DRUG CONTROL - Multiparameter, human-based
DIMDI Reg.-Nr.: DE/CA22/1116-1-IVD
|Drug Control - Level I||KG 1667||20 x 5 ml|
|Drug Control - Level II||KG 1668||20 x 5 ml|
|Drug Control - Level III||KG 1669||20 x 5 ml|
For use in the quality control of clinical chemistry assays, particularly drug residue analysis.
BGT Drug Controls are based on lyophilised human serum. Constituent concentrations are available at 3 levels.
Each batch of serum is distributed to approximately 150 laboratories and values are assigned by a consensus of results obtained by these laboratories. A control range, for individual parameters and for each parameter method, is provided for each batch of serum. The control range is equivalent to the assigned mean ± 2 S.D.
Serum must only be reconstituted using the following procedure:
Open the vial carefully, avoiding any loss of material.
Reconstitute by pipetting exactly 5 ml of distilled water at +20 to +25°C into the vial.
Replace the rubber stopper and leave to stand for 30 minutes out of bright light before use.
Swirl gently several times during the reconstitution period to ensure that the contents are completely dissolved.
Prior to use, mix the contents by inverting the vials the formation of foam should be avoided. Ensure that no lyophilised material remains unreconstituted.
The serum is then ready for use with either a manual test or with an automated instrument.
STABILITY AND STORAGE
Unreconstituted serum is stable up to the expiry date shown on the side of each individual bottle when stored at +2 to +8°C. Once reconstituted the components of the Drug Control Sera are stable for 4 weeks at +2 to +8°C in the absence of bacterial contamination.
PRECAUTIONS AND WARNINGS
This serum has been tested for the HIV (Human Immunodeficiency Virus) antibody, ABsAg and HCV and found to be non-reactive. However, as no method can offer complete assurance as to the absence of infectious agents, this material should be handled as though capable of transmitting infectious disease.
This product has been developed for IN VITRO diagnostic use only.