COAG115C COAG115D COAG115E For In Vitro Diagnostics Use Only

Lot Number
25 T 50 T 100 T Catalogue Number
Storage Temperature
STORE AT 2-8°C Expiry Date (Year / Month)

Warning, Read Enclosed Documents

D- D-DIMER LATEX INSTRUCTIONS FOR USE
Instructions For Use
PRODUCT CODE: COAG115 Manufactured By

FOR IN-VITRO DIAGNOSTIC USE ONLY

D-DIMER LATEX
use.

Intended Use: Qualitative Method:

Warnings and Precautions: 1. Mark positions on the test slide for specimens and, as
D-Dimer Latex Test is intended for the rapid qualitative or semi-
- For invitro diagnostic use only. needed, for positive and negative controls.
quantitative evaluation of circulating derivatives of cross-linked fibrin
- Harmful if swallowed. Avoid contact with skin and eyes. Do not 2. Place 15ul of the reagent within a well on a test card. Avoid
degradation products (XL-FDP) in human plasma.
empty into drains.
touching the surface of the Test card.
- Wear suitable protective clothing.
Summary: 3. Accurately pipette 15ul of undiluted plasma or of control
- Caution: All reagents in D-Dimer latex kit contain 0.1% Sodium
During blood coagulation, fibrinogen is converted to fibrin by the solution inside the same well next to the drop of Latex
azide as a preservative. Do not ingest or allow to contact skin or
activation of thrombin. The resulting fibrin monomers polymerize to reagent.
mucous membranes. Sodium azide may form explosive azides in
form a soluble gel of non cross linked fibrin. The fibrin gel is then 4. Mix the Latex reagent and sample with a stirrer until the
metal plumbing. Use proper disposal procedures.
converted to cross-linked fibrin by thrombin activated factor VIII to Latex is uniformly distributed.
- Caution: The positive control in D-Dimer Latex kit contains
form an insoluble fibrin clot. Production of plasmin, the major clot-lysing 5. Rock the Test card gently by hand for exactly 3 minutes.
components of human origin. Each individual blood donation
enzyme, is triggered when a fibrin clot is formed. 6. At exactly 3 minutes, check for agglutination under a strong
intended for the production of this reagent is tested for HBsAg,
Fibrinogen and fibrin are both cleaved by the fibrinolytic enzyme light source.
anti-HCV, anti HIV1 and 2. Only donations with negative findings
plasmin to yield degradation products from cross-linked fibrin contain
are employed. As complete absence of infectious agents can
D-Dimer. Therefore, Cross-linked fibrin degradation products (DL-FDP)
never be assured, all materials derived from human blood should Note: If test reading is delayed beyond 3 minutes, the latex suspension
are a specific marker of fibrinolysis.
be treated as potentially infectious and handled with due care may dry out giving a false agglutination pattern. If this is suspected, the
following the precautions recommended for biohazardous specimen must be retested.
Test Principle:
material.
D-Dimer Latex is a rapid agglutination assay utilizing latex beads
coupled with a highly specific D-Dimer monoclonal antibody. XL-FDP 7. Discard the Test card and stirrer into a biohazard container –
Storage and Stability: Do not reuse.
present in a plasma sample bind to the coated latex beads, which
Store at 2~8oC. Do not freeze.
results in visible agglutination occurring when the concentration of D-
D-Dimer reagents are stable until expiration dates marked on the outer Semi-quantitative Method:
Dimer is above the threshold of detection of the assay.
packaging.
1. Prepare serial dilutions of the test plasma with Buffer as
Specimen Collection and Preparation:
Reagents: follows:
Plasma prepared from whole blood anticoagulated with sodium
1:2 dilution – 100ul of plasma plus 100ul of buffer solution.
citrate is recommended. The use of EDTA and heparin will result in an
Component COAG115C COAG115D COAG115E 1:4 dilution – 100ul of 1:2 dilution Plus 100ul Buffer solution.
increased level of false positive reactions. After separation of the
D-Dimer Latex 1: 8 dilution – 100ul of 1:4 dilution plus 100ul Buffer solution.
0.4 ml 0.8 ml 1.6 ml plasma by centrifugation (1500g for 15 minutes at 4-10oC), specimens
Reagent may be tested directly for the presence of XL-FDP. Defibrination of the 2. Test each dilution as described in the qualitative method.
D-Dimer Positive plasma is not recommended.
0.2 ml 0.4 ml 0.8 ml
Control Plasma Storage/Stability: -20oC: 2 weeks. Quality Control:
D-Dimer It is recommended that both Positive and Negative controls be
0.2 ml 0.4 ml 0.8 ml
Negative Control PROCEDURE: included in each batch of tests to ensure proper functioning of the
Dilution Buffer 5.0 ml 10 ml 20 ml system. Control Solutions should be tested by the same procedures as
Reusable Test NOTE: patient samples.
1 1 1
Cards - Equilibrate reagents to room temperature (20 – 25oC) before use.
Stirrers 1 x 25 2 x 25 4 x 25 - Latex Reagent should be mixed by inversion immediately prior to D-Dimer positive control consists of a solution of human D-Dimer at a
level of approximately 0.80 mg/l (800 ng/ml).

