The Creative Approach to Bioscience

D-Dimer
Turbi Latex (For Statlab T)
REF: 585 001-ST 50 Test REF: 585 002-ST 100 Test
R1 Diluent 1 X 8 ml R1 Diluent 1 X 16 ml
R2 Latex 1 X 2.0 ml R2 Latex 1 X 4 ml
Calibrator 1 X 1 ml Calibrator 1 X 1 ml
REF: 585 002-1ST 100 Test
R1 Diluent 1 X 16 ml
R2 Latex 1 X 4 ml
Storage and Stability
Intended Use
Reagents in the original vial is stable to the expiration date on the
In vitro diagnostic reagents for the quantitative determination of vial label when capped and stored at (2 - 8 ºC). Immediately following
D-Dimer in human Plasma on STatlab T by means of particle- the completion of an assay run, the reagent vial should be capped
enhanced turbidimetric immunoassay. until next use in order to maximize curve stability. Do not freeze
[Link] D-Dimer latex reagent should have a white, turbid
Background appearance free of granular particulate. Visible agglutination or
precipitation may be a sign of deterioration, and the reagent should
be discarted.
The D-dimer assay is specific for fibrin derivatives. In this assay, the
presence of cross linked D-dimer domain is diagnostic for lysis of The reagent1 should be clear and colourless. Any turbidity may be
a fibrin clot, and confirm that thrombin was formed and factor XIII sign of deterioration and reagent should be discarted.
was activated with reactive fibrinolysis. Since fibrinogen derivatives
do not contain the cross-linked D-dimer domain, they are not
recognized by the D-dimer assay, even when presence in high Specimen Collection and Preparation
concentration. In other words, Fibrin derivatives in plasma containing
D-Dimer (XDP) are specific markers for fibrinolysis, as opposed to Citrated, platelet-poor plasma is used for the d-dimer assay.
fibrinogenolysis. D-dimers are detected by immunoassays using Citrated, platelet-poor plasma is prepared from venous blood collected
monoclonal antibodies specific for the cross-linked D-dimer domain into 3.2 % trisodium citrate at a ratio of 9 : 1. The citrate concentration
in fibrinogen. must be adjusted in patients with a HCT >55%. Plasma should be
separated as soon as possible after the specimen is obtained.
Test Principle D-dimers are stable for 8 hours in citrated plasma maintained at
room temperature, 7days at 2 - 8 ºC or 2 months at at -20 ºC.
This D-dimer test is based upon reinforced immunoturbidimetry. Reagent Preparation and Stability
Monoclonal anti D-dimer antibodies in the reagent react with the
D-dimer antigen in the sample, forming antigen/antibody complexes
that increase the work solution turbidity. Spectrum D-dimer reagents (R1 & R2) are supplied ready-to-use
and stable up to the expiry date labeled on the bottles when properly
stored refrigerated at 2 – 8 oC.
Reagents
D-dimer Calibrator: Reconstitute with 1 ml distelled water. mix
R1 Reagent1 gently and incubate at room temperature for 10 minutes before use.
Tris-HCl 125 mM
Stability: 1 month at at -20 ºC.
R2 Latex reagent
Latex particles coated with mouse anti-human D-Dimer monoclonal Calibration curve
antibodies.
Preservatives.
Cal. 5: Calibrator
Calibrator Cal. 4: 250 lCal. 5 + 250 l saline
Human serum.D-Dimer concentration is stated on the vial label. Cal. 3: 250 lCal. 4 + 250 l saline
Cal. 2: 250 lCal. 3 + 250 l saline
All raw materials of human origin used in the manufacture of this Cal. 1: 250 l saline
product showed no reactivity when tested for HBsAg, anti-HIV-1/2
and HCV with commercially available test methods. However, this
product should be handled as though capable of transmitting infectious Concentration Cal. 1 Cal. 2 Cal. 3 Cal. 4 Cal. 5
diseases (for example:
the undiluted C = 0 0.71 1.42 2.85 5.7
Precautions and Warnings 5.7 g /ml )
For in vitro diagnostic use only. Do not pipette by mouth. Reagents Quality Control
containing sodium azide must be handled with precaution. Sodium
azide can form explosive azides with lead and copper plumbing. Control sera are recommended to monitor the perfomance of manual
Since absence of infectious agents cannot be proven, all specimens and automated assay procedures. Each laboratory should establish
and reagents obtained from human blood should always be handled its own Quality Control Scheme and corrective actions if controls do
with precaution using established good laboratory practices. not meet the acceptable tolerances.
Disposal of all waste material should be in accordance with local Materials required but not provided
guidelines.

As with other diagnostic tests, results should be interpreted considering D-Dimer control (Ref : 405 001)
all other test results and the clinical situation of the patient.
Procedure Expected Values
Calibration setup The determination of reference ranges for D-dimer concentrations
of clinically healthy individuals is very difficult.
1- Select programs from main screen. Suggested value in plasma with this method < 0.5 g/ml.
2- Press LIST to select D-Dimer These data are to be interpreted as a guide. Each laboratory should
establish its own reference intervals
3- ADD/EDIT standard concentrations as shown (5 standards) .
References
Bick R.L. et al. thromb res 1992;65:785-90
Gaffney PJ. Fibrinolysis supplement 2.1993;7:2-8
Bover, P. et al. int J Epidemiol 1994;23:2027
Janssen M.G. et al. Thromb Haemost 1997;77:262-6

ORDERING INFORMATION

CATALOG NO. QUANTITY

585 001-ST 50 test

4- Save changes then Exit. 585 002-ST 100 test
585 002-1ST 100 test
5- Press Stop to quit then back to home screen.

6- . Follow the analyzer instructions to construct the calibration curve

and afterwards start testing the specimen.

7- Pipette into a cuvette

Reagent1 (R1) 160 l
Latex (R2) 40 l
Calibrator or Sample 16 l
[Link] each calibrator/specimen test, mix and read immediately

Calculation
The analyzer will form the calibration curve by calculating the
absorbance difference (A2-A1) of each point of the calibration curve
and plotting the values obtained against the D-Dimer concentration
of calibrator dilution. D-Dimer concentration in the sample is calculated
by interpolation of its (A2-A1) in the calibration curve.

Sensitivity
0.08 g /ml .

Linearity
7.5 g /ml .

specimens showing higher concentration should be diluted 1+2 using

physiological saline and repeat the assay (result×3).

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
[Link]
E-mail:info@[Link]

IFUFTI28 Rev.(4),23/6/2024