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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.
<br />
'''HIPAA'''


The [[Health Insurance Portability and Accountability Act]] (HIPAA) is a set of U.S. federal regulatory requirements that attempts to modernize the flow of healthcare information, stipulate how personally identifiable information (PII) (often referred to as "protected health information" or "PHI") maintained by healthcare providers and insurers should be protected from fraud and theft, and address limitations on healthcare insurance coverage in the U.S. HIPAA spans five sections or "titles," mandating health care information access, portability, privacy, and security, as well as stipulations on medical savings accounts, group health insurance requirements, and other tax- and legal-status-related issues.
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>


Normally, HIPAA regulations would put strict requirements on how and when PII can be managed, used, shared, and stored. However, the COVID-19 pandemic has seen a relaxation of some of those requirements by the U.S. Department of Health and Human Services' (HHS) Office for Civil Rights (OCR). The HHS is currently maintaining a list of announcements, notifications, guidance documents, bulletins, and other resources as they relate to HIPAA and the public health emergency. Important notes pulled from that information reveal<ref name="HHS_HIPAA20">{{cite web |url=https://www.hhs.gov/hipaa/for-professionals/special-topics/hipaa-covid19/index.html |title=HIPAA and COVID-19 |publisher=Department of Health and Human Services |date=11 May 2020 |accessdate=18 May 2020}}</ref>:
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>


* Family, friends, and others identified by the patient as being involved in their care may receive PHI from a covered health care provider, particularly when they deem that sharing in the patient's best interest. Additionally, "[a] covered entity also may share information about a patient as necessary to identify, locate, and notify family members, guardians, or anyone else responsible for the patient’s care, of the patient’s location, general condition, or death."
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.
 
* "Covered health care providers will not be subject to penalties for violations of the HIPAA Privacy, Security, and Breach Notification Rules that occur in the good faith provision of telehealth during the COVID-19 nationwide public health emergency. This Notification does not affect the application of the HIPAA Rules to other areas of health care outside of telehealth during the emergency." This exercising of enforcement discretion will last until OCR provides a notice otherwise. Telehealth should optimally be performed in a private setting, whenever possible, using non-public facing communication technologies. Providers should opt to use the most secure services possible, "but will not be penalized for using less secure products in their effort to provide the most timely and accessible care possible to patients during the public health emergency."
 
* The OCR extended its enforcement discretion to include business associates of covered health care providers, allowing them to share PHI data "without risk of a HIPAA penalty." The OCR adds that "[s]ome HIPAA business associates have been unable to timely participate in these efforts [to ensure the health and safety of the public] because their BAAs do not expressly permit them to make such uses and disclosures of PHI." Like the enforcement discretion of telehealth provision by covered health care providers, the business associate must still make a good-faith effort in the "use or disclosure of the covered entity’s PHI" for public health and health oversight activities. Similarly, this exercising of enforcement discretion will last until OCR provides a notice otherwise.
 
* The OCR also extended its enforcement discretion to include covered health care providers and business associates operating community-based COVID-19 testing sites (CBTS)—"which includes mobile, drive-through, or walk-up sites that only provide COVID-19 specimen collection or testing services to the public"—during the public health emergency. This enforcement discretion, however, "does not apply to covered health care providers or their business associates when such entities are performing non-CBTS related activities, including the handling of PHI outside of the operation of a CBTS."
 
* Additionally, the OCR [https://www.hhs.gov/about/news/2021/01/19/ocr-announces-notification-enforcement-discretion-use-online-web-based-scheduling-applications-scheduling-covid-19-vaccination-appointments.html extended its enforcement discretion] to "covered health care providers or their business associates in connection with the good faith use of online or web-based scheduling applications ... for the scheduling of individual appointments for COVID-19 vaccinations during the COVID-19 nationwide public health emergency."
 
