Hemoglobin A1c Control
HbA1c Control
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Cat. No.:
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K29C-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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This product is for the purpose of monitoring accuracy and precision in the quantitative
determination of human Hemoglobin A1c (HbA1c) in blood by automated immunoassay.
FOR IN VITRO DIAGNOSTIC USE.
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CONTROL PREPARATION
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Reconstitute vials with 0.5 mL deionized water. Gently mix for
10 minutes. Observe for undissolved material. The reconstituted
controls may be dispensed in 0.1 mL aliquots, sealed tightly and frozen
at -20°C.
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STORAGE AND HANDLING
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1.
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Store controls at 2-8°C. Stable until expiration date if sealed
tightly. PROTECT FROM LIGHT AND HEAT.
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2.
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Reconstituted controls retain their assigned values for at least three months
if frozen. If not frozen, the reconstituted controls are stable at least
one month if stored at 2-8°C and sealed tightly.
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3.
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Do not freeze and thaw more than once.
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4.
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Do not store in a self-defrosting freezer.
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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 ®
Hemoglobin A1c 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.
| CONTROL LEVEL |
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%
NGSP Units (RECOMMENDED)
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mmol / mol Hb
IFCC Units
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MEAN |
RANGE |
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MEAN |
RANGE |
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Level 1
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5.0 % |
4.0 - 6.0 % |
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31 |
25 - 37 |
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Level 2
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11.9 % |
10.4 - 13.4 % |
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107 |
93 - 121 |
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