The Creative Approach to Bioscience

D-Dimer
Turbi Latex
REF: 585 001 50 Test REF: 585 002 100 Test REF: 585 003 80 Test
R1 Diluent 1 X 20 ml R1 Diluent 2 X 20 ml R1 Diluent 2 X 16 ml
R2 Latex 1 X 5 ml R2 Latex 2 X 5 ml R2 Latex 2 X 4 ml
Calibrator 1 vial Calibrator 1 vial Calibrator 1 vial
REF: 585 001-1 50 Test REF: 585 002-1 100 Test REF: 585 004 500 Test
R1 Diluent 1 X 20 ml R1 Diluent 2 X 20 ml R1 Diluent 5 X 40 ml
R2 Latex 1 X 5 ml R2 Latex 2 X 5 ml R2 Latex 5X 10 ml
Without calibrator Without calibrator Without calibrator

Intended Use Deterioration

In vitro diagnostic reagents for the quantitative determination of The D-Dimer latex reagent should have a white, turbid appearance
D-Dimer in human plasma by means of particle-enhanced free of granular particulate. Visible agglutination or precipitation
turbidimetric immunoassay. may be a sign of deterioration, and the reagent should be
discarded.
Background
The Reagent1 should be clear and colourless. Any turbidity maybe
The D-dimer assay is specific for fibrin derivatives. In this assay, sign of deterioration and reagent should be discarded.
the presence of cross linked D-dimer domain is diagnostic for lysis
of a fibrin clot, and confirm that thrombin was formed and factor XIII Specimen Collection and Preservation
was activated with reactive fibrinolysis. Since fibrinogen derivatives
do not contain the cross-linked D-dimer domain, they are not Citrated, platelet-poor plasma is used for the d-dimer assay.
recognized by the D-dimer assay, even when present in high Citrated, platelet-poor plasma is prepared from venous blood
concentration. In other words, Fibrin derivatives in plasma containing collected into 3.2 % trisodium citrate at a ratio of 9 : 1. The citrate
D-Dimer (XDP) are specific markers for fibrinolysis, as opposed concentration must be adjusted in patients with a HCT >55%.
to fibrinogenolysis. D-dimers are detected by immunoassays using Plasma should be separated as soon as possible after the
monoclonal antibodies specific for the cross-linked D-dimer domain specimen is obtained. D-dimers are stable for 8 hours in citrated
in fibrinogen. plasma maintained at room temperature, 7days at 2 - 8 ºC or 2
months at -20 ºC.

Test Principle Reagent Preparation

This D-dimer test is based upon reinforced immunoturbidimetry. Spectrum D-dimer reagents (R1 & R2) are supplied ready-to-use
Monoclonal anti D-dimer antibodies in the reagent react with the and stable up to the expiry date labeled on the bottles when properly
D-dimer antigen in the sample, forming antigen/antibody complexes stored refrigerated at 2 – 8 oC.
that increase the working solution turbidity.
D-dimer Calibrator: Reconstitute with distilled water as mentioned
Reagents on vial label. Mix gently and incubate at room temperature for 10
minutes before use.
R1 Reagent1
Stability: 1 month at -20 ºC.
Tris-HCl 125 mM
Calibration curve
R2 Latex reagent Generate a calibration curve by serial dilutions of the supplied
calibratror to cover the range between 0.2 l/ml to the upper limit
Latex particles coated with mouse anti-human D-Dimer monoclonal of the calibrator.
antibodies. Cal. 6: Calibrator
Preservatives. Cal. 5: 200 l Cal. 6 + 200 l saline
Cal. 4: 200 l Cal. 5 + 200 l saline
Calibrator Cal. 3: 200 l Cal. 4 + 200 l saline
Human serum. D-Dimer concentration is stated on the vial label. Cal. 2: 200 l Cal. 3 + 200 l saline
Cal. 1: 200 l saline
All raw materials of human origin used in the manufacture of this
product showed no reactivity when tested for HBsAg, anti-HIV- Concentration Cal.1 Cal.2 Cal.3 Cal.4 Cal.5 Cal.6
1/2 and HCV with commercially available test methods. However, (for example:
this product should be handled as though capable of transmitting the undiluted C = 0.18 0.37 0.74 1.48 2.95 5.9
infectious diseases 5.9 g /ml )

