLocal20" /><ref name="MehtaMystery20" /> Others have taken matters into their own hands in regards to reagent component shortages. Noting Irish laboratories' difficulties sourcing lysis buffer (for isolating molecules of interest and keeping them stable), Cork Institute of Technology's Dr. Brigid Lucey worked with several other virologists and microbiologists, as well as pharmaceutical company Eli Lilly, to produce a custom-formulated yet high-quality lysis buffer for not only Irish laboratories but also other countries can take advantage of. "We are happy to share what we found with other countries and it’s important our scientists retain their skills to make this kind of formulation because we may need to do this again in the future if we get other pandemics," she said.<ref name="RocheIrish20" />

			One other challenge lies in the accuracy of serology-based antibody tests, let alone how much they actually tell us about immunity. FierceBiotech's Conor Hale touch upon this in late April<ref name="HaleCongress20">{{cite web \|url=https://www.fiercebiotech.com/medtech/congress-urges-fda-to-better-police-evaluate-covid-19-antibody-tests \|title=Congress urges FDA to better police, evaluate COVID-19 antibody tests \|author=Hale, C. \|work=Fierce Biotech \|date=27 April 2020 \|accessdate=01 May 2020}}</ref>:

			<blockquote>Compared to molecular tests—which sequence and match the RNA of the novel coronavirus to produce a result—the FDA has described antibody tests that gauge the body’s immune system response as a less-complicated endeavor that could proceed without review, dubbed “regulatory flexibility” by Commissioner Stephen Hahn. This policy shift has led to confusion, with some antibody test developers falsely claiming their tests are FDA-approved or could diagnose COVID-19 at home. Still others have sold outrightly fraudulent tests online.</blockquote>

			At least in the U.S., these problems are compounded by company participation in test validation of EUAs being voluntary.<ref name="HaleCongress20" /> As a memorandum from Congress puts it: "FDA is unable to validate the accuracy of antibody tests that are already on the market, and companies are ignoring requests from the Department of Health and Human Services (HHS) to voluntarily submit their tests for validation ... FDA has failed to police the coronavirus serological antibody test market, has taken no public enforcement action against any company, and has not conveyed any clear policy on serological tests..."<ref name="SORPremim20">{{cite web \|url=https://oversight.house.gov/sites/democrats.oversight.house.gov/files/ECP%20Staff%20Report%20on%20Preliminary%20Findings%20of%20the%20Subcommittee%E2%80%99s%20Coronavirus%20Antibody%20Testing%20Investigation.pdf \|format=PDF \|title=Preliminary Findings of the Subcommittee’s Coronavirus Antibody Testing Investigation \|author=Subcommittee on Economic and Consumer Policy \|publisher=U.S. House of Representatives \|date=24 April 2020 \|accessdate=01 May 2020}}</ref> The entire memorandum is revealing in the challenges of attempting to relax social distancing measures under the pretense of the effectiveness of antibody testing. Entities such as the University of California - San Francisco<ref name="FarleyTesting20">{{cite web \|url=https://www.ucsf.edu/news/2020/04/417276/testing-tests-covid-19-antibody-assays-scrutinized-accuracy-ucsf-uc-berkeley \|title=Testing the Tests: COVID-19 Antibody Assays Scrutinized for Accuracy by UCSF, UC Berkeley Researchers \|author=Farley, P.; Sanders, R. \|work=UCSF News \|date=27 April 2020 \|accessdate=01 May 2020}}</ref> and the University of California - Berkeley<ref name="SandersWhat20">{{cite web \|url=https://news.berkeley.edu/2020/04/27/what-covid-19-antibody-tests-can-tell-us-and-what-they-cant/ \|title=What COVID-19 antibody tests can tell us, and what they can’t \|author=Sanders, R. \|work=Berkeley News \|date=27 April 2020 \|accessdate=01 May 2020}}</ref> have been emphasizing the importance elements such as sensitivity, specificity, proper training, and the unknowns of the predictive ability of the test. With public confusion growing and expectations increasingly out of line with the science<ref name="AlltuckerAnti20">{{cite web \|url=https://www.usatoday.com/story/news/health/2020/04/30/coronavirus-antibody-tests-immunity-mayo-clinic-who/3038740001/ \|title=Antibody tests were supposed to help guide US reopening plans. They've brought more confusion than clarity amid coronavirus \|author=Alltucker, K. \|work=USA Today \|date=30 April 2020 \|accessdate=01 May 2020}}</ref>, it's more important than ever for leaders across government, healthcare, and the media to continue to not spread misinformation and not make decisions based on poor scientific evidence.


