Having demonstrated a low-cost paper-based multiplexed system for home-based detection of bacterial and viral pathogen DNA or RNA, we are developing an equally user-friendly system to measure proteins and small molecules with ELISA-like precision and sensitivity. The immunoassay at home (IA@H) will be a home-based system for measuring the concentrations of multiple-protein and small-molecule biomarkers to extend health, monitor the progression of inflammatory diseases, and guide their treatment.  

Traditionally, all clinical tests must be ordered by physicians. Direct Access Testing (DAT) is, however, done without prior physician authorization. Direct-to-consumer testing can take the form of at-home point-of-care testing, at-home sample collection, or traditional phlebotomy/laboratory testing at a clinical laboratory. In this presentation, we will discuss how DAT in the proper setting can drive healthcare delivery, promote health literacy, and simplify patients' lives.

Chronic kidney disease (CKD) affects 1 in 7 US adults, and over 90% of those with the disease are asymptomatic. Early screening and detection of kidney disease are associated with lower lifetime costs and better health outcomes in patients, often with other health conditions such as diabetes and high blood pressure. Recently, NCQA has approved self-collection laboratory-tested samples as a valid sample type for eGFR measurements for 2024. At-home testing to detect and monitor chronic conditions for kidney markers (UACR and eGFR) allows healthcare gap closure in patients in care deserts or other disparate populations.

The SARS-CoV-2 pandemic impacted healthcare delivery systems and accelerated alternative delivery strategies. Remote specimen collection with samples sent to a central laboratory as well as at-home testing options have shifted the paradigm in the patient journey. The goal of this talk is to explore how laboratory medicine is pivoting to meet the needs of alternative delivery strategies for diagnostics and the impact on the central laboratory. Objectives: 1) understand the position of the clinical laboratory in the healthcare ecosystem; 2) examine the future of remote specimen collection and at home testing; 3) discuss key points of consideration with alternative delivery strategies on diagnostic testing.

At-home, self-collection of capillary blood samples opens new opportunities to improve accessibility and compliance across many diagnostic fronts. This talk will provide an overview of new technologies and products enabling at-home specimen collection, describe recent validation efforts comparing capillary specimen accuracy versus gold-standard venous draws, and discuss the challenges facing widespread adoption of at-home microsampling solutions.

Mobile health is revolutionizing healthcare, providing patients with access to critical services, personal data tracking, and doctors, regardless of their location. As the number of health applications for smartphones, wearables, tablets, and other digital technologies grows, more people will use them to take control of their own health. This session will explore mobile health technologies and how digital health is transforming the future of laboratory medicine.

Artificial intelligence (AI) and machine learning (ML) are poised to change not only our daily lives but also revolution the practice of medicine. Machine learning in particular has shown great promise in identifying testing errors, pattern recognition, and analyzing complex datasets to predict disease. This presentation provides examples of how AI/ML has been used in laboratory and point-of-care (POC) testing including prediction of COVID-19 using an innovative mass spectrometry-based technique, prediction of burn-related sepsis and acute kidney injury, and application of ML on a POC platform for military applications. Discussion of generative AI for diagnostics will also be included.

The National Institute of Biomedical Imaging and Bioengineering (NIBIB), through its Rapid Acceleration of Diagnostics Technology (RADx Tech) Program, helped lead the country through the COVID-19 pandemic by accelerating POC and home-based diagnostic development and catalyzing the fundamental shift towards the acceptance and widespread use of self-testing. The RADx Tech program represents a new paradigm by which NIBIB, in partnership with others, can drive innovation in medical technology R&D. While efforts to address unmet COVID-19 testing needs continue, new initiatives that leverage the program’s innovation funnel methodology and novel collaborations have arisen. This session will present lessons learned, highlight new diagnostic directions, and provide opportunities to partner with NIBIB in technology development, validation, and commercialization.