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New diagnostics technologies such as microarrays, next generation, or massively parallel sequencing, are generating an unprecedented amount of data. This requires a sophisticated knowledge of bioinformatics for proper storage, analysis, and mining of these very large data sets.

The application of Matrix-Assisted Laser Desorption Ionization–Time of Flight Mass Spectrometry or MALDI-TOF MS, to microbial identification is revolutionizing clinical microbiology, providing rapid identification with minimal sample preparation and potential cost savings.

And our guest today is Dr. Nader Rifai, Editor-in-Chief of Clinical Chemistry and Chair of the Clinical Chemistry Trainee Council, to announce the launch of a new program from AACC's Clinical Chemistry Trainee Council, the Question Bank. And Dr. Rifai, why was the Question Bank created?

The discovery phase of proteomics is critical in the identification of suitable markers for exploration and validation of promising new clinical tests. But can laboratories be certain if what they believe they are measuring is, in fact, what they actually measuring?

This is the October 2013 issue of Clinical Chemistry: Volume 59, Issue 10.

The analysis of circulating cell-free tumor DNA has considerable potential for the detention and monitoring of cancers. Substantial effort has been made to identify cancer associated genetic changes that might be suitable for use as new tumor markers. However, only a few of these genetic markers have been translated into clinical use.

The clinical microbiology laboratory is sometimes considered low-tech, particularly when compared to the high degree of automation found in the clinical chemistry laboratory. However, systems are emerging for the clinical microbiology laboratory with the potential to automate almost all areas of testing, including inoculation of primary culture plates, detection of growth on culture media, susceptibility testing, and extraction and detection of nucleic acids from clinical specimens.

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.