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A Latex D-Dimer Reliably Excludes Venous Thromboembolism
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).
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