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Epic Test Code LAB313 D-Dimer, Quantitative Analysis

Performing Location(s)

MIB, CRH, LFH, OCH, FTT, FOX

Includes

Quantitative analysis for D-dimer

Specimen Type

Platelet Poor Plasma

Preferred Container

Blue top tube (3.2% sodium citrate)

Blood Tube Draw Volume

Min 90% draw volume  

Minumum Volume to Submit for Testing

2.7 mL Plasma

  • Multiple test can be performed from this volume. For question please contact the lab at 547-3975.  

Transportation Needs

Deliver specimen to the laboratory within 1 hour of collection. If not possible see “storage requirements”

Storage Requirements

If request is for D-Dimer only or a D-Dimer and PT/INR, keep sample in original container and transport at room temperature.
If D-Dimer is requesting with a PTT or any other coagulation assays then Prepare Platelet Poor Plasma:

1. Centrifuge tube at 1500 g for 10 minutes

2. Use a plastic transfer pipette to remove plasma (staying away from the buffy coat layer) and transfer top 2/3 of plasma to a plastic aliquot tube.
3. Centrifuge this aliquot tube at 1500 g for 10 minutes.

4. Transfer top 3/4 of plasma (do not disturb button at bottom of tube) into another plastic aliquot tube.
5. Label this tube with patient information and a PLASMA sticker.

6. Freeze plasma within 24 hrs in a -15° to -25°C freezer until ready to transport.

7. Plasma must be transported to the laboratory frozen.

Causes for Rejection

Clotted specimen

Mislabeled or unlabeled specimen

Less than 90% draw for Vacutainer tubes

Collection in any tube other than 3.2% plastic sodium citrate blue top tube

Whole blood > 24 hours old

Plasma received > 24 hours old unless separated from cells and frozen at -15° to -25°C

Hemolysis > 500 mg/dL (>4+)

 

Days of Analysis

All

Additional Information

Interpretive Guidelines:

D-Dimer levels are most frequently elevated in cases of deep vein thrombosis (DVT) and pulmonary embolism (PE).

This test has a full FDA exclusion claim as a Negative predictive value for DVT and PE.  
Other circumstances may lead to a high D-dimer level, in particular:

Old age, pregnancy, peripheral ateriopathy, disseminated intravascular coagulation (DIC), coronary disease, thrombolytic treatment, cancer, liver disease, infection, inflammation, hematoma, and post surgical stage.

The likelihood of a DVT or a PE with a D-dimer level below 500 ng/ml is very low.
D-dimer assay can be used as an aid in diagnosis of venous thromboembolism (DVT or PE)
When used in conjunction with a non-high clinical pretest probability (PTP) assessment model, D-dimer may be used to exclude pulmonary embolism disease and venous thromboembolism.

 

Additional Information:

It is suggested that the FDP test adds no clinical value when the D-Dimer is elevated since FDP will be positive if D-Dimer is positive 

Limitations

Therapeutic dose anticoagulant therapy for >24 hours
Fibrinolytic therapy within previous 7 days
Trauma or surgery within previous 4 weeks
Disseminated malignancies
Aortic aneurysm
Sepsis, severe infections, pneumonia, severe skin infections
Liver cirrhosis
Pregnancy

Interference from: Hemoglobin > 500 mg/dL

                             Bilirubin > 18 mg/dL

                             Triglycerides >1327 mg/dL

                             Rheumatoid factor > 1400 IU/mL

                             Grossly lipemic specimens can be ultra-centrifuged

 

Patient samples may contain heterophilic antibodies (e.g. human anti-mouse antibodies (HAMA  and Rheumatoid factors) that could react in immunoassays to give falsely elevated or depressed results.  The monoclonal antibody (MA-8D3) used in the test latex reagents has major specificity for the D-Dimer domain of cross linked Fibrin Degradation Products. A low cross- reactivity to Fibrinogen Degradation Products was seen with plasma samples spiked with purified fragments D and E above 10 mg/mL.

 

Specimens from patient who have received a preparation of mouse monoclonal antibody for diagnosis or therapy may contain human anti-mouse antibody (HAMA). The presence of HAMA may cause an over estimation of results in immunoassays that utilize mouse monoclonal antibodies. The test reaction buffer contains a blocking agent against HAMA to minimize this interference on the assay results.

 

Method will detect concentrations of D-dimer as low as 215 and as high as 128,000 ng/mL (FEU).

Available STAT

Yes

Reference Values

Population Units Reference Range
All populations ng/mL (FEU) 215-499
Fibrinogen Equivalent Units
Interpretive Guidelines
  • D-Dimer levels are most frequently elevated in cases of deep vein thrombosis (DVT) and pulmonary embolism (PE).
  • Other circumstances may lead to a high D-dimer level, in particular:
    • Old age, pregnancy, peripheral ateriopathy, disseminated intravascular coagulation (DIC), coronary disease, thrombolytic treatment, cancer, liver disease, infection, inflammation, hematoma, and post surgical stage.
  • The likelihood of a DVT or a PE with a D-dimer level below 500 ng/ml is very low.

 

Methodology

Turbidimetric detection of D-dimer/antibody aggregation

CPT Code

85379

Last Updated

16-Apr-18