Clinical laboratories face severe shortages of medical laboratory technologists (MLT). Point-of-care testing (POCT) can be useful to provide testing when MLTs are not available. However, given clinical staff shortages, the added burden of POCT can be a barrier. Here, I describe a model implemented in our region whereby medical laboratory assistants (MLA) have been trained to perform POCT. The MLAs are supervised by MLTs working off-site. Oversight of POCT by the laboratory ensures quality assurance practices are in place. MLAs are trained in specimen collection and processing, removing many of the pre-analytical errors often associated with POCT. 

The COVID-19 pandemic has accelerated the pace at which point-of-care (POC) testing is being adopted in the community pharmacy setting. Increasing numbers of community pharmacies are interested in developing their POC test-and-treat programs, including large pharmacy chains, as the US increasingly looks to this setting as a public health destination. After two years of the pandemic, the question is not if community pharmacies will adopt, but how.

Molecular diagnostics has evolved rapidly over the last several years. Many products reaching the market have focused on decentralized testing, whether at the doctor’s office or at home. The SARS-CoV-2 pandemic only fueled the need for more accurate, lower cost, rapid, and readily available molecular tests. PCR-based testing platforms have dominated molecular diagnostics in sensitivity and specificity. In recent times, CRISPR-based assays have started to demonstrate improved capabilities for diagnostics. The ability to program certain Cas enzymes with gRNAs to detect specific nucleic acid sequences with high sensitivity and specificity makes CRISPR a highly desired platform for molecular diagnostics.

At-home testing can improve disease management and promote wellness. However, to successfully bridge the gap between home testing and patient management, clinical care teams must develop protocol to engage the target patient group. In this presentation, we will explore the use of home testing in the healthcare setting, and strategies that allow for growth. To promote access and increase efficiency, integration into digital health will be important for home testing.

A variety of clinical laboratory diagnostics are being marketed to consumers. This direct access testing allows the public to obtain laboratory testing without seeing a physician. This presentation will present the benefits and risks of direct access testing.

The NIH Rapid Acceleration of Diagnostic Technologies (RADx Tech) initiative was launched on April 29, 2020 to urgently expand SARS-CoV2 diagnostics. The initiative is a public-private partnership with unique resources for accelerating innovation, validation, and authorization of test platforms. In 2.5 years, RADx Tech supported companies received 46 EUAs and increased U.S. capacity by more than 5 billion tests, helping drive a paradigm shift to predominantly OTC and point-of-care COVID testing.

The Yager laboratory has been working for over a decade to develop technologies to allow low-cost home (or low resource setting) testing for disease states based on multi-dimensional paper microfluidics. During the pandemic, we extended a DARPA-funded project to perform rapid isothermal NAAT multiplexed testing of panels of viruses and bacteria. Lately we developed a common platform for also performing extremely sensitive assays for biomarkers of wellness and chronic diseases.

Access to molecular diagnostic testing within the home grew significantly during the pandemic as patients purchased platforms, such as Cue Health and Lucira. Additionally, many patients opted to use self-collection devices from commercial reference laboratories coupled with telehealth services for not only COVID-19 testing but also other disease areas, including sexual health and women's health. The drivers of adoption were convenience, the ability to access testing without the risk of catching COVID, anonymity, and improved reimbursement. As we enter the post-COVID pandemic phase, what happens to home-based molecular diagnostics? Do patients return to pre-pandemic testing channels (e.g., primary care, urgent care) or will they expand the use of molecular diagnostics to other indications (e.g., flu, sexual health)?