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POCT Hemoglobin A1c
|Test group||Hemoglobin A1c|
|Performed by||Authorized Point of Care testing site staff|
|In House Availability||During clinic hours|
|Method||DCA 2000: Spectrophotometry (total hemoglobin), Latex agglutination inhibition (Hgb A1c)|
|Container type||Lavender or Green top vacutainer, or DCA 2000 capillary tube|
|Amount to Collect||Fingerstick sample or 1 mL blood if collected in vacutainer|
|Sample type||Fingerstick or Anticoagulated whole blood|
|Preferred volume||0.1 mL blood|
|Min. Volume||0.1 mL blood|
|Synonyms||Glyco-hgb; Glycohemoglobin; Glycosylated hemoglobin|
|Stability||Samples must be tested within 5 minutes after filling DCA capillary|
|Additional information|| Comparison with central laboratory test:
In patients with elevated A1c levels, results determined by the point of care DCA2000 may run approximately 0.4 units lower than the HPLC method.
NOTE: The American Diabetes Association has indicated that point of care Hgb A1c analyzers are not sufficiently accurate for use in diagnosis of diabetes and that only laboratory based A1c analyzers should be used for this purpose. Point of care Hgb A1c analyzers like the DCA platform are intended for monitoring trends in glucose control over time. When Hgb A1c is measured with the DCA, clinicians can be reasonably (95%) certain that an absolute change in A1c of more than about 0.7 - 0.8 represents a statistically significant change in glycemic control. When Hgb A1c is measured with the central lab assay, clinicians can be reasonably certain (95%) that an absolute change in A1c of 0.5 or more represents a statistically significant change in glycemic control (Clinical Chemistry 57:205-214, 2011, supplementary Table 1).
This method is useful for samples having between 7.0 and 24.0 g/dL of hemoglobin. Patients with severe anemia or polycythemia must not be tested with this assay.
Hemoglobin F less than 10% will not affect the assay. Patients with high levels of Hgb F (e.g. HPFH) must be referred for another method.
This method is NOT recommended for patients with Hemoglobin C or Hemoglobin S.
Bilirubin greater than 20.0 mg/dL has been shown not to interfere with this assay.
Triglycerides greater than 1347 mg/dL have been shown not to interfere with this assay.
Samples that are noted to be severely lipemic or frozen for long periods of time are not recommended with this assay system.
Common oral diabetic medications (Diabinase, Orinase, Tolinase, Micronase, Dymelor, Glipizide) do not interfere with this methodology.
In diabetic patients who have experienced recent blood loss, hemolysis or have elevated reticulocyte counts for other reasons the HgBA1c level may be lowered and may not reflect actual glycemic control.
|LDT or Mod FDA?||No|
|Last Updated||5/22/2013 1:56:24 PM|
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