* "[T]he HIPAA Privacy Rule permits a covered entity to disclose the protected health information (PHI) of an individual who has been infected with, or exposed to, COVID-19, with law enforcement, paramedics, other first responders, and public health authorities1 without the individual’s HIPAA authorization, in certain circumstances." OCR provides [https://www.hhs.gov/sites/default/files/covid-19-hipaa-and-first-responders-508.pdf numerous examples], including: "when the disclosure is needed to provide treatment," "when such notification is required by law," when a public health authority must be notified "to prevent or control spread of disease," "when first responders may be at risk of infection," when preventing or lessening "a serious and imminent threat to the health and safety of a person or the public," and when responding to a law enforcement inquiring concerning a lawfully detained inmate or other individual.
 
* "The HIPAA Privacy Rule permits HIPAA covered entities (or their business associates on the covered entities’ behalf) to use or disclose PHI for treatment, payment, and health care operations, among other purposes, without an individual’s authorization." ICR provides [https://www.hhs.gov/sites/default/files/guidance-on-hipaa-and-contacting-former-covid-19-patients-about-blood-and-plasma-donation.pdf more details] in its guidance, noting however that reasonable effort must still be made to protect PHI, and that this does not apply to activities that constitute marketing.
 
* Similarly, the HIPAA Privacy Rule "permits covered entities or their business associates to disclose PHI to [a health information exchange (HIE)] for the HIE to report PHI to a [public health authority (PHA)] conducting public health activities" in a variety of circumstances. For more on those circumstances, see the [https://www.hhs.gov/sites/default/files/hie-faqs.pdf December 2020 guidance]].
 
* The public health emergency does not change restrictions on disclosing PHI to the media. This includes the prohibition of media crews in, for example, emergency departments where COVID-19 patients are being treated, as PHI is found everywhere in that setting. Only when every patient who is or will be in a potentially filmed area has signed a HIPAA authorization form can this be done.
 
 
'''CLIA'''
 
The [[Clinical Laboratory Improvement Amendments]] (CLIA) are a set of U.S. federal regulatory requirements applied to all non-research-based clinical laboratory testing performed on humans. These requirements are intended to further ensure a higher standard of quality in clinical laboratory testing, focusing in on improving the accuracy, reliability, and timeliness of tests. (The implications of these requirements on U.S. clinical labs and their ability to test for COVID-19 are discussed later, in the next section.)
 
CLIA uses seven different criteria 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.
 
Anything but waived testing requires meeting "the CLIA quality system standards, such as those for proficiency testing, quality control and assessment, and personnel requirements. The standards for moderate and high complexity testing differ only in the personnel requirements."<ref name="CDCTestCom" /> As the Centers for Medicare and Medicaid Services (CMS) points out in a frequently asked questions (FAQ) document—and as can be verified on the FDA's EUA page<ref name="FDAEmerg20">{{cite web |url=https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas#individual-serological |title=In Vitro Diagnostics EUAs |publisher=U.S. Food and Drug Administration |date=20 August 2020 |accessdate=23 August 2020}}</ref>—a huge majority of COVID-19 tests are only authorized for moderate or high complexity testing, and thus labs certified to do that sort of testing.<ref name="CMSFAQ">{{cite web |url=https://www.cms.gov/files/document/frequently-asked-questions-faqs-clia-guidance-during-covid-19-emergency-updated-12-17-2020.pdf |format=PDF |title=Frequently Asked Questions (FAQs), CLIA Guidance During the COVID-19 Emergency |author=Centers for Medicare and Medicaid Services |date=17 December 2020 |accessdate=07 September 2021}}</ref> As of September 2021, only 14 of 260 FDA EUAed molecular diagnostic tests are approved to be performed in a CLIA-waived laboratory setting.<ref name="FDAEmerg20" />
 
CMS' FAQ, as well as their March 2020 guidance document, provides additional insight in regards CLIA and COVID-19<ref name="CMSFAQ" /><ref name="WrightClinical20">{{cite web |url=https://www.cms.gov/files/document/qso-20-21-clia.pdf-0 |format=PDF |title=Clinical Laboratory Improvement Amendments (CLIA) Laboratory Guidance During COVID-19 Public Health Emergency |author=Wright, D.R. |publisher=Centers for Medicare and Medicaid Services |date=26 March 2020 |accessdate=18 May 2020}}</ref>:
 
* CLIA regulations remain firmly in effect during the U.S.-declared public health emergency; a Section 1135 waiver, under the Social Security Act, that modifies or suspends CLIA requirements is not within the authorizing jurisdiction of the CLIA program. Additionally, CMS in general does not have the authority "to grant waivers or exceptions that are not established in statute or regulation."
 
