Does an immunochromatographic D-dimer exclude acute lower limb deep venous thrombosis?

Rathan M. Subramaniam, Rebekah Heath, Kim Cox, Tina Chou, Joanna Stewart, Jamie Sleigh

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Background: A pre-test probability score and D-dimer may reduce the need for ultrasound examinations for excluding lower limb deep venous thrombosis (DVT). Objective: To establish the accuracy of an immunochromatographic D-dimer assay called 'Simplify' for diagnosis of acute DVT by complete (calf veins included) lower limb ultrasound examination. Methods: A total of 453 consecutive patients presented to the ED of a tertiary centre with suspected first episode of DVT, were prospectively recruited. A pre-test probability score (Hamilton Score), an immunochromatographic D-dimer and a complete, single, unilateral lower limb ultrasound examination were performed in all patients. All patients with a negative ultrasound examination were followed up for 3 months. Results: There were 159 men and 294 women with a mean age of 55.8 years (SD 20.3). Of the 227 patients with a negative D-dimer, 214 patients had negative ultrasound examinations and 13 patients had isolated calf DVT. Among the 226 patients with a positive D-dimer, 74 patients had DVT and 152 patients had negative ultrasound examinations. The sensitivity, specificity, positive and negative predictive values were 85.1% (75.8-91.8), 58.5% (53.4-63.5), 32.7% (26.6-38.9) and 94.3% (90.4-96.9), respectively. One hundred and sixty-five patients had an unlikely Hamilton Score and a negative D-dimer. The negative predictive value of the immunochromatographic D-dimer in an unlikely Hamilton Score population was 98.8% (95.7-99.8%). Conclusion: An unlikely probability Hamilton Score and a negative immunochromatographic D-dimer reliably exclude both proximal and isolated calf DVT.

Original languageEnglish (US)
Pages (from-to)457-463
Number of pages7
JournalEMA - Emergency Medicine Australasia
Volume18
Issue number5-6
DOIs
StatePublished - Oct 1 2006

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Venous Thrombosis
Lower Extremity
fibrin fragment D
Veins
Sensitivity and Specificity

Keywords

  • D-dimer
  • Deep venous thrombosis
  • Ultrasound

ASJC Scopus subject areas

  • Emergency Medicine

Cite this

Does an immunochromatographic D-dimer exclude acute lower limb deep venous thrombosis? / Subramaniam, Rathan M.; Heath, Rebekah; Cox, Kim; Chou, Tina; Stewart, Joanna; Sleigh, Jamie.

In: EMA - Emergency Medicine Australasia, Vol. 18, No. 5-6, 01.10.2006, p. 457-463.

Research output: Contribution to journalArticle

Subramaniam, Rathan M. ; Heath, Rebekah ; Cox, Kim ; Chou, Tina ; Stewart, Joanna ; Sleigh, Jamie. / Does an immunochromatographic D-dimer exclude acute lower limb deep venous thrombosis?. In: EMA - Emergency Medicine Australasia. 2006 ; Vol. 18, No. 5-6. pp. 457-463.
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abstract = "Background: A pre-test probability score and D-dimer may reduce the need for ultrasound examinations for excluding lower limb deep venous thrombosis (DVT). Objective: To establish the accuracy of an immunochromatographic D-dimer assay called 'Simplify' for diagnosis of acute DVT by complete (calf veins included) lower limb ultrasound examination. Methods: A total of 453 consecutive patients presented to the ED of a tertiary centre with suspected first episode of DVT, were prospectively recruited. A pre-test probability score (Hamilton Score), an immunochromatographic D-dimer and a complete, single, unilateral lower limb ultrasound examination were performed in all patients. All patients with a negative ultrasound examination were followed up for 3 months. Results: There were 159 men and 294 women with a mean age of 55.8 years (SD 20.3). Of the 227 patients with a negative D-dimer, 214 patients had negative ultrasound examinations and 13 patients had isolated calf DVT. Among the 226 patients with a positive D-dimer, 74 patients had DVT and 152 patients had negative ultrasound examinations. The sensitivity, specificity, positive and negative predictive values were 85.1{\%} (75.8-91.8), 58.5{\%} (53.4-63.5), 32.7{\%} (26.6-38.9) and 94.3{\%} (90.4-96.9), respectively. One hundred and sixty-five patients had an unlikely Hamilton Score and a negative D-dimer. The negative predictive value of the immunochromatographic D-dimer in an unlikely Hamilton Score population was 98.8{\%} (95.7-99.8{\%}). Conclusion: An unlikely probability Hamilton Score and a negative immunochromatographic D-dimer reliably exclude both proximal and isolated calf DVT.",
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