As the laboratory and IVD industry gears up for what’s expected to be the largest in-person meeting since the COVID-19 pandemic, our editors and analysts will be in Chicago and on the scene. We see several issues on the horizon that we’ll be curious to see how laboratorians and IVD industry leaders address. Lab labor shortages, inflation [though the laboratory has ALWAYS been an inflation-aware place], and the progression of lab automation are things we’ll have an eye out for. Additionally, we will watch for how some of the mergers that occurred in the last year will be presented [will any new M&A be announced?], and the usual fare: new product launches, software tweaks and menu adds.
In terms of scheduled sessions in the early going, we are particularly interested in the following:
LTDs – Getting the Laboratory’s Take: Lab-developed tests are critical to some laboratory practice and were crucial in the early going of the COVID-19 pandemic. Yet they exist in a gray area of regulation, and many LDTs have become “product like” large businesses. For this reason, there’s always been a lot of talk about regulating them. Multiple legislative bills have been recently introduced into the US congress and viable routes for passage currently exist. AACC’s session “Valid Vital LDTs: Current State of Regulation Legislation of Laboratory-Developed Tests” should go a long way to give us the state of the LDT. Speaking will be Eric Konnick, MD, University of Washington, Karen Kaul, MD, PhD, Evanston Hospital, David Flannery, MD, Cleveland Clinic, Dennis Dietzen, PhD, DABCC, FAACC, Washington University School of Medicine, and Jonathan Genzen, MD, PhD, ARUP Laboratories
Super Villains and Lab Safety: We can’t resist this theme, but it’s also a very important topic. Why do lab staff ignore safety rules? Do they really think they can get super powers? Study some real and imagined lab safety incidents and their consequences. Discover what motivates laboratory staff to behave safely. The presenter is Dan Scungio, MT (ASCP), SLS, CQA (ASQ), CHOP, Sentara Healthcare Learn how to use safety stories to teach others in order to improve your lab safety culture, and find out which methods of lab safety training will prevent injuries and exposures in the laboratory.
How People Try to Beat Drug Testing and Defend Positive Results This session is timely, and as we understand it, already sold out. People try to beat drug tests either by ingesting flushing/ detoxifying agents or adding adulterants in vitro (household and Internet based chemicals such as Stealth, Urine Luck, Urine Aid, zinc sulfate) to urine. However, specimen integrity testing and specialized dipstick and chromatography-based assays are available to detect these adulterants. Methods to identify adulterated specimens and popular defense for positive result (eating poppy seed cake, passive inhalation of marijuana, etc.) will be discussed in this Roundtable session. The session leader is Amitava Dasgupta, PhD, DABCC, University of Kansas Medical Center
“Chematology” Explored – We find this an interesting presentation. Hematology and chemistry have been kept separate as lab disciplines but this could be questioned: as the session organizers says “Peripheral blood is a rich resource of information about a patient. Clinical chemistry analysis has historically focused on clues from serum or plasma. However, many conditions also leave their mark on the cellular portion of blood. This session aims to provide clinical chemists with foundational knowledge on routine hematology testing.” Led by Sean Campbell, PhD, DABCC, FAACC, Montefiore Medical Center
Where are we with Home Testing? Home testing is here, but it arrived by emergency means. Has it been well thought out? Few issues will be more hotly debated, as POC testmakers and lab analyzer makers may disagree, and some are at the same companies! Roche will host a panel – INSIGHTS AND IMPACT OF HOME TESTING AND SELF COLLECTION, representing various viewpoints, discussing the pros and cons of home testing and self-collection to illustrate the impact on the healthcare system. Discussions will focus on evaluating the need and strategic opportunity for home testing and self-collected samples returned to the lab for testing. Healthcare challenges such as reimbursement, impact to testing volume as well as customer receptivity based on drivers and barriers to home testing and self-collection will be considered from the perspectives of the laboratory as well as those involved in care delivery and digital innovation.
Traumatic Brain Injury, now a Concern of the Laboratory – GFAP is a specific marker of astrocyte injury in either white or gray matter that is elevated in patients with traumatic intracranial abnormalities on CT, and its discovery and use has turned traumatic brain injury from an area of limited concern to the laboratory to a major focus. CTs are the normal standard because there has been no significant lab test. Glasgow Coma Scale (GCS) score and clinical evaluation only provide subjective information, leading many to use CT. Abbott will host a seminar Wednesday featuring the latest research on GFAp and UCH-L1. The company’s scientists will reveal its findings from research and clinical studies in TBI and
A Lot of Automation on Display: If one thing unites the COVID-19 pandemic and the current inflation and labor shortages it’s this – labs need to be efficient. And IVD vendors will be ready – Beckman Coulter will present its DxA 5000 Fit Designed for medium-sized labs that run fewer than 5,000 tests a day, the DxA 5000 Fit allows mid-sized labs to enjoy the same benefits as larger-volume labs, the company says, with space savings. The DxA 5000 Fit also incorporates comprehensive pre-analytical sample quality assessment.
