Evaluation of a quantitative D-Dimer latex immunoassay for acute pulmonary embolism diagnosed by computed tomographic angiography

David A. Froehling, Paul R. Daniels, Stephen J. Swensen, John A. Heit, Jayawant Mandrekar, Jay H Ryu, Peter L. Elkin

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

OBJECTIVE: To determine the sensitivity and specificity of a quantitative plasma fibrin D-dimer latex immunoassay (LIA) for the diagnosis of acuta pulmonary embolism. SUBJECTS AND METHODS: Study subjects were Mayo Clinic Rochester inpatients and outpatients with suspected acute pulmonary embolism; all had undergone quantitative D-dimer LIA testing and multidetector-row computed tomographic (CT) angiography between August 3, 2001, and November 10, 2003. Multidetector-row CT angiography was the diagnostic reference standard. RESULTS: Of 1355 CT studies, 203 (15%) were positive for acute pulmonary embolism. Median B-dimer levels were significantly higher for patients with acute pulmonary embolism (1425 ng/ml) than for patients without (500 ng/mL) (P<.001). Tlte highest specificity that optimizes sensitivity for acute pulmonary embolism was achieved by using a discriminant value of 300 ng/mL, which yielded a sensitivity of 0.94 (95% confidence interval [CI], 0.89-0.97), a specificity of 0.27 (95% CI, 0.25-0.30), and a negative predictive value of 0.96 (95% CI, 0.93-0.98). CONCLUSION: The quantitative D-dimer LIA with a discriminant value of 300 ng/mL had high sensitivity and high negative predictive value but low specificity for the diagnosis of acute pulmonary embolism. On the basis of these results, we believe that a negative quantitative D-dimer LIA result and a low pretest probability of thromboembolism together are sufficient to exclude acute pulmonary embolism.

Original languageEnglish (US)
Pages (from-to)556-560
Number of pages5
JournalMayo Clinic Proceedings
Volume82
Issue number5
DOIs
StatePublished - 2007

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Latex
Pulmonary Embolism
Immunoassay
Angiography
Confidence Intervals
Sensitivity and Specificity
Thromboembolism
fibrin fragment D
Inpatients
Outpatients

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Evaluation of a quantitative D-Dimer latex immunoassay for acute pulmonary embolism diagnosed by computed tomographic angiography. / Froehling, David A.; Daniels, Paul R.; Swensen, Stephen J.; Heit, John A.; Mandrekar, Jayawant; Ryu, Jay H; Elkin, Peter L.

In: Mayo Clinic Proceedings, Vol. 82, No. 5, 2007, p. 556-560.

Research output: Contribution to journalArticle

Froehling, David A. ; Daniels, Paul R. ; Swensen, Stephen J. ; Heit, John A. ; Mandrekar, Jayawant ; Ryu, Jay H ; Elkin, Peter L. / Evaluation of a quantitative D-Dimer latex immunoassay for acute pulmonary embolism diagnosed by computed tomographic angiography. In: Mayo Clinic Proceedings. 2007 ; Vol. 82, No. 5. pp. 556-560.
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abstract = "OBJECTIVE: To determine the sensitivity and specificity of a quantitative plasma fibrin D-dimer latex immunoassay (LIA) for the diagnosis of acuta pulmonary embolism. SUBJECTS AND METHODS: Study subjects were Mayo Clinic Rochester inpatients and outpatients with suspected acute pulmonary embolism; all had undergone quantitative D-dimer LIA testing and multidetector-row computed tomographic (CT) angiography between August 3, 2001, and November 10, 2003. Multidetector-row CT angiography was the diagnostic reference standard. RESULTS: Of 1355 CT studies, 203 (15{\%}) were positive for acute pulmonary embolism. Median B-dimer levels were significantly higher for patients with acute pulmonary embolism (1425 ng/ml) than for patients without (500 ng/mL) (P<.001). Tlte highest specificity that optimizes sensitivity for acute pulmonary embolism was achieved by using a discriminant value of 300 ng/mL, which yielded a sensitivity of 0.94 (95{\%} confidence interval [CI], 0.89-0.97), a specificity of 0.27 (95{\%} CI, 0.25-0.30), and a negative predictive value of 0.96 (95{\%} CI, 0.93-0.98). CONCLUSION: The quantitative D-dimer LIA with a discriminant value of 300 ng/mL had high sensitivity and high negative predictive value but low specificity for the diagnosis of acute pulmonary embolism. On the basis of these results, we believe that a negative quantitative D-dimer LIA result and a low pretest probability of thromboembolism together are sufficient to exclude acute pulmonary embolism.",
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AU - Mandrekar, Jayawant

AU - Ryu, Jay H

AU - Elkin, Peter L.

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N2 - OBJECTIVE: To determine the sensitivity and specificity of a quantitative plasma fibrin D-dimer latex immunoassay (LIA) for the diagnosis of acuta pulmonary embolism. SUBJECTS AND METHODS: Study subjects were Mayo Clinic Rochester inpatients and outpatients with suspected acute pulmonary embolism; all had undergone quantitative D-dimer LIA testing and multidetector-row computed tomographic (CT) angiography between August 3, 2001, and November 10, 2003. Multidetector-row CT angiography was the diagnostic reference standard. RESULTS: Of 1355 CT studies, 203 (15%) were positive for acute pulmonary embolism. Median B-dimer levels were significantly higher for patients with acute pulmonary embolism (1425 ng/ml) than for patients without (500 ng/mL) (P<.001). Tlte highest specificity that optimizes sensitivity for acute pulmonary embolism was achieved by using a discriminant value of 300 ng/mL, which yielded a sensitivity of 0.94 (95% confidence interval [CI], 0.89-0.97), a specificity of 0.27 (95% CI, 0.25-0.30), and a negative predictive value of 0.96 (95% CI, 0.93-0.98). CONCLUSION: The quantitative D-dimer LIA with a discriminant value of 300 ng/mL had high sensitivity and high negative predictive value but low specificity for the diagnosis of acute pulmonary embolism. On the basis of these results, we believe that a negative quantitative D-dimer LIA result and a low pretest probability of thromboembolism together are sufficient to exclude acute pulmonary embolism.

AB - OBJECTIVE: To determine the sensitivity and specificity of a quantitative plasma fibrin D-dimer latex immunoassay (LIA) for the diagnosis of acuta pulmonary embolism. SUBJECTS AND METHODS: Study subjects were Mayo Clinic Rochester inpatients and outpatients with suspected acute pulmonary embolism; all had undergone quantitative D-dimer LIA testing and multidetector-row computed tomographic (CT) angiography between August 3, 2001, and November 10, 2003. Multidetector-row CT angiography was the diagnostic reference standard. RESULTS: Of 1355 CT studies, 203 (15%) were positive for acute pulmonary embolism. Median B-dimer levels were significantly higher for patients with acute pulmonary embolism (1425 ng/ml) than for patients without (500 ng/mL) (P<.001). Tlte highest specificity that optimizes sensitivity for acute pulmonary embolism was achieved by using a discriminant value of 300 ng/mL, which yielded a sensitivity of 0.94 (95% confidence interval [CI], 0.89-0.97), a specificity of 0.27 (95% CI, 0.25-0.30), and a negative predictive value of 0.96 (95% CI, 0.93-0.98). CONCLUSION: The quantitative D-dimer LIA with a discriminant value of 300 ng/mL had high sensitivity and high negative predictive value but low specificity for the diagnosis of acute pulmonary embolism. On the basis of these results, we believe that a negative quantitative D-dimer LIA result and a low pretest probability of thromboembolism together are sufficient to exclude acute pulmonary embolism.

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