Instructions

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IVD CAPSULE D-Dimer - Instructions for Use (IFU)

REF P02.00050

IVD CAPSULE D-Dimer 2022_05_EN_V1.0

English

Intended use

The IVD CAPSULE D-Dimer is a single use, rapid in vitro

diagnostic test for the quantitative measurement of D-Dimer in

human sodium citrate anticoagulated venous whole blood. The

IVD CAPSULE D-Dimer is intended to be used, in conjunction

with clinical pretest probability, in the aid in the diagnosis of

venous thromboembolism (VTE) including deep vein

thrombosis (DVT), pulmonary embolism (PE) and

disseminated intravascular coagulation (DIC), in patients

suspected of DVT, PE or DIC (according to CLSI H59-A

D-Dimer testing is often ordered in the primary care and

emergency room (ER) with symptoms of a serious condition

(e.g., chest pain and difficulty in breathing).

The IVD CAPSULE D-Dimer is to be used with the

abioSCOPE 2.0 in vitro diagnostic test system. The system is

intended for professional use in clinical laboratory settings, in

hospitals and point of care (PoC) locations including near-

patient testing.

Summary

D-Dimer is formed by the breakdown of cross-linked fibrin

degradation products, and its presence in human plasma is a

well-established marker indicative of fibrinolytic activity.

D-Dimer analysis is critical for the exclusion of thromboembolic

events such as deep vein thrombosis (DVT), pulmonary

embolism (PE) and disseminated intravascular coagulation

(DIC)

. Elevated D-dimer levels are present in conditions

associated with increased coagulation activation, such as

during DVT, PE and DIC as mentioned earlier, but D-Dimer is

also increased in numerous other conditions including acute

aortic dissection, obstetrical complications, third trimester

pregnancy, surgery or polytrauma. Therefore, this test is used

predominantly as an exclusion test in patients suspected of

DVT or PE in combination with a pre-test probability

1, 3-5

Test principle

The blood sample is mixed with a solution composed of

fluorescently labelled antibodies specific to human D-Dimer.

The blood sample, now containing the D-Dimer-antibody

complex, is loaded onto the capsule of the kit.

Patient material is passively drawn through the capsule by

capillary action and passes through a built-in separator that

excludes red blood cells and particles from the measurement

area.

After passing through the separator, the D-Dimer-antibody

complex is captured by antibodies immobilized on the

capsule’s read-out area.

The quantity of captured D-Dimer is proportional to the

fluorescence generated by the fluorophore conjugated to the

detection antibody. Therefore, the measured fluorescence

signal is proportional to the concentration of D-Dimer within the

sample. The abioSCOPE automatically calculates the

concentration of each sample and displays it on the instrument

screen. D-Dimer concentrations are expressed in fibrinogen

equivalent unit (FEU) which corresponds to the concentration

of fibrinogen initially present in the sample that leads to the

measured level of D-Dimer. The equivalence between these

two measurement units is approximately 2 ng/ml FEU = 1 ng/ml

of D-Dimer.

Reagents

Each assay contains one vial with 100 µl of the abioMIX

reagent. The abioMIX reagent is composed of a fluorescently

labelled anti-human D-Dimer antibody, dissolved in a

phosphate buffered saline solution supplemented with bovine

serum albumin, Tween-20 and ProClin300 preservative (Table

1).

Ingredient

Concentration

Fluorescently labelled anti-human D-

Dimer antibody

4.50 g/ml

Bovine serum albumin

0.1% (w/v)

Tween 20 (CAS number 005-64-5)

1% (v/v)

ProClin 300 (CAS number 55965-84-9)

0.04% (v/v)

Table 1| Composition of the abioMIX reagent.

Materials included

• 1x D-Dimer capsule

• 1x vial of abioMIX reagent

• 1x capillary blood collector (abioPIPETTE)

• 1x desiccant bag

• 1 x printed Instructions for Use (IFU)

Sample collection and handling

Venous whole blood is collected in designated trisodium

citrate blood tubes by venous puncture and anticoagulated

according to the manufacturer’s protocol, in conformity with the

recommendations for haemostasis tests. Prepare a trisodium

citrate anti-coagulated blood tube. Turn the plunger clockwise

by one quarter to activate the provided abioPIPETTE. Outside

the test tube press on the abioPIPETTE's plunger and maintain

the pressure. Insert the abioPIPETTE into the tube. Release

the plunger to completely fill the abioPIPETTE with blood and

then remove it. 50 µl of blood are loaded.

Test procedures

1. Use the abioPIPETTE filled with 50 µl of venous whole

blood that was collected according to “Sample collection

and handling”.

2. Pick up the abioMIX vial and flick it to move the abioMIX

down to the bottom before use. Pierce the cap with the tip

of the filled abioPIPETTE without pushing the plunger and

insert it fully into the vial. Next, push on the

abioPIPETTE’s plunger to dispense the entire blood

Summary of content (4 pages)

PAGE 1
IVD CAPSULE D-Dimer - Instructions for Use (IFU) REF P02.00050 English Intended use The IVD CAPSULE D-Dimer is a single use, rapid in vitro diagnostic test for the quantitative measurement of D-Dimer in human sodium citrate anticoagulated venous whole blood.
PAGE 2
IVD CAPSULE D-Dimer - Instructions for Use (IFU) REF P02.00050 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. 4. 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). Outside the vial, push down the plunger completely and hold the pressure.
PAGE 3
IVD CAPSULE D-Dimer - Instructions for Use (IFU) REF P02.00050 • Consistently high or low values from assay kits from the same batch. In such cases the kit should not be used. Limitations • • • • Test results should be interpreted within the complete clinical picture. Definitive diagnosis and/or clinical decision should not be based solely on the results of any single diagnostic test but made after all clinical and laboratory findings are evaluated.
PAGE 4
IVD CAPSULE D-Dimer - Instructions for Use (IFU) REF P02.00050 selectivity was established in accordance with the recommendation of the CLSI document EP07, 3rd edition 11 and its supplement EP37, 1st edition 12. No interference was observed on the three D-Dimer samples at these concentrations (bias within +/- 10%) (Table 6).