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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. 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, 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. 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. 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. 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. 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.

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, "simple tests with a low risk for an incorrect result."

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