November 2011 Clinical Laboratory News: Volume 37, Number 11

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A New Approach to Quality Control
How Can Risk Management Help Labs?
By Bill Malone

CLIA regulations set basic requirements for testing external QC materials, but so far, a comprehensive approach to QC that suits regulators and a majority of the lab community has not emerged. Now the Clinical and Laboratory Standards Institute has published a long-awaited guideline based on risk management that aims to fill this gap.

Antinuclear Antibody Testing Dilemmas
Does High Throughput Trump Sensitivity?
By Genna Rollins

Antinuclear antibody test results tend to be used inappropriately by some clinicians as a screening test for autoimmune rheumatic diseases. Labs have a key role in educating physicians about the limitations of the various testing methods and in making the best use of the tests.


Lipids and Lipoproteins
The Value of the CDC Lipid Standardization Program
By Mary M. Kimberly, PhD

CDC’s efforts to standardize lipid and lipoprotein measurements have been invaluable to improving public health and have helped laboratories deliver meaningful test results to assess the risk of cardiovascular disease. In anticipation of the soon-to-be-released ATP IV guidelines, this review of the agency’s Lipid Standardization Program provides insight on what the panel is considering.


Health R&D Funding Stalled


Federal Panel’s PSA Recommendations Stoke Controversy
Does the Harm Finally Outweigh the Benefit of PSA Testing?
By Genna Rollins

The controversy recently heated up over use of the prostate-specific antigen test as a screening tool for prostate cancer. The influential U.S. Preventive Services Task Force advised against PSA testing in healthy men, citing that the potential harms associated with screening and treatment outweighed the benefits of detecting early stage prostate cancer.

Robert H. Christenson Chosen as AACC President-Elect

AACC’s secretary announced the results of the association’s 2011 Election.


Regulatory Profiles
Industry Profiles
Diagnostic Profiles
News from the FDA

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Next Month

D-dimer in Pulmonary Embolism

Changes Coming to Proficiency Testing