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Different accuracies of rapid enzyme-linked immunosorbent, turbidimetric, and agglutination D-dimer assays for thrombosis exclusion: impact on diagnostic work-ups of outpatients with suspected deep vein thrombosis and pulmonary embolism.
Semin Thromb Hemost 2006; 32(7):678-93ST

Abstract

The requirement for a safe diagnostic strategy should be based on an overall posttest incidence of venous thromboembolism (VTE) of less than 1%, with a negative predictive value of more than 99 to 100% during 3-month follow-up. Compression ultrasonography (CUS) and spiral computed tomography (CT) currently are the methods of choice to confirm or rule out deep venous thrombosis (DVT) and pulmonary embolism (PE), respectively. CUS has a negative predictive value (NPV) of 97 to 98%, indicating the need to improve the diagnostic work-up of patients with suspected DVT by clinical score assessment and D-dimer testing. Spiral CT as a stand-alone method detects all clinically relevant PEs and a large number of alternative diagnoses. It rules out PE with a NPV of 98 to 99%. Spiral CT is expensive, emphasizing the need to improve the diagnostic work-up of patients with suspected PE by the use of clinical score assessment and D-dimer testing. Clinical score assessment for DVT and PE has not safely ruled out VTE in multicenter studies and in routine daily practices. Modification of the Wells clinical score assessment for DVT by elimination of the "minus 2 points" for alternative diagnosis will improve the reproducibility of the clinical score assessment. The combination of a first negative CUS and a negative SimpliRed or an enzyme-linked immunosorbent assay (ELISA) VIDAS D-dimer of < 1,000 ng/mL safely exclude DVT (NPV > 99%) irrespective of clinical score assessment and without the need to repeat CUS in approximately 60 to 70% of patients. The rapid quantitative and qualitative agglutination D-dimer assays for the exclusion of VTE are not sensitive enough as stand-alone tests and should be used in combination with clinical score assessment. A normal rapid ELISA VIDAS D-dimer test as a stand-alone test safely excludes DVT and PE, with a NPV of 99 to 100%, irrespective of clinical score, without the need of CUS or spiral CT. The combined strategy of a rapid ELISA VIDAS D-dimer followed by objective testing with CUS for DVT and by spiral CT for PE will reduce the need for noninvasive imaging techniques by 40 to 50%.

Authors+Show Affiliations

Hemostasis and Thrombosis Research, Department of Hematology, University Hospital Antwerp, Belgium. postbus@goodheartcenter.demon.nlNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Review

Language

eng

PubMed ID

17024595

Citation

Michiels, Jan J., et al. "Different Accuracies of Rapid Enzyme-linked Immunosorbent, Turbidimetric, and Agglutination D-dimer Assays for Thrombosis Exclusion: Impact On Diagnostic Work-ups of Outpatients With Suspected Deep Vein Thrombosis and Pulmonary Embolism." Seminars in Thrombosis and Hemostasis, vol. 32, no. 7, 2006, pp. 678-93.
Michiels JJ, Gadisseur A, van der Planken M, et al. Different accuracies of rapid enzyme-linked immunosorbent, turbidimetric, and agglutination D-dimer assays for thrombosis exclusion: impact on diagnostic work-ups of outpatients with suspected deep vein thrombosis and pulmonary embolism. Semin Thromb Hemost. 2006;32(7):678-93.
Michiels, J. J., Gadisseur, A., van der Planken, M., Schroyens, W., De Maeseneer, M., Hermsen, J. T., ... Pattynama, P. M. (2006). Different accuracies of rapid enzyme-linked immunosorbent, turbidimetric, and agglutination D-dimer assays for thrombosis exclusion: impact on diagnostic work-ups of outpatients with suspected deep vein thrombosis and pulmonary embolism. Seminars in Thrombosis and Hemostasis, 32(7), pp. 678-93.
Michiels JJ, et al. Different Accuracies of Rapid Enzyme-linked Immunosorbent, Turbidimetric, and Agglutination D-dimer Assays for Thrombosis Exclusion: Impact On Diagnostic Work-ups of Outpatients With Suspected Deep Vein Thrombosis and Pulmonary Embolism. Semin Thromb Hemost. 2006;32(7):678-93. PubMed PMID: 17024595.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Different accuracies of rapid enzyme-linked immunosorbent, turbidimetric, and agglutination D-dimer assays for thrombosis exclusion: impact on diagnostic work-ups of outpatients with suspected deep vein thrombosis and pulmonary embolism. AU - Michiels,Jan J, AU - Gadisseur,Alain, AU - van der Planken,Marc, AU - Schroyens,Wilfried, AU - De Maeseneer,Marianne, AU - Hermsen,Jan T, AU - Trienekens,Paul H, AU - Hoogsteden,Henk, AU - Pattynama,Peter M P, PY - 2006/10/7/pubmed PY - 2006/12/9/medline PY - 2006/10/7/entrez SP - 678 EP - 93 JF - Seminars in thrombosis and hemostasis JO - Semin. Thromb. Hemost. VL - 32 IS - 7 N2 - The requirement for a safe diagnostic strategy should be based on an overall posttest incidence of venous thromboembolism (VTE) of less than 1%, with a negative predictive value of more than 99 to 100% during 3-month follow-up. Compression ultrasonography (CUS) and spiral computed tomography (CT) currently are the methods of choice to confirm or rule out deep venous thrombosis (DVT) and pulmonary embolism (PE), respectively. CUS has a negative predictive value (NPV) of 97 to 98%, indicating the need to improve the diagnostic work-up of patients with suspected DVT by clinical score assessment and D-dimer testing. Spiral CT as a stand-alone method detects all clinically relevant PEs and a large number of alternative diagnoses. It rules out PE with a NPV of 98 to 99%. Spiral CT is expensive, emphasizing the need to improve the diagnostic work-up of patients with suspected PE by the use of clinical score assessment and D-dimer testing. Clinical score assessment for DVT and PE has not safely ruled out VTE in multicenter studies and in routine daily practices. Modification of the Wells clinical score assessment for DVT by elimination of the "minus 2 points" for alternative diagnosis will improve the reproducibility of the clinical score assessment. The combination of a first negative CUS and a negative SimpliRed or an enzyme-linked immunosorbent assay (ELISA) VIDAS D-dimer of < 1,000 ng/mL safely exclude DVT (NPV > 99%) irrespective of clinical score assessment and without the need to repeat CUS in approximately 60 to 70% of patients. The rapid quantitative and qualitative agglutination D-dimer assays for the exclusion of VTE are not sensitive enough as stand-alone tests and should be used in combination with clinical score assessment. A normal rapid ELISA VIDAS D-dimer test as a stand-alone test safely excludes DVT and PE, with a NPV of 99 to 100%, irrespective of clinical score, without the need of CUS or spiral CT. The combined strategy of a rapid ELISA VIDAS D-dimer followed by objective testing with CUS for DVT and by spiral CT for PE will reduce the need for noninvasive imaging techniques by 40 to 50%. SN - 0094-6176 UR - https://www.unboundmedicine.com/medline/citation/17024595/Different_accuracies_of_rapid_enzyme_linked_immunosorbent_turbidimetric_and_agglutination_D_dimer_assays_for_thrombosis_exclusion:_impact_on_diagnostic_work_ups_of_outpatients_with_suspected_deep_vein_thrombosis_and_pulmonary_embolism_ L2 - http://www.thieme-connect.com/DOI/DOI?10.1055/s-2006-951296 DB - PRIME DP - Unbound Medicine ER -