Sensitivity and Specificity of the Semiquantitative Latex Agglutination D-Dimer Assay for the Diagnosis of Acute Pulmonary Embolism as Defined by Computed Tomographic Angiography

David A. Froehling, Peter L. Elkin, Stephen J. Swensen, John A. Heit, V. Shane Pankratz, Jay H Ryu

Research output: Contribution to journalArticle

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Abstract

Objective: To determine the sensitivity and specificity of the semiquantitative latex agglutination plasma fibrin D-dimer assay for the diagnosis of acute pulmonary embolism by using computed tomographic (CT) angiography as the diagnostic reference standard. Patients and Methods: From January 1, 1998, to June 26, 2000, patients who had both semiquantitative latex agglutination plasma fibrin D-dimer testing and CT angiography for suspected acute pulmonary embolism were selected for the study. A D-dimer value greater than 250 ng/mL was considered positive for thromboembolic disease. Diagnosis of acute pulmonary embolism was based solely on the interpretation of the CT angiogram. The D-dimer assay results were then compared with the CT angiographic diagnoses. Results: Of 946 CT studies, 172 (18%) were positive for acute pulmonary embolism. The D-dimer assay was positive for 612 (65%) of the 946 patients. For acute pulmonary embolism, the D-dimer assay had a sensitivity of 0.83 (95% confidence interval [CI], 0.76-0.88), a specificity of 0.39 (95% CI, 0.36-0.43), a negative likelihood ratio of 0.44 (95% CI, 0.32-0.62), and a negative predictive value of 0.91 (95% CI, 0.87-0.94). Conclusions: The semiquantitative latex agglutination plasma fibrin D-dimer assay had moderate sensitivity and low specificity for the diagnosis of acute pulmonary embolism. When used alone, the results of this test were insufficient to exclude this serious and potentially fatal disorder. Approximately two thirds of our patients had positive D-dimer assays and required further evaluation to exclude acute pulmonary embolism.

Original languageEnglish (US)
Pages (from-to)164-168
Number of pages5
JournalMayo Clinic Proceedings
Volume79
Issue number2
StatePublished - 2004

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Agglutination
Latex
Pulmonary Embolism
Angiography
Sensitivity and Specificity
Confidence Intervals
fibrin fragment D

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Sensitivity and Specificity of the Semiquantitative Latex Agglutination D-Dimer Assay for the Diagnosis of Acute Pulmonary Embolism as Defined by Computed Tomographic Angiography. / Froehling, David A.; Elkin, Peter L.; Swensen, Stephen J.; Heit, John A.; Shane Pankratz, V.; Ryu, Jay H.

In: Mayo Clinic Proceedings, Vol. 79, No. 2, 2004, p. 164-168.

Research output: Contribution to journalArticle

Froehling, David A. ; Elkin, Peter L. ; Swensen, Stephen J. ; Heit, John A. ; Shane Pankratz, V. ; Ryu, Jay H. / Sensitivity and Specificity of the Semiquantitative Latex Agglutination D-Dimer Assay for the Diagnosis of Acute Pulmonary Embolism as Defined by Computed Tomographic Angiography. In: Mayo Clinic Proceedings. 2004 ; Vol. 79, No. 2. pp. 164-168.
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abstract = "Objective: To determine the sensitivity and specificity of the semiquantitative latex agglutination plasma fibrin D-dimer assay for the diagnosis of acute pulmonary embolism by using computed tomographic (CT) angiography as the diagnostic reference standard. Patients and Methods: From January 1, 1998, to June 26, 2000, patients who had both semiquantitative latex agglutination plasma fibrin D-dimer testing and CT angiography for suspected acute pulmonary embolism were selected for the study. A D-dimer value greater than 250 ng/mL was considered positive for thromboembolic disease. Diagnosis of acute pulmonary embolism was based solely on the interpretation of the CT angiogram. The D-dimer assay results were then compared with the CT angiographic diagnoses. Results: Of 946 CT studies, 172 (18{\%}) were positive for acute pulmonary embolism. The D-dimer assay was positive for 612 (65{\%}) of the 946 patients. For acute pulmonary embolism, the D-dimer assay had a sensitivity of 0.83 (95{\%} confidence interval [CI], 0.76-0.88), a specificity of 0.39 (95{\%} CI, 0.36-0.43), a negative likelihood ratio of 0.44 (95{\%} CI, 0.32-0.62), and a negative predictive value of 0.91 (95{\%} CI, 0.87-0.94). Conclusions: The semiquantitative latex agglutination plasma fibrin D-dimer assay had moderate sensitivity and low specificity for the diagnosis of acute pulmonary embolism. When used alone, the results of this test were insufficient to exclude this serious and potentially fatal disorder. Approximately two thirds of our patients had positive D-dimer assays and required further evaluation to exclude acute pulmonary embolism.",
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AU - Froehling, David A.

