Controls, Elitech Clinical Chemistry: ELITROL I 10 x 5 ML

Description

Intended Use

ELITech Clinical Systems ELITROL I & ELITROL II are multiparametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods.

For use on Generic Chemistry Analysers as well as Selectra Pro and Mach 5 Analysers.

Composition

ELITROL I are lyophilised control sera prepared from human serum. The concentrations and activities have been adjusted to be in the normal range or at the normal threshold (ELITROL I) or in the pathological range (ELITROL II).

MATERIALS REQUIRED BUT NOT PROVIDED
– General Laboratory equipment.

WARNINGS AND PRECAUTIONS
– These controls are for professional in vitro diagnostic use only.
– These controls are prepared from human material tested by FDA or CE approved methods and found to be negative for HbsAg, anti-HCV antibody and anti-HIV1&2 antibodies. However as no test method can rule out the potential risk of infection with absolute certainty, handle cautiously as potentially infectious.

– Take normal precautions and adhere to good laboratory practice.
– Use clean or single use laboratory equipment only to avoid contaminations.
– For more information, Safety Data Sheet (SDS) is available on request for professional user.

WASTE MANAGEMENT
Disposal of all waste material should be in accordance with local, state and Federal regulatory requirements.

PREPARATION
– Carefully open the vial, avoiding the loss of lyophilizate.
– Add in exactly 5 mL of distilled/deionized water.
– Carefully close the vial and dissolve the contents completely by
occasional gentle swirling within 30 minutes.
– Do not shake to avoid the formation of foam.
Important: With the exception of alkaline phosphatase, all
enzymes can be measured immediately.
To activate the alkaline phosphatase, incubate the reconstituted
control serum for one hour at 25 °C.

PRODUCT DETERIORATION

– The control may present a slightly hazy appearance after reconstitution. This has no effect on the performances of the product. All presence of particules would indicate deterioration.
– Do not use the product if there is visible evidence of biological, chemical or physical deterioration.

DAMAGED PACKAGING
Do not use the control if the damages of packaging might have an effect on the product performance (leakages).

STABILITY AND STORAGE
Prior to reconstitution :
– Stored at 2-8 °C and protected from light.
– Do not use after expiration date indicated on the vial label.
After reconstitution :
– Stability of the components:
Between 15 and 25 °C : 12 hours
Between 2 and 8 °C : 5 days
Between -25 and -15 °C : 4 weeks (when frozen once)
Exceptions:
– Stability of total bilirubin (when stored protected from light) :
Between 15 and 25 °C : 8 hours
Between 2 and 8 °C : 24 hours
Between -25 and -15 °C : 2 weeks (when frozen once)
– Stability of direct bilirubin (when stored protected from light) :
Between 15 and 25 °C : 4 hours
Between 2 and 8 °C : 8 hours
Between -25 and -15 °C : 2 weeks (when frozen once)