	==References==		==References==
	{{Reflist\|colwidth=30em}}		{{Reflist\|colwidth=30em}}

Shawndouglas at 18:50, 1 May 2020

2020-05-01T18:50:46Z

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Shawndouglas at 21:50, 28 April 2020

2020-04-28T21:50:39Z

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Shawndouglas at 20:42, 28 April 2020

2020-04-28T20:42:48Z

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Shawndouglas at 15:59, 12 April 2020

2020-04-12T15:59:29Z

← Older revision		Revision as of 15:59, 12 April 2020
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	Reports of reagent shortages appeared in March and April from various sources<ref name="HerperShortage20">{{cite web \|url=https://www.statnews.com/2020/03/10/shortage-crucial-chemicals-us-coronavirus-testing/ \|title=Shortage of crucial chemicals creates new obstacle to U.S. coronavirus testing \|work=STAT \|author=Herper, M.; Branswell, H. \|date=10 March 2020 \|accessdate=10 April 2020}}</ref><ref name="HaleQiagen20">{{cite web \|url=https://www.fiercebiotech.com/medtech/qiagen-aims-to-more-than-quadruple-its-covid-19-reagent-production-6-weeks \|title=Qiagen aims to more than quadruple its COVID-19 reagent production in 6 weeks \|work=Fierce Biotech \|author=Hale, C. \|date=18 March 2020 \|accessdate=10 April 2020}}</ref><ref name="MehtaMystery20">{{cite web \|url=https://www.chemistryworld.com/mystery-surrounds-uk-claim-of-covid-19-test-reagent-shortage/4011457.article \|title=Mystery surrounds UK claim of Covid-19 test reagent ‘shortage’ \|work=Chemistry World \|author=Mehta, A. \|date=03 April 2020 \|accessdate=10 April 2020}}</ref><ref name="RocheIrish20">{{cite web \|url=https://www.irishtimes.com/news/science/irish-scientists-develop-reagent-in-effort-to-ease-covid-19-testing-delays-1.4223897 \|title=Irish scientists develop reagent in effort to ease Covid-19 testing delays \|work=The Irish Times \|author=Roche, B. \|date=08 April 2020 \|accessdate=10 April 2020}}</ref>, though whether the shortage is a real supply issue or "a consequence of restrictive policies on where and how testing could be completed" is argued by some.<ref name="NoltingLocal20" /><ref name="MehtaMystery20" /> Others have taken matters into their own hands in regards to reagent component shortages. Noting Irish laboratories' difficulties sourcing lysis buffer (for isolating molecules of interest and keeping them stable), Cork Institute of Technology's Dr. Brigid Lucey worked with several other virologists and microbiologists, as well as pharmaceutical company Eli Lilly, to produce a custom-formulated yet high-quality lysis buffer for not only Irish laboratories but also other countries can take advantage of. "We are happy to share what we found with other countries and it’s important our scientists retain their skills to make this kind of formulation because we may need to do this again in the future if we get other pandemics," she said.<ref name="RocheIrish20" />		Reports of reagent shortages appeared in March and April from various sources<ref name="HerperShortage20">{{cite web \|url=https://www.statnews.com/2020/03/10/shortage-crucial-chemicals-us-coronavirus-testing/ \|title=Shortage of crucial chemicals creates new obstacle to U.S. coronavirus testing \|work=STAT \|author=Herper, M.; Branswell, H. \|date=10 March 2020 \|accessdate=10 April 2020}}</ref><ref name="HaleQiagen20">{{cite web \|url=https://www.fiercebiotech.com/medtech/qiagen-aims-to-more-than-quadruple-its-covid-19-reagent-production-6-weeks \|title=Qiagen aims to more than quadruple its COVID-19 reagent production in 6 weeks \|work=Fierce Biotech \|author=Hale, C. \|date=18 March 2020 \|accessdate=10 April 2020}}</ref><ref name="MehtaMystery20">{{cite web \|url=https://www.chemistryworld.com/mystery-surrounds-uk-claim-of-covid-19-test-reagent-shortage/4011457.article \|title=Mystery surrounds UK claim of Covid-19 test reagent ‘shortage’ \|work=Chemistry World \|author=Mehta, A. \|date=03 April 2020 \|accessdate=10 April 2020}}</ref><ref name="RocheIrish20">{{cite web \|url=https://www.irishtimes.com/news/science/irish-scientists-develop-reagent-in-effort-to-ease-covid-19-testing-delays-1.4223897 \|title=Irish scientists develop reagent in effort to ease Covid-19 testing delays \|work=The Irish Times \|author=Roche, B. \|date=08 April 2020 \|accessdate=10 April 2020}}</ref>, though whether the shortage is a real supply issue or "a consequence of restrictive policies on where and how testing could be completed" is argued by some.<ref name="NoltingLocal20" /><ref name="MehtaMystery20" /> Others have taken matters into their own hands in regards to reagent component shortages. Noting Irish laboratories' difficulties sourcing lysis buffer (for isolating molecules of interest and keeping them stable), Cork Institute of Technology's Dr. Brigid Lucey worked with several other virologists and microbiologists, as well as pharmaceutical company Eli Lilly, to produce a custom-formulated yet high-quality lysis buffer for not only Irish laboratories but also other countries can take advantage of. "We are happy to share what we found with other countries and it’s important our scientists retain their skills to make this kind of formulation because we may need to do this again in the future if we get other pandemics," she said.<ref name="RocheIrish20" />


