In the January editorial of Clinical Chemistry, Few Point-of-Care Hemoglobin A1c Assay Methods Meet Clinical Needs, by David E. Bruns1 and James C. Boyd, there’s a key paragraph that goes beyond the HbA1c methods covered by the study by Lenters-Westra and Slingerland (Six out of eight hemoglobin A1c point-of care instruments do not meet the generally accepted analytical performance criteria. Clin Chem 2010;56:44 –52.)

“There is increasing recognition of a need to improve the precision of HbA1c assays, in view of the low biological variability of Hb A1c. The NGSP plans to reduce the
acceptability specification for level 1 laboratories to 0.70% and for manufacturers of all Hb A1c methods to <0.75% in 2010 (http://www.ngsp.org/ ngsp/prog/News/manuf09.html; accessed October 28, 2009). The College of American Pathologists (CAP) also has recognized the need to tighten total error criteria for Hb A1c and is in the process of
revising the criteria used in grading proficiency tests (http://www.
ngsp.org/ngsp/prog/News/manuf09.html; accessed October 28, 2009). In 2007,
the limit specified by the CAP for acceptability on HbA1c proficiency testing was +/- 15% of the target value. This limit was lowered to +/-12% in 2008 and to +/-10% in 2009, and it will be lowered to +/-8% in 2010 and to +/-6% in 2011. “

As these quality requirements tighten, how are we going to respond?

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Lenters-Westra and Slingerland have produced a study that tells us many HbA1c methods don’t meet current quality requirements. Given the immiment narrowing of quality requirements, how many methods are going to be able to meet those future qualityrequirements?

This is a real gut check moment for many constituencies:

• For EQA and Proficiency Testing organizations other than CAP, are you going to follow NGSP and CAPs lead and shrink the size of their quality requirements?

• For diagnostic manufacturers, are you going to remove methods and instruments from the market that don’t meet the current quality requirements? Will you invest in the precision improvements necessary to meet the current and future quality requirements?

• For regulatory authorities, are you going to support the NGSP and CAP, or are you going to allow deficient methods to remain on the market?

• For laboratories, are you going to get rid of any methods that don’t meet the NGSP and CAP requirements? Are you going to use the future quality requirements as criteria for any future method purchases?

In other words, there are many ways that these new quality requirements can be undermined, either by manufacturers, regulators, and/or laboratories. It will take commitment from all of them if we are to move forward and improve HbA1c precision.

A failure of these new quality requirements will deliver a chilling message: that quality really doesn’t matter in the medical laboratory.

A victory here will build a foundation for other methods to build upon.

What's your choice going to be?