Clinical Chemistry Podcast

In the past decade there has been a rapid increase in the number of individuals who have had their entire genome sequenced. Over the next decade that number will go from the thousands to the millions. These people are having their genomes sequenced for research, recreational interest, and clinical testing.

Vitamin D insufficiency has been widely associated with numerous negative health outcomes, including higher all-cause mortality, although no mechanism has been formally established for such observations.

Clinical trials, epidemiologic and most types of clinical research, include the acquisition of biological samples to be analyzed either immediately after collection, or in the future for biomarkers related to the study hypotheses. Tested biomarkers include those used to monitor subjects' health and to detect harmful side effects or to follow impact of therapeutic interventions.

Biomarkers are playing increasingly important roles in the detection and management of patients with cancer. Despite an enormous number of publications on cancer biomarkers, few of these biomarkers are in widespread clinical use.

Biomarkers are playing increasingly important roles in the detection and management of patients with cancer. Despite an enormous number of publications on cancer biomarkers, few of these biomarkers are in widespread clinical use.

A major objective of the International Federation of Clinical Chemistry and Laboratory Medicine, or IFCC, Task Force on implementation of Hemoglobin A1c Standardization is to develop quality targets with the measurement of Hemoglobin A1c.

Medical laboratories provide valuable services to aid in patient diagnosis and management, but systematic evidence of laboratory medicine's specific contribution to the overall process of healthcare is not easy to come by. Even the widely quoted claim that laboratory medicine results are responsible for a 70% of all clinical decisions seems to elude objective verification.

Over the past 20 years or so there have been several studies published showing an association between decreased concentrations of vitamin D in blood and the risks of cardiovascular disease, stroke, cancer, fractures, even overall mortality.

Rapid urine pregnancy tests have been available for over 30 years. They can be performed in minutes and are used at home, in doctors' offices and in emergency rooms. Doctors in particular rely on these tests to rule out pregnancy in order to prevent fetal injury or death that could be caused by certain medical procedures or drugs.

Recently, the New England Journal of Medicine partnered with Area9 Learning, a physician-led pioneer in adaptive learning, to create a platform with smart technology that adapts to clinicians' learning goals and knowledge gaps to deliver the information they need to know.

Aggressive strategies to lower Low Density Lipoprotein cholesterol in circulation are recommended for prevention of cardiovascular events. Most often laboratories report LDL-cholesterol based on an equation using measured values of total cholesterol, HDL - cholesterol and triglycerides, the so called Friedewald calculation named after the first author who published that work in Clinical Chemistry back in 1972.

Medical laboratories frequently encounter clinically unexpected results that require timely clinical evaluation because they may indicate an imminent life-threatening condition or a major clinical deterioration. Laboratories, therefore, need to identify and report such results sooner than they normally would, and have policies and procedures that minimize the possibility of patient harm due to delayed clinical attention. The concept of these so-called "panic values" was raised by George Lundberg in 1970, but a variety of other terms have since appeared in the literature. For example, urgent, critical, acute, alert, abnormal, markedly or significantly abnormal, clinically significant, vital, red or orange or yellow zone values, and various combinations of terms.

In December 2013 the genetics laboratory 23andMe stopped marketing direct-to-consumer disease predictive genetic testing in order to comply with a directive from the US Food and Drug Administration. The FDA's action was intended to protect the American public from questionable disease risk predictions.

Big data now seems to be everywhere. Google search queries are used to predict flu outbreaks and airline statistics or mined to determine the best hour of which day to book plane tickets. Clinical laboratories can also benefit from these trends. Given the emerging importance of reproducible data analysis pipelines, one could think of a special group of trained big data experts that could be available to regulatory agencies and to clinical laboratories for review and auditing of their processes and practices, and who may be able to offer suggestions for improvements.