Instructions

IVD CAPSULE D-Dimer - Instructions for Use (IFU)
REF P02.00050
IVD CAPSULE D-Dimer 2022_05_EN_V1.0
sample into the abioMIX reagent vial. Hold the pressure
on the plunger of the abioPIPETTE and remove the
abioPIPETTE. The plunger can be released outside of the
vial.
3. Tap the vial at least 10 times on a hard surface to mix
thoroughly the blood-abioMIX solution and proceed
immediately to the next step (note: a well-mixed sample
will have a homogenous color).
4. Outside the vial, push down the plunger completely and
hold the pressure. Insert the abioPIPETTE as far as
possible into the vial. Release the plunger to completely
fill the abioPIPETTE with the mix and remove the
abioPIPETTE. Press the plunger gently to deposit the
mixture evenly on the entire surface of the membrane
(white area) in the center of the capsule. The mixture
should be dispensed slowly to allow the solution to wick
into the capsule. Ensure that the pipette tip does not
scrape the membrane.
5. Fold the lid over to close the capsule. Hold the capsule
only by the edges. Be careful not to touch the bottom side
of the capsule.
6. To start the measurement, touch the button “measure” on
the abioSCOPE reader. The tray will open automatically.
7. Place the capsule onto the tray according to the guided
capsule position on the screen, then touch the button
“close tray”.
To measure the sample, refer to the abioSCOPE 2.0 User
Manual.
Storage and stability
The IVD CAPSULE D-Dimer has a shelf life of 5 months when
refrigerated (at 2°C to 8°C), as indicated by the expiration date
printed on the label. Allow the IVD CAPSULE D-Dimer to warm
up to room temperature before opening and use it immediately
after.
The blood sample mixed with the abioMIX reagent should be
immediately loaded onto the D-Dimer capsule and the filled
capsule immediately measured.
Sample stability
It is preferred to analyse the samples as soon as possible after
venous punction. Whole blood samples must be stored at room
temperature (20 to 25 °C) before measurement.
Traceability and calibration
IVD CAPSULE D-Dimer is calibrated by the manufacturer
using a purified preparation of human D-Dimer in trisodium
citrate anticoagulated plasma supplemented with red blood
cells. Each lot of IVD CAPSULE D-Dimer is calibrated using a
weighted 5 parameter logistic curve fit data reduction method.
The instrument automatically reads in the lot-specific
calibration data that are embedded within the capsule’s chip,
eliminating the need for calibration by the user. D-Dimer values
assigned to the calibration material are directly traceable to the
highest available reference material, so that results for a given
measurand is comparable across methods and laboratories.
Quality control
The abioSCOPE evaluates internal controls at power-on and
after insertion of the capsule. If controls fail, the abioSCOPE
displays a specific error message.
It is recommended to use external reference material for quality
control. Contact the manufacturer for assistance and follow the
applicable local regulations and guidelines.
The IVD CAPSULE D-Dimer is calibrated to measure human
D-Dimer in sodium citrate anticoagulated whole blood samples.
Quality control results obtained with external reference material
that differs in terms of sample matrix (e.g., serum or plasma)
should by analysed with caution.
The control intervals should be adapted to each laboratory’s
individual requirements. Values obtained should fall within the
defined target range provided by the manufacturer of the
reference material. Each laboratory should establish corrective
measures to be taken if values fall outside of the defined
ranges.
Warnings and precautions
• For in vitro diagnostic use.
• The IVD CAPSULE D-Dimer must be kept refrigerated
until use.
• Do not freeze.
• Allow the abioMIX reagent vial to reach room temperature
before use.
• This product requires the handling of human specimens. It
is recommended that all human-sourced material is
considered potentially infectious. Universal precautions
that apply to the user’s facility should be applied for
handling and disposal of materials during and after
testing
6
.
• Do not use reagents after the expiry date printed on the
box.
• Do not use the diagnostic kit if the pouch is damaged.
• Incubation of the specimen in the abioMIX for more than
5 minutes may impact test results.
• If the whole blood sample is not immediately analysed, it
is important to homogenize the sample (i.e., ensure the
resuspension of the blood cells) before performing the
test.
• The abioSCOPE 2.0 should be regularly cleaned and
decontaminated (see the User Manual)
Reagent deterioration
The following observations indicate reagent deterioration:
• Presence of turbidity in the abioMIX vial.