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K-ASSAY
Since 1983
K-Assay
 
Clinical Diagnostics
Immunoassay Reagents
 
Alpha-1 Microglobulin
A-1 Microglobulin
Cat. No.: KAI-056
Type.: Reagent
Method: Immunoturbidimetric
Format: Liquid
Linearity: Serum/Plasma:   1.0 - 137.0 mg/L   (or value of highest calibration point)
Urine:   0.2 - 34.0 mg/L   (or value of highest calibration point)
Sample: Serum, Plasma, Urine


KIT COMPOSITION
Note: Typically manufactured only by request.

R1:   1 X 50 mL buffer
R2:   1 X 50 mL antibody

Tests / Kit:
277 serum/plasma (Hitachi 717)
400 urine (Hitachi 717)
(Can Vary Based On Analyzer Model)
    
KAI-056
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.


INTENDED USE
For the quantitative determination of human Alpha-1 Microglobulin in human urine, 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.  It is recommended that R-2 be gently inverted once a week after it is opened.

PERFORMANCE
Precision

Precision - Within Run
Serum
Sample I Sample II Sample III
N = 10 N = 10 N = 10
Mean = 7.1 Mean = 32.1 Mean = 66.1
S.D. = 0.145 S.D. = 0.263 S.D. = 0.540
C.V. = 2.04% C.V. = 0.82% C.V. = 0.82%

Urine
Sample I Sample II Sample III
N = 10 N = 10 N = 10
Mean = 0.7 Mean = 3.3 Mean = 17.4
S.D. = 0.029 S.D. = 0.012 S.D. = 0.059
C.V. = 3.93% C.V. = 0.37% C.V. = 0.34%


Precision - Between Runs
Serum
Sample I Sample II Sample III
N = 15 N = 15 N = 15
Mean = 7.5 Mean = 32.3 Mean = 67.1
S.D. = 0.15 S.D. = 0.31 S.D. = 1.27
C.V. = 2.0% C.V. = 0.9% C.V. = 1.9%

Urine
Sample I Sample II Sample III
N = 15 N = 15 N = 15
Mean = 0.72 Mean = 3.3 Mean = 17.2
S.D. = 0.046 S.D. = 0.04 S.D. = 0.31
C.V. = 6.3% C.V. = 1.2% C.V. = 1.8%

Accuracy / Correlation
A comparison of the K-ASSAY ®   Alpha-1 Microglobulin assay and the latex agglutination method of another company is given below:

Serum samples:
y = 1.00x + 2.83
r = 1.00
n = 55
x = Company A's latex reagent
y = K-ASSAY ®   Alpha-1 Microglobulin assay

Urine samples:
y = 1.00x - 0.52
r = 1.00
n = 55
x = Company A's latex reagent
y = K-ASSAY ®   Alpha-1 Microglobulin assay


Assay Range
Serum/Plasma:   1.0 - 137.0 mg/L   (or value of highest calibration point)
Urine:   0.2 - 34.0 mg/L   (or value of highest calibration point)

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