Clinical Chemistry Podcast

The substantial technological advancements in next-generation sequencing (NGS), combined with dropping costs, have allowed for a swift diffusion of NGS applications in clinical settings.

This is the November2016 issue of Clinical Chemistry, Volume 62, Issue 11.

Measurement of serum cancer antigen 125 (CA125) is the standard approach for epithelial ovarian cancer (EOC) diagnostics and follow-up. However, the clinical specificity is not optimal because increased values are also detected in healthy controls and in benign diseases.

Electrophoretic separation of serum and urine proteins has played a central role in diagnosing and monitoring plasma cell disorders. Despite limitations in resolution and analytical sensitivity, plus the necessity for adjunct methods, protein gel electrophoresis and immunofixation electrophoresis (IFE) remain front-line tests.

Circulating tumor DNA (ctDNA) has emerged as a good candidate for tracking tumor dynamics in different cancer types, potentially avoiding repeated tumor biopsies. Many different genes can be mutated within a tumor, complicating procedures for tumor monitoring, even with highly sensitive next-generation sequencing (NGS) strategies.

Most people perceive pilots who don't fly for the commercial airlines as daredevils who always "fall out of the sky." My acquaintances are genuinely surprised to learn that I, a medical doctor and a clinical chemist, am one of those presumed reckless individuals.

Cardiac troponin is integral in the investigation of acute coronary syndromes. Modern high-sensitivity versions of troponin assays are able to detect very low concentrations and potentially identify disease sooner.

The Ebola outbreak in the fall of 2015 led to emergent responses by hospitals to prepare for potential patients. This included preparedness efforts by laboratories, which was challenging as they was evolving and at times contradicting information about how samples from patients under investigation for Ebola should be handled.

It is no secret that laboratory tests are overordered in the clinical environment; a recent metaanalysis demonstrated that tests are overused by 20.6% on average. The ordering of unnecessary tests on such a massive scale may impact not only direct healthcare costs, but also patient safety, and may lead to unnecessary follow-up investigation and iatrogenic blood loss due to excess phlebotomy. Unfortunately, in large hospitals with high patient volumes, it would be impractical for laboratory directors to evaluate every test individually for appropriateness, and even more difficult to convince providers to change ordering practices. Meeting other evidence-based quality objectives in laboratory ordering is similarly labor-intensive.

Initial detection and reporting by clinical microbiology laboratories is a sentinel marker for foodborne outbreak surveillance systems. Initiation of a public health investigation is reliant on the rapid initial identification of pathogens of interest. Diagnostics for Escherichia coli have evolved to reduce identification turnaround time, incorporating technologies for rapid identification (MALDI-TOF MS) and serogrouping (O157 antiserum or latex agglutination). Reporting of these isolates to a public health agency may initiate further laboratory investigations, such as pulsed-field gel electrophoresis, for confirmation that isolates may be related to a common source (clonal population).

Next generation sequencing is increasingly available in clinical laboratories, enabling the sequencing of more genes for relatively lower costs.

The practice of medicine is not always clear-cut. Healthcare providersare often faced with difficult decisions such as what test to perform on patients, what treatment should be given, and what type of follow-up is needed. Providers have a duty to enhance the wellbeing and minimize harm to their patients.

The basic problem shared by many of the biostatistical methods used in marker research is that they relate numbers to other numbers, rather than to anything that we might care about in the real world.

The role of branched-chain amino acids (BCAAs) in cardiovascular disease (CVD) remains poorly understood. We hypothesized that baseline BCAA concentrations predict future risk of CVD and that a Mediterranean diet (MedDiet) intervention may counteract this effect.

Pneumatic tube systems have become a primary way of automating the transport of clinical specimens in medical centers. These may travel within the floors of a building and also between buildings. Although this provides convenience and speed of transport, the excessive acceleration forces and the prolonged time and distance travelled have been linked to pre-analytical variation including hemolysis of blood specimens. As a result, it has been suggested that users regularly assess the forces encountered in a pneumatic tube system.

Postmarket surveillance is an important monitor of the safety of pharmaceuticals and medical devices after regulatory approval and entry to the market. Although premarket studies are substantial, costs prohibit examination of heterogeneous populations or rare events over long durations.

There are nearly 60,000 community pharmacies in the United States today. In addition to being sources of prescriptions and medications, they're also often a site for wellness visits, vaccinations, acute illness diagnosis and treatment, as well as monitoring of chronic disease. Pharmacies often offer a convenient alternative to physician offices because of their accessible locations and extended service hours. Approximately 18% of pharmacies in the U.S. have CLIA-waived status, which means they can perform any of the approximately 120 CLIA-waived tests. Many pharmacists help patients make drug dosage decisions in specialized centers such as coumadin in diabetes clinics. With pharmacists performing and interpreting more laboratory tests, what does this mean for the clinical laboratory community? Do pharmacists receive the proper training to perform and interpret laboratory tests? And how do we ensure the quality of testing?