HemoCue Glucose 201 RT Manuel D'utilisation page 52

Results
The displayed range is 0–27.8 mmol/L (0–500 mg/dL) for a
whole blood system and 0–31 mmol/L (0–560 mg/dL) for a
plasma equivalent system. The method used in the HemoCue
Glucose 201 RT system has been demonstrated to be linear
between 0–27.8 mmol/L (0–500 mg/dL) for a whole blood
system and 0–31 mmol/L (0–560 mg/dL) for a plasmaequiv-
alent system. If the results exceeds the measuring range of
the system "HHH" will be displayed. If patient assessment
does not align with results from the HemoCue Glucose 201
RT system the test results should be verified against a ref-
erence method.
Limit of Blank
The Limit of Blank for the Glucose 201RT system is 0.22 mmol/L
(4 mg/dL) for a whole blood system and 0.25 mmol/L
(4.4 mg/dL) for a plasma equivalent system.
By definition LoB is the highest measurement result achieved
when the analyte is not present in the sample; definition
according to CLSI Document EP17-A Vol. 24, No.34, Protocols
for Determination of Limits of Detection and Limits of
Quantification; Approved Guideline.
Limitations of the method/procedure
a) The measured blood glucose value of, grossly lipemic
specimens (intralipids >500 mg/L), turbid specimens,
specimens containing >7 % methemoglobin and
high concentrations of glucosamine (>1.44 mmol/L,
>26 mg/dL) may give incorrect results and should be
interpreted with caution.
b) At normal oral administration of xylose the
HemoCue Glucose 201 RT system does not have any
interference (Xylose <1.44 mmol/L, <22 mg/dL).
However the high dosage used during a xylose
absorption test may give incorrect results and should
be interpreted with caution.
c) It is verified according to CLSI Document EP7-A2
that the HemoCue Glucose 201 RT System does
not have any interference at teurapeutic levels for
oral administration of Ascorbic Acid. Intravenous
administration of Ascorbic Acid that leads to blood
concentrations > 10 mg/dL of Ascorbic Acid may give
incorrect results and should be interpreted with cau-
tion.
d) The HemoCue Glucose 201 RT system has no inter-
ference in blood specimens with hematocrit levels
from 20 % to 70 %.
e) A HemoCue Glucose 201 RT Analyzer with plasma
conversion multiplies the measured whole blood
glucose value by a factor of 1.11 and displays a
plasma equivalent result. Since this factor is based
on the relationship between plasma and whole
blood at normal hematocrit, care should be taken
when evaluating results in situations where the
hematocrit may be extreme.
f) The measurement needs to be started no later than
40 seconds after filling the microcuvette.
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