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Multicenter evaluation of a new quantitative highly sensitive D-dimer assay, the Hemosil D-dimer HS 500, in patients with clinically suspected venous thromboembolism.
Thromb Res. 2010 May; 125(5):398-401.TR

Abstract

INTRODUCTION

D-dimer testing is widely used in conjunction with clinical pretest probability (PTP) for venous thromboembolism (VTE) exclusion. We report on a multicenter evaluation of a new, automated, latex enhanced turbidimetric immunoassay [HemosIL D-Dimer HS 500, Instrumentation Laboratory (IL)].

MATERIALS AND METHODS

747 consecutive outpatients with suspected proximal deep vein thrombosis (DVT, n=401) or pulmonary embolism (PE, n=346) were evaluated at four university hospitals in a management study with a 3 month follow-up. Samples were tested at each center using the new D-dimer assay on an automated coagulation analyzer [ACL TOP (IL)], with clinical cut-off for VTE at 500 ng/mL (FEU).

RESULTS

The sensitivity and negative predictive value (NPV) were 100% for all PTP subgroups (no false negative results); for both sensitivity and NPV the lower limit of the 95% CI in patients with moderate/low PTP was higher than 95%. The overall specificity was 45.1% (95%CI: 41.1-49.3%). Higher specificity value was recorded in the low PTP subgroup [49.2% (95%CI: 41.7-56.7)]. No significant differences were found between patients suspected of having DVT or PE; sensitivity and NPV were 100%. The reproducibility of the assay was good, being the total CVs% less than 10% for D-dimer concentration near the clinical cut-off.

CONCLUSIONS

The new, highly sensitive D-dimer assay proved to be accurate when used for VTE diagnostic work-up in outpatients. Based on 100% sensitivity and NPV and lower limit of the 95% CI higher than 95%, the assay can be used as a stand-alone test in patients with non high PTP.

Authors+Show Affiliations

Dept Angiology and Blood Coagulation Marino Golinelli, University Hospital S Orsola-Malpighi, Bologna, Italy. cristina.legnani@aosp.bo.itNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Evaluation Study
Journal Article
Multicenter Study

Language

eng

PubMed ID

19683797

Citation

Legnani, Cristina, et al. "Multicenter Evaluation of a New Quantitative Highly Sensitive D-dimer Assay, the Hemosil D-dimer HS 500, in Patients With Clinically Suspected Venous Thromboembolism." Thrombosis Research, vol. 125, no. 5, 2010, pp. 398-401.
Legnani C, Cini M, Scarvelis D, et al. Multicenter evaluation of a new quantitative highly sensitive D-dimer assay, the Hemosil D-dimer HS 500, in patients with clinically suspected venous thromboembolism. Thromb Res. 2010;125(5):398-401.
Legnani, C., Cini, M., Scarvelis, D., Toulon, P., Wu, J. R., & Palareti, G. (2010). Multicenter evaluation of a new quantitative highly sensitive D-dimer assay, the Hemosil D-dimer HS 500, in patients with clinically suspected venous thromboembolism. Thrombosis Research, 125(5), 398-401. https://doi.org/10.1016/j.thromres.2009.07.013
Legnani C, et al. Multicenter Evaluation of a New Quantitative Highly Sensitive D-dimer Assay, the Hemosil D-dimer HS 500, in Patients With Clinically Suspected Venous Thromboembolism. Thromb Res. 2010;125(5):398-401. PubMed PMID: 19683797.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Multicenter evaluation of a new quantitative highly sensitive D-dimer assay, the Hemosil D-dimer HS 500, in patients with clinically suspected venous thromboembolism. AU - Legnani,Cristina, AU - Cini,Michela, AU - Scarvelis,Dimitrios, AU - Toulon,Pierre, AU - Wu,Jogin R, AU - Palareti,Gualtiero, Y1 - 2009/08/15/ PY - 2009/06/05/received PY - 2009/07/19/revised PY - 2009/07/21/accepted PY - 2009/8/18/entrez PY - 2009/8/18/pubmed PY - 2010/7/28/medline SP - 398 EP - 401 JF - Thrombosis research JO - Thromb. Res. VL - 125 IS - 5 N2 - INTRODUCTION: D-dimer testing is widely used in conjunction with clinical pretest probability (PTP) for venous thromboembolism (VTE) exclusion. We report on a multicenter evaluation of a new, automated, latex enhanced turbidimetric immunoassay [HemosIL D-Dimer HS 500, Instrumentation Laboratory (IL)]. MATERIALS AND METHODS: 747 consecutive outpatients with suspected proximal deep vein thrombosis (DVT, n=401) or pulmonary embolism (PE, n=346) were evaluated at four university hospitals in a management study with a 3 month follow-up. Samples were tested at each center using the new D-dimer assay on an automated coagulation analyzer [ACL TOP (IL)], with clinical cut-off for VTE at 500 ng/mL (FEU). RESULTS: The sensitivity and negative predictive value (NPV) were 100% for all PTP subgroups (no false negative results); for both sensitivity and NPV the lower limit of the 95% CI in patients with moderate/low PTP was higher than 95%. The overall specificity was 45.1% (95%CI: 41.1-49.3%). Higher specificity value was recorded in the low PTP subgroup [49.2% (95%CI: 41.7-56.7)]. No significant differences were found between patients suspected of having DVT or PE; sensitivity and NPV were 100%. The reproducibility of the assay was good, being the total CVs% less than 10% for D-dimer concentration near the clinical cut-off. CONCLUSIONS: The new, highly sensitive D-dimer assay proved to be accurate when used for VTE diagnostic work-up in outpatients. Based on 100% sensitivity and NPV and lower limit of the 95% CI higher than 95%, the assay can be used as a stand-alone test in patients with non high PTP. SN - 1879-2472 UR - https://www.unboundmedicine.com/medline/citation/19683797/Multicenter_evaluation_of_a_new_quantitative_highly_sensitive_D_dimer_assay_the_Hemosil_D_dimer_HS_500_in_patients_with_clinically_suspected_venous_thromboembolism_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0049-3848(09)00334-X DB - PRIME DP - Unbound Medicine ER -