This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on Web of Science (62)  • Contact me when this article is cited  Related Content  • Related article  • Similar articles in this journal  Topic Collections  • Venous Thromboembolism  • Cardiovascular System  • Alert me on articles by topic  Social Bookmarking   What's this?

Shannon M. Bates, MD, CM; Anne Grand'Maison, MD; Marilyn Johnston, ART; Ivy Naguit, MLT; Michael J. Kovacs, MD; Jeffrey S. Ginsberg, MD

Arch Intern Med. 2001;161:447-453.

Background  D-Dimer, a cross-linked fibrin degradation product, has a high sensitivity in patients with suspected venous thrombosis. Traditional latex D-dimer assays, however, have not been sufficiently sensitive to exclude venous thromboembolism.

Methods  To determine the clinical utility of a latex D-dimer assay (MDA D-Dimer; Organon Teknika Corporation, Durham, NC) in patients with suspected venous thromboembolism, we conducted a retrospective cohort study involving 595 unselected patients at 4 tertiary care hospitals. Patients had blood drawn for performance of the D-dimer assay and underwent objective testing for venous thromboembolism. Pretest probability was determined using validated models in 571 patients. Patients were classified as venous thromboembolism positive or negative according to results of objective tests and 3-month follow-up. The sensitivities, specificities, predictive values, and negative likelihood ratios of the assay were calculated for all patients and for subgroups of patients with known cancer or a low, moderate, or high pretest probability of venous thromboembolism.

Results  The prevalence of venous thromboembolism was 19.0% (113/595). Of those who had a pretest probability assessment, 35.9% had a low pretest probability, 49.7% a moderate pretest probability, and 14.4% a high pretest probability. Using a discriminant value of 0.50 µg fibrinogen equivalent units per milliliter, the assay showed an overall sensitivity of 96%, a negative predictive value of 98%, a specificity of 45%, and a negative likelihood ratio of 0.09. In patients with a low or moderate pretest probability, the sensitivity, negative predictive value, and negative likelihood ratio were 97%, 99%, and 0.07, respectively.

Conclusions  The MDA D-Dimer assay is the first latex agglutination assay with sufficient sensitivity to be clinically useful in the exclusion of venous thromboembolism. A negative result has the potential to be used as the sole test to exclude venous thromboembolism in patients with a low or moderate pretest probability of disease.

From the Department of Medicine, McMaster University (Drs Bates, Grand'Maison, and Ginsberg), and the Hamilton Civic Hospitals Research Centre (Mss Johnston and Naguit and Dr Ginsberg), Hamilton, Ontario; and the Department of Medicine, University of Western Ontario, London (Dr Kovacs).

Corresponding author: Shannon M. Bates, MD, CM, McMaster University Medical Centre, Thromboembolism Unit, HSC 3W15, 1200 Main St W, Hamilton, Ontario, Canada L8V 1C3 (e-mail: batesm{at}mcmaster.ca).

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?

RELATED ARTICLE

Archives of Internal Medicine Reader's Choice: Continuing Medical Education
Arch Intern Med. 2001;161(3):487-488.
FULL TEXT  

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Evaluation of a Quantitative D-Dimer Latex Immunoassay for Acute Pulmonary Embolism Diagnosed by Computed Tomographic Angiography
Froehling et al.
Mayo Clin Proc. 2007;82:556-560.
ABSTRACT | FULL TEXT  

Prospective Study of the Incidence and Risk Factors of Postsplenectomy Thrombosis of the Portal, Mesenteric, and Splenic Veins
Stamou et al.
Arch Surg 2006;141:663-669.
ABSTRACT | FULL TEXT  

Importance of Pretest Probability Score and D-Dimer Assay Before Sonography for Lower Limb Deep Venous Thrombosis
Subramaniam et al.
Am. J. Roentgenol. 2006;186:206-212.
ABSTRACT | FULL TEXT  

Meta-Analysis: The Value of Clinical Assessment in the Diagnosis of Deep Venous Thrombosis
Goodacre et al.
ANN INTERN MED 2005;143:129-139.
ABSTRACT | FULL TEXT  