	~~===2.5 Regulatory and recommended requirements for reporting test results===~~
	Epidemiology can broadly be split into two categories: descriptive epidemiology and analytical epidemiology. Descriptive epidemiology involves studies and other activites that deal with geographical comparisons and temporal trend descriptions of disease. As such, the collection and use of quality incidence data is vital to developing hypotheses.<ref name="NaitoUtil14">{{cite journal \|title=Utilization and application of public health data in descriptive epidemiology \|journal=Journal of Epidemiology \|author=Naito, M. \|volume=24 \|issue=6 \|pages=435–6 \|year=2014 \|doi=10.2188/jea.je20140182 \|pmid=25327184 \|pmc=PMC4213216}}</ref> Analytical epidemiology allows for the testing of those hypotheses using both experimental and obsevational studies, as well as control groups. Similarly, the collection and use of quality experimental and observational data is vital for providing or disproving hypotheses.<ref name="CDCPrinc12">{{cite book \|url=https://www.cdc.gov/csels/dsepd/ss1978/SS1978.pdf \|format=PDF \|title=Principles of Epidemiology in Public Health Practice \|author=Centers for Disease Control and Prevention \|edition=3rd \|publisher=Centers for Disease Control and Prevention \|year=2012 \|accessdate=11 April 2020}}</ref> In both cases, proper reporting of data is critical to the success of epidemiologists' response to outbreaks and pandemics, as well as the credibility of their research.<ref name="HamiltonUsing19">{{cite book \|chapter=Chapter 5: Using Technologies for Data Collection and Management \|title=The CDC Field Epidemiology Manual \|author=Hamilton, J.J.; Hopkins, R.S. \|editor=Rasmussen, S.A.; Goodman, R.A. \|publisher=Oxford University Press \|edition=4th \|pages=71–104 \|year=2019 \|isbn=9780190933692}}</ref><ref name="vonElmTheStren07">{{cite journal \|title=The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: Guidelines for reporting observational studies \|journal=PLoS Medicine \|author=von Elm, E.; Altman, D.G.; Egger, M. et al. \|volume=4 \|issue=10 \|at=e296 \|year=2007 \|doi=10.1371/journal.pmed.0040296 \|pmid=17941714 \|pmc=PMC2020495}}</ref>