Fortress Diagnostics Ltd., Unit 2C Antrim Technology Park, Antrim, BT41 1QS (United Kingdom)
Tel: +44 (0) 2894 487676 | Fax: +44 (0) 2894 469933 | Website: www.fortressdiagnostics.com COAG 115 – D- DIMER LATEX | Revision No. 12 JAN/17 | Page 1 of 2
 The amount of XL-FDP detected in a specimen will depend on several
RESULTS: interrelated factors in vivo, such as the severity of the thrombotic
episode, the rate of cross linked fibrin formation, and the time elapsed
A. Qualitative Assay: after the thrombotic event until blood is drawn from the patient.
Elevated levels of XL-FDP as an indication of reactive fibrinolysis have also
For the qualitative assay protocol, the following pattern of results been reported in surgery, trauma, sickle cell disease, Liver disease, severe
should be obtained: infection, sepsis, inflammation and malignancy. D-Dimer levels also rise
during normal pregnancy but very high levels are associated with
complications.
D-Dimer latex does not cross-react with fibrinogen, factor XIIIa cross
Undiluted Plasma D-Dimer (XL-FDP) concentration:
linked fibrinogen or fibrinogen degradation products.
Negative less than 0.20 mg/L (200 ng/ml)
Specific Performance Characteristics:
Positive Greater than 0.20 mg/L (200 ng/ml)
Note: All values in mg/L (ng/ml) are approximate.
Plasma from one hundred and seventy (170) apparently healthy,
voluntary blood donors was tested using D-Dimer latex. A negative result
B. Semi-quantitative Assay:
was obtained for one hundred and sixty two (162) of the samples. This
equates to a specificity of 95.3% (162/170).
Approximate levels of XL-FDP containing the D-Dimer domain, for
One hundred and fortyfive (145) plasma samples from patients judged to
specimen dilutions are shown in Table 1. As with all semiquantitative tests,
be suffering from or having a high probability for thrombotic episode,
some variability in dose-response can be expected.
were tested, by D-Dimer Latex and another aggluatination reference
method. The correlation coefficient was r=0.94 and the regression
equation was y=1.19x.
APPROXIMATE RANGE OF d-DIMER SAMPLE DILUTION
Intra assay precision (within run) reproducibility was determined for 10
(XL-FDP) mg/L (ng/ml) Undil 1:2 1:4 1:8 replicates of 3 plasma samples that contained different levels of XL-FDP.
<0.2 (<200) - - - - The results were equivalent for all replicates.
0.2-0.4 (200-400) + - - - Interassay (run to run) reproducibility was determined using 10 plasma
0.4-0.8 (400-800) + + - - samples with XL-FDP titres ranging from 1 to 16. In 10 runs, the replicates
0.8-1.6 (800-1600) + + + - of these specimens did not vary by more than one titer.
1.6-3.2 (1600-3200)* + + + + In an anticoagulant study of 50 parallel citrated, EDTA and heparin
plasma samples, the correlation between titres (based on XL-FDP) values
was r=0.91 for citrated samples, r=0.73 for EDTA samples and r=0.78 for
+ = agglutination and -= No agglutination heparin samples. Citrate is the anticoagulant of choice.
 = Levels of XL-FDP greater than 3.2 mg/l (3200 ng/ml) can be No assay interference was demonstrated with D-Dimer Latex with spiked
estimated by further dilutions beyond 1:8. specimens containing potential interfering substances at the following
concentrations: Bilirubin 0.2,g/ml, Hb 5.0 mg/ml, Lipids 30 mg/ml and
LIMITATIONS OF THE PROCEDURE: proteins (gamma globulins) 0.06 g/ml.

Clinical diagnosis should not be based on the result of D-Dimer Latex References:
alone. Clinical Signs and other relevant test information should be 1. Gaffney, P.J Distinction between fibrinogen and fibrin
included in the diagnostic decision. Degradation products in Plsma. Clin chem, Acta 65 (1): 109-
115:1975.
EXPECTED VALUES:

A positive result, indicating active fibrinolysis, should be obtained with

Biorex D-Dimer Latex test when XL-FDP (D-Dimer) levels are at or greater
than approximately 0.20 mg/L (200 mg/L). Plasma Specimens from
normal subjects are expected to give negative results because their
plasma XL-FDP concentrations are typically less than 0.20 mg/L
(200ng/ml). Due to many variables that may affect results, each
laboratory should establish its own normal range.
Elevated levels of XL-FDP (containing the D-Dimer domain) have been
demonstrated in patients by a combination of immunoprecipitation and
gel electrophoresis techniques. Monoclonal antibodies allow the specific
detection of the D-Dimer domain. Monoclonal antibody based D-Dimer
assay is of diagnostic value in disseminated intravascular coagulation
and acute vascular diseases, including pulmonary embolism (PE) and
deep vein thrombosis (DVT), conditions that are difficult to detect reliably
by clinical examination.

Fortress Diagnostics Ltd., Unit 2C Antrim Technology Park, Antrim, BT41 1QS (United Kingdom)
Tel: +44 (0) 2894 487676 | Fax: +44 (0) 2894 469933 | Website: www.fortressdiagnostics.com COAG 115 – D- DIMER LATEX | Revision No. 12 JAN/17 | Page 2 of 2