AU - Elkin, Peter L.

AU - Swensen, Stephen J.

AU - Heit, John A.

AU - Shane Pankratz, V.

AU - Ryu, Jay H

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N2 - Objective: To determine the sensitivity and specificity of the semiquantitative latex agglutination plasma fibrin D-dimer assay for the diagnosis of acute pulmonary embolism by using computed tomographic (CT) angiography as the diagnostic reference standard. Patients and Methods: From January 1, 1998, to June 26, 2000, patients who had both semiquantitative latex agglutination plasma fibrin D-dimer testing and CT angiography for suspected acute pulmonary embolism were selected for the study. A D-dimer value greater than 250 ng/mL was considered positive for thromboembolic disease. Diagnosis of acute pulmonary embolism was based solely on the interpretation of the CT angiogram. The D-dimer assay results were then compared with the CT angiographic diagnoses. Results: Of 946 CT studies, 172 (18%) were positive for acute pulmonary embolism. The D-dimer assay was positive for 612 (65%) of the 946 patients. For acute pulmonary embolism, the D-dimer assay had a sensitivity of 0.83 (95% confidence interval [CI], 0.76-0.88), a specificity of 0.39 (95% CI, 0.36-0.43), a negative likelihood ratio of 0.44 (95% CI, 0.32-0.62), and a negative predictive value of 0.91 (95% CI, 0.87-0.94). Conclusions: The semiquantitative latex agglutination plasma fibrin D-dimer assay had moderate sensitivity and low specificity for the diagnosis of acute pulmonary embolism. When used alone, the results of this test were insufficient to exclude this serious and potentially fatal disorder. Approximately two thirds of our patients had positive D-dimer assays and required further evaluation to exclude acute pulmonary embolism.

AB - Objective: To determine the sensitivity and specificity of the semiquantitative latex agglutination plasma fibrin D-dimer assay for the diagnosis of acute pulmonary embolism by using computed tomographic (CT) angiography as the diagnostic reference standard. Patients and Methods: From January 1, 1998, to June 26, 2000, patients who had both semiquantitative latex agglutination plasma fibrin D-dimer testing and CT angiography for suspected acute pulmonary embolism were selected for the study. A D-dimer value greater than 250 ng/mL was considered positive for thromboembolic disease. Diagnosis of acute pulmonary embolism was based solely on the interpretation of the CT angiogram. The D-dimer assay results were then compared with the CT angiographic diagnoses. Results: Of 946 CT studies, 172 (18%) were positive for acute pulmonary embolism. The D-dimer assay was positive for 612 (65%) of the 946 patients. For acute pulmonary embolism, the D-dimer assay had a sensitivity of 0.83 (95% confidence interval [CI], 0.76-0.88), a specificity of 0.39 (95% CI, 0.36-0.43), a negative likelihood ratio of 0.44 (95% CI, 0.32-0.62), and a negative predictive value of 0.91 (95% CI, 0.87-0.94). Conclusions: The semiquantitative latex agglutination plasma fibrin D-dimer assay had moderate sensitivity and low specificity for the diagnosis of acute pulmonary embolism. When used alone, the results of this test were insufficient to exclude this serious and potentially fatal disorder. Approximately two thirds of our patients had positive D-dimer assays and required further evaluation to exclude acute pulmonary embolism.

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