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 <500 ng/ml was negative. For the age adjusted cut-off, we used the formula: Age (years) ∗ 10. The diagnostic standard was imaging demonstrating PE or DVT within 3 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 (n = 1834) was 48 ± 16 years, with 676 (37%) male, and 1081 (59%) white. The mean age of evaluated for DVT (n = 1752) was 53 ± 16 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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 63-70 |
| Number of pages | 8 |
| Journal | Thrombosis Research |
| Volume | 166 |
| DOIs | |
| State | Published - Jun 1 2018 |
| Externally published | Yes |
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Keywords
- Age-adjustment
- D-dimer
- Deep vein thrombosis
- Emergency department
- Pulmonary embolism
ASJC Scopus subject areas
- Hematology
Cite this
International, multicenter evaluation of a new D-dimer assay for the exclusion of venous thromboembolism using standard and age-adjusted cut-offs. / Parry, Blair Alden; Chang, Anna Marie; Schellong, Sebastian M.; House, Stacey L.; Fermann, Gregory J.; Deadmon, Erin K.; Giordano, Nicholas J.; Chang, Yuchiao; Cohen, Jason; Robak, Nancy; Singer, Adam J.; Mulrow, Mary; Reibling, Ellen T.; Francis, Samuel; Griffin, S. Michelle; Prochaska, Jürgen H.; Davis, Barbara; McNelis, Patricia; Delgado, Joao; Kümpers, Philipp; Werner, Nikos; Gentile, Nina T.; Zeserson, Eli; Wild, Philipp S.; Limkakeng, Alexander T.; Walters, Elizabeth Lea; LoVecchio, Frank; Theodoro, Daniel; Hollander, Judd E.; Kabrhel, Christopher.
In: Thrombosis Research, Vol. 166, 01.06.2018, p. 63-70.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - International, multicenter evaluation of a new D-dimer assay for the exclusion of venous thromboembolism using standard and age-adjusted cut-offs
AU - Parry, Blair Alden
AU - Chang, Anna Marie
AU - Schellong, Sebastian M.
AU - House, Stacey L.
AU - Fermann, Gregory J.
AU - Deadmon, Erin K.
AU - Giordano, Nicholas J.
AU - Chang, Yuchiao
AU - Cohen, Jason
AU - Robak, Nancy
AU - Singer, Adam J.
AU - Mulrow, Mary
AU - Reibling, Ellen T.
AU - Francis, Samuel
AU - Griffin, S. Michelle
AU - Prochaska, Jürgen H.
AU - Davis, Barbara
AU - McNelis, Patricia
AU - Delgado, Joao
AU - Kümpers, Philipp
AU - Werner, Nikos
AU - Gentile, Nina T.
AU - Zeserson, Eli
AU - Wild, Philipp S.
AU - Limkakeng, Alexander T.
AU - Walters, Elizabeth Lea
AU - LoVecchio, Frank
AU - Theodoro, Daniel
AU - Hollander, Judd E.
AU - Kabrhel, Christopher
PY - 2018/6/1
Y1 - 2018/6/1
N2 - 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 <500 ng/ml was negative. For the age adjusted cut-off, we used the formula: Age (years) ∗ 10. The diagnostic standard was imaging demonstrating PE or DVT within 3 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 (n = 1834) was 48 ± 16 years, with 676 (37%) male, and 1081 (59%) white. The mean age of evaluated for DVT (n = 1752) was 53 ± 16 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.
AB - 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 <500 ng/ml was negative. For the age adjusted cut-off, we used the formula: Age (years) ∗ 10. The diagnostic standard was imaging demonstrating PE or DVT within 3 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 (n = 1834) was 48 ± 16 years, with 676 (37%) male, and 1081 (59%) white. The mean age of evaluated for DVT (n = 1752) was 53 ± 16 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.
KW - Age-adjustment
KW - D-dimer
KW - Deep vein thrombosis
KW - Emergency department
KW - Pulmonary embolism
UR - http://www.scopus.com/inward/record.url?scp=85045389159&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85045389159&partnerID=8YFLogxK
U2 - 10.1016/j.thromres.2018.04.003
DO - 10.1016/j.thromres.2018.04.003
M3 - Article
VL - 166
SP - 63
EP - 70
JO - Thrombosis Research
JF - Thrombosis Research
SN - 0049-3848
ER -