The marriage of connected diagnostics and care automation has the potential to reshape how low acuity routine care is delivered and take over a trillion dollars out of the annual global healthcare spend. These technologies will dramatically increase access to quality care, reduce costs, and improve outcomes for billions of people around the world. The pandemic has accentuated the need for decentralized diagnostic systems and loosened regulatory barriers, opening the door for a wave of innovation in the field.

Francis Bacon wrote that “A prudent question is one-half of wisdom.” Task #1 for defining when a home test is fit for purpose for COVID-19 home testing is to ask what we would have the patient do with the result? For ruling-out the possibility of COVID-19 illness, high diagnostic sensitivity is critical so that patients with disease will rarely have a falsely negative result. On the other hand, if the patient is to be quarantined regardless of result, then the test’s purpose may be to direct the user when to seek clinical care, regardless of their symptoms. These and other relevant COVID-19 home testing issues will be discussed with examples of technologies, and just how they might be effectively utilized.

In this talk, we will discuss how Sherlock Biosciences is harnessing powerful tools like CRISPR and synthetic biology to develop a new generation of diagnostic tests that bring accurate and actionable health information wherever and whenever it is needed. With its engineering biology platforms, the company will solve a range of diagnostic challenges in environments ranging from clinical labs to low resources areas, including the home.

Optical waveguides are an optimal biosensor platform.  Evanescent illumination, where the light field extends a fraction of the wavelength above the sensor surface, provides a clean signal for surface reactions with minimal background. Signal develops quickly and results can be quantitated in a few minutes. The LightDeck® evanescent wave sensors often don’t require wash steps. We describe tests for SARS-CoV-2 antibodies in blood and antigen from nasal swab samples.

We will briefly introduce our rapid immunohistochemistry product line including both instrument and reagent kits and focus on a novel lateral flow device, CoNAb for exclusively detecting neutralizing antibody against SARS-CoV-2. We will show its comparable sensitivity and specificity to cPass ELISA and how to interpret CoNAb results, its correlation with protective level of neutralizing antibody for both wildtype and the delta variant.

CRISPR diagnostics can augment gold-standard PCR-based testing if they can be made rapid, portable, and accurate. We report the development of an amplification-free CRISPR-Cas13a assay for direct detection of SARS-CoV-2 from nasal swab RNA. Integrated with a reader device based on a mobile phone, this assay has the potential to enable rapid, low-cost, point-of-care screening for SARS-CoV-2.

Among the different actions associated with facing the COVID-19 pandemic in Brazil, FIOCRUZ, an institution linked to the ministry of Health in Brazil, was involved with the development and production of diagnostic tests and operation of large automated plants. Additional tools are necessary for the decentralized differential diagnosis and a new POC multiplex molecular platform is being developed and are under evaluation.

Point-of-care detection technologies that enable decentralized, fast, sensitive, selective, and cost-effective diagnostics of COVID-19 infection are urgently needed around the world. We will present an overview of the work from our group on use of LAMP isothermal amplification at the point-of-care for detection of SARS CoV-2 and other pathogens to address the growing need for such technologies in developed countries as well as in low-resource settings where access to highly specialized laboratories and state-of-the-art diagnostic technologies is limited.

We are developing a rapid, affordable, and easy to use minimally instrumented nucleic acid testing system for point-of-care infectious disease diagnosis. This platform technology is designed to detect viruses or bacteria from blood, urine, or swab samples through integrated sample preparation, isothermal nucleic acid amplification, and lateral flow detection.

Qorvo Biotechnologies aims to bring a unique approach to the diagnostic landscape. Using high volume Bulk Acoustic Wave (BAW) technology (in billions of mobile phones globally), the Omnia^TM platform is designed to facilitate high performance Immunoassay testing in remote patient settings. This talk will present the background technology and discuss the EUA approved SARS-CoV-2 antigen product and what it presents to aid in the national testing strategy.

This presentation describes the challenges of point-of-care testing (POCT) and the different models, strategies, and information technology and analytics used to implement an effective point-of-care (POC) governance program at medical institutions. Emphasis will be placed on demonstrating escalating needs for POC governance in the current regulatory environment, including the need to integrate higher complexity POCT within increasingly complex clinical and EHR workflows.

Point-of-care testing allows providers to bring high quality care to patients in many types of environments beyond the traditional hospital or clinical setting, including underserved populations. This talk will discuss some analytical, quality, and regulatory considerations for performing point-of-care testing outside of the hospital environment. The speaker will share experiences in implementing point-of-care testing for a street medicine program providing medical care to the homeless in Los Angeles.

Laboratories implementing new testing are required to evaluate test performance in their setting. With the COVID-19 pandemic, new technologies have been developed that can provide molecular diagnostics and antigen testing at the point-of-care. Sites implementing these tests need guidance in how to validate, implement and manage these tests based on best practice. This presentation will focus on the Clinical and Laboratory Standards Institute (CLSI) resources that are available to assist staff in the implementation of new tests and validation of laboratory developed tests.

The Eikon platform, is designed to complete all necessary steps in a “sample to result” process. The user, whether at home, school, or work will be able to “walk away” while the system provides rapid results through the app in less than 30 minutes. In this presentation, Co-Diagnostics’ CEO Dwight Egan will introduce the Eikon platform.

Bringing high performance molecular testing outside of the laboratory has significant benefits as well as some concerns. More definitive testing will better direct treatment decisions helping with things like antibiotic resistance as well as things like isolation procedures for COVID-19. This lecture will discuss technologies available and how they pertain to particular disease states, including defining the need for point-of-care molecular testing, describing newer technologies that amplify nucleic acids, and explaining how these technologies can apply to specific disease states.

Point of care testing’s immediate results can be transformational in how we treat and diagnose conditions. However, historical challenges in implementation as well as performance have kept POCT from reaching its full impact. But with recent advancements in testing technology as well as shifting demand and expectations around testing, in part due to COVID-19, that’s changing. In this talk Dr. Brian DuChateau will review the advancements in testing technology, how this addresses past pain points, and what this symbolizes for the future of healthcare.