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9
PERFORMANCE CHARACTERISTICS
9.1
Assay Dynamic Range
The range of the assay is between 0.7 - 100 ng/mL.
9.2
Specificity of Antibodies (Cross Reactivity)
The following substances were tested for cross reactivity of the assay:
Component
Cross reactivity
Human Leptin
Rat Leptin
Mouse Leptin
Human Insulin
Human Proinsulin
Rat Insulin
Human C-Peptide
Glucagon
IGF-I
N.D.: Not detectable
9.3
Sensitivity
The analytical sensitivity of the DRG ELISA was calculated by adding 2 standard deviations from the mean of 20 replicate
analyses of the Standard 0 and was found to be 0.7 ng/mL.
9.4
Reproducibility
9.4.1
Intra Assay
The within assay variability is shown below:
Sample
n
Mean (ng/mL)
1
20
2
20
3
20
9.4.2
Inter Assay
The between assay variability is shown below:
Sample
n
Mean (ng/mL)
1
6
2
6
3
6
Version 10.0
2017/05 - vk
Leptin Sandwich ELISA EIA-2395
100 %
<0.2 %
<0.2 %
N.D.
N.D.
N.D.
N.D.
N.D.
N.D.
CV (%)
3.2
7.3
27.5
7.1
1.1
4.2
CV (%)
1.4
6.9
3.7
3.7
9.7
9.1
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