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Validation of a new D-dimer microparticle enzyme immunoassay (AxSYM D-Dimer) in patients with suspected pulmonary embolism (PE).
Thromb Res. 2007; 120(4):471-6.TR

Abstract

OBJECTIVES

The aim of the study was to evaluate a new automated assay for D-dimer testing (AxSYM D-Dimer) based on microparticle enzyme-immunoassay technology by comparing it with three well established D-dimer assays.

PATIENTS AND METHODS

The performance of the new assay was evaluated in 280 plasma samples that were collected prospectively from out-patients included in a management study evaluating a decision based algorithm.

RESULTS

58/280 patients (21%) had PE diagnosed by CT. Median values of AxSYM D-dimer in patients with PE were 3689 ng/mL (range 775-9000). Comparison analysis displayed excellent agreement with VIDAS (kappa=0.84) and Asserachrom (kappa=0.81) D-dimer assays. A strong correlation was found between AxSYM and the VIDAS (r=0.96) and Asserachrom (r=0.89) D-dimer assays. The highest cut-off value for AxSYM that yielded a sensitivity of 100% was 765 ng/mL with a specificity of 50%. At the cut-off level <500 ng/mL, the sensitivity and specificity of AxSYM D-dimer were 100% and 34%; VIDAS 100% and 42%; Asserachrom 100% and 40%; and STALiatest 100% and 37%, respectively. AxSYM D-dimer was negative in 75 patients (33.8%). None of these had PE at the initial work-up or VTE during the 3-month follow-up.

CONCLUSIONS

AxSYM D-dimer seems to be safe and effective in ruling out PE in out-patients. The cut-off level can be set at 500 to 750 ng/mL, at which the assay displays a performance that is comparable to that of the ELISA based assays. However, further studies are needed to confirm the safety of the assay and to determine the most optimal cut-off level in patients with venous thromboembolism.

Authors+Show Affiliations

Department of Medicine, Østfold Hospital Trust, Fredrikstad, Norway. waleed.ghanima@so-hf.noNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Research Support, Non-U.S. Gov't
Validation Study

Language

eng

PubMed ID

17161451

Citation

Ghanima, W, and P M. Sandset. "Validation of a New D-dimer Microparticle Enzyme Immunoassay (AxSYM D-Dimer) in Patients With Suspected Pulmonary Embolism (PE)." Thrombosis Research, vol. 120, no. 4, 2007, pp. 471-6.
Ghanima W, Sandset PM. Validation of a new D-dimer microparticle enzyme immunoassay (AxSYM D-Dimer) in patients with suspected pulmonary embolism (PE). Thromb Res. 2007;120(4):471-6.
Ghanima, W., & Sandset, P. M. (2007). Validation of a new D-dimer microparticle enzyme immunoassay (AxSYM D-Dimer) in patients with suspected pulmonary embolism (PE). Thrombosis Research, 120(4), 471-6.
Ghanima W, Sandset PM. Validation of a New D-dimer Microparticle Enzyme Immunoassay (AxSYM D-Dimer) in Patients With Suspected Pulmonary Embolism (PE). Thromb Res. 2007;120(4):471-6. PubMed PMID: 17161451.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Validation of a new D-dimer microparticle enzyme immunoassay (AxSYM D-Dimer) in patients with suspected pulmonary embolism (PE). AU - Ghanima,W, AU - Sandset,P M, Y1 - 2006/12/08/ PY - 2006/08/24/received PY - 2006/10/31/revised PY - 2006/11/08/accepted PY - 2006/12/13/pubmed PY - 2007/10/19/medline PY - 2006/12/13/entrez SP - 471 EP - 6 JF - Thrombosis research JO - Thromb Res VL - 120 IS - 4 N2 - OBJECTIVES: The aim of the study was to evaluate a new automated assay for D-dimer testing (AxSYM D-Dimer) based on microparticle enzyme-immunoassay technology by comparing it with three well established D-dimer assays. PATIENTS AND METHODS: The performance of the new assay was evaluated in 280 plasma samples that were collected prospectively from out-patients included in a management study evaluating a decision based algorithm. RESULTS: 58/280 patients (21%) had PE diagnosed by CT. Median values of AxSYM D-dimer in patients with PE were 3689 ng/mL (range 775-9000). Comparison analysis displayed excellent agreement with VIDAS (kappa=0.84) and Asserachrom (kappa=0.81) D-dimer assays. A strong correlation was found between AxSYM and the VIDAS (r=0.96) and Asserachrom (r=0.89) D-dimer assays. The highest cut-off value for AxSYM that yielded a sensitivity of 100% was 765 ng/mL with a specificity of 50%. At the cut-off level <500 ng/mL, the sensitivity and specificity of AxSYM D-dimer were 100% and 34%; VIDAS 100% and 42%; Asserachrom 100% and 40%; and STALiatest 100% and 37%, respectively. AxSYM D-dimer was negative in 75 patients (33.8%). None of these had PE at the initial work-up or VTE during the 3-month follow-up. CONCLUSIONS: AxSYM D-dimer seems to be safe and effective in ruling out PE in out-patients. The cut-off level can be set at 500 to 750 ng/mL, at which the assay displays a performance that is comparable to that of the ELISA based assays. However, further studies are needed to confirm the safety of the assay and to determine the most optimal cut-off level in patients with venous thromboembolism. SN - 0049-3848 UR - https://www.unboundmedicine.com/medline/citation/17161451/Validation_of_a_new_D_dimer_microparticle_enzyme_immunoassay__AxSYM_D_Dimer__in_patients_with_suspected_pulmonary_embolism__PE__ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0049-3848(06)00472-5 DB - PRIME DP - Unbound Medicine ER -