* Laboratories choosing to use temporary testing sites for remotely (from home or another temporary location) viewing and reporting on cytology slides and images may do so if certain defined conditions are met. (Consult [https://www.cms.gov/medicareprovider-enrollment-and-certificationsurveycertificationgeninfopolicy-and-memos-states-and/clinical-laboratory-improvement-amendments-clia-laboratory-guidance-during-covid-19-public-health the memo] for those defined conditions.)
 
* Proficiency testing (PT) is still required if a CLIA-certified lab is still performing testing and issuing patient results. However, should a PT provider need to postpone, suspend, or cancel a proficiency testing event, "[l]aboratories will not be penalized for lack of PT results ... so long as the cancelation is documented (including the notification from the PT program), and PT is conducted in a timely manner after the public health emergency ends. However, labs should consider performing their own self-assessment to ensure reliable testing."
 
* Alternate specimen collection devices (e.g., viral transport media, flocked nasopharyngeal swabs) used outside the manufacturer's instructions still require the establishment of performance specifications and assay validation prior to patient use. The FDA provides [https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2 additional guidance] on this topic.
 
* Laboratories performing laboratory developed tests (LDTs) are still required to be CLIA-certified and meet the requirements for high complexity testing. However, if the state government of such a laboratory has opted to take responsibility for authorizing an LDT (in order to expedite COVID-19 testing), then engagement with the FDA is not required.
 
* "CMS will temporarily exercise enforcement discretion under CLIA for the duration of the COVID-19 public health emergency for the use of authorized SARS-CoV-2 molecular and antigen POC tests on asymptomatic individuals outside of the test’s authorization."<ref name="CMSPOCAgTest20">{{cite web |url=https://www.cms.gov/files/document/clia-sars-cov-2-point-care-test-enforcement-discretion.pdf |format=PDF |title=Updated CLIA SARS-CoV-2 Molecular and Antigen Point of Care Test Enforcement Discretion |publisher=Centers for Medicare and Medicaid Services |date=07 December 2020 |accessdate=07 September 2021}}</ref>
 
* As of May 2021<ref name="CAPResponds21">{{cite web |url=https://www.cap.org/laboratory-improvement/news-and-updates/cap-responds-to-your-covid-19-questions |title=CAP Responds to Your COVID-19 Questions |publisher=College of American Pathologists |date=2021 |accessdate=07 September 2021}}</ref>, a CLIA specialty or subspecialty has not yet been assigned to COVID-19 testing authorized under the EUA pathway. Testing may be performed by laboratories based on intended use and by CMS specialty and subspecialty assigned to similar FDA-cleared or -approved tests with similar characteristics to the EUA being used.


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

Revision as of 18:16, 3 February 2022

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.[1][2][3][4] 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[1][3][4], 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.[5][6] 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.

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.[7][8] 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.[9] 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 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.[9] 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.[10]

These POL's operate in a different environment than your average public health laboratory or 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[9], "simple tests with a low risk for an incorrect result."[11]

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[12] (the FDA claims that EUAed SARS-CoV-2 tests authorized for "use at the point of care" are considered CLIA-waived tests[13]), and 2. serology testing still being considered moderate- to high-complexity in nature[12], 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[14][15][16], 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.

