RF (Ver. 2)
Rheumatoid Factor (Ver. 2)
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Cat. No.:
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KAI-230
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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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6.65 - 600 IU/mL
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Sample:
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Serum or Plasma
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KIT COMPOSITION
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INTENDED USE
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For the quantitative determination of human IgG rheumatoid factor antibodies in patient serum or plasma (citric acid, EDTA, or lithium heparin)
based on immunoturbidimetric assay. The presence of IgG RF antibodies, in conjunction with clinical findings and other laboratory tests, is an aid
in the diagnosis of rheumatoid arthritis (RA).
FOR IN VITRO DIAGNOSTIC USE.
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REAGENT PREPARATION
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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 until the
expiration date indicated on the package and bottle labels.
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PERFORMANCE
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Precision
The precision for the
K-ASSAY ®
RF (Ver.2) assay was determined using packaged reagents, clinical serum samples, and an Abbott Architect c8000 chemistry analyzer according to the CLSI EP5-A3 guideline. Representative data are below.
Single Site Precision
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Sample
1 |
Sample
2 |
Sample
3 |
Sample
4 |
| Mean (IU/mL) |
13.72 |
22.22 |
101.38 |
519.46 |
| N |
80 |
80 |
80 |
80 |
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| Repeatability, S.D. |
0.57 |
0.41 |
0.56 |
2.58 |
| Repeatability, C.V. % |
4.1 |
1.8 |
0.6 |
0.5 |
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| Within-Laboratory, S.D. |
0.57 |
0.50 |
0.83 |
3.60 |
| Within-Laboratory, C.V. % |
4.2 |
2.2 |
0.8 |
0.7 |
Multi-Site Precision
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Sample
1 |
Sample
2 |
Sample
3 |
Sample
4 |
| Mean (IU/mL) |
14.13 |
21.24 |
101.69 |
532.83 |
| N |
75 |
75 |
75 |
75 |
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| Repeatability, S.D. |
0.64 |
0.54 |
0.75 |
4.44 |
| Repeatability, C.V. % |
4.5 |
2.5 |
0.7 |
0.8 |
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| Reproducibility, S.D. |
1.02 |
1.03 |
1.61 |
7.86 |
| Reproducibility, C.V. % |
7.2 |
4.9 |
1.6 |
1.5 |
Accuracy / Correlation
Testing was performed on an Abbott Architect c8000 analyzer according to the CLSI EP9-A3 guideline. A comparison of the
K-ASSAY ®
RF (ver.2) assay and company A's RF assay was performed with the following results:
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Linear Regression:
y = 1.001x + 1.331
r = 0.989
n = 178
x = company A's RF
y = K-ASSAY ® RF (Ver.2)
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x
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min
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=
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5.1 IU/mL
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y
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min
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=
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6.77 IU/mL
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max
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=
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558.8 IU/mL
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max
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=
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550.92 IU/mL
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mean
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=
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124.5 IU/mL
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mean
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=
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128.94 IU/mL
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Linearity
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The regession equation for the linear range (6.65 - 600 IU/mL) was:
y = 0.992x + 2.41 with an r value of 0.9986.
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Assay Range
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INTERFERENCE
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Testing was performed on an Abbott Architect c8000 analyzer according to
the CLSI EP07-3rd edition guideline with the following results.
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Ascorbic Acid :
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No interference up to 50 mg/dL
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Bilirubin, Conjugated :
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No interference up to 20 mg/dL
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Bilirubin, Unconjugated :
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No interference up to 20 mg/dL
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Chyle :
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No interference up to 1,500 FTU
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Hemoglobin :
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No interference up to 500 mg/dL
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Total Cholesterol :
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No interference up to 400 mg/dL
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Total Triglycerides :
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No interference up to 1,000 mg/dL
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