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Quality Requirements and Standards
Quality of HbA1c in 2014, Part Two E-mail

The second installment discussing the quality of HbA1c devices in 2014, based on the new study by Lenters-Westra and Slingerland in Clinical Chemistry. The good news: now 4 out of 7 methods meet the minimum analytical performance. The bad news: that's still 3 of 7 that don't. There's still a lot of room for improvement.

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Quality of HbA1c in 2014 E-mail

Lenters-Westra and Slingerland have just published a new review of HbA1c POC devices. The good news: now 4 out of 7 methods meet the minimum analytical performance. The bad news: that's still 3 of 7 that don't. There's still a lot of room for improvement.

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The Case for Tighter Glucose Quality Requirements E-mail

While the responses to FDA's Draft Guidelines for better Glucose Devices have been almost entirely critical, there is a case to be made for tighter glucose goals, particularly on the analytical side. Here's a summary of the studies that bolster the "pro" side for making changes to how glucose goals are set.

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FDA hears Defiance in the face of Draft Glucose Guidelines E-mail

It's becoming clear that the 2014 Draft Guidelines on Glucose Meters have raised the ire of nearly everyone in the laboratory marketplace. Here's an overview of the key opinions.

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The Elephant in the Laboratory E-mail

As with January of every year, there’s an impulse to set goals. Perhaps a worthy goal of 2014 would be to choose the right goals for quality.

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