Hemoglobin A1c
HbA1c
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Cat. No.:
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KAI-196 or KAI-197
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Type:
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Reagent
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Method:
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Immunoturbidimetric
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Format:
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Liquid (Lyophilized Calibrator)
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Linearity:
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2.0 - 16.0 %
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Sample:
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Whole Blood
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KIT COMPOSITION
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INTENDED USE
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For the quantitative determination of human Hemoglobin A1c (HbA1c) in blood.
The determination of HbA1c is most commonly performed for the evaluation
of glycemic control in diabetes mellitus. HbA1c values provide an
indication of glucose levels over the preceding 4-8 weeks. A higher
HbA1c value indiciated poorer glycemic control.
FOR IN VITRO DIAGNOSTIC USE.
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REAGENT PREPARATION
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R1 and Hemolysis reagents are supplied as ready to use liquids. R2 is
prepared by pouring the entire contents of the R2b vial into the R2a vial.
Mix gently.
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STORAGE AND HANDLING
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Unopened reagents are stable to the expiration date stated on the labels.
Do not use the reagents past their expiration date. R1 and R2
are stable for at least one month after opening when stored at 2-8°C.
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PERFORMANCE
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Precision
Precision was establish by assaying two blood samples following NCCLS protocol
EP5 on a Hitachi 917.
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Precision - Within Run
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Sample I
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Sample II
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Mean = 5.48
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Mean = 10.28
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S.D. = 0.078
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S.D. = 0.176
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C.V. = 1.43%
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C.V. = 1.72%
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Precision - Day to Day
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Sample I
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Sample II
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Mean = 5.48
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Mean = 10.28
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S.D. = 0.152
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S.D. = 0.275
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C.V. = 2.77%
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C.V. = 2.68%
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Accuracy / Correlation
A study using 40 human specimens between this Hemoglobin A1c procedure and an automated HPLC
procedure (Tosoh) yielded the following results:
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y = 1.050x - 0.481
r = 0.988
n = 40
x = Tosoh Test Kit
y = K-ASSAY ® Hemoglobin A1c assay
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Assay Range
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INTERFERENCE
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Bilirubin :
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No interference up to 50 mg/dL
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Ascorbic Acid :
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No interference up to 50 mg/dL
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Triglycerides :
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No interference up to 2,000 mg/dL
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Carbamylated Hb :
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No interference up to 7.5 mmol/L
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Acetylated Hb :
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No interference up to 5.0 mmol/L
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It has been reported that results may be inconsistent in patients who have
the following conditions: opiate addiction, lead poisoning, alcoholism, ingest
large doses of aspirin.
It has been reported that elevated levels of HbF may lead to underestimation
of HA1c. Also, it has been reported that labile intermediated (Schiff
base) are not detected and do not interfere with HbA1c determination by
immunoassay.
It has been determined that Hemoglobin variants HbA2, HbC, and HbS do not
interfere with this method.
Other very rare variants of hemoglobin (e.g. HbE) have not been assessed.
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