Patients are more engaged in their health. POCT allows patients access to laboratory testing in the privacy of their homes, but patients may not understand test limitations and misinterpret results. This presentation will review the advantages and limitations of home testing, explore the ways that patients are accessing POCT, and provide opportunities for new models of POCT delivery that can ensure quality of test results as well as professional interpretation.

In recent years, there has been an expansion of at-home testing well beyond just pregnancy or glucose meter tests – for example, “23 and Me,” “Ancestry.com,” and COVID tests. Many of these tests are cheaper and more convenient than testing at a licensed clinical laboratory. In this presentation, the pros and cons of at-home testing will be discussed.  The roles of clinical laboratory professionals to promote the use of at-home tests for public health safety and patient care management will also be explored.

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 pharmacy will adopt, but how. This session will describe lessons learned and share critical voice of the customer (VoC) community pharmacy data uncovered over the past few years.

Home COVID-19 testing is beneficial to public health by improving testing access, providing anonymity of results, easing overcrowding at healthcare venues, and reducing risk of disease transmission. Effective home testing devices must be fit for the intended purpose with straightforward use of diagrammatic instructions for use and interpretation, and documentation for comprehension and performance by non-technical individuals with limited literate skills. Coupling testing with smart devices allows access to care, epidemiological linkage, healthcare provider notification, and public health notification. This session will help specify and discuss characteristics for safe and successful home use in diverse communities. 

We have been developing two-dimensional porous networks for ultra-low-cost point-of-care disease detection and management; readout is by optical imaging. The COVID-19 pandemic and the restriction of people to their homes has opened up new markets for a full range of rapid home testing. We are now developing rapid multiplexed nucleic acid testing a home for a panel of respiratory pathogens under support of WRF and the Emergent Ventures fund.  

Non-invasive diagnostics are urgently needed to address supply-chain and logistical deficiencies in the current COVID-19 testing environment. We developed quantitative multiplex assays that can assess SARS-CoV-2 gRNA (N2 and NL) (LOD: 6.25 copy number per reaction), Antigen (N) (3.5 TCID50), and Antibody (IgG RBD) (LOD:  30pg/ml)  non-invasively in a sample of saliva with performance that surpasses current EUA assays, with TAT in 1.5 hours, deployable at the population level.

COVID-19 has stressed worldwide demand for POC testing. Companies have had to innovate and develop at a rapid pace to meet pandemic demands. This presentation will discuss how Qorvo Biotechnologies has developed a breakthrough platform to address todays COVID-19 testing needs, and highlight what that differentiation means clinically. It will also show what investments have done to position for future success beyond COVID. 

Co-Diagnostics New Eikon Platform provides inexpensive, fast, and accurate PCR Results for At-Home and Point-of-Care Testing. 

The programmable nature of sequence-specific targeting by CRISPR-Cas nucleases has revolutionized a wide range of genomic applications and is now emerging as a new method for nucleic acid detection. This talk will touch on the therapeutics capabilities of Mammoth's CRISPR platform, and then focus on current efforts and future potential for CRISPR-based detection and its impact across a continuum of diagnostic applications, particularly as it relates to the COVID-19 pandemic.

The COVID-19 pandemic brought new popularity and a new user base for isothermal nucleic acid amplifications, especially LAMP. We will survey recent developments in the field such as widespread adoption of closed-tube endpoint monitoring. We will identify knowledge gaps in the fundamental understanding of isothermal amplification methods, and we will discuss some of our own group’s research efforts toward making LAMP more robust and ready to adopt for future emergencies.

Rapid and early detection of the novel coronavirus SARS-CoV-2, the causative agent of the COVID-19, plays a crucial role in reducing transmission of the virus and facilitating early intervention and treatment. In this talk, I will present our All-In-One Dual CRISPR-Cas12a (AIOD-CRISPR) technology for SARS-CoV-2 testing. I will introduce our low-cost diagnostic devices and detection platforms, enabling simple, affordable, instrument-free molecular diagnostics of SARS-CoV-2 at the point of care.

Point-of-care rapid molecular and antigen detection tests for COVID-19 were developed quickly during the second wave of the pandemic. Here, I will discuss our experiences with quickly verifying and validating the performance of these tests, while also developing and supporting quality assurance programs suitable for testing in non-traditional environments, performed by diverse groups of individuals. 

This presentation will highlight current and emerging trends in rapid and point-of-care diagnostic testing for infectious diseases. Gaps in current diagnostics for infectious diseases and future directions for research and development will be discussed using specific use cases. This presentation will cover diagnostics for respiratory infections, emerging diagnostics for sepsis, and diagnostic needs for urinary tract symptoms. Point-of-care testing for SARS-CoV-2 will be included. The presentation will emphasize workflow considerations, implementation, and the role of diagnostics in antimicrobial stewardship strategies.

Direct amplification in molecular assays is desired due to its speed, ease of use, and avoidance of extraction reagents.  However, clinical specimens contain a wide range of inhibitors that can hinder both the accuracy and sensitivity of an assay.  In this session, you will learn about Meridian’s latest technologies which are the newest solution for overcoming PCR inhibition and provide a fast-track method for developing room-temperature stable assays for POC applications.

Laboratory detection of SARS-CoV-2 using nucleic acid amplification technologies is considered the gold standard with maximum sensitivity and specificity compared to other testing modalities. Innovation and development of SARS-CoV-2 molecular assays were high throughout the pandemic, offering much successes. Yet there are challenges that are important to recognize including inclusivity of testing and lingering detection. This session will explore these successes of molecular testing but also the challenges.

COVID-19 demonstrated the value of offering CLIA-waived point-of-care tests in non-traditional settings. Additionally, the need to promote frequent, sequential testing with rapid receipt of results opened the door for new models for home-based testing. As we move forward, the value of such testing strategies for pathogens other than SARS-CoV-2 have been recognized. This presentation will examine future of community/home-based testing for various respiratory pathogens.

If one thing is clear as we roll into 2022, it is that IVD point of care medical diagnostics have taken on new importance in global healthcare.  However, designing, developing and manufacturing these complex lab-on-a-chip systems in a rapid and commercially viable manner remains challenging. This presentation will examine these challenges and explore which key decision-making factors are important when considering an in-house effort vs outsourcing to a partner.