Predictive Value of the Rapid Whole Blood Agglutination D-Dimer Assay (AGEN SimpliRED) in Community Outpatients with Suspected Deep Venous Thrombosis

Julieta E Hayag, MD; Prem P Manchanda, MD

Spring 2006 - Volume 10 Number 1


Context: D-dimer assay has been used to screen patients with deep venous thrombosis (DVT). Because both the predictive value and sensitivity/specificity of the test vary according to the type of assay, prevalence, and pretest probability of DVT, clinicians must know the local performance of the d-dimer assay.
Objective: To evaluate the predictive value of the rapid whole blood agglutination d-dimer Assay (AGEN SimpliRED) in community outpatients with suspected DVT in the Kaiser Permanente (KP) Mid-Atlantic Region.
Design: Retrospective, randomized, cross-sectional review of electronic medical records of patients with suspected DVT who underwent d-dimer testing for venous thromboembolism.
Methodology: A total of 5104 patients with suspected venous thromboembolism underwent d-dimer testing using AGEN SimpliRED from April 2001 to December 2002. A total of 551 electronic medical records were reviewed, and results of d-dimer assay and compression ultrasonography were tabulated. Records were analyzed to determine later diagnosis of DVT or unexplained death occurring as late as six months after initial testing.
Results: Electronic records showed a 5.3% disease prevalence. Ten patients were excluded from data analysis. A total of 129 (23.8%) patients had positive d-dimer; the positive predictive value was 20.2% (CI, 13.2% to 27%). A total of 412 (76.1%) patients had negative test results; three of these patients had DVT shown by compression ultrasonography; negative predictive value was 99.3% (CI, 98.4% to 100%). Calculated sensitivity was 89.7%; specificity was 79.9%.
Conclusion: In the outpatient setting, the rapid whole blood agglutination d-dimer assay (AGEN SimpliRED) used in combination with both clinical judgment and compression ultrasonography exhibited a high negative predictive value comparable with previously reported values. *Approved by KP Mid-Atlantic Institutional Review Board on April 2004.


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