	The proper reporting of COVID-19 case data is no exception. In the United States, the CDC has taken a standardized approach to collecting reports on "individuals with at least one respiratory specimen that tested positive for the virus that causes COVID-19."<ref name="CDCInformRepo20">{{cite web \|url=https://www.cdc.gov/coronavirus/2019-ncov/php/reporting-pui.html \|title=Information for Health Departments on Reporting Cases of COVID-19 \|author=Centers for Disease Control and Prevention \|work=Coronavirus Disease 2019 (COVID-19) \|publisher=Centers for Disease Control and Prevention \|date=21 March 2020 \|accessdate=21 March 2020}}</ref> Their COVID-19 Case Report Form is designed to collect a wide variety of information about a COVID-19 case, including patient demographics, epidemiological characteristics, exposure and contact history, and clinical diagnosis and treatment procedures. Currently, the CDC is asking local and state health departments to submit case reports, and asking healthcare providers to contact those health departments when "concerned that a patient may have COVID-19." The CDC has also slimmed its reporting requirements, limiting reporting of "persons under investigation" to areas where testing must be forwarded to the CDC due to insufficient capacity to test locally.<ref name="CDCInformRepo20" /> Electronic reporting using the CDC's system is preferred, but they have a protocol for those areas unable to submit electronically. Canada has similar reporting expectations, with their own case report form and electronic data submission process through the Public Health Agency of Canada.<ref name="CanadaInterim20">{{cite web \|url=https://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection/health-professionals/interim-guidance-surveillance-human-infection.html \|title=Interim national surveillance guidelines for human infection with Coronavirus disease (COVID-19) \|author=Government of Canada \|publisher=Government of Canada \|date=10 February 2020 \|accessdate=11 April 2020}}</ref> And in the European Union, member countries and the U.K. are asked to report through the Early Warning and Response System.<ref name="ECDCCaseDef20">{{cite web \|url=https://www.ecdc.europa.eu/en/case-definition-and-european-surveillance-human-infection-novel-coronavirus-2019-ncov \|title=Case definition and European surveillance for COVID-19, as of 2 March 2020 \|author=European Centre for Disease Prevention and Control \|publisher=European Centre for Disease Prevention and Control \|work=COVID-19 Portal \|date=02 March 2020 \|accessdate=11 April 2020}}</ref>

	Somewhat related are any internal reporting requirements, particularly for test reporting in labs and medical facilities. The [[International Statistical Classification of Diseases and Related Health Problems]] (ICD) is a system of diagnostic codes for classifying diseases, including nuanced classifications of a wide variety of signs, symptoms, abnormal findings, complaints, social circumstances, and external causes of injury or disease. Their ICD-10-CM code set has been modified to include lab testing codes for COVID-19, as has the [[Current Procedural Terminology]] (CPT) code set. [https://www.mgma.com/data/data-stories/coding-guidance-for-new-icd-10-cm-and-lab-testing Green and Bradley] provide insight into these additions<ref name="GreenCoding20">{{cite web \|url=https://www.mgma.com/data/data-stories/coding-guidance-for-new-icd-10-cm-and-lab-testing \|title=Coding guidance for new ICD-10-CM and lab testing codes for COVID-19 \|work=MGMA Stat \|author=Green, C.; Bradley, V. \|date=01 April 2020 \|accessdate=11 April 2020}}</ref>, as does the [https://www.aappublications.org/news/2020/03/12/coding031220 American Academy of Pediatrics].<ref name="AAPHowTo20">{{cite web \|url=https://www.aappublications.org/news/2020/03/12/coding031220 \|title=How to use ICD-10-CM, new lab testing codes for COVID-19 \|author=AAP Division of Health Care Finance \|publisher=American Academy of Pediatrics \|date=12 March 2020 \|accessdate=11 April 2020}}</ref>


	==References==		==References==
	{{Reflist\|colwidth=30em}}		{{Reflist\|colwidth=30em}}

