International, multicenter evaluation of a new D-dimer assay for the exclusion of venous thromboembolism using standard and age-adjusted cut-offs

Blair Alden Parry, Anna Marie Chang, Sebastian M. Schellong, Stacey L. House, Gregory J. Fermann, Erin K. Deadmon, Nicholas J. Giordano, Yuchiao Chang, Jason Cohen, Nancy Robak, Adam J. Singer, Mary Mulrow, Ellen T. Reibling, Samuel Francis, S. Michelle Griffin, Jürgen H. Prochaska, Barbara Davis, Patricia McNelis, Joao Delgado, Philipp Kümpers & 10 others Nikos Werner, Nina T. Gentile, Eli Zeserson, Philipp S. Wild, Alexander T. Limkakeng, Elizabeth Lea Walters, Frank LoVecchio, Daniel Theodoro, Judd E. Hollander, Christopher Kabrhel

Research output: Contribution to journalArticle

5 Citations (Scopus)

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 languageEnglish (US)
Pages (from-to)63-70
Number of pages8
JournalThrombosis Research
Volume166
DOIs
StatePublished - Jun 1 2018
Externally publishedYes

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Venous Thromboembolism
Pulmonary Embolism
Venous Thrombosis
Hospital Emergency Service
Sensitivity and Specificity
fibrin fragment D
Multicenter Studies

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 journalArticle

Parry, BA, Chang, AM, Schellong, SM, House, SL, Fermann, GJ, Deadmon, EK, Giordano, NJ, Chang, Y, Cohen, J, Robak, N, Singer, AJ, Mulrow, M, Reibling, ET, Francis, S, Griffin, SM, Prochaska, JH, Davis, B, McNelis, P, Delgado, J, Kümpers, P, Werner, N, Gentile, NT, Zeserson, E, Wild, PS, Limkakeng, AT, Walters, EL, LoVecchio, F, Theodoro, D, Hollander, JE & Kabrhel, C 2018, 'International, multicenter evaluation of a new D-dimer assay for the exclusion of venous thromboembolism using standard and age-adjusted cut-offs', Thrombosis Research, vol. 166, pp. 63-70. https://doi.org/10.1016/j.thromres.2018.04.003
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. / International, multicenter evaluation of a new D-dimer assay for the exclusion of venous thromboembolism using standard and age-adjusted cut-offs. In: Thrombosis Research. 2018 ; Vol. 166. pp. 63-70.
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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.",
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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

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JO - Thrombosis Research

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