Variation in the diagnostic performance of D-dimer for suspected deep vein thrombosis
Goodacre et al.
QJM 2005;98:513-527.
ABSTRACT | FULL TEXT  

Screening for pulmonary embolism with a D-dimer assay: do we still need to assess clinical probability as well?
Hammond and Hassan
JRSM 2005;98:54-58.
ABSTRACT | FULL TEXT  

Clinical Usefulness of D-Dimer Depending on Clinical Probability and Cutoff Value in Outpatients With Suspected Pulmonary Embolism
Righini et al.
Arch Intern Med 2004;164:2483-2487.
ABSTRACT | FULL TEXT  

Combined use of rapid D-dimer testing and estimation of clinical probability in the diagnosis of deep vein thrombosis: systematic review
Fancher et al.
BMJ 2004;329:821.
ABSTRACT | FULL TEXT  

Anticoagulation Monitoring
Smythe and Caffee
Journal of Pharmacy Practice 2004;17:317-326.
ABSTRACT  

Diagnosis of Lower-Extremity Deep Vein Thrombosis in Outpatients
Riddle and Wells
ptjournal 2004;84:729-735.
FULL TEXT  

D-Dimer Testing for Deep Venous Thrombosis: A Metaanalysis
Heim et al.
Clin. Chem. 2004;50:1136-1147.
ABSTRACT | FULL TEXT  

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 et al.
Mayo Clin Proc. 2004;79:164-168.
ABSTRACT  

Does This Patient Have Pulmonary Embolism?
Chunilal et al.
JAMA 2003;290:2849-2858.
ABSTRACT | FULL TEXT  

Turbidimetric D-Dimer Test in the Diagnosis of Pulmonary Embolism: A Metaanalysis
Brown et al.
Clin. Chem. 2003;49:1846-1853.
ABSTRACT | FULL TEXT  

Rational Use of D-Dimer Measurement to Exclude Acute Venous Thromboembolic Disease
Frost et al.
Mayo Clin Proc. 2003;78:1385-1391.
ABSTRACT  

Evaluation of D-Dimer in the Diagnosis of Suspected Deep-Vein Thrombosis
Wells et al.
NEJM 2003;349:1227-1235.
ABSTRACT | FULL TEXT  

British Thoracic Society guidelines for the management of suspected acute pulmonary embolism
Thorax 2003;58:470-483.
FULL TEXT  

A Diagnostic Strategy Involving a Quantitative Latex D-Dimer Assay Reliably Excludes Deep Venous Thrombosis
Bates et al.
ANN INTERN MED 2003;138:787-794.
ABSTRACT | FULL TEXT  

The D-Dimer Test for Deep Venous Thrombosis: Gold Standards and Bias in Negative Predictive Value
Philbrick and Heim
Clin. Chem. 2003;49:570-574.
ABSTRACT | FULL TEXT  

Combination of a Normal D-Dimer Concentration and a Non-High Pretest Clinical Probability Score Is a Safe Strategy to Exclude Deep Venous Thrombosis
Schutgens et al.
Circulation 2003;107:593-597.
ABSTRACT | FULL TEXT  

Diagnosis of pulmonary embolism
Kearon
CMAJ 2003;168:183-194.
ABSTRACT | FULL TEXT  

Cost-Effectiveness Analysis of Diagnostic Strategies for Suspected Pulmonary Embolism Including Helical Computed Tomography
Perrier et al.
Am. J. Respir. Crit. Care Med. 2003;167:39-44.
ABSTRACT | FULL TEXT  

How we manage venous thromboembolism during pregnancy
Bates and Ginsberg
Blood 2002;100:3470-3478.
ABSTRACT | FULL TEXT  

Clinical Assessment and D-dimer Testing in Deep Venous Thrombosis
Kearon and Ginsberg
ANN INTERN MED 2002;137:371-372.
FULL TEXT  

Plasma D-Dimers in the Diagnosis of Venous Thromboembolism
Kelly et al.
Arch Intern Med 2002;162:747-756.
ABSTRACT | FULL TEXT  

A negative quantitative latex D-dimer assay helped to rule out venous thromboembolism
Pelouze
Evid. Based Med. 2001;6:188-188.
FULL TEXT