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 ultra-sonography; 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.
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 ultra-sonography; 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.
Authors: A Cogo; A W Lensing; M M Koopman; F Piovella; S Siragusa; P S Wells; S Villalta; H R Büller; A G Turpie; P Prandoni Journal: BMJ Date: 1998-01-03
Authors: Scott M Stevens; C Gregory Elliott; Karen J Chan; Marlene J Egger; Kirmanj M Ahmed Journal: Ann Intern Med Date: 2004-06-15 Impact factor: 25.391