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K-ASSAY
Since 1983
K-Assay
 
Clinical Diagnostics
Immunoassay Reagents
 
Insulin
Cat. No.: KAI-040   or   KAI-071
Type.: Reagent
Method: Immunoturbidimetric
Format: Liquid
Linearity: 1 - 100 µIU/mL
Sample: Serum, Plasma


KIT COMPOSITION
Cat. No. KAI-040
R1:   1 X 13.5 mL buffer
R2:   1 X 5 mL antibody

Tests / Kit:   100 (Hitachi 917)
(Can Vary Based On Analyzer Model)
    
KAI-040
Click Image To Enlarge       

Click here for an example package insert.

Click here for the Safety Data Sheets (SDS):
Reagent-1 (R-1)
Reagent-2 (R-2)

Click here for information about recommended calibrators and controls.




Cat. No. KAI-071
R1:   2 X 13.5 mL buffer
R2:   2 X 5 mL antibody

Tests / Kit:   200 (Hitachi 917)
(Can Vary Based On Analyzer Model)

    
KAI-071
Click Image To Enlarge       

Click here for an example package insert.

Click here for the Safety Data Sheets (SDS):
Reagent-1 (R-1)
Reagent-2 (R-2)

Click here for information about recommended calibrators and controls.


INTENDED USE
For the quantitative determination of human insulin in serum and plasma by immunoturbidimetric assay.
FOR IN VITRO DIAGNOSTIC USE.

REAGENT PREPARATION
The reagents are ready to use and do not require reconstitution.

STORAGE AND HANDLING
All reagents should be stored refrigerated (2-8°C).  Return all reagents to 2-8°C promptly after use.  Unopened reagents can be used for one year from the date of manufacture, as indicated by the expiration date on the package and bottle labels.  Opened reagents can be used for one month if stored at 2-8°C.

PERFORMANCE
Precision
The within-run, between-run, and total precision for the K-ASSAY ®   Insulin assay was determined using packaged reagents, human serum samples, and a Roche / Hitachi 917 analyzer.

Precision - Within Run
Sample I Sample II Sample III
N = 10 N = 10 N = 10
Mean = 18.81 Mean = 27.82 Mean = 73.17
S.D. = 0.224 S.D. = 0.192 S.D. = 0.760
C.V. = 1.19% C.V. = 0.69% C.V. = 1.04%

Precision - Between Runs
Sample I Sample II Sample III
N = 10 N = 10 N = 10
Mean = 12.21 Mean = 25.9 Mean = 68.74
S.D. = 0.530 S.D. = 0.777 S.D. = 1.693
C.V. = 4.34% C.V. = 3.00% C.V. = 2.46%

Accuracy / Correlation
A comparison of the K-ASSAY ®   Insulin assay and another company's Insulin EIA was performed with the following results:

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

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

Assay Range
1 - 100 µIU/mL

INTERFERENCE
No cross-reactivity with pro-insulin was observed.   Hemoglobin, bile, or rheumatoid factor did not interefere with the assay.
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