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Home Essays Quality Requirements and Standards
Quality Requirements and Standards
Quality of HbA1c in 2014, Part Three E-mail

The third installment discussing the quality of HbA1c devices in 2014, based on the new study by Lenters-Westra and Slingerland in Clinical Chemistry. In this part, Dr. Westgard looks at data from the second reagent lot tested, as well as provides an analysis using IFCC units and reference methods.

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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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Quality Requirments and Standards