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For many taking a home pregnancy test can be upsetting, particularly if there is not complete confidence in the result. The November 2013 print issue of Clinical Chemistry published a paper from a group led by Dr. Ann Gronowski that reported false-negative results in point-of-care and over-the-counter qualitative hCG devices.

Maintaining long-term stability of analytical procedures is an important responsibility for clinical laboratories. This process typically includes a comparison of current and new reagent lots through paired measurements of patient or control samples, with defined criteria for acceptance and rejection of the new lot.

This is the September 2013 issue of Clinical Chemistry: Volume 59, Issue 9. On the cover this month: A pregnant woman with a flower blossom on her glowing belly. Pregnancy should be a time of joy and anticipation. Although most pregnancies progress without major complications, one medically important complication is gestational diabetes, a condition associated with adverse outcomes for both the mother and fetus. The prevalence of gestational diabetes is increasing in parallel with the prevalence of obesity and type 2 diabetes. Will more efficient and more scientifically based approaches to diagnosis and treatment keep up with the added demands on healthcare systems? In this issue of Clinical Chemistry, Coustan provides readers with an overview of current controversies as well as current recommendations for gestational diabetes care.

MicroRNAs are present in body fluids and have the potential to serve as disease biomarkers. A study in the April 2013 issue of Clinical Chemistry explored the clinical value of microRNAs in serum and urine as biomarkers for idiopathic childhood nephrotic syndrome.

Pregnant women identified as high risk based on the prenatal screen can then undergo invasive procedures such as amniocentesis to confirm the diagnosis. Unfortunately, a large number of women with unaffected pregnancies undergo invasive procedures, putting the fetus at unnecessary risk for miscarriage.

Maintaining long-term stability of analytical procedures is an important undertaking for clinical laboratories. This process typically includes comparison of current and new reagent lots through paired measurement of patient and control samples, with defined criteria for acceptance and rejection of the new lot.

Personalized medicine implies that an individual's unique genetic makeup provides key information to guide prevention, diagnosis, and treatment of disease. It's highly probable that no one besides yourself has ever been born or ever will be again with your precise DNA sequence, unless you are an identical twin and even then maybe not.

August 2013 Audio Summary

The US Food and Drug Administration has long maintained its right to regulate LDTs; however until recently they've chosen to exercise discretion and have left this to the individual laboratories and other regulatory agencies. This is now in a state of change, and the FDA has stated that it would issue guidance on its oversight of Laboratory Developed Tests.

Prenatal development involves a series of highly-organized genetic and epigenetic events. Abnormalities in the epigenetic control of developmental processes have been implicated in infertility, spontaneous abortion, intra-uterine growth abnormalities, and numerous post-natal consequences.

Human growth hormone is an important peptide hormone that stimulates growth, cell reproduction, and cell regeneration. Measuring growth hormone in the blood is an important clinical assay, but may be problematic due to heterogeneity of the hormone that may arise from alternative splicing, different post-translational or modifications, oligomerization, formation of complexes, and proteolytic processing. Although standards for growth hormone are available, data from external quality assessment programs show large differences exist between measurement results obtained with different assays.

The collection and transport of dried blood spots has facilitated population screening of newborns worldwide. In the July 2013 issue of Clinical Chemistry, researchers from the Wadsworth Center at the New York State Department of Health in Albany described a convenient technique to extract DNA from these dried blood spots to further expand screening to nucleic acid testing.

Alzheimer's disease is a complex progressive neurodegenerative disease leading to loss of memory and cognitive function, and pathologically characterized by amyloid plaques and tangles that are formed largely by fibular forms of beta-amyloid and hyper-phosphorylated tau proteins. During the past two decades, cumulative molecular and clinical studies have provided the basis for our understanding of the molecular characteristics and progressive pathologic features of these hallmarks.

On the cover this month: American West Rodeo Cowboy Boots with Riding Spurs. Images of traditional leather boots on old weathered wood planks have long been identified with Texas, whose largest city, Houston, is the site of this year's AACC Annual Meeting and Clinical Lab Expo. Houston's summers may be hot, and Houston may not be the first place you think of as being trendy or hip; yet Forbes Magazine recently named Houston as America' s coolest city to live in. The downtown has been revitalized with an exquisite restaurant scene, professional sports facilities, musical entertainmen t, museums, theaters, and a modern convention center. And when you includ e the breadth of science that will be presented at the Annual Meeting, you wi ll realize that the AACC and Houston have it all!

The format of communicating scientific, technical, and medical information through professional journals has changed relatively little over the past 300 years. Although advances and information technology have dramatically altered search and discovery of scientific information, moving from a static to a living document, or exploiting social media tools to disseminate scientific information, has been slow coming.