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Evaluation of a rapid qualitative immuno-chromatography D-dimer assay (Simplify D-dimer) for the exclusion of pulmonary embolism in symptomatic outpatients with a low and intermediate pretest probability. Comparison with two automated quantitative assays.
Thromb Res. 2009; 123(3):543-9.TR

Abstract

The performance of a rapid qualitative solid-phase immuno-chromatography-based D-dimer assay (Simplify D-dimer) for diagnosing pulmonary embolism (PE) was evaluated in 469 outpatients with a low or intermediate pretest probability. They were referred to the emergency department of a university hospital during a 4-month period. Test results were compared to those of two automated quantitative assays. Simplify D-dimer assay result was positive in all 47 patients in whom the diagnosis of PE was retained and in 219 of the 422 patients without PE (51.2%), leading to a sensitivity of 100% (95%CI, 92.5 to 100%), a specificity of 48.8% (95%CI, 44.0 to 53.6%) and a negative predictive value (NPV) of 100% (95%CI, 98.2 to 100%). These results compared favorably with those of the Vidas D-dimer New assay [sensitivity=100% (95%CI, 92.5 to 100), specificity=49.8% (95%CI, 45.0 to 54.6%) and NPV=100% (95%CI, 98.3 to 100%)] and the STA-Liatest D-DI assay [sensitivity=100% (95%CI, 92.5 to 100%), specificity=48.1% (95%CI, 43.3 to 52.9%) and NPV=100% (95%CI, 98.2 to 100%)]. The inter-observer (n=2) variability was very good with 1.7% discordant readings and a kappa coefficient (K) value=0.97 (95%CI, 0.93 to 1.00). In conclusion, the Simplify D-dimer assay could be a valuable tool for ruling out PE in out-patients but a specific learning course of those having to work with is required in order to minimize the number of ambiguous reading and to overcome the inter-observer variability.

Authors+Show Affiliations

Université de Nice-Sophia Antipolis, Faculté de Médecine, Service d' Hématologie Biologique, Nice, France. toulon.p@chu-nice.frNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Evaluation Study
Journal Article

Language

eng

PubMed ID

18692869

Citation

Toulon, Pierre, et al. "Evaluation of a Rapid Qualitative Immuno-chromatography D-dimer Assay (Simplify D-dimer) for the Exclusion of Pulmonary Embolism in Symptomatic Outpatients With a Low and Intermediate Pretest Probability. Comparison With Two Automated Quantitative Assays." Thrombosis Research, vol. 123, no. 3, 2009, pp. 543-9.
Toulon P, Lecourvoisier C, Meyniard O. Evaluation of a rapid qualitative immuno-chromatography D-dimer assay (Simplify D-dimer) for the exclusion of pulmonary embolism in symptomatic outpatients with a low and intermediate pretest probability. Comparison with two automated quantitative assays. Thromb Res. 2009;123(3):543-9.
Toulon, P., Lecourvoisier, C., & Meyniard, O. (2009). Evaluation of a rapid qualitative immuno-chromatography D-dimer assay (Simplify D-dimer) for the exclusion of pulmonary embolism in symptomatic outpatients with a low and intermediate pretest probability. Comparison with two automated quantitative assays. Thrombosis Research, 123(3), 543-9. https://doi.org/10.1016/j.thromres.2008.05.013
Toulon P, Lecourvoisier C, Meyniard O. Evaluation of a Rapid Qualitative Immuno-chromatography D-dimer Assay (Simplify D-dimer) for the Exclusion of Pulmonary Embolism in Symptomatic Outpatients With a Low and Intermediate Pretest Probability. Comparison With Two Automated Quantitative Assays. Thromb Res. 2009;123(3):543-9. PubMed PMID: 18692869.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of a rapid qualitative immuno-chromatography D-dimer assay (Simplify D-dimer) for the exclusion of pulmonary embolism in symptomatic outpatients with a low and intermediate pretest probability. Comparison with two automated quantitative assays. AU - Toulon,Pierre, AU - Lecourvoisier,Claire, AU - Meyniard,Olivier, Y1 - 2008/08/09/ PY - 2007/05/17/received PY - 2008/05/19/revised PY - 2008/05/29/accepted PY - 2008/8/12/pubmed PY - 2009/4/3/medline PY - 2008/8/12/entrez SP - 543 EP - 9 JF - Thrombosis research JO - Thromb. Res. VL - 123 IS - 3 N2 - The performance of a rapid qualitative solid-phase immuno-chromatography-based D-dimer assay (Simplify D-dimer) for diagnosing pulmonary embolism (PE) was evaluated in 469 outpatients with a low or intermediate pretest probability. They were referred to the emergency department of a university hospital during a 4-month period. Test results