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| 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 grew in 2020, and into 2021, 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—became 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/2020/04/05/998460/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 September 2021}}</ref> At times during the pandemic, laboratory 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 these rapid point-of-care molecular test kits are now becoming more readily available around the globe, including the United States, thanks in part to the U.S. Food and Drug Administration's Emergency Use Authorization (EUA) process.
| | 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>: |
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| Despite at-home kits becoming more available, quick and effective laboratory-based testing remains important, particularly as the delta variant continues to put strains on some U.S. states and their testing efforts into the late summer of 2021.<ref name="ScottWhy21">{{cite web |url=https://www.vox.com/coronavirus-covid19/2021/9/1/22642745/us-covid-19-test-numbers-delta-variant |title=Why can’t America fix its Covid-19 testing problems? |author=Scott, D. |work=Vox |date=01 September 2021 |accessdate=06 September 2021}}</ref><ref name="ZogaNBC21">{{cite web |url=https://www.nbcdfw.com/news/nbc-5-responds/nbc-5-responds-searching-for-a-covid-19-test-youre-not-alone/2734134/ |title=NBC 5 Responds: Searching for a COVID-19 Test? You're Not Alone |author=Zoga, D. |work=NBC DFW |date=03 September 2021 |accessdate=06 September 2021}}</ref> As such, it remains 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 CLIA, including public health laboratories. Of the more than 297,000 non-exempt CLIA-registered labs in the U.S., only 38,742 or 13.0 percent of them are certified to perform moderate- and high-complexity testing as of August 2021.<ref name="CMSEnroll19">{{cite web |url=https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/statupda.pdf |format=PDF |title=CLIA Update - August 2021 |author=Centers for Medicare and Medicaid Services, Division of Clinical Laboratory and Quality |date=August 2021 |accessdate=07 September 2021}}</ref> Your public health labs and commercial diagnostic labs fall into this category, with investments in the personnel, training, certifications, and equipment to conduct those sorts of tests. Contrast this with the small yet numerous [[Physician office laboratory|physician office laboratories]] (POLs) and how they operate. As of August 2021, some 42.4 percent of non-exempt [[CLIA]]-certified laboratories in the United States are POLs.<ref name="CMSEnroll19" /> Located in an ambulatory or outpatient care setting, these labs test specimens from human patients to assist with the diagnosis, treatment, or monitoring of a patient condition. Testing in the clinical lab generally depends on three common methodologies to meet those goals: comparing the current value of a tested substance to a reference value, examining a specimen with microscopy, and detecting the presence of infection-causing pathogens.<ref name="GarrelsOatis">{{cite book |url=https://books.google.com/books?id=LM9sBQAAQBAJ |title=Laboratory and Diagnostic Testing in Ambulatory Care: A Guide for Healthcare Professionals |author=Garrels, M.; Oatis, C.S. |publisher=Elsevier Health Sciences |edition=3rd |year=2014 |pages=368 |isbn=9780323292368 |accessdate=09 April 2020}}</ref>
| | * BioFire Diagnostics' BioFire Respiratory Panel 2.1-EZ |
| | * Cepheid's Xpert Omni SARS-CoV-2 |
| | * Cepheid's Xpert Xpress SARS-CoV-2 |
| | * Cepheid's Xpert Xpress SARS-CoV-2/Flu/RSV |
| | * Mesa Biotech's Accula SARS-Cov-2 Test |
| | * Roche Molecular Systems' cobas SARS-CoV-2 |
| | * Roche Molecular Systems' cobas SARS-CoV-2 & Influenza A/B |
| | * Visby Medical's COVID-19 Point of Care Test |
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| These POL's operate in a different environment than your average [[public health laboratory]] or [[Reference lab#Referral and diagnostic|reference lab]] that receives, processes, and reports on specimens ''en masse''. The POL is typically a smaller operation, performing simple laboratory testing that can produce useful diagnostic data cheaply and rapidly. Rather than performing advanced pathology and molecular diagnostic procedures that require specific equipment and expertise, the POL typically focuses on blood chemistry, urinalysis, and other testing domains that don't require significant resources and provide rapid results. This can be seen in [[Centers for Medicare and Medicaid Services]] statistics reported in August 2021 that show 69.3 percent of non-exempt POLs in the U.S. are certified to provide CLIA-waived tests<ref name="CMSEnroll19" />, "simple tests with a low risk for an incorrect result."<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>
| | 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> |
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| As of September 2021, with 1. all but several handfuls of the current EUAed molecular ''in vitro'' diagnostic COVID-19 test kits being limited to moderate- and high-complexity CLIA labs<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> (the FDA claims that EUAed SARS-CoV-2 tests authorized for "use at the point of care" are considered CLIA-waived tests<ref name="FDA_FAQS20">{{cite web |url=https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2 |title=FAQs on Diagnostic Testing for SARS-CoV-2 |author=U.S. Food and Drug Administration |publisher=U.S. Food and Drug Administration |date=25 March 2021 |accessdate=07 September 2021}}</ref>), and 2. serology testing still being considered moderate- to high-complexity in nature<ref name="FDAInVitroEUAs21" />, a significant majority of clinical laboratories are left with only a handful of CLIA-waived options for assisting with the effort to test the U.S. population for SARS-CoV-2 infection. Given the rapid rate of change at multiple levels of government and society and the continual spreading of misinformation<ref name="SimoniteTheProf20">{{cite web |url=https://www.wired.com/story/professors-call-bullshit-covid-19-misinformation/ |title=The Professors Who Call ‘Bullshit’ on Covid-19 Misinformation |author=Simonite, T. |work=Wired |date=24 March 2020 |accessdate=09 April 2020}}</ref><ref name="SuciuDuring20">{{cite web |url=https://www.forbes.com/sites/petersuciu/2020/04/08/during-covid-19-pandemic-it-isnt-just-fake-news-but-seriously-bad-misinformation-that-is-spreading-on-social-media/ |title=During COVID-19 Pandemic It Isn't Just Fake News But Seriously Bad Misinformation That Is Spreading On Social Media |author=Suciu, P. |work=Forbes |date=08 April 2020 |accessdate=09 April 2020}}</ref><ref name="SoucheraySurgeon21">{{cite web |url=https://www.cidrap.umn.edu/news-perspective/2021/07/surgeon-general-warns-covid-19-misinformation |title=Surgeon General warns of COVID-19 misinformation |author=Soucheray, S. |work=CIDRAP |publisher=University of Minnesota |date=15 July 2021 |accessdate=07 September 2021}}</ref>, it's important to remember these fundamental differences in laboratories when trying to explain to someone why even in September 2021 they will still find it challenging to go to their primary care physician and get tested for SARS-CoV-2 in the doctor's office. Should researchers develop and the FDA provide EUAs for more CLIA-waived point-of-care assays, these differences may become less noticeable, and more people will be able to be tested.
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| ==References== | | ==References== |
| {{Reflist|colwidth=30em}} | | {{Reflist|colwidth=30em}} |
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[1]:
- BioFire Diagnostics' BioFire Respiratory Panel 2.1-EZ
- Cepheid's Xpert Omni SARS-CoV-2
- Cepheid's Xpert Xpress SARS-CoV-2
- Cepheid's Xpert Xpress SARS-CoV-2/Flu/RSV
- Mesa Biotech's Accula SARS-Cov-2 Test
- Roche Molecular Systems' cobas SARS-CoV-2
- Roche Molecular Systems' cobas SARS-CoV-2 & Influenza A/B
- 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."[2] 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.[3]
References
