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GlucoTrol Quality Control Material
Description
EuroTrol GlucoTrol

Intended purpose/Intended Use

EuroTrol GlucoTrol NG is an assayed glucose control intended for professional use in the verification of the precision and accuracy of the HemoCue Glucose systems.

IVD Medical Device

EuroTrol GlucoTrol NG complies with IVD Medical Device Directive 98/79/EC and carries the CE mark. EuroTrol GlucoTrol NG is for in vitro diagnostic use only.

Summary
EuroTrol GlucoTrol NG is a quality control material with a known Glucose concentration. EuroTrol GlucoTrol NG may be used in the periodic verification of the precision and accuracy of the HemoCue Glucose systems. Please refer to local guidelines for recommended frequency of use.

Reagents
EuroTrol GlucoTrol NG is produced at five physiologically relevant levels (Level 1, 2, 3, 4 & 5). Each vial containing 1.0 mL of purified bovine plasma with glucose.

Storage and Stability
EuroTrol GlucoTrol NG should be stored unopened in the refrigerator at 2-8°C (35-46°F). Stored unopened at this temperature it is guaranteed stable as indicated until the expiration date on the outer box. After opening the vial, it is stable for 30 days when properly recapped and stored at 2-8°C (35-46°F) or at room temperature 15-30°C (59-86°F).

Procedures/instructions for use

  1. Allow the vial to stand for 15 minutes at room temperature 15-30°C (59-86°F).
  2. Gently mix the vial 8-10 times before sampling.
  3. Do not fill the cuvette from the vial. Dispense a drop of the control material onto a hydrophobic surface, for example a plastic film or Prowipe. Fill the cuvette according to the manufacturer’s instructions. Wait one minute before placing the cuvette in the instrument.
  4. Wipe any excess material from the vial and the cap with a clean tissue. Recap the vial tightly.
  5. If the control does not perform as expected, review the instructions for use of the instrument to see if the test was performed correctly. Check the expiration date and storage conditions for the control and the cuvettes. Repeat the test. If the control still does not perform as expected, contact technical assistance.



Precautions

  1. For in vitro diagnostic use only.
  2. Caution: EuroTrol GlucoTrol NG is an Animal Blood Product. Bovine based materials do not carry biohazards for man, such as Hepatitis B Surface Antigen (HbsAg), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV-1.HIV-2). This product is free from TSE.
  3. It is good laboratory practice to follow the same precautions as with patient samples when handling or disposing vials.
  4. This product should not be disposed of in general waste. Consult local environmental authorities for proper disposal.
  5. EuroTrol GlucoTrol NG is not to be used as a calibrator.

Expected results
The mean assay value provided on the enclosed assay sheet is derived from replicate analyses on factory calibrated HemoCue Glucose systems. The values are valid on the HemoCue Glucose systems as referred to on the assay sheet. Values for “ HemoCue whole blood systems” are applicable for HemoCue Glucose systems reporting plasma equivalent values. Not all HemoCue Glucose Systems are available worldwide.