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AIDIAN QuikRead go HbA1c Kurzanleitung Seite 6

In-vitro-test
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Interference
Interfering substance
Biotin
Bilirubin
Glucose
Intralipids
Rheumatoid factor
Albumin
Glycated albumin
Vitamin C (Ascorbic acid)
Acetaminophen
Acetylcysteine
Acetylsalicylic acid
Ampicillin
Cefoxitin
Cyclosporine A
Cyclosporine C
Doxycycline
Glyburide
Heparin
Ibuprofen
Levodopa
Metformin
Methyldopa
Metronidazole
Phenylbutazone
Rifampicin
Salicylic acid
Theophylline
Measuring range
The QuikRead go instrument displays the HbA1c results in mmol/mol and/or percentages
(%). The calculated estimated average glucose (eAG) can be displayed with mmol/mol
or % -results.
Unit
Measuring range
13 Traceability
The calibrators used to calibrate the HbA1c assay of the QuikRead go HbA1c test are
traceable to the IFCC Reference Measurement Procedure
14 Method comparison
Finger prick capillary blood and anticoagulated whole blood samples from 170 patients were
measured with the QuikRead go HbA1c method at a NPT clinical site. The reference values
were determined with an HPLC method at clinical laboratory. Summary of correlation study
is presented in Tables 4 and 5.
Table 4. Method comparison. QuikRead go HbA1c compared to a laboratory HPLC method.
Capillary sample
y = 1.02 x -1.8
N =
Range =
170
29–130
mmol/mol
Table 5. Estimated difference at clinically significant HbA1c concentrations.
Expected value
(mmol/mol)
42
48
53
15 Disposal
● Dispose of contents according to national and local law.
● All patient samples and sample collectors, controls, used caps, cuvettes and tubes
should be handled and disposed of as potentially infectious material.
● Materials used in various QuikRead go kit components:
Paper: Instructions for use
Cardboard: Kit box including its inner parts and sample collector box
Plastic: Cuvettes, reagent caps, cuvette rack, plungers, plunger and capillary tubes,
filling inside capillary tube and the filling of sample collector box, swabs and extraction
vials and tubes
Glass: Capillaries
Metal: Reagent cap tubes, cuvette lids, plunger and capillary tube caps
Several (not to be recycled): Lids of reagent cap tubes, foil covering cuvette rack,
unopened cuvettes and unused sample collectors
● When used in accordance with Good Laboratory Practice, good occupational hygiene,
and the instructions for use, the reagents supplied should not present a hazard to
health.
HbA1c
mmol/mol
20–140
Passing-Bablok analysis
HPLC method
Correlation
coefficient
r = 0.990
Observed value
(mmol/mol)
41
47
52
No significant interference (≤ 10%) found
up to concentration
3.51 mg/l
200 mg/l
10 g/l
20 g/l
780 000 IU/l
150 g/l
7.7 g/l
52.5 mg/l
156 mg/l
150 mg/l
30 mg/l
75 mg/l
6600 mg/l
1.8 mg/l
5.0 mg/l
18 mg/l
0.72 mg/l
3300 U/l
219 mg/l
7.5 mg/l
12 mg/l
22.5 mg/l
123 mg/l
321 mg/l
48 mg/l
286 mg/l
60 mg/l
HbA1c
%
4.0–15.0
.
8
Venous blood sample
y = 1.02 x -2.1
N =
Range =
170
29–130
mmol/mol
Difference (%)
-2.5
-1.9
-1.6
eAG
mmol/l
3.8–21.3
Correlation
coefficient
r = 0.990

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