A Diagnostic Strategy Involving a Quantitative Latex d-Dimer Assay Reliably Excludes Deep Venous Thrombosis

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Abstract
Because clinical diagnosis is inaccurate, objective testing is usually considered necessary when patients present with suspected deep venous thrombosis (DVT). To determine whether a negative result on a quantitative latex d-dimer assay eliminates the need for further investigation in patients with a low or moderate pretest probability of DVT. Prospective cohort study. Three tertiary care hospitals in Canada. 556 consecutive outpatients with suspected first DVT. Patients were categorized as having a low, moderate, or high pretest probability of DVT and then underwent d-dimer testing. Patients with low or moderate pretest probability and a negative d-dimer result had no further diagnostic testing and received no anticoagulant therapy. Serial compression ultrasonography was performed in all other patients. Patients who did not receive a diagnosis of DVT were followed for symptomatic venous thromboembolism. Objectively confirmed symptomatic venous thromboembolic events during 3 months of follow-up. 283 patients (51%) had low or moderate pretest probability and a negative d-dimer result. One of these patients had DVT during follow-up (negative likelihood ratio, 0.05 [CI, 0.01 to 0.23]). The negative likelihood ratio of the d-dimer test in all patients was 0.03 (CI, 0.01 to 0.16). A negative result on a quantitative latex d-dimer assay safely eliminates the need for further testing in patients with low or moderate pretest probability of DVT.