References

  1. ↑ 1.0 1.1 Madrigal, A.C.; Meyer, R. (31 March 2020). "Private Labs Are Fueling a New Coronavirus Testing Crisis". The Atlantic. https://www.theatlantic.com/health/archive/2020/03/next-covid-19-testing-crisis/609193/. Retrieved 07 April 2020. 
  2. ↑ Hale, C. (17 March 2020). "FDA opens the gates to commercial coronavirus testing without agency review". FierceBiotech. https://www.fiercebiotech.com/medtech/fda-opens-gates-to-commercial-coronavirus-testing-without-agency-review. Retrieved 07 April 2020. 
  3. ↑ 3.0 3.1 Appleby, J. (28 March 2020). "Why It Takes So Long To Get Most COVID-19 Test Results". NPR - Health Shots. https://www.npr.org/sections/health-shots/2020/03/28/822869504/why-it-takes-so-long-to-get-most-covid-19-test-results. Retrieved 07 April 2020. 
  4. ↑ 4.0 4.1 Ryan-Mosley, T. (5 April 2020). "Why some covid-19 tests in the US take more than a week". MIT Technology Review. https://www.technologyreview.com/2020/04/05/998460/covid-19-test-results-faster-commercial-labs-delays-coronavirus/. Retrieved 07 September 2021. 
  5. ↑ Nguyen, T.; Bang, D.D.; Wolff, A. (2020). "2019 novel coronavirus disease (COVID-19): Paving the road for rapid detection and point-of-care diagnostics". Micromachines 11 (3): 306. doi:10.3390/mi11030306. PMID 32183357. 
  6. ↑ Yang, T.; Wang, Y.-C.; Shen, C.-F.; Cheng, C.-M. (2020). "Point-of-care RNA-based diagnostic device for COVID-19". Diagnostics 10 (3): 165. doi:10.3390/diagnostics10030165. 
  7. ↑ Scott, D. (1 September 2021). "Why can’t America fix its Covid-19 testing problems?". Vox. https://www.vox.com/coronavirus-covid19/2021/9/1/22642745/us-covid-19-test-numbers-delta-variant. Retrieved 06 September 2021. 
  8. ↑ Zoga, D. (3 September 2021). "NBC 5 Responds: Searching for a COVID-19 Test? You're Not Alone". NBC DFW. https://www.nbcdfw.com/news/nbc-5-responds/nbc-5-responds-searching-for-a-covid-19-test-youre-not-alone/2734134/. Retrieved 06 September 2021. 
  9. ↑ 9.0 9.1 9.2 Centers for Medicare and Medicaid Services, Division of Clinical Laboratory and Quality (August 2021). "CLIA Update - August 2021" (PDF). https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/statupda.pdf. Retrieved 07 September 2021. 
  10. ↑ Garrels, M.; Oatis, C.S. (2014). Laboratory and Diagnostic Testing in Ambulatory Care: A Guide for Healthcare Professionals (3rd ed.). Elsevier Health Sciences. pp. 368. ISBN 9780323292368. https://books.google.com/books?id=LM9sBQAAQBAJ. Retrieved 09 April 2020. 
  11. ↑ Centers for Disease Control and Prevention (6 August 2018). "Clinical Laboratory Improvement Amendments (CLIA): Test complexities". https://www.cdc.gov/clia/test-complexities.html. Retrieved 09 April 2020. 
  12. ↑ 12.0 12.1 "In Vitro Diagnostics EUAs - Molecular Diagnostic Tests for SARS-CoV-2". U.S. Food and Drug Administration. 7 September 2021. 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. Retrieved 07 September 2021. 
  13. ↑ U.S. Food and Drug Administration (25 March 2021). "FAQs on Diagnostic Testing for SARS-CoV-2". U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2. Retrieved 07 September 2021. 
  14. ↑ Simonite, T. (24 March 2020). "The Professors Who Call ‘Bullshit’ on Covid-19 Misinformation". Wired. https://www.wired.com/story/professors-call-bullshit-covid-19-misinformation/. Retrieved 09 April 2020. 
  15. ↑ Suciu, P. (8 April 2020). "During COVID-19 Pandemic It Isn't Just Fake News But Seriously Bad Misinformation That Is Spreading On Social Media". Forbes. 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/. Retrieved 09 April 2020. 
  16. ↑ Soucheray, S. (15 July 2021). "Surgeon General warns of COVID-19 misinformation". CIDRAP. University of Minnesota. https://www.cidrap.umn.edu/news-perspective/2021/07/surgeon-general-warns-covid-19-misinformation. Retrieved 07 September 2021. 
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