Storage and Stability Quality Control

Reagents in the original vial are stable to the expiration date stated Control sera are recommended to monitor the perfomance of manual
on the vial label when capped and stored at (2 - 8 ºC). Do not freeze and automated assay procedures. Each laboratory should establish
reagents.Open vial is stable for 3 months when stored at (2-8 ºC). its own Quality Control Scheme and corrective actions if controls
do not meet the acceptable tolerances.
Precautions and Warnings
Materials required but not provided
For in vitro diagnostic use only. Do not pipette by mouth. Reagents
containing sodium azide must be handled with precaution. Sodium D-Dimer control (Ref : 405 001)
azide can form explosive azides with lead and copper plumbing.
Since absence of infectious agents cannot be proven, all specimens
and reagents obtained from human blood should always be handled
with precaution using established good laboratory practices.
Disposal of all waste material should be in accordance with local
guidelines.
As with other diagnostic tests, results should be interpreted
considering all other test results and the clinical situation of
the patient
Procedure Expected Values
The determination of reference ranges for D-dimer concentrations
1.Bring the reagents and the photometer to 37ºC of clinically healthy individuals is very difficult.
2.Assay conditions:
Suggested value in plasma with this method < 0.5 g/ml.
Wavelength 578 nm
Temperature 37ºC These data are to be interpreted as a guide. Each laboratory should
Cuvette 1cm light path establish its own reference intervals.
zero adjustment distilled water
3.Pipette into a cuvette : Waste disposal
Disposal of all waste material should be in accordance with local
Reagent1 (R1) 400 l guidelines.

Latex (R2) 100 l References

1-Bick R.L. et al. thromb res 1992;65:785-90
Calibrator or Sample 40 l 2-Gaffney PJ. Fibrinolysis supplement 2.1993;7:2-8
3- Bover, P. et al. int J Epidemiol 1994;23:2027
4- Janssen M.G. et al. Thromb Haemost 1997;77:262-
4.Mix and read absorbance immediately (A1). After 3 minutes of
the sample addition, read (A2).
Calculation
Calculate the absorbance difference (A2-A1) of each point of the ORDERING INFORMATION
calibration curve and plot the values obtained against the D-dimer
concentration of calibrator dilution. D-dimer concentration in the CATALOG NO. QUANTITY
sample is calculated by interpolation of its (A2-A1) in the calibration
curve. 585 001 50 Test
585 002 100 Test
Detection limit 585 003 80 Test
585 001-1 50 Test
85-115% 585 002-1 100 Test
585 004 500 Test
Precision

CV (%)
Intra-Run Inter-Run
Low 1.13 2.31
Medium 1.65 0.98
High 1.17 1.01

Sensitivity
Up to 0.08 g /ml .
Linearity
Up to 7.5 g /ml .
specimens showing higher concentration should be diluted 1+2
using physiological saline and the assay is repeated.Results are
multiplied by 3.

Interfering Substances
No interference for :
Heparin 50 g/mL)
Na-citrate (1000 g/mL)
Heparin (50 g/mL)
Triglyceride (2500 g/mL)
EDTA (5 g/mL)
Haemoglobin (1000 g/mL)
Bilirubin (20 g/mL) and has interferences for: Turbidity (> 1.25%).

Egyptian Co for Biotechnology - Spectrum Diagnostics (S.A.E)

Obour city industrial area. block 20008 piece 19 A. Cairo. Egypt.
Tel: +202 4489 2248 - Fax: +202 4489 2247
www.spectrum-diagnostics.com
E-mail:[email protected]

MDSS GmbH
EC REP Schiffgraben 41
30175 Hannover, Germany IFUFTI28 Rev.(1), 1/12/2021