How to ensure regulations don’t stymie much-needed COVID-19 point-of-care testing

Traditional diagnostic testing is performed for the benefit of the individual patient, to diagnose or monitor a condition, such as home blood glucose monitoring for diabetes care. But COVID-19 is a highly transmissible viral infection with significant population-based consequences, and point-of-care testing in the community should benefit the collective rather than an individual. The pandemic has clearly demonstrated that we need a different approach.

Consider two illustrative hypothetical case studies to demonstrate these barriers. In the first, imagine that a small performing arts studio, with five employees, wishes to offer regular testing to employees and future patrons. The studio must address must the following requirements:

The process is so complex that the studio owner in this case would ultimately need to contract with a third party company to perform the testing, incorporate physician and CLIA-certified laboratory oversight, and perform data management. These requirements greatly increase the costs and make testing economically impractical.

The second case study reflects a real-world scenario. A hotel brand, which the authors worked with, hoped to have employee and patron testing available at properties throughout the United States. The hotel has particular interest in testing to enhance safety for group events (for example, corporate meetings and weddings) and personal services such as spa visits. The hotel central office realized that for CLIA-waiver status, each state has different requirements and approval processes, and each hotel will require a physician authorized in that state to order tests. And there will be further barriers to test distribution, as manufactures must ship directly to where the test is being performed—as a result, the hotel cannot receive the tests centrally and distribute them.

It is unclear why it remains so challenging for businesses to implement COVID-19 point of care testing and why more tests are not approved for use in nonmedical settings. Businesses, store owners, and organizations obviate many of the above barriers if a test is approved for OTC use. However, to date, there are only two COVID-19 diagnostic tests approved for this purpose, with associated pricing likely prohibiting widespread use (4, 5). This may stem from the economics of opportunity for testing companies; selling to individuals at a higher unit price may be more profitable than lowering the unit price to sell larger numbers to businesses. Vendors may also fear that pricing tests too low may give the public the perception that they are lower quality.

Several things must happen to make this process more feasible and more efficient:

Companies need to pursue home/OTC EUA for appropriate tests, and the CLIA and FDA regulations need to be updated to deal with the present pandemic realities and those that may occur in the coming years. COVID-19 infection rates across the United States are decreasing, and we have increasing availability of very effective vaccines. As a result, we have the opportunity to reopen schools and evaluate reopening businesses and communities in a safe manner.

But achieving and maintaining the “new normal” requires widespread testing outside of traditional settings—and, consequently, reform of intrastate barriers, medical practice, and laboratory licensing requirements. Now is the time to make these crucial changes if we hope to continue to make progress against the virus. We cannot sit still.