BIOLABO

! www.biolabo.fr
MANUFACTURER:
BIOLABO S.A.S D-DIMER Turbidimetric Immunoassay
Les Hautes Rives, Reagent for determination of D-Dimer
! 02160, Maizy, France in human plasma
! REF 13210 R1 3 x 7 mL R2 3 x 4 mL
R3 2 x 1 mL R4 2 x 7 mL

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TECHNICAL SUPPORT AND ORDERS IVD
Tel: (33) 03 23 25 15 50
[email protected] Made in France
Latest revision: www.biolabo.fr! I: corresponds to significant modifications!

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INTENDED USE SAFETY CAUTIONS (1) (2)
This reagent is designated for professional use in laboratory (automated · Material Safety Data Sheet is available upon request.
method). · Each human donor unit used to manufacture this product was tested
This Latex immunoassay is a quantitative test to determine D-Dimer in and found non-reactive for HbsAg, antibody to Hepatitis C and antibody
citrated human plasma. It can be used to exclude the presence of to HIV-1/HIV-2.
thrombosis in patients with suspected thrombotic disorders and as an aid · Products from animal origin were approved ante and post mortem by
in the management of patients with Covid-19 disease. veterinarians inspection.
· However, no test method can offer complete assurance that infectious
agents are absent. All specimens or reagents from biological origin
GENERALITIES (3-6) (12) (13) should be handled as potentially infectious.
Fibrin fragments containing D-Dimer antigen is always present in · Waste disposal: Respect legislation in force in the country.
plasma because of plasmin degradation. After an injury or in case of Any serious incident that has occurred in connection with the device is
conditions associated with increased haemostatic activity, the D-Dimer notified to the manufacturer and the competent authority of the Member
concentration increases in plasma. The determination of D-Dimer is an State in which the user and/or patient is based.
aid in the diagnosis of thrombosis. Deep vein thrombosis (DVT),
pulmonary embolism (PE) and disseminated intravascular coagulation REAGENTS PREPARATION
(DIC) are associated with elevated level of D-Dimer. A negative D- Reagents (R1, R2, and R4) are ready to use.
Dimer test result has a high negative predictive value for patient with a Swirl gently Latex reagent (R2) before each use to homogenise latex
suspected thrombotic disorder. particles
I This test should be used with other clinical and diagnostic information Calibrator (R3):
in order to diagnose and manage patients. · Add exactly 1 mL of demineralised water (15-25°C).
In patients with Covid-19 disease, increasing plasma D-dimer · Recap and wait for approximately 15 minutes at room temperature.
concentration is seen with worsening disease. Markedly elevated D- · Gently agitate until the content is completely dissolved.
dimer is a prognostic marker for mortality and can be used as an aid in
managing anticoagulant treatment of hospitalized Covid-19 patients STABILITY AND STORAGE
Stored away from light, well caped in the original vial at 2-8°C,
PRINCIPLE reagents are stable when stored and used as described:
D-DIMER reagent consists in sub-micron sized polystyrene particles Unopened:
coupled to monoclonal antibodies specific for D-Dimer. When plasma · Until expiry date stated on the label of the Kit
specimen containing D-Dimer is exposed to the reagent, the particles Once opened:
will agglutinate, giving rise to increased light-scattering. · Reagents (R1, R2, R4) are stable 8 weeks at 2-8°C
This phenomenon leads to an increase of absorbance proportional to
· Calibrator (R3) must be reconstituted without delay.
the concentration of D-Dimer in the specimen. This absorbance is
Once reconstituted,
measured in spectrometry at 700 nm (600 – 800). · Calibrator (R3) is stable 7 days at 2-8°C and 24h at 20-25°C when free
from contamination.
REAGENTS
