The truCOLLECT Whole Blood Collection Kit (Class I Device), is an alternative to phlebotomy for small volume decentralized blood collection.  After collection, whole capillary blood is stabilized by active desiccation allowing shipment and long-term storage at ambient temperature.   An efficient and automatable DNA extraction and purification protocol was developed that yields high quality DNA for NGS and other assays.  Protocols for plasma protein extraction (anti-SARS IgG titer determination) are available.

Clinical metagenomics: a diagnostic in its infancy. While specific uses are discovered, deployments engineered, case reports published; necessary clinical evidence is lacking for broad uptake to be successful. In addition, there are technological and methodological challenges which must be solved before clinical metagenomics is mainstream. However, these obstacles will be mitigated in clinical metagenomics as they have in other fields of medicine encountering novel technologies, often earlier than optimistic projections.

This talk will weigh the advantages and disadvantages of the various NGS applications for detection of antimicrobial resistance, discuss the use of whole genome sequencing to predict phenotypic antimicrobial susceptibility testing and describe the status of applying targeted and metagenomic next-generation sequencing to detect antimicrobial resistance.

Antimicrobial Susceptibility Testing (AST) is one of the primary functions of the clinical microbiology laboratory, and yet many laboratories take a ‘test and report all’ approach to AST. This presentation will describe various strategies for smart AST, from test methods, troubleshooting and reporting.

Point-of-care testing provides rapid results which can be immediately used for clinical decision making. It also can result in overuse, runaway costs, and confusion when results differ from conventional testing.  Diagnostic stewardship is essential for management of point-of-care testing. This presentation will highlight the benefits, limitations, and how we can best steward point-of-care testing for maximum patient impact.

Sepsis diagnostic workflows can be complex and expensive, and don't always lead to the best patient outcomes. Host-immune-response testing offers the potential to change early workflows in patients with suspected acute infections and sepsis. Here I will cover some tests in development and the potential they have to improve patient outcomes while streamlining diagnostic workflows.

In the diagnosis of infectious diseases, we endeavor to deploy evidence-based practices driven by the best available science. There are often gray areas or gaps in the literature, which can lead to “controversy” and a diversity of practices. In this lecture we will discuss five suboptimal practices in clinical microbiology, and we can do better, both within the laboratory and through laboratory stewardship programs.  

Primary.Health deploys diagnostics to protect the health of millions of patients. Primary’s software platform is deployed across tens of thousands of schools, clinics and community sites to provide access to diagnostics and treatments. In this talk we discuss the challenges and opportunities of working with diagnostics at scale and the importance of accessible diagnostics for improving patient outcomes.

Fluorescent nanodiamond particles from 200 to 800 nm were surface-functionalized with carboxyl groups and used for conjugation to antibodies for an Ebola coat glycoprotein.  These particles were then characterized for their utility in lateral flow. Particles were evaluated using an IVIS-50 imaging system (Perkin Elmer) to look at particle distribution along the strip or analyzed using an AX-2X-S reader (Axxin, Fairfield, Australia) for detection of fluorescence.  Analysis details will be presented.

Molecular testing, especially syndromic panel testing, has increased in frequency of use for many patient types. While often beneficial, confusion can arise due to the widespread availability of this testing combined with limited frontline clinician education about significance. This presentation will discuss scenarios in which syndromic panel testing can help or hurt patient management and present suggestions for how to optimize use.

This talk will introduce a new program that has been created at the FDA’s Center for Devices and Radiological Health (CDRH) for technology preparedness and for assessing diagnostic and therapeutic medical devices that use microfluidics. Because microfluidics-based devices may be different from a functional standpoint than traditional macro-scale technologies, the technological and regulatory considerations may be unique to this emerging platform. Despite the increased use and the knowledge gaps in this field, currently there are no FDA recognized regulatory tools specifically for evaluating common risks associated with microfluidics devices. The talk will cover current programmatic activities including how we are addressing the knowledge gaps by working with external stakeholders.

Antimicrobial Susceptibility Testing is critical in modern clinical care due to high rates of bacterial antibiotic resistance. Unfortunately, traditional culture-based AST assays take 3-5 days; hence, physicians prescribe broad-spectrum antibiotics without appropriate knowledge of their efficacy, resulting in poor clinical outcomes and accelerating the proliferation of multi-drug-resistant pathogens. We discuss these challenges and demonstrate a prototype device for AST testing with a simple colorimetric readout and a scalable design.

This talk will detail historical and current trends in SARS-CoV-2 testing at the University of Washington Department of Laboratory Medicine and Pathology.