Abstract
BACKGROUND: We evaluated the diagnostic performance of the Triage D-dimer test, a new fast quantitative point-of-care whole blood D-dimer assay and compared it with the Vidas D-dimer assay.
MATERIALS AND METHODS: The study population comprised 319 outpatients for whom D-dimer testing was requested in order to rule out venous thromboembolism (VTE). Routine testing consisted of a plasma ELISA D-dimer analysis (Vidas). For all included patients, an additional EDTA whole blood D-dimer test (Triage) was performed. Patients were classified by reference imaging or by follow-up of the medical record. Accuracy indices, receiver operating characteristics and the kappa coefficient for agreement were calculated using the cutoff values recommended by the manufacturer.
RESULTS: Prevalence of VTE was 14%. Sensitivity and specificity for VTE were 98% (95%CI: 88-100) and 34% (95%CI: 28-40) for Vidas and 91% (95%CI: 78-97) and 42% (95%CI: 36-48) for Triage, respectively. The differences in sensitivity and specificity between both D-dimer assays were statistically significant (McNemar, p
CONCLUSIONS: The Triage and Vidas D-dimer tests show comparable diagnostic accuracy. Vidas showed a significant higher sensitivity. Our findings strongly suggest lowering the cutoff for the Triage D-dimer test from 400 to 350 ng/mL. In this way specificity lowers from 42 to 38%, but, more importantly, sensitivity increases from 91 to 95%.
MATERIALS AND METHODS: The study population comprised 319 outpatients for whom D-dimer testing was requested in order to rule out venous thromboembolism (VTE). Routine testing consisted of a plasma ELISA D-dimer analysis (Vidas). For all included patients, an additional EDTA whole blood D-dimer test (Triage) was performed. Patients were classified by reference imaging or by follow-up of the medical record. Accuracy indices, receiver operating characteristics and the kappa coefficient for agreement were calculated using the cutoff values recommended by the manufacturer.
RESULTS: Prevalence of VTE was 14%. Sensitivity and specificity for VTE were 98% (95%CI: 88-100) and 34% (95%CI: 28-40) for Vidas and 91% (95%CI: 78-97) and 42% (95%CI: 36-48) for Triage, respectively. The differences in sensitivity and specificity between both D-dimer assays were statistically significant (McNemar, p
CONCLUSIONS: The Triage and Vidas D-dimer tests show comparable diagnostic accuracy. Vidas showed a significant higher sensitivity. Our findings strongly suggest lowering the cutoff for the Triage D-dimer test from 400 to 350 ng/mL. In this way specificity lowers from 42 to 38%, but, more importantly, sensitivity increases from 91 to 95%.
| Original language | English |
|---|---|
| Pages (from-to) | 735-741 |
| Number of pages | 7 |
| Journal | Thrombosis Research |
| Volume | 121 |
| Publication status | Published - 2008 |
Keywords
- venous thromboembolism