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Thrombosis and bleeding are among the foremost causes of morbidity and mortality, and the recent introduction of novel anticoagulants, anti-thrombotic, and hemostatic drugs has increased the need for rapid and accurate assessment of their activities. While the usual laboratory assessment of hemostasis, such as prothrombin time and other coagulation tests, are often effective, these methods may not identify all bleeding disorders.

On the cover this month: Inside a Vial Store. As new technologies are developed for using biological specimens to diagnose and treat disease, as well as to evaluate genetic risks, both researchers and patients are becoming more aware of the importance and benefits of biobanking. The last 2 decades have seen an increasing interest in the collection and storage of biological samples for further investigation. Although the number of biological specimens that have been collected and stored worldwide is not known, it is likely to be in the millions. This issue of Clinical Chemistry contains a Q and A feature in which 5 experts focus on quality management, biobank network design, the long-term sustainability of biobanks, public perceptions, and the controversial issue of returning of research results to biospecimen donors.

Turnaround times are often long in PCR-based tests because multiple reactions are usually performed in parallel using programmable thermal cyclers. These methods typically use a single protocol, placing constraints on assay design.

Using prohibited substances to enhance performance in sports, often referred to as doping, is a practice that's been with us all of recorded history. In ancient time, athletes or combatants were often supplied diets and supplements considered beneficial to enhance their performance.

Estimating Glomerular Filtration Rate or GFR is important for the detection and monitoring of impairment of renal function for safety in the use of potentially nephrotoxic pharmaceuticals and radiographic contrast media, and for administration of correct dosage of drugs cleared by the kidneys. Even though it is not ideal, serum creatinine is widely used as a marker for calculating Glomerular Filtration Rates.

Where are all the new omics-based tests? That's the question that Patrick Bossuyt asks in his paper appearing in the October 2014 issue of Clinical Chemistry. After billions of dollars worldwide have been spent upon omics-based research and announcements of many biomarker discoveries, clinical medicine has not gone through a radical change, despite all of the investment of time, money, and the collaboration of thousands of study participants.

Fragile X Syndrome is a severe neurodevelopmental disorder which is both complex and heterogeneous in both clinical phenotype and epigenotype. It is also one of the major inherited conditions co-morbid with autistic behaviors.

Translation of novel biomarkers into clinical care for the evaluation of therapeutic safety and efficacy has been slow and the degree of rigor with which new markers and methods to measure them are validated varies considerably. In an opinion article published in the July issue of Clinical Chemistry, Drs. Russell Grant and Andrew Hoofnagle provide some guidance with a minimal list of experiments that would allow potential users of novel biomarkers to evaluate their quality and potential reproducibility.

In a 2009 study in Clinical Chemistry, Dr. Erna Lenters and Dr. Robbert Slingerland evaluated eight different points of care instruments measuring hemoglobin A1c and came to the conclusion that six of the eight did not meet generally accepted analytical performance criteria.

MicroRNAs measured in blood samples are promising, minimally invasive biomarker candidates that have recently been the target of many case control studies. However, the influence of age and gender is confounding variables and MicroRNAs remain largely unknown.

Analysis of circulating RNA in the plasma of pregnant women can be a powerful tool for noninvasive prenatal testing and research. However, unbiased and high throughput detection of circulating RNA in plasma is a technical challenge.

The cover of the September 2014 issue of Clinical Chemistry tells it all: one million downloads! That's the number of Clinical Chemistry podcasts that have been downloaded since the feature was initiated in 2009. It's a relatively new feature in the 60 years of publication of the journal, and the word podcast itself is only been in the vernacular for about 10 years.

This is the September 2014 issue of Clinical Chemistry, Volume 60, Issue 9.

Performing measurements that are comparable over time and location and across assays is essential for insuring appropriate clinical and public health practice. One step toward achieving this goal is using assays that are traceable to a higher-order reference measurement system or harmonized by using internationally recognized procedures.

Analysis of Human Chorionic Gonadotropin or hCG is usually associated with monitoring or detecting pregnancy. It is also a protein tumor marker for some cancers. In males, hCG stimulates testosterone production and has the potential to be abused by athletes in an attempt to enhance performance in sports.

There are few scientific papers that do not include the use of the P value to evaluate the statistical significance of results. However, use of this statistic may be misleading, as noted by a recent paper by Regina Nuzzo in the journal Nature. That paper served as a basis for commentary with additional examples by Drs. Jim Boyd and Tom Annesley in the July 2014 issue of Clinical Chemistry.

Chronic kidney disease is an important risk factor for cardiovascular morbidity and mortality. This risk is all the more important for patients undergoing hemodialysis. In the presence of clinical signs of an acute myocardial infarction, the universal definition includes the finding of a serum cardiac troponin concentration above the 99 percentile as defined by healthy individuals, together with time dependant changes in serum and troponin concentrations. But in contrast to individuals with normal kidney function the troponin concentrations in patients with chronic kidney disease, but no myocardial infarction, may already be at concentrations higher than the 99 percentile of a healthy population.

Central nervous system infections, including diseases like meningitis and encephalitis, are important public heath concerns across the globe, as they occur commonly and/or associated with high rates of mortality and morbidity. Measurement of biomarkers provide objective indicators of normal function or pathology, and can present information that may assist diagnosis, assessment of health condition, and evaluation of treatment safety and efficacy.

Early detection of acute myocardial infarction is crucial for deciding the course of treatment to preserve and prevent further damage to the myocardial tissue. During the last several years there has been a burgeoning interest in circulating microRNAs as potential novel biomarkers for acute myocardial infarction.