Shawndouglas at 15:53, 12 April 2020

2020-04-12T15:53:30Z

← Older revision		Revision as of 15:53, 12 April 2020
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	===2.5 Regulatory and recommended requirements for reporting test results===		===2.5 Regulatory and recommended requirements for reporting test results===
	Epidemiology can broadly be split into two categories: descriptive epidemiology and analytical epidemiology. Descriptive epidemiology involves studies and other activites that deal with geographical comparisons and temporal trend descriptions of disease. As such, the collection and use of quality incidence data is vital to developing hypotheses.<ref name="NaitoUtil14">{{cite journal \|title=Utilization and application of public health data in descriptive epidemiology \|journal=Journal of Epidemiology \|author=Naito, M. \|volume=24 \|issue=6 \|pages=435–6 \|year=2014 \|doi=10.2188/jea.je20140182 \|pmid=25327184 \|pmc=PMC4213216}}</ref> Analytical epidemiology allows for the testing of those hypotheses using both experimental and obsevational studies, as well as control groups. Similarly, the collection and use of quality experimental and observational data is vital for providing or disproving hypotheses.<ref name="CDCPrinc12">{{cite book \|url=https://www.cdc.gov/csels/dsepd/ss1978/SS1978.pdf \|format=PDF \|title=Principles of Epidemiology in Public Health Practice \|author=Centers for Disease Control and Prevention \|edition=3rd \|publisher=Centers for Disease Control and Prevention \|year=2012 \|accessdate=11 April 2020}}</ref> In both cases, proper reporting is critical to the success of epidemiologists' response to outbreaks and the credibility of their research.<ref name="HamiltonUsing19">{{cite book \|chapter=Chapter 5: Using Technologies for Data Collection and Management \|title=The CDC Field Epidemiology Manual \|author=Hamilton, J.J.; Hopkins, R.S. \|editor=Rasmussen, S.A.; Goodman, R.A. \|publisher=Oxford University Press \|edition=4th \|pages=71–104 \|year=2019 \|isbn=9780190933692}}</ref><ref name="vonElmTheStren07">{{cite journal \|title=The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: ~~guidelines~~ for reporting observational studies \|journal=PLoS Medicine \|author=von Elm, E.; Altman, D.G.; Egger, M. et al. \|volume=4 \|issue=10 \|at=e296 \|year=2007 \|doi=10.1371/journal.pmed.0040296 \|pmid=17941714 \|pmc=PMC2020495}}</ref>		Epidemiology can broadly be split into two categories: descriptive epidemiology and analytical epidemiology. Descriptive epidemiology involves studies and other activites that deal with geographical comparisons and temporal trend descriptions of disease. As such, the collection and use of quality incidence data is vital to developing hypotheses.<ref name="NaitoUtil14">{{cite journal \|title=Utilization and application of public health data in descriptive epidemiology \|journal=Journal of Epidemiology \|author=Naito, M. \|volume=24 \|issue=6 \|pages=435–6 \|year=2014 \|doi=10.2188/jea.je20140182 \|pmid=25327184 \|pmc=PMC4213216}}</ref> Analytical epidemiology allows for the testing of those hypotheses using both experimental and obsevational studies, as well as control groups. Similarly, the collection and use of quality experimental and observational data is vital for providing or disproving hypotheses.<ref name="CDCPrinc12">{{cite book \|url=https://www.cdc.gov/csels/dsepd/ss1978/SS1978.pdf \|format=PDF \|title=Principles of Epidemiology in Public Health Practice \|author=Centers for Disease Control and Prevention \|edition=3rd \|publisher=Centers for Disease Control and Prevention \|year=2012 \|accessdate=11 April 2020}}</ref> In both cases, proper reporting of data is critical to the success of epidemiologists' response to outbreaks and pandemics, as well as the credibility of their research.<ref name="HamiltonUsing19">{{cite book \|chapter=Chapter 5: Using Technologies for Data Collection and Management \|title=The CDC Field Epidemiology Manual \|author=Hamilton, J.J.; Hopkins, R.S. \|editor=Rasmussen, S.A.; Goodman, R.A. \|publisher=Oxford University Press \|edition=4th \|pages=71–104 \|year=2019 \|isbn=9780190933692}}</ref><ref name="vonElmTheStren07">{{cite journal \|title=The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: Guidelines for reporting observational studies \|journal=PLoS Medicine \|author=von Elm, E.; Altman, D.G.; Egger, M. et al. \|volume=4 \|issue=10 \|at=e296 \|year=2007 \|doi=10.1371/journal.pmed.0040296 \|pmid=17941714 \|pmc=PMC2020495}}</ref>

