Description
INTENDED USE
This in vitro diagnostic device is intended for the quality control of the performances of ELITech Clinical Systems reagents, used for CK-MB quantitative determination.
This in vitro diagnostic device is for professional use only.
COMPOSITION
– Lyophilized product prepared from human serum and human CK-MB.
– Sodium azide < 0.1 % (w/w)
– CK-MB concentrations are lot-specific.
MATERIALS REQUIRED BUT NOT PROVIDED
– ELITech Clinical Systems reagent, used for CK-MB quantitative determination.
– General Laboratory equipment.
TRACEABILITY
The traceability is indicated on the instructions for use of the ELITech Clinical Systems reagent used in combination with the recommended calibration factor.
PRECAUTIONS FOR USE AND WARNINGS
– Consult Safety Data Sheet (SDS) for a proper handling.
– Each unit of human blood used in the manufacture of this product was tested and found to be negative/nonreactive for the presence of HbsAg, HCV and HIV1/2.
The methods used were FDA-approved. Nevertheless, since the risk of infection cannot be fully excluded
these products must be handled as potentially infectious. In case of exposure, follow the guidelines of the competent health authorities.
– Take precautions when handling broken glass vials as sharp edges can injure the user.
– These products contain sodium azide which may react with lead or copper plumbing to form potentially
explosive metal azides. When disposing of these reagents always flush with copious amounts of water to prevent azide build up.
– Take normal precautions and adhere to good laboratory practice.
– Use clean or single use laboratory equipment only to avoid contaminations.
WASTE MANAGEMENT
Disposal of all waste material should be in accordance with local, state and federal regulatory requirements
(please refer to the Safety Data Sheet (SDS)).
PREPARATION
– Carefully open the vial, avoiding the loss of lyophilizate.
– Add exactly 3 mL of distilled or deionized water.
– Carefully close the vial and dissolve the contents completely within 30 minutes by occasional gentle
stirring avoiding the formation of foam.
PRODUCT DETERIORATION
– The product after reconstitution should be clear. Cloudiness would indicate deterioration.
– Do not use the product if there is visible evidence of contamination or damage (e.g. particle matter after
reconstitution).
– Damage to the container may impact on product performance. Do not use the product if there is physical
evidence of deterioration (e.g. leakages).
STABILITY
Prior to reconstitution :
– Store at 2-8 °C and protect from light. Do not freeze.
– Do not use after the expiry date stated on the vial label.
After reconstitution :
– These products are stable 5 days at 2-8 °C.
– These products should be immediately and tightly capped to prevent contamination and evaporation.
PROCEDURE
To use CK-MB CONTROL, follow the procedure described in the instructions for use of the ELITech Clinical
Systems reagent used.
LIMITATIONS
Using CK-MB CONTROL has been validated with the ELITech systems (Analyzers and reagents used for
CK-MB quantitative determination).
Using any other system should be validated by the laboratory.
VALUES
The concentrations are indicated in the value sheet enclosed in the kit.
Individual laboratories may obtain values different from those announced. Technique, equipment and experimental error may produce slightly different values.
Each laboratory should determine their own mean values.
For users of Selectra instruments allowing data import for tests, calibrators and controls, use corresponding
barcode, available on the value sheet.
Reviews
There are no reviews yet.