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Test ID: D-Dimer
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D-Dimer
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Useful For
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Diagnosis of intravascular coagulation and fibrinolysis (DIC), especially when combined with clinical information and other laboratory test data (e.g., platelet count, fibrinogen assay, prothrombin time and activated partial thromboplastin time).Along with the physician's pretestprobapility assessment D.Dimer level at a specific cut off can be used to exclude the diagnosis of acute pulmonary embolism or DVT.
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Method name and description
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Turbidimetric Immunoassay.
Test is performed using different analyzer platforms.
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Clinical information
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Increased levels of D-Dimer are found in various conditions including:
- Deep vein thrombosis (DVT)
- Pulmonary Embolism (PE)
- Disseminated Intravascular Coagulation (DIC)
- Post-surgery.
- Cancer Cases.
- Liver Cirrhosis.
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Specimen type / Specimen volume / Specimen container
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Plasma Na Cit. Plasma poor platelets.
Specimen Volume:2.7 ml.
Container/Tube: Light-blue top (3.2% sodium citrate).
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Collection instructions / Special Precautions / Timing of collection
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- Samples collected in HMC facilities MUST reach the coagulation laboratory within 1 hour of collection.
- Samples collected in non-HMC facilities / external clients: MUST reach coagulation laboratory within 1 hour of collection, if not applicable, centrifuge the whole blood and carefully remove the plasma (by pipette not by decanting) and send it in a temperature-controlled environment (18- 25 ºC) within 2 hours of centrifugation. If the transportation of the plasma can’t be within a maximum of 2 hours, prepare platelet-poor plasma as follows:
- Re-centrifuge the plasma again.
- Remove the top portion of plasma leaving approximately 250 ul in the bottom to discard.
- The double-centrifuged plasma should be aliquoted into labeled plastic tubes.
- Freeze immediately at -20 ºC or below
- Specimens must arrive frozen.
- If patient HCT is >55%, test will not be processed. The ordering Physician will be contacted to reorder the test and call the patient to go to Phlebotomy for recollection. Instruct the patient to inform the phlebotomy about his high HCT% , the phlebotomy will contact the lab to request a coagulation tube after adjusting amount of anticoagulant.
Note:
Collection of blood for coagulation testing through intravenous lines that have been previously flushed with heparin should be avoided, if possible. If the blood must be drawn through an indwelling catheter, possible heparin contamination and specimen dilution must be considered. When obtaining specimens from indwelling lines that may contain heparin, the line should be flushed with 5 mL of saline, and the first 5 mL of blood or 6-times the line volume (dead space volume of the catheter) be drawn off and not used for coagulation testing. For those specimens collected from a normal saline lock (capped off venous port) twice the dead space volume of the catheter and extension set should be discarded.
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Relevant clinical information to be provided
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Patient/family history of thrombotic disorder. History of chronic diseases.
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Storage and transport instructions
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Specimen Rejection Criteria
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Specimens with no label or missing required identification
Broken, leaking or contaminated specimen
Clotted samples
Under-filled or overfilled sample tubes.
Wrong sample container sample received
Improper specimen transport temperature (e.g. like specimens which are needed to be sent on ice)
Old specimen (test-dependent)
Grossly Hemolyzed sample (test-dependent)
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Biological reference intervals and clinical decision values
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The DLMP laboratories use a number of different platforms for this test. Please refer to the below:
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Facility
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Platform
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Reference range
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QRI, NCCCR, RRC-Lab, HMGH, AWH and ABHA
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ACL TOP
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Reference range :0.0-0.49 mg/L FEU
* D‐Dimer test has been cleared by the Food and Drug Administration (FDA) to exclude Venous Thromboembolism (VTE) and pulmonary embolism (PE) at a cut‐off of 0.46 mg/LFEU in patients where a physician's Pretest Probability assessment (PTP) indicates a non‐high probability of pulmonary embolism. (<0.46 mg/LFEU is considered negative).
*If D‐Dimer test is used for clinical conditions other than exclusion of Venous Thromboembolism (VTE) or pulmonary embolism (PE), then the test should be used as an aid in the diagnosis.
The reference range and cut-off value are quoted from Reagent instructions for use (IFU) provided by manufacture .
The reference range is verified by the lab.
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AKH and Cuban
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Sysmex
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Reference Range: 0 - 0.46 mg/L FEU
* D-Dimer test has been cleared by the Food and Drug Administration (FDA) to exclude Venous Thromboembolism (VTE) and pulmonary embolism (PE) at a cut-off of 0.50 mg/LFEU in patients where a physician's Pretest Probability assessment (PTP) indicates a non-high probability of pulmonary embolism. (<0.50 mg/LFEU is considered negative).
*If D-Dimer test is used for clinical conditions other than exclusion of Venous Thromboembolism (VTE) or pulmonary embolism (PE), then the test should be used as an aid in the diagnosis.
The reference range is established by lab.
The cut-off value is quoted from Reagent instructions for use (IFU) provided by manufacture.
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Factors affecting test performance and result interpretation
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The following substances may potentially interfere with the DD HS-up to :
Triglycerides : 15 mmol/L
Hemoglobin : 0.5 g/dL
Bilirubin: 307.8 umol/L
Vary according to the platform used for processing the test.
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Turnaround time / Days and times test performed / Specimen retention time
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Stat:1 hour.
Routine:4 horrs/Daily/NA
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