34
EN
Calibration and
traceability:
The results are equivalent to the plasma glucose
concentration (capillary plasma referenced). The
GLUCOFIX
®
TECH GK system is calibrated using
capillary plasma values determined with a Yellow
Springs 2300 analyser (YSI). The YSI analyser is
calibrated (as a secondary reference measurement
procedure) using a series of YSI standards (primary
calibrators) which are taken from the NIST (National
Institute of Standards and Technology, USA).
Test strip storage
conditions:
- Temperature: 4 to 30 °C (39.2 to 86 °F) (both for
unopened vial and after opening).
- Relative Humidity: 20 to 90% (both for unopened
vial and after opening).
β-Ketone measurement specifications
Unit of measurement:
mmol/L.
Test range:
0.1 - 8.0 mmol/L.
Hæmatocrit range:
20 - 60% (haematocrit compensated).
Test strip:
GLUCOFIX
®
TECH β-Ketone Sensor.
Sample size:
Minimum 0.8 μL.
Test time:
8 seconds.
Assay Method:
Electrochemical, β-hydroxybutyrate dehydrogenase
based method.
Mediator: 1.10-phenanthroline-5.6-dione.
Calibration and
traceability:
The GLUCOFIX
®
TECH GK system is calibrated using
capillary plasma values determined by means of the
Stanbio β-Hydroxybutyrate LiquiColor
®
Procedure No.
2440
(Stanbio Laboratory, 1261 North Main Street,
Boerne, Texas 78006). The analyzer used to run the
Stanbio kit (secondary reference measurement
procedure) is calibrated using a series of β-hydroxy-
butyrate standards (primary calibrators) prepared
gravimetrically at Stanbio Laboratory.
Test strip Storage
Conditions:
Temperature: 4 to 30 °C (39.2 to 86 °F).
10. T
echnical specifications
