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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.

This is the March 2015 issue of Clinical Chemistry, Volume 61, Issue 3.

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.

Hemoglobin A1c is widely used to monitor glycemic control and is now recommended for use in the diagnosis of diabetes. Although hemoglobin A1c has high reliability compared to the oral glucose tolerance test, there are certain settings in which such testing may be problematic and there is a growing interest in alternative markers of hyperglycemia.

Although hemoglobin A 1 C has high reliability , there a re certain settings in which hemoglobin A1C testing is thought to be problematic. 1 , 5 - anhydroglucitol or 1,5 - deoxyglucose is a monosaccharide originating mainly fr om foods and closely resembles glucose in structure , but is usually excreted by the kidneys.

Prenatal testing using blood specimens rather than more invasive sampling has been successfully used for common chromosome disorders and for clinically significant copy number variations . H owever , detecting single gene disorders which are caused by mutations remains an analytical challenge .

Human saliva has been increasingly used for biomarker development to allow noninvasive detection of diseases. Extracellular RNA was discovered in saliva about 10 years ago, and since then the nature, origin , and characterization of salivary RNA have been actively pursued.

This is the February 2015 issue of Clinical Chemistry, Volume 61, Issue 2.

In the last year, multiple clinical studies have shown the diagnosti c power of testing a patient's exome. Clinical exome testing is now available at over a dozen clinical laboratories in the US , and has been performed for thousands of patients.

Next generation sequencing (NGS)13 technology, also known as massively parallel sequencing (MPS), is being incorporated rapidly to clinical laboratory testing. Current applications include detection of germline variants in inherited diseases, somatic variants in cancers, subpopulations of circulating cell-free DNA, and single viral or microbial genomes in infections or metamicrobial genomes in normal or altered human flora. Each application is unique and has its advantages and disadvantages.

This is the January 2015 special Molecular Diagnostics issue of Clinical Chemistry, Volume 61, Issue 1.

Extreme sports, extreme eating, extreme weight loss, extreme makeovers, just when you think you've heard it all, how about Extreme PCR?

Extreme sports, extreme eating, extreme weight loss, extreme makeovers, just when you think you've heard it all, how about Extreme PCR?