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Specifications
EN
Intended purpose
The HemoCue Glucose 201 RT System is intended for quantitative determination
of glucose in whole blood (capillary, venous or arterial), supplementing the clini-
cal evidence in the diagnosis of diabetes, the detection of idiopathic hypoglycemia,
monitoring patients with diabetes and monitoring neonatal blood glucose levels.
The system should not be used on critically ill neonates in neonatal intensive care
settings. The HemoCue Glucose 201 RT System is an automated system for profes-
sional use by healthcare professionals and laboratory personnel, intended for near-
patient (point-of-care) and laboratory testing. The HemoCue Glucose 201 RT System
is for In Vitro Diagnostics use only. The HemoCue Glucose 201 RT Analyzer is only to
be used with HemoCue Glucose 201 RT Microcuvettes.
IVD Medical Device Regulation
The HemoCue Glucose 201 RT System complies with the IVD Medical Device
Regulation (EU) 2017/746 and carries the CE mark.
Principles of the method/procedure
Principle of the method
The chemical reaction in the cavity has two phases, hemolysis and the glucose reac-
tion. The glucose reaction is a modified glucose dehydrogenase method in which
a tetrazolium salt (MTT) is used to obtain a quantification of glucose in visible light.
α-D-glucose is transformed to β-D-glucose using mutarotase. Glucose dehydroge-
nase acts as a catalyst for the oxidation of β-D-glucose, to form NADH, which in the
presence of diaphorase produces a colored formazan with MTT.
Principle of the procedure
The system consists of an analyzer together with microcuvettes. The micro cuvette
serves both as a pipette and as a measuring cuvette and is for single-use only.
A blood sample of approximatly 4 μL is drawn into the cavity by capillary action. The
measurement takes place in the analyzer in which the transmittance is measured
and the absorbance and glucose level is calculated. The calibration of the HemoCue
Glucose 201 RT System is traceable to the ID GC-MS reference method which is cali-
brated by NIST Standard reference material. The HemoCue Glucose 201 RT is factory
calibrated and needs no further calibration.
Composition
The microcuvette is made of copolyester plastic and contains the following reagent:
<75 μg/g cuvette MTT (methylthiazolyldiphenyl tetrazolium), <130 μg/g cuvette
saponin, <40 μg/g cuvette sodium fluoride, <525 μg/g cuvette enzyme mix: muta-
rotase (bacterial), glucose dehydrogenase (bacterial), diaphorase (bacterial), NAD
(nicotinamide-adenine- dinucleotide), and non-reactive ingredients.
Warning and precaution
In accordance with "Good Laboratory Practices", intervention levels and normal val-
ues should be established by each laboratory when instituting a new method. The
specimen collection should be done according to instruction for use to reduce the
risk of incorrect results. In cases of severe hypotension and peripheral circulatory
failure, glucose measurement from capillary samples may be misleading. In such
circumstances it is recommended that the glucose level should be measured using
venous or arterial whole blood. The measurement needs to be started no later than
40 seconds after filling the microcuvette. If a second sample is to be taken, fill a new
microcuvette from a new drop of blood. This should not be done until the measure-
ment of the first sample is completed. Do not remeasure the microcuvette. If the
result exceeds the measuring range of the system "HHH" will be displayed.
Always handle blood specimens with care as they may be infectious. Consult local
environmental authorities for proper disposal.
Storage and handling
HemoCue Glucose 201 RT Microcuvettes
The microcuvettes are to be stored at 0–30 °C (32–86 °F). Unused HemoCue
Glucose 201 RT Microcuvettes should be kept in the original package but once an
individual package is opened, the microcuvette must be used immediately or dis-
carded. Use the microcuvettes prior to the expiration date that is printed on the
package.
HemoCue Glucose 201 RT Analyzer
The analyzer can be stored and transported at 0–50 °C (32–122 °F). Operating tem-
perature is 15–27 °C (59–80 °F). Allow the analyzer to reach operating temperature
(app. 30 minutes) before use. The analyzer should not be operated at high (i.e. >90%
non-condensing) humidity.
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