KIT COMPOSITION
|
Reagent 1 (R-1)
|
|
Reagent 2 (R-2)
|
PERFORMANCE
Sensitivity
An investigation of the absorbance change per minute for ten
replicates of two samples, with known concentrations of fructosamine,
indicated that an absorbance change per minute of 0.042 was
aproximately equivalent to 1 mmol/L fructosamine.
Precision
Precision studies were performed following a modification of the procedure
contained in NCCLS document EP5-T2.
Within Day (n=20) :
|
Mean |
S.D. |
C.V. % |
1.97
5.57
|
0.04
0.10
|
2.0
1.8
|
Day to Day (n=20) :
|
Mean |
S.D. |
C.V. % |
1.91
5.72
|
0.06
0.14
|
3.1
2.4
|
|
Correlation
Results obtained with this reagent (y) in 45 samples ranging
in fructosamine from 1.17 - 5.94 mmol/L, were compared with those obtained in the same samples
using a reagent (x) based on the same methodology. The correlation coefficient was 0.988 and
the regression equation was:
y = 0.88x + 0.28 (Std Err of Y Est = 0.19)
Assay Range
1.0 - 10.0 mmol/L
INTERFERENCE
All interference studies were performed according to the procedures recommended in NCCLS
guideline No. EP7-P for interference testing in clinical chemistry.
| Bilirubin |
Up to 20 mg/dL has been demonstrated to have a
negligible effect (<5%) |
| |
| Hemoglobin |
Up to 200 mg/dL has been demonstrated to have a
negligible effect (<5%) |
| |
| Glucose |
Up to 600 mg/dL has been demonstrated to have a
negligible effect (<5%) |
|
Tel: (206) 575-8068