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A recent shift in the Department of Health and Human Services’ approach to regulation of laboratory developed tests has left the waters surrounding these tests murkier than ever and has many in the laboratory community concerned about duplicative oversight.
Remodeling a lab can be a frustrating, tedious, and at times surprising process, but one that’s becoming increasingly common as small, cramped spaces for each kind of laboratory have fallen out of fashion, and as automation of clinical laboratory processes have become more common.
A look at the history of Human Leukocyte Antigen testing highlights how methods have changed since the 1960s. While the idea that a transplant donor and recipient must be compatible for a successful procedure, the meaning behind compatibility has evolved over time.
Laboratories around the country are dropping the race modifier in estimated glomerular filtration rate calculations of kidney function. The National Kidney Foundation and American Society for Nephrology Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney Diseases mentions that the new formula does not include race in the…
Maternal-fetal medicine owes much of its successes in recent decades to the contributions of the clinical laboratory. Yet recent controversy around noninvasive prenatal screening shows that laboratorians have work to do in order to ensure clinicians can translate advances in medical technology into better patient care.
The COVID-19 pandemic and the need for rapid, reliable testing has heightened interest in saliva as a convenient and reliable testing medium for infectious diseases. Researchers and laboratorians are investigating oral fluid’s potential in detecting and monitoring other infectious diseases and cancers.

Ask the Expert

Gyorgy Abel, MD, PhD, assess predictions about the COVID-19 pandemic and the expected influenza epidemic (sometimes called the “twindemic”), lab preparation for the twindemic, and what’s coming with joint COVID/flu testing in the spring and beyond.

Bench Matters

Although most contemporary immunoassays are extremely robust and display excellent sensitivity and specificity, they are still susceptible to interferences. It is critical that laboratories have the ability both to detect and rule out assay interference as a source of error.

Federal Insider

A report from the Department of Health and Human Services found huge increases in the use of telehealth by Medicare beneficiaries during the COVID-19 pandemic, with specialists such as behavioral health providers seeing the highest telehealth utilization relative to other providers.

Industry Playbook

Laboratory Stewardship

Laboratories have tried many tactics to guide ordering practices and optimize the laboratory test menu, but what happens if the laboratory does not have ownership of the entire menu? Is the chance to guide stewardship through the menu lost?
Supply chain challenges have plagued the clinical laboratory throughout the COVID-19 pandemic. Increased, unpredictable demand for laboratory testing has coincided with global delays and raw material shortages. The pandemic exposed the weaknesses of “just in time” inventory management, leaving many laboratories without inventory. Laboratories worldwide have endured alternating shortages, from…
Patient blood management (PBM) is a multimodality, multidisciplinary approach to stewardship in transfusion medicine. It involves optimization of anemia and hemostasis with a goal of avoiding unnecessary transfusions. Now considered standard of care, PBM is patient-centered and can improve quality while reducing costs. The recent intermittent national blood shortages make…

Regulatory Roundup

The Sample

A recent article shows research that if manufacturers redesign their immunoassays to include preconjugation of biotinylated capture antibody to streptavidin, they could make them more accurate and robust against biotin interference.