Prod Info for Insulin (L) Reagent

When a saline blank is used as a sample, the absorbance change is <= 0.0023/min. When a calibrator, having an insulin concentration of around
20 mIU/mL, is assayed, the absorbance (after subtracting the saline blank) is within the range of 0.003 to 0.038/min.

Specificity

When a sample with a known value is assayed, the result is within 15% of the assigned value.

Precision

The following results were obtained on a Hitachi 917 analyzer with human serum.

Precision Assay: Within Run

Sample I Sample II Sample III

N=10
Mean=18.81
SD=0.224
CV=1.19% N=10
Mean=27.82
SD=0.192
CV=0.69% N=10
Mean=73.17
SD=0.760
CV=1.04%

Precision Assay: Between Runs

Sample I Sample II Sample III

N=10
Mean=12.21
SD=0.530
CV=4.34% N=10
Mean=25.9
SD=0.777
CV=3.00% N=10
Mean=68.74
SD=1.693
CV=2.46%

Assay Range

1.0 to 100 mIU/mL (or value of highest calibration point)

Correlation

A comparison of the K-ASSAY Insulin and another company’s Insulin EIA was performed with the following results:

Serum Sample

y
r
n
x
y
= 0.8061x + 2.8674
= 0.997
= 32
= another company's Insulin assay
= K-ASSAY Insulin Assay

Plasma Sample

y
r
n
x
y
= 0.8161x + 4.5552
= 0.986
= 47
= another company's Insulin assay
= K-ASSAY Insulin Assay

INTERFERENCE

Bilirubin F	No interference up to 19.3 mg/dL
Bilirubin C	No interference up to 19.9 mg/dL
Hemoglobin	No interference up to 450 mg/dL
Lipemia	No interference up to a formazin turbidity of 1,550
RF	No interference up to 450 IU/mL

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