R1 D-DIMER Reaction Buffer SPECIMEN COLLECTION AND HANDLING (7)
Buffer Plasma (citrate).
Sodium azide < 0.1%, 2-methylisothiazol-3(2H)-one < 0,0015% Mix freshly drawn blood (9 Volumes) with buffered tri-sodium citrate
solution 0.109M (1 volume). The ratio is critical. Trauma or stasis during
R2 D-DIMER Latex Reagent blood sampling should be avoided. Inverse immediately after sampling.
Polystyrene particles coated with monoclonal antibodies The presence of any clots in a specimen is a cause for rejection.
Buffer Centrifuge for 10 min. at 3000g and extract supernatant for analysis
Sodium azide< 0.1%, 2-methylisothiazol-3(2H)-one < 0,0015%
LIMITS (10)
EUH208: May produce an allergic reaction.
Turbid or opalescent plasma may cause erratic results and should be
EUH210: Safety data sheet available on request interpreted with caution: dilute the sample and re-assay
R3 D-DIMER Calibrator Patients who have received mouse monoclonal antibodies for diagnosis
Freeze-dried citrated plasma enriched with D-Dimer. Human origin or therapy may have plasmas containing anti-mouse antibodies (HAMA).
Additives of components from bovine plasma Such antibodies may lead to false enhance D-Dimer concentration. The
BSA < 4% same may occur with Rheumatoid Factor.
Sodium azide < 0,001% For a more comprehensive review of factors affecting this assay refer to
R4 D-DIMER Dilution Buffer the publication of Young D.S.
For dilution of D-DIMER Calibrator (Standard curve) and plasma of
patients. MATERIAL REQUIRED BUT NOT PROVIDED
These reagents are not classified as harmful regarding 1272/2008/ EC 1. Basic medical analysis laboratory equipment
Regulation 2. Coagulation analyzer with turbidimetric detection between 600-800nm
3. Demineralized water
4. REF CO4000: Solution for cleaning measuring system of analysers.
DD_220E_IFU_13210_V06_20231214
CALIBRATION (9) (11) QUALITY CONTROL
· REF 13210 D-DIMER Calibrator (R3) traceable to an In-House · REF 13211 D-DIMER Control 1
Reference Preparation which value was assigned using a working · REF 13212 D-DIMER Control 2
calibrator traceable according to ISO 17511:2020, section 5.6.
· External quality control program.
· Batch specific value is indicated in the certificate of analysis and on It is recommended to control in the following cases:
the label of the vial. · At least once a run
· Construct the standard curve as indicated in the application of the · At least once within 24 hours
analyser used · When changing vial of reagent
The calibration frequency depends on proper instrument functions and · After maintenance operations on the instrument
on the preservation of the reagent. If control is out of range, apply following actions:
1. Prepare a fresh control serum and repeat the test
REFERENCE INTERVAL (6) (8) (14) (15) 2. If control is still out of range, use a new vial of fresh calibrator
3. If control is still out of range, use a new vial of reagent and reassay
Plasma < 200 ng/mL (DDU)
If control is still out of range, please contact BIOLABO technical support
D-DIMER increase in patients with deep venous thrombosis (DVT), or your local Agent.
pulmonary embolism, disseminated intravascular coagulation, severe
COVID-19 disease and trauma. D-DIMER increase also during PROCEDURE
pregnancy and with age. Manual procedure:
As there is no internationally established standard for D DIMER, the Wavelength for measure in spectrophotometry: 700 (600 – 800) nm
concentration in any given specimen may differ when determined using
Automated procedure:
D-DIMER assays from different manufacturers.
Refer to Operator’s manual and validated application for the method.
Each laboratory should establish its own reference intervals and cut off
levels for the population that it serves. Note: 405nm is used as wavelength to optimize the sensitivity of the
method with nephelometric reading (i.e. SOLEA100, Thrombolyzer)

