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Quality Requirements and Standards
FDA hears concerns on Blood Glucose Meters E-mail

On March 16 and 17, 2010, the FDA held a public meeting to discuss concerns about the quality of Blood Glucose Meters. As slides and transcripts have become available of this meeting, Dr. Westgard reviews some of the key points.

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HbA1c in 2010, Part X E-mail

The next-to-last installment of an extended discussion of HbA1c methods and the analytical quality necessary for patient care. While we may have found problems with many HbA1c methods at the point of care, are methods any better in the central laboratory?

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HbA1c in 2010, Part XI E-mail

In this, the final installment of an extended discussion of HbA1c methods and the analytical quality necessary for patient care, we hear feedback from the original authors of the 2010 study. Please Login (at right) or Register to view article

 
What's the Q of D? Vitamin D Performance Requirements E-mail

In 2009, US laboratories were reporting surges in the number of vitamin D tests being ordered - increases of 50% to even 100%. But beyond the growth in testing and usage, what's the quality required by this type of testing?

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Why Not Evidence-Based Method Specifications? E-mail
Written by James O. Westgard, PhD, FACB   

In the March 2002 issue of Clin Chem, the NACB published a long paper about the use of laboratory tests for patients with diabetes. Dr. Westgard examines their "evidence-based" recommendations, and finds some poor Sigma values. (Preview)

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