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7
Procedure
Materials required but not provided
The following materials are required to perform the test but are not provided or they are
available also separately. The materials provided are listed in Section 4. "Reagents".
Material
QuikRead go
Instrument with
®
software version 8.1.1 or newer
QuikRead go
Sample Collector 1µl
®
QuikRead go
HbA1c Control Set
®
Fingertip lancets
Assay procedure
Before starting an assay, read and follow the QuikRead go instrument and QuikRead go
HbA1c test instructions for use. Open the foil pouch of the cuvette rack, and mark the
opening date on the cuvette rack.
Sample collection (see figures 1–6)
QuikRead go Sample Collector 1μl is required for transferring the sample into a prefilled
cuvette. The QuikRead go HbA1c kit contains 25 pieces of the sample collectors (QuikRead
go Sample Collector 1µl).
1. A prefilled cuvette must reach room temperature (18...25ºC) before use. This will take 15
minutes for an individual refrigerated (2...8ºC) prefilled cuvette. Do not touch the clear
flat surfaces in the lower part of the cuvette (the optical part). Remove the foil cover from
the cuvette. Beware of splashing the liquid. Condensed solution on the foil cover has no
effect on results. The test must be performed within 1 hour of opening the cuvette.
2. Open the sample collector box slightly to get one single sample collector out of the box.
The package filling can be discarded.
3. Hold the sample collector almost horizontally and take the sample by placing the tip just
beneath the blood drop. Fill the capillary part of the sample collector completely.
4. Check that the capillary part is completely filled. Ensure that there are no air bubbles in
the capillary part. Do not wipe the sample collector. If there is excess of sample on the
sample collector, discard the sample collector and take a new sample with a new sample
collector.
5. Insert the sample collector into the cuvette within 1 minute. The sample collector does
not touch the solution in the cuvette. The sample collector remains in the cuvette during
the whole test measurement procedure.
6. Close the cuvette tightly with the HbA1c Reagent Cap. Do not press down the violet
inner part of the reagent cap. Perform the test within 5 minutes. Keep the cuvette upright
and do not shake.
Note! If a venous sample is used, it is recommended to take the sample directly from the
tube. Tilt the tube slightly and collect the sample just beneath the surface of the sample with
the sample collector. Do not wipe the sample collector.
Analysing the sample (see figures 7–9)
Begin the test by turning on the instrument. For full instructions, see the QuikRead go
instrument instructions for use. The display will guide you through the test.
7. Choose Measure on the display of the QuikRead go instrument. Insert user ID and
patient ID if needed.
8. Place the cuvette in the measurement well of the instrument. The barcode should
be facing you as shown in the Figure 8. The display shows how the measurement is
proceeding.
9. The result appears on the display and the cuvette rises up automatically when the
measurement in completed.
Analysing the control
Please see the instructions for use provided with each control set. Analyse control samples
as patient samples but choose Quality Control on the display of the QuikRead go
instrument. The result will be stored as a control measurement.
8
Quality control
For quality control use QuikRead go HbA1c Control Set (Cat. no. 154520). Regular use of
controls is recommended. Please consult Section 16. "Troubleshooting" and contact Aidian
or your local distributor if you observe any changes in test functionality.
QuikRead go HbA1c Control Set features two ready-to-use liquid controls: QuikRead
go HbA1c Control and QuikRead go HbA1c Control High. The control values have been
determined for the QuikRead go instrument. The control is applied using the same procedure
as for venous blood sample. Perform the test as outlined in Section 7. "Procedure", use the
same control sample volume as for unknown blood specimens (1 μl). Analyse control samples
by choosing Quality Control on the display of the QuikRead go instrument.
Quality control testing must be performed in accordance with applicable national or
local regulations or accreditation requirements and laboratory standard Quality Control
Procedures.
It is recommended to perform the control at least with each new shipment and new reagent
lot and every time an unexpected result is obtained.
The control should be used each time new QuikRead go system users are trained.
9
Results' interpretation
The HbA1c result should not be interpreted without patient's medical history, clinical
examination and other laboratory findings.
HbA1c measuring units
Three different measuring units are used for reporting the results of the QuikRead go
HbA1c test. The result will be displayed in mmol/mol HbA1c (aligned to the IFCC Reference
Procedure
) or in % HbA1c (aligned to the DCCT study assay, also known as NGSP-HbA1c
8,9
or in eAG (estimated average blood glucose), where a HbA1c value is converted to an
equivalent glucose value. Linear relationship between these HbA1c results and estimated
average glucose (eAG) have been established
according to the national recommendations. Choose the right units from the instrument
display: Settings -> Measurement Flow -> Test Parameters. Please see the instrument
manual.
NGSP
=
IFCC
=
eAG (mmol/l)
=
eAG (mg/dl)
=
If necessary, please consult Section 16. "Troubleshooting", and repeat the test.
0.0915 x IFCC + 2.15%
10.93 x NGSP – 23.5 mmol/mol
1.59 x DCCT-HbA1c (%) – 2.59
28.7 x HbA1c (%) – 46.7
Cat. no.
Additional info
133893
154457
154520
For quality control
‒
. Patient's HbA1c values should be reported
10
9
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)
9
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