I PERFORMANCES
CALCULATION
On automatic analyser Thrombolyzer Compact X at 37°C (DDU units):
Precision: The analyzer provides directly result (DDU units).
Within-run N = 20 Level 1 Level 2 Between run N = 20 Level 1 Level 2 Refer to the manual of instrument used.
Mean (ng/mL) 595 1203 Mean (ng/mL) 595 1203 To convert results in Fibrinogen equivalent units (FEU), multiply the
result (DDU) by 2.5
S.D. ng/mL 11.2 33.3 S.D. ng/mL 6.4 25.9
Samples upper of the measuring range should be manually diluted and
C.V. % 1.9 2.8 C.V. % 1.1 2.2 re-assayed. No result outside the measuring range should be used for
On automatic analyser SOLEA 100 at 37°C (DDU units): diagnosing nor for patient management
Precision:
Within-run Between run REFERENCES
Level 1 Level 2 Level 3 Level 1 Level 2 Level 3
N = 20 N = 20 (1) Occupational Safety and Health Standards; Bloodborne pathogens
Mean (ng/mL) 214 409 1092 Mean (ng/mL) 408 1029 3210
(29CFR1910.1030) Federal Register July 1, (1998) ; 6, p.267-280
(2) Directive du conseil de l’Europe (90/679/CEE) J. O. de la communauté
S.D. ng/mL 6.2 8.9 43.5 S.D. ng/mL 10 46 97 européenne n°L374 du 31.12.1990, p.1-12
C.V. % 2.9 2.2 4.0 C.V. % 2.4 4.4 3.0 (3) Heit, J.A. et al. Determinants of plasma fibrin D-Dimer sensitivity for acute
pulmonary embolism as defined by pulmonary angiography. Arch Pathol Lab
Measuring Range: between 100 and 3200 ng/mL Med, 123:235-239,1999
Detection limit: approx. 98 ng/mL (4) Bounameaux, H., et al. Plasma measurement of D-Dimer as diagnosis aid
in suspected venous thromboembolism: an overview. Thromb Haemostas,
Comparison studies with commercially available reagent: 71:1-6,1994
On SOLEA 100 and Sysmex CA-1500 with human specimens (n=50) between (5) Pfitzner S.A. et al. Fibrin detected in plasma of patients with disseminated
114 and 3095 ng/mL intravascular coagulation by fibrin-specific antibodies consists primarily tof
high molecular weight factor XIII-cross linked and plasmin-modified
y = 0.95 x r = 0.9466 complexes partially containing fibrinopeptide A. Thromb Haemostas, 78:
1069-1078, 1997
Prozone effect: Tested up to 12800 ng/mL, no prozone effect is detected in the
(6) Lindhal T. et al. Clinical evaluation of a diagnosis strategy for deep venous
measuring range (between 100 and 3200 ng/mL).
thrombosis with exclusion by low plasma levels of fibrin degradation product
Cut-off : 200 ng/mL D-Dimer. Scan J Lab Invest, 58: 307-316, 1998
(7) CLSI Approved Guideline H21-A5
Interferences
(8) Gardiner, C. Et al. An evaluationof rapid D-Dimer assays for the exclusion of
Triglycerides Negative interference from 3.31 mmol/L deep vein thrombosis. British Journal of Haematology, 128:842-848, 2005
Total bilirubin No interference up to 855 µmol/L! (9) Section 5.6 of ISO 17511- Measurements of quantities in biological samples-
metrological traceability of values assigned to calibrators and controls
Heparin No interference up to 100 U/mL!
(10) YOUNG D.S., Effect of Drugs on Clinical laboratory Tests, 4th Ed. (1995)
Fragmin No interference up to 100 U/mL p 3-216 to 3-216
Haemoglobin Negative interference from 1.86 mmol/L ! (11) EN ISO 17511 In vitro diagnostic medical devices - Measurement of
quantities in biological samples - Metrological traceability of values assigned
Other substances may interfere (see § Limits) to calibrators and control materials
On Board stability: Reagents (R1, R2) may be stored at 15°C (8 hours per day) (12) ROSTAMI, Mehrdad; MANSOURITORGHABEH, Hassan. D-dimer level in
for 7 days. COVID-19 infection: a systematic review. Expert review of hematology,
2020, 13.11: 1265-1275.
Calibration Stability: Make a new calibration when changing reagent batch, if (13) COVID-19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID-
quality control results are found out of the established range and after 19) Treatment Guidelines. National Institutes of Health. Available at
maintenance operations. https://www.covid19treat mentguidelines.nih.gov/. Accessed [2022-05-05].
Performances will depend on Instrument used. (14) BALLEGEER, V., et al. Fibrinolytic response to venous occlusion and fibrin
Performances and stability data on Thrombolyzer Compact X are available on fragment D-dimer levels in normal and complicated pregnancy. Thrombosis
and haemostasis, 1987, 58.08: 1030-1032.
request.
(15) KARIO, Kazuomi; MATSUO, Takefumi; KOBAYASHI, Hiroko. Which factors
affect high D-dimer levels in the elderly?. Thrombosis research, 1991, 62.5:
501-508.

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IVD H2O !
Manufacturer Expiry date In vitro diagnostic Storage temperature Dematerialized water Biological risk

REF LOT ®
Product Reference See Insert Batch number Store away from light Sufficient for Dilute with

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