Scientific article
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Different D-dimer assays with age-adjusted cutoffs to exclude pulmonary embolism : secondary analysis of ADJUST-PE study

Published inJournal of thrombosis and haemostasis, vol. 23, no. 8, p. 2531-2539
Publication date2025-08
First online date2025-04-17
Abstract

Background: The multicenter prospective ADJUST-PE study proved the safety of an age-adjusted D-dimer (AADD) cutoff to exclude pulmonary embolism (PE).

Objectives: Assess the safety of different D-dimer (DD) assays using AADD in patients included in ADJUST-PE in Geneva compared with the originally used VIDAS DD Exclusion test.

Methods: This was a preplanned secondary analysis. The VIDAS DD Exclusion test was repeated to ensure reproducible results in thawed samples. Other tests performed were Innovance DD test, STA Liatest, Tina-quant DD, and the point-of-care LumiraDx test. The main outcome was venous thromboembolic risk (VTE) at initial testing or within 3 months after PE exclusion by a negative DD test using AADD ("failure rate"). The secondary outcome measure was to compare each assay with VIDAS in the classification of patients as having a negative vs positive AADD result.

Results: A total of 602 patients were included and 597 were available for analysis. Fourteen percent had PE confirmed at baseline. Failure rates were <2% for all tests. The risk of a change in classification from positive original VIDAS AADD to negative AADD result was similar to the repeated VIDAS (comparator) for Innovance and LumiraDx and higher for STA Liatest and Tina-quant. For the latter 2 assays, 3 and 5 patients with negative AADD had PE, respectively.

Conclusion: Innovance and LumiraDx assays had similar safety in excluding PE by AADD compared with VIDAS. STA Liatest and Tina-quant classified a higher proportion of patients with a negative AADD, among whom 3 and 5 had PE, respectively.

Keywords
  • D-dimer
  • Age-adjusted cutoff
  • Diagnosis
  • Pulmonary embolism
  • Humans
  • Pulmonary Embolism / diagnosis
  • Pulmonary Embolism / blood
  • Fibrin Fibrinogen Degradation Products / analysis
  • Female
  • Male
  • Aged
  • Middle Aged
  • Prospective Studies
  • Predictive Value of Tests
  • Reproducibility of Results
  • Venous Thromboembolism / diagnosis
  • Venous Thromboembolism / blood
  • Biomarkers / blood
  • Age Factors
  • Risk Factors
  • Adult
  • Aged, 80 and over
  • Switzerland
Citation (ISO format)
ROBERT-EBADI, Helia et al. Different D-dimer assays with age-adjusted cutoffs to exclude pulmonary embolism : secondary analysis of ADJUST-PE study. In: Journal of thrombosis and haemostasis, 2025, vol. 23, n° 8, p. 2531–2539. doi: 10.1016/j.jtha.2025.04.007
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Article (Published version)
Identifiers
Journal ISSN1538-7836
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Creation10/10/2025 7:01:23 AM
First validation11/24/2025 9:00:56 AM
Update time11/24/2025 9:00:56 AM
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