Automation vendors abound: Inpeco will be at the meeting with a “Tailor-made Automation Designed for You”, where booth visitors will have the opportunity to co-design their own laboratory automation solution with our Automation Solutions Consultants in the booth, and highlighting the Inpeco DreamLab mobile app. ASP will be on site with workflow analysis and recommendations on how best to eliminate bottlenecks and get the analysis completed on time with automation. Yaskawa will display its High-Speed Specimen Processing platform that the company says can process up to 1,200 specimens per hour for rack-based pre-analytic sorting and post-analytic foil sealing, sorting/archiving. Its Auto Sorter™ XN Designed for the Sysmex® XN-Series hematology line provides pre- and post-analytic specimen processing for demanding laboratory environments. 30-year Japan-based automation veteran IDS produces high-quality Clinical Laboratory Automation products for production line systems and customized offerings, with integrated development and automated manufacturing.
The Future: Tuesday’s Clinical Translational Science Division Lunch and Learn will feature discussions of new technologies, like micro-mechanical PT/INR testing using smartphones and verifying kidney stone composition using artificial intelligence. Keynote speakers Troy Feener, MSc., Ryan Groves, and Ruben Y. Luo, PhD, DABCC, will give talks about mass spectrometry to enable precision infection management, harnessing metabolomics as a platform for rapid infectious disease diagnosis, and “wash-free”immunoassays for faster result. The CTS Division event is supported by ET Healthcare and Thermo Fisher Scientific. Plus, AACC’s Disruptive Technology Award competition Monday afternoon. Finalists include: Biological Dynamics, Inc. — Verita Isolation Platform, Nanopath — Nanopath Platform and Visby Medical — Visby Medical PCR Point-of-Care Tests
Is the Patient Infected? Ask The Algorithm: HIV, HCV, syphilis, and Lyme disease rely on a self-collection algorithmic approach for accurate diagnosis. This creates unique challenges for the clinical laboratory, including management and adaptation to evolving guidelines, assurance that proper test sequence is followed by clinicians, education of providers with respect to changes in recommended algorithms, and reporting results with clarity. Neil Anderson, Washington University in St. Louis moderates a panel with Elitza Theel of Mayo Clinic
I’m Out of Control, Now What? The Use of Analytical Goals and Interlaboratory Reports for QC Troubleshooting Tuesday, July 26, 2022, 6:00–7:30 PM Location: Hyatt Regency McCormick Place, Regency Ballroom A Reception: 5:30–6:00 PM CE Information: 1.5 contact hours how 2 performance indicators in your interlaboratory can support your QC troubleshooting. QC Specialist Bio‑Rad will host a discuss how analytical goals help with QC troubleshooting. Brooke M. Katzman, Ph.D. Co-Director Hospital Clinical Laboratory Mayo Clinic, Christopher McCudden, Ph.D. Clinical Biochemist/ Associate Professor the Ottawa Hospital/ University of Ottawa and Nico Vandepoele, BSc. Scientific and Professional Affairs Manager Bio‑Rad Laboratories
Point of Care is Not an Island, or Shouldn’t Be: Siemens will host “Going Beyond the Lab with Point-of-Care Testing in Critical Care Environments” demonstrating their comprehensive POC blood analysis testing portfolio. Siemens analyzers range from handheld to benchtop systems and delivers results that are comparable no matter where the testing takes place. The company’s end-to-end portfolio integrates seamlessly into hospital networks with what the company calls a POC Ecosystem™
Breath Testing: The technology for breath-based IVD testing continues to advance, in this case to H. pylori testing. With “gut health” a high focus area, and with a new study showing a link between Alzheimer’s and H. pylori, it’s all the more important – https://neurosciencenews.com/alzheimers-gut-genetics-21058/ Meridian Biosicence, recently announced to be purchased by SD Biosensor, will present its Breath ID, the result of an acquisition from Exalenz Bioscience in 2020 but now presented to a large in-person audience. The company says the state-of-the-art BreathID® Smart urea breath test system for H. pylori detection intuitively combines market-leading diagnostic accuracy with efficient automation, all in a compact footprint for maximizing mid-range testing throughput.