August 2010 Clinical Laboratory News: Volume 36, Number 8

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COVER STORIES

The Trials of Testosterone Testing
Immunoassays Faulty in Women and Children, But What's the Solution?
By Genna Rollins

Testosterone measurements by direct immunoassays are unreliable at low concentrations, particularly in women and children. Now industry leaders have issued a call-to-action to improve and standardize the tests.

 

Lab Compliance Programs
What Does it Take to Stay Out of Trouble?
By Bill Malone

 In a post-healthcare reform new era of high scrutiny and aggressive investigation, a good compliance program is key for labs. Labs that do not have a program in place now will be under the gun to develop one, as language buried in the healthcare reform law has made such initiatives mandatory. For labs that already have a compliance program, experts are warning that new federal initiatives will require labs to move into high gear in this area, and merely token efforts will leave a lab exposed.

 

SERIES ARTICLES

Multiple Myeloma
Laboratory Testing for Plasma Cell Proliferative Processes
By David F. Keren, MD

 Multiple myeloma, a highly lethal neoplasm of plasma cells, was the first disease for which the clinical laboratory could measure a quantifiable tumor marker, the Bence Jones protein. Today, the Bence Jones protein and related monoclonal (M) protein markers are extremely important for detecting, classifying, staging, and monitoring multiple myeloma.

 

NEWS BRIEF

State Obesity Report Highlights Diabetes

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Regulatory Profiles

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News from the FDA

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Next Month

FDA Moves on Lab-Developed Tests

Mass Spectrometry: Ready for Routine Use?