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Cystatin C
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Cat. No.:
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KAI-074
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Type:
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Reagent
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Method:
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Immunoturbidimetric
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Format:
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Liquid
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Linearity:
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0.06 - 8.00 mg/L (0.05 - 6.80 mg/L*)
(* ERM-DA471/IFCC Standardized)
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Measuring Range:
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0.40 - 8.00 mg/L (0.34 - 6.80 mg/L*)
(* ERM-DA471/IFCC Standardized)
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Sample:
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Serum, EDTA Plasma, Lithium Heparin Plasma
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KIT COMPOSITION
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INTENDED USE
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For the quantitative determination of human cystatin C in serum, EDTA plasma, or lithium heparin plasma
by immunoturbidimetric assay. Cystatin C measurements are used as an aid in the diagnosis and
treatment of renal diseases.
FOR IN VITRO DIAGNOSTIC USE.
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REAGENT PREPARATION
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The reagents are ready to use and do not require reconstitution.
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STORAGE AND HANDLING
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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.
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PERFORMANCE
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Precision
The precision for the
K-ASSAY ®
Cystatin C assay was determined using packaged reagents, control material, and a Roche / Hitachi 917 analyzer according to the CLSI EP5-A2 guideline.
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Sample
1 |
Sample
2 |
Sample
3 |
Sample
4 |
| N |
80 |
80 |
80 |
80 |
| Mean (mg/L) |
0.511 |
0.968 |
1.999 |
4.389 |
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| Within Run S.D. |
0.006 |
0.007 |
0.013 |
0.030 |
| Within Run C.V. % |
1.094 |
0.712 |
0.640 |
0.690 |
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| Between Run S.D. |
0.005 |
0.024 |
0.019 |
0.079 |
| Between Run C.V. % |
1.066 |
2.496 |
0.960 |
1.811 |
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| Between Day S.D. |
0.005 |
0.017 |
0.014 |
0.023 |
| Between Day C.V. % |
0.928 |
1.776 |
0.707 |
0.525 |
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| Total S.D. |
0.007 |
0.024 |
0.027 |
0.088 |
| Total C.V. % |
1.421 |
2.462 |
1.353 |
2.008 |
Accuracy / Correlation
Testing was performed on a Roche / Hitachi 917 analyzer according to the CLSI EP9-A2 guideline. A comparison of the
K-ASSAY ®
Cystatin C and another company's Cystatin C assay was performed with the following results:
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Linear Regression:
y = 1.0093x - 0.0411
r = 0.9983
n = 50
x = another company's cystatin C assay
y = K-ASSAY ® Cystatin C assay
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x
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min
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=
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0.41 mg/L
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y
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min
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=
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0.40 mg/L
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max
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=
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7.43 mg/L
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max
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=
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7.68 mg/L
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mean
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=
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2.650 mg/L
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mean
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=
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2.633 mg/L
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Linearity
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0.06 - 8.00 mg/L (0.05 - 6.80 mg/L*)
(* ERM-DA471/IFCC Standardized)
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Measuring Range
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0.40 - 8.00 mg/L (0.34 - 6.80 mg/L*)
(* ERM-DA471/IFCC Standardized)
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INTERFERENCE
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Testing was performed on a Roche / Hitachi 917 analyzer according to
the CLSI EP7-A2 guideline with the following results.
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Bilirubin, Conjugated :
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No interference up to 60 mg/dL
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Bilirubin, Unconjugated :
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No interference up to 60 mg/dL
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Hemoglobin :
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No interference up to 900 mg/dL
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Intralipid :
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No interference up to 11 g/L
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Rheumatoid Factor :
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No interference up to 1,000 IU/L
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Triglycerides :
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No interference up to 1,500 mg/dL
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