PRINCIPLE
CK-MB control is intended to check the accuracy of the CK-MB assays using ELITECH reagents. It must be used to evaluate the performances of the assay procedure and to detect possible analytical deviations due to the reagents or the analysers used.
COMPOSITION
CK-MB Control is prepared from human serum and human derived isoenzyme. This product is freeze-dried and its level is in the pathological range.
TRACEABILITY (1)
Concentration value for CK-MB Control is traceable to IFCC method.
PRECAUTIONS
– Respect the normal precautions and good laboratory practice. All human material should be considered as potentially infectious. All products derived from blood are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and antibodies to HCV and HIV1/HIV2. However, handle cautiously as potentially infectious.
– Use clean or single use laboratory equipment only to avoid contaminations.
– Waste disposal : respect the legal requirements.
– CK-MB Control contains less than 0.1% sodium azide. Sodium azide can react with copper and lead plumbing to form explosive metal azides. If discharge in the canalisations, rinse with plenty of water.
PREPARATION
1. Remove vials from refrigerator and allow to warm to room temperature for 15 to 20 minutes.
2. Carefully open the vial, avoiding the loss of lyophilizate. Volumetrically add exactly 3.0 mL of distilled or deionized water. The water used for reconstitution should be at room temperature (22-28°C).
3. Carefully close the vial and dissolve the contents completely by occasional gentle swirling (10 times) avoiding the formation of foam.
4. Let the vials remain at room temperature for 20 minutes, then invert gently 10 times.
5. Let the vials remain at room temperature for an additional 20 minutes. Then invert 10 times and gently swirl.
6. Use immediately or refrigerate at 2-8°C for future use.
Note : If turbidity or contaminations appear after reconstitution, discard immediately.
STABILITY AND STORAGE
Prior to reconstitution, when stored at 2-8°C and protected from light, CK-MB Control is stable until the expiry date stated on the label.
After reconstitution, the control is stable 7 days when stored at 2-8°C.
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