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K-ASSAY
Since 1983
K-Assay
 
Clinical Diagnostics
Immunoassay Reagents
 
IgM
Immunoglobulin M
Cat. No.: KAI-015
Type.: Reagent
Method: Immunoturbidimetric
Format: Liquid
Linearity: 10 - 350 mg/dL
Sample: Serum


KIT COMPOSITION
R1:   4 X 20 mL buffer
R2:   2 X 10 mL antibody

Tests / Kit:   285 (Hitachi 717)
(Can Vary Based On Analyzer Model)
    
KAI-015
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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 IgM in serum by imunoturbidimetric assay.   Measurement of IgM aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
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

Precision - Within Run
Sample I Sample II Sample III
N = 20 N = 20 N = 20
Mean = 69 Mean = 138 Mean = 207
S.D. = 0.64 S.D. = 1.11 S.D. = 1.35
C.V. = 0.9% C.V. = 0.8% C.V. = 0.7%

Precision - Between Runs
Sample I Sample II Sample III
N = 7 N = 7 N = 7
Mean = 94 Mean = 183 Mean = 345
S.D. = 1.4 S.D. = 0.9 S.D. = 3.5
C.V. = 1.5% C.V. = 0.5% C.V. = 1.0%

Accuracy / Correlation
A comparison of the K-ASSAY ®   IgM kit and an INCSTAR IgM Test Kit was performed on a Hitachi 704 automated analyzer and a COBAS Mira.  The test results provided the following data:

y = 1.0927x - 0.71
r = 0.98835
n = 45
x = INCSTAR IgM Test Kit
y = K-ASSAY ®   IgM assay

x min = 23 y min = 21
  max = 392   max = 438
  mean = 138   mean = 150

Assay Range
10 - 350 mg/dL

INTERFERENCE
Bilirubin :     No interference up to 20 mg/dL
Hemoglobin :     No interference up to 500 mg/dL
Lipemia :     No interference up to 5%