KIT COMPOSITION
Reagent 1 (R-1) Buffer Reagent
Reagent 2a (R-2a) Buffer Reagent
Reagent 2b (R-2b) Antibody Reagent
Hemolysis Reagent
PERFORMANCE
Sensitivity
Sensitivity was investigated by reading the change in absorbance at 660 nm for a saline sample
and a whole blood sample with a known concentration. Ten replicates of each sample were performed.
The results of this investigation indicated that, on the analyzer used (Hitachi 717), the HbA1c
reagent showed little or no drift on the zero sample. Under the reaction conditions described,
a 0.073 absorbance change is approximately equivalent to 1.0% HbA1c.
Precision
The following results were obtained by assaying two blood samples following NCCLS protocol EP5
on a Hitachi 917.
Precision Assay: Within Run
| Sample I |
Sample II |
Mean=5.48
SD=0.078
CV=1.43%
|
Mean=10.28
SD=0.176
CV=1.72%
|
Precision Assay: Between Runs
| Sample I |
Sample II |
Mean=5.48
SD=0.152
CV=2.77%
|
Mean=10.28
SD=0.275
CV=2.68%
|
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