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QuikRead go
1
Intended use
QuikRead go
HbA1c is an in vitro diagnostic test for quantitative measurement of glycated
®
hemoglobin (HbA1c) from a finger prick capillary blood or anticoagulated (EDTA or heparin)
venous whole blood sample. The test is carried out using the automated QuikRead go
instrument. The assay is intended to be used by trained healthcare professionals in clinical
laboratories and near-patient testing (NPT) settings. The test can be used in monitoring the
long-term blood glucose control in individuals with diabetes mellitus, as an aid in diagnosis
of diabetes and in identifying patients at risk of developing diabetes mellitus.
For in vitro diagnostic use only.
2
Summary and explanation of the test
Hemoglobin (Hb) is an iron-containing protein located in red blood cells. The most prevalent
variant of Hb in adults is HbA covering over 95% of total Hb. Glycation of HbA is a two-step
process where glucose binds chemically to the N-terminal end of hemoglobin beta chain
This process happens in every red blood cell. The relative amount of HbA1c increases
with glucose levels in blood during the life span of red blood cells (2–3 months)
result, HbA1c concentration rises in individuals who have chronic elevated blood sugar
levels, meaning diabetic patients. HbA1c is a measure of long-term glycemic status for
diabetic patients whereas blood glucose levels represent the daily variations. Quantitative
measurement of HbA1c concentration is an established method used for estimating the
status of diabetes treatment
mellitus
.
7
3
Principles of the procedure
QuikRead go HbA1c is an immunoturbidimetric test based on agglutination reaction. The
blood sample is added into the cuvette containing a hemolysing solution with latex particles.
The released hemoglobin is bound to the latex particles. The addition of a second reagent
containing anti-HbA1c antibodies induces an agglutination reaction together with the latex-
bound HbA1c. Hemoglobin and HbA1c bind to the particles in the same ratio that is present
in the blood.
The change in turbidity is measured photometrically. The turbidity is thus proportional to the
amount of HbA1c molecules bound to the latex and, moreover, to the proportion of HbA1c
in total hemoglobin. The calibration data of the test is in the barcode label of the cuvette,
which QuikRead go instrument reads automatically before the start of the measurement.
The HbA1c measurement range of the assay is 20–140 mmol/mol.
4
Reagents
Content of the kit
Component
name and origin
QuikRead go HbA1c
Reagent Caps
Prefilled cuvettes
QuikRead go Sample Collector 1µl
(sample collector)
Instructions for use
Reagent caps contain methylchloroisothiazolinone and methylisothiazolinone, please see
Section 5. "Warnings and precautions".
Storage
Kit component
Reagent Caps
Prefilled cuvettes
in foil pouch
Sample collector
Mark the date of opening the foil pouch on to the cuvette rack.
Reagent preparation and storage conditions
All reagents are ready to use. Let the reagents reach room temperature. Keep the HbA1c
Reagent Caps away from moisture. Close the aluminium tube immediately after taking out
the required number of reagent caps.
Reagent deterioration
Do not use cuvettes with visible dirt in the solution. The solution shall be milky and
homogenous.
HbA1c
®
. HbA1c can also be used as an aid in diagnosis of diabetes
4–6
Opened at 2...8ºC
6 months
6 months
Single prefilled cuvette:
1 hour
Storage at 2...25°C until the expiry date of the
QuikRead go Sample Collector 1µl package
QuikRead go
Symbol
Cat. no. 151058
25 tests
25
25 x 0.9 ml
25
Opened at
18...25ºC
2 months
2 months
HbA1c
®
Unopened at
Unopened at
2...8ºC
18...25ºC
Until the
expiry date of
2 months
the kit
English
®
.
1
. As a
2,3
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