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K-ASSAY
Since 1983
K-Assay
 
Clinical Diagnostics
Immunoassay Controls
 
Microalbumin Urine Control
Cat. No.: K37C-4M
Type.: Control


KIT COMPOSITION
Level 1 Human Urine 2 x 7 mL, liquid
Level 2 Human Urine 2 x 7 mL, liquid
    
K37C-4M
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Click here for an example package insert.

Click here for the Safety Data Sheet (SDS).


INTENDED USE
The K-ASSAY ®   Microalbumin Urine Controls are intended as a means of monitoring various microalbumin assay methods to validate quantitation of patient samples.  Control materials having known component concentrations are an integral part of diagnostic procedures.  Daily monitoring of control values establishes intra-laboratory parameters for accuracy and precision of the test method.
FOR IN VITRO DIAGNOSTIC USE.

CONTROL PREPARATION
 1.  Remove controls from the refrigerator and allow to come to room temperature (20-25°C), about 15-30 minutes.

 2.  Invert gently to assure homogeneity of the contents.  Avoid foaming.   Treat the control as you would a patient sample in accordance with instructions in the K-ASSAY ®   Microalbumin assay package insert.

 3.  Immediately recap the controls and return to 2-8°C when not in use.

STORAGE AND HANDLING
 1.  The controls should be stored at 2-8°C.  When stored at 2-8°C, the controls are stable until the expiration date stated on the label.

 2.  When stored at 2-8°C between each use, the controls are stable for six months after opening.

 3.  When using the control with the Micral Test Strips, the control will remain stable for six months after opening, until after 10 uses, or until the expiration date, whichever occurs first.

 4.  Discard the controls if turbid or if there is any evidence of microbial contamination.

EXPECTED VALUES
The following values are given as an example.  The expected values for the K-ASSAY ®   Microalbumin Control are continually being revised through ongoing quality assurance.   As a result, the expected values may change from lot to lot.  Please refer to the package insert and/or vial labels for each lot for the expected values.

 REAGENT   LEVEL 1   LEVEL 2 
 MEAN 
 (mg/dL) 
 RANGE 
 (mg/dL) 
 MEAN 
 (mg/dL) 
 RANGE 
 (mg/dL) 
 K-ASSAY ®  Microalbumin   0.92   0.74 - 1.10   6.32   5.06 - 7.58 
 Siemens/Dade Creatinine   27.98   22.38 - 33.57   222.93   178.35 - 267.52