International, multicenter evaluation of a new D-dimer assay for the exclusion of venous thromboembolism using standard and age-adjusted cut-offs.
Thromb Res
; 166: 63-70, 2018 06.
Article
en En
| MEDLINE
| ID: mdl-29656169
ABSTRACT
INTRODUCTION:
We sought to determine the test characteristics of an automated INNOVANCE D-dimer assay for the exclusion of pulmonary embolism (PE) and deep venous thrombosis (DVT) in emergency department (ED) patients using standard and age-adjusted cut-offs.METHODS:
Cross-sectional, international, multicenter study of consecutive patients with suspected DVT or PE in 24 centers (18 USA, 6 Europe). Evaluated patients had low or intermediate Wells PE or DVT scores. For the standard cut-off, a D-dimer result <500â¯ng/ml was negative. For the age adjusted cut-off, we used the formula Age (years)â¯∗â¯10. The diagnostic standard was imaging demonstrating PE or DVT within 3â¯months. We calculated test characteristics using standard methods. We also explored modifications of the age adjustment multiplier.RESULTS:
We included 3837 patients and excluded 251. The mean age of patients evaluated for PE (nâ¯=â¯1834) was 48⯱â¯16â¯years, with 676 (37%) male, and 1081 (59%) white. The mean age of evaluated for DVT (nâ¯=â¯1752) was 53⯱â¯16â¯years, with 710 (41%) male, and 1172 (67%) white. D-dimer test characteristics for PE were sensitivity 98.0%, specificity 55.4%, negative predictive value (NPV) 99.8%, positive predictive value (PPV) 11.4%, and for DVT were sensitivity 92.0%, specificity 44.8%, NPV 98.8%, PPV 10.3%. Age adjustment increased specificity (59.6% [PE], 51.1% [DVT]), but increasing the age-adjustment multiplier decreased sensitivity without increasing specificity.CONCLUSIONS:
INNOVANCE D-dimer is highly sensitive and can exclude PE and DVT in ED patients with low- and intermediate- pre-test probability. Age-adjustment increases specificity, without increasing false negatives.Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Productos de Degradación de Fibrina-Fibrinógeno
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Tromboembolia Venosa
Tipo de estudio:
Clinical_trials
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Observational_studies
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Prevalence_studies
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Prognostic_studies
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Risk_factors_studies
Límite:
Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Thromb Res
Año:
2018
Tipo del documento:
Article
País de afiliación:
Estados Unidos