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ASO / RF / CRP Control
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Cat. No.:
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K55C-4M
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Type:
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Control
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KIT COMPOSITION
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INTENDED USE
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The K-ASSAY ®
ASO/RF/CRP Control is intended to be used as a consistent test sample of known concentrations for monitoring
the K-ASSAY ®
Anti-Streptolysin O (ASO),
Rheumatoid Factor, RF (Ver.2),
C-Reactive Protein (CRP),
and wide range CRP
immunoturbidimetric assays.
FOR IN VITRO DIAGNOSTIC USE.
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CONTROL PREPARATION
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1.
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Carefully and slowly remove rubber stopper and let air enter vacuum-sealed bottle.
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2.
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Carefully add exactly 2 mL purified water (at room temperature) to bottle.
DO NOT MIX.
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3.
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Replace rubber stopper.
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4.
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Let bottle sit at room temperature for 10 minutes.
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5.
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Mix by slowly swirling bottle numerous times. DO NOT SHAKE or induce foaming.
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6.
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Continue to mix until all contents have dissolved completely.
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7.
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Before each subsequent use, be sure to mix bottle by slowly swirling.
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STORAGE AND HANDLING
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Store lyophilized and reconstituted controls at 2-8°C. Return all controls
to 2-8°C promptly after use. Unopened controls can be used for one year from
the date of manufacturing as indicated by the expiration date on the package and
bottle labels.
Reconstituted controls can be used for 2 weeks if stored at 2-8°C.
Reconstituted controls can also be frozen immediately after reconstitution at -20°C for
2 months and then thawed ONE TIME ONLY.
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EXPECTED VALUES
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The following values are given as an example. The expected values for the
K-ASSAY ®
ASO/RF/CRP 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.
| ANALYTE |
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LEVEL 1 |
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LEVEL 2 |
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MEAN |
RANGE |
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MEAN |
RANGE |
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ASO
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258 IU/mL |
232 - 284 IU/mL |
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427 IU/mL |
384 - 470 IU/mL |
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RF
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32 IU/mL |
22 - 42 IU/mL |
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82 IU/mL |
66 - 98 IU/mL |
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CRP
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1.1 mg/dL |
0.8 - 1.4 mg/dL |
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3.8 mg/dL |
3.3 - 4.3 mg/dL |
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CRP(3) Cal E
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11.12 mg/L |
8.89 - 13.34 mg/L |
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37.41 mg/L |
29.93 - 44.89 mg/L |
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CRP(3) Cal F
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11.5 mg/L |
9.2 - 13.8 mg/L |
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37.1 mg/L |
29.7 - 44.6 mg/L |
ASO: Standardized against the WHO NIBSC Anti-Streptolysin-O standard material.
RF: Standardized against the WHO International Reference Preparation of Rheumatoid Arthritis Serum.
CRP, CRP(3): Standardized against CAP/BCR/IFCC Reference Preparation for Proteins in Human
Serum (RPPHS), lot 91/0619.
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