			The proper reporting of COVID-19 case data is no exception. In the United States, the CDC has taken a standardized approach to collecting reports on "individuals with at least one respiratory specimen that tested positive for the virus that causes COVID-19."<ref name="CDCInformRepo20">{{cite web \|url=https://www.cdc.gov/coronavirus/2019-ncov/php/reporting-pui.html \|title=Information for Health Departments on Reporting Cases of COVID-19 \|author=Centers for Disease Control and Prevention \|work=Coronavirus Disease 2019 (COVID-19) \|publisher=Centers for Disease Control and Prevention \|date=21 March 2020 \|accessdate=21 March 2020}}</ref> Their COVID-19 Case Report Form is designed to collect a wide variety of information about a COVID-19 case, including patient demographics, epidemiological characteristics, exposure and contact history, and clinical diagnosis and treatment procedures. Currently, the CDC is asking local and state health departments to submit case reports, and asking healthcare providers to contact those health departments when "concerned that a patient may have COVID-19." The CDC has also slimmed its reporting requirements, limiting reporting of "persons under investigation" to areas where testing must be forwarded to the CDC due to insufficient capacity to test locally.<ref name="CDCInformRepo20" /> Electronic reporting using the CDC's system is preferred, but they have a protocol for those areas unable to submit electronically. Canada has similar reporting expectations, with their own case report form and electronic data submission process through the Public Health Agency of Canada.<ref name="CanadaInterim20">{{cite web \|url=https://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection/health-professionals/interim-guidance-surveillance-human-infection.html \|title=Interim national surveillance guidelines for human infection with Coronavirus disease (COVID-19) \|author=Government of Canada \|publisher=Government of Canada \|date=10 February 2020 \|accessdate=11 April 2020}}</ref> And in the European Union, member countries and the U.K. are asked to report through the Early Warning and Response System.<ref name="ECDCCaseDef20">{{cite web \|url=https://www.ecdc.europa.eu/en/case-definition-and-european-surveillance-human-infection-novel-coronavirus-2019-ncov \|title=Case definition and European surveillance for COVID-19, as of 2 March 2020 \|author=European Centre for Disease Prevention and Control \|publisher=European Centre for Disease Prevention and Control \|work=COVID-19 Portal \|date=02 March 2020 \|accessdate=11 April 2020}}</ref>

			Somewhat related are any internal reporting requirements, particularly for test reporting in labs and medical facilities. The [[International Statistical Classification of Diseases and Related Health Problems]] (ICD) is a system of diagnostic codes for classifying diseases, including nuanced classifications of a wide variety of signs, symptoms, abnormal findings, complaints, social circumstances, and external causes of injury or disease. Their ICD-10-CM code set has been modified to include lab testing codes for COVID-19, as has the [[Current Procedural Terminology]] (CPT) code set. [https://www.mgma.com/data/data-stories/coding-guidance-for-new-icd-10-cm-and-lab-testing Green and Bradley] provide insight into these additions<ref name="GreenCoding20">{{cite web \|url=https://www.mgma.com/data/data-stories/coding-guidance-for-new-icd-10-cm-and-lab-testing \|title=Coding guidance for new ICD-10-CM and lab testing codes for COVID-19 \|work=MGMA Stat \|author=Green, C.; Bradley, V. \|date=01 April 2020 \|accessdate=11 April 2020}}</ref>, as does the [https://www.aappublications.org/news/2020/03/12/coding031220 American Academy of Pediatrics].<ref name="AAPHowTo20">{{cite web \|url=https://www.aappublications.org/news/2020/03/12/coding031220 \|title=How to use ICD-10-CM, new lab testing codes for COVID-19 \|author=AAP Division of Health Care Finance \|publisher=American Academy of Pediatrics \|date=12 March 2020 \|accessdate=11 April 2020}}</ref>

	* https://www.mgma.com/data/data-stories/coding-guidance-for-new-icd-10-cm-and-lab-testing
	* https://relief.unboundmedicine.com/relief/view/Coronavirus-Guidelines/2355002/all/Reporting_COVID_19_in_the_United_States
	* https://www.cdc.gov/coronavirus/2019-ncov/php/reporting-pui.html
	* https://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection/health-professionals/interim-guidance-surveillance-human-infection.html

	==References==		==References==
	{{Reflist\|colwidth=30em}}		{{Reflist\|colwidth=30em}}