Ampath Chats

Clinical Use of the D-Dimer Assay

Ampath Chats
Clinical Use of the D-Dimer Assay
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PATHCHAT Edition No. 21
Please contact your local Ampath pathologist for more information.

What Are D-Dimers?

🔹 D-Dimer is a marker of fibrinolysis, formed during the breakdown of fibrin clots.

  • Coagulation results in the formation of fibrin clots.
  • Fibrinolysis is the breakdown of these clots.
  • D-Dimer is a specific product of cross-linked fibrin degradation by plasmin.
  • Elevated D-Dimer levels indicate increased clot formation and breakdown.

Clinical Applications of D-Dimer Testing

1. Exclusion of Venous Thromboembolism (VTE) in Specific Patients

  • Deep vein thrombosis (DVT).
  • Pulmonary embolism (PE).

2. Prediction of Recurrent VTE

  • Helps assess the risk of VTE recurrence.

3. Diagnosis and Monitoring of Disseminated Intravascular Coagulation (DIC)

  • D-Dimer levels are elevated in DIC, aiding in diagnosis and disease progression monitoring.

D-Dimer Testing at Ampath

🔹 Ampath uses an ELISA-based D-Dimer assay, which provides:

  • High sensitivity (excellent negative predictive value).
  • Acceptable specificity.
  • Rapid turnaround time (<1 hour).
  • Quantitative results available 24/7.

Patient Preparation & Sample Collection

🔹 To ensure accurate results:
Avoid excessive trauma or prolonged stasis during venesection.
Collect blood in a citrate tube (blue top), ensuring a minimum fill of 4 mL.
Samples remain stable for up to 24 hours at room temperature.

D-Dimer Reference Range

Normal D-Dimer levels: <0.50 mg/L.

D-Dimer as a Diagnostic Tool

🔹 High Negative Predictive Value for VTE Diagnosis:
In low-risk patients, a normal D-Dimer level effectively rules out thrombosis.
Most useful in young patients without co-morbidities and recent symptoms.
Eliminates unnecessary imaging tests (e.g., venograms, CT pulmonary angiograms).

🔹 Limitations – A Positive D-Dimer Does NOT Confirm Thrombosis:
🚨 D-Dimer levels can be elevated due to other conditions (false positives).

Common Causes of False-Positive & False-Negative D-Dimer Results

False Positives (Elevated D-Dimer Without VTE):

  • Recent surgery.
  • Haemorrhage.
  • Trauma.
  • Malignancy.
  • Sepsis or severe infection.
  • Advanced age with co-morbidities.
  • Pregnancy.
  • Liver disease.

🚨 False Negatives (Normal D-Dimer Despite VTE):

  • Symptoms older than 7–10 days.
  • Patient already on anticoagulation (heparin or warfarin).
  • Children (lower baseline D-Dimer levels).
  • Small or distal DVT.
  • Upper extremity DVT.
  • Hypofibrinolysis (poor clot breakdown).

D-Dimer & Disseminated Intravascular Coagulation (DIC)

DIC is a serious condition caused by widespread clotting and fibrinolysis, leading to:

  • Consumption of clotting factors & platelets.
  • Uncontrolled bleeding.

🔹 Diagnosis Requires Both Clinical & Laboratory Findings:

  • D-Dimer is significantly elevated in DIC.
  • The International Society for Thrombosis and Haemostasis (ISTH) scoring system helps diagnose DIC.

ISTH DIC Scoring System:

  1. Determine if the patient has a known underlying disorder associated with DIC.
  2. If YES, order coagulation tests and assign scores based on the following:

Platelet Count:

  • >100 × 10⁹/L → Score 0.
  • 50–100 × 10⁹/L → Score 1.
  • <50 × 10⁹/L → Score 2.

Fibrin Marker (D-Dimer Level):

  • No increase → Score 0.
  • Moderate increase → Score 2.
  • Strong increase → Score 3.

Prolonged Prothrombin Time (PT):

  • <3 seconds → Score 0.
  • 3–5.9 seconds → Score 1.
  • >6 seconds → Score 2.

Fibrinogen Level:

  • >1 g/dL → Score 0.
  • <1 g/dL → Score 1.

🔹 Scoring Interpretation:

  • Score ≥5: Compatible with overt DIC – Repeat scoring daily.
  • Score <5: Suggests non-overt DIC – Repeat in 1–2 days.

D-Dimer & Venous Thromboembolism (VTE) Risk Stratification

All patients should undergo a pre-test probability assessment using clinical prediction rules.

  • The Wells Score is commonly used to estimate the likelihood of DVT or PE.

Wells Prediction Rule for Diagnosing DVT

Clinical Features & Scoring:

  • Malignancy → Score 1.
  • Paralysis, paresis, or recent limb immobilization → Score 1.
  • Bedridden >3 days or major surgery within 12 weeks → Score 1.
  • Local tenderness along the deep vein system → Score 1.
  • Entire leg swollen → Score 1.
  • Calf swelling >3 cm compared to asymptomatic leg → Score 1.
  • Pitting oedema in symptomatic leg → Score 1.
  • Collateral superficial veins → Score 1.
  • Alternative diagnosis as likely as DVT → Score -2.

Interpreting the Total Score:

  • Low probability (<1 point).
  • Intermediate probability (1–2 points).
  • High probability (>2 points).

Wells Prediction Rule for Diagnosing PE

Clinical Features & Scoring:

  • Signs & symptoms of DVT → Score 3.
  • No alternative diagnosis more likely than PE → Score 3.
  • Heart rate >100 bpm → Score 1.5.
  • Recent surgery or immobilization → Score 1.5.
  • Previous DVT or PE → Score 1.5.
  • Haemoptysis → Score 1.
  • Malignancy → Score 1.

Interpreting the Total Score:

  • Low probability (<2 points).
  • Intermediate probability (2–6 points).
  • High probability (>6 points).

Key Takeaways for Clinicians

D-Dimer has high negative predictive value – a normal result effectively rules out VTE in low-risk patients.
D-Dimer should not be used alone to diagnose thrombosis – pre-test probability assessment is essential.
False positives and false negatives are common – consider clinical context before interpreting results.
D-Dimer levels can help assess VTE recurrence risk and should be monitored after anticoagulation therapy.