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EDUCATION :: DIABETES


immunoassay, enzymatic, or boronate affinity, that have undetected shortening of RBC survival, to a degree that will cause a reduction in HbA1c that is unrelated to the patient’s average glucose level during the prior two to three months. How is one to determine when HbA1c, in the presence of a disease state, such as a hemoglo- binopathy, is clinically inaccurate due to RBC survival issues? A methodology that indicates if a hemoglobin variant is present must be used.


It has been suggested that prior clinical information in the medical record could be reviewed to determine if there are any conditions that will cause significant shortening of the red cell survival time. This approach may not be feasible in a high-volume reference labora- tory, or in facilities that have isolated medical records for outpatient and inpatient encounters. It will not be useful in selecting patients that have a clinically silent hemoglobinopathy but have never been tested for this condition. Another solution is to implement a method for HbA1c testing which will also detect most hemoglo- binopathies and allow the laboratory to report the comment: “The presence of a hemoglobinopathy in this patient may cause a reduction in red cell survival, which could falsely reduce the measured HbA1c level. Please consider fructosamine or glycated albumin test- ing to monitor this patient’s level of glycemic control.” In many healthcare systems, the use of HbA1c is mandated by predetermined practice guidelines that are tied to reimbursement and a quality scorecard. These


electronic monitoring systems cannot accept this com- ment as satisfying the requirement for a quantitative HbA1c result. It may be necessary to modify these qual- ity systems to allow for these selected patients to meet the quality guidelines by alternative testing methods.


Summary


More specific than a cartographer with a GPS at the Greenwich Observatory.


Lucica® Glycated Albumin-L liquid reagent


HbA1c testing has been promoted as a required test to monitor glycemic control in all diabetic patients. Many methods have been evaluated for analytical interferences from the presence of com- mon, abnormal hemoglobin molecules, and labo- ratory acceptance of certain methods have been based solely on a manufacturer’s claim of lack of analytical interferences. There is growing evidence that it is also important to identify the clinical status of a patient where there is significantly decreased red cell survival, as the HbA1c will be falsely lowered. While many conditions which shorten RBC life can be suspected by a review of the patient’s medical record or prior laboratory results, there are patients with inherited abnormalities in hemoglobin structure or globin synthesis rate that have reduced RBC survival times which are clinically silent. These are the patients that will benefit from the use of a method for HbA1c that highlights the presence of the abnormal hemoglobin molecules. In these cases, one is not seeking a HbA1c result that is free of analytical interferences, but instead one which allows the testing to be directed to another method which is less dependent on the assumption of a normal RBC lifespan, such as fructosamine or glycated albumin.


REFERENCES


1. Cohen R, Franco R, Khera P, et al. Red cell life span heterogeneity in hematologically normal people is sufficient to alter HbA1c. Blood. 2008;112(10):4284-4291.


2. Sacks D. Measurement of Hemoglobin A1c: A new twist on the path to harmony. Diabetes Care. 2012;35(12):2674-2680.


3. Rhea J, Koch D, Ritchie J, et al. Unintended Reporting of Misleading HbA1c Values When Using Assays Incapable of Detecting Hemoglobin Variants. Arch Pathol Lab Med. 2013;137(12):1788-1791.


4. Summary of Revisions: Standards of Medical Care in Diabetes. 2018. Diabetes Care. 2017;41(Supplement 1): S4-S6.


ekfusa.com  +1 800 531 5535 STANBIOChemistry


® from EKF Diagnostics 44 JULY 2019 MLO-ONLINE.COM


Thomas P. Lohmann, MD, serves as Director of Medical and Scientific Affairs for Sebia-USA. Lohmann is board certified in Anatomic and Clinical Pathology and has 40 years of experience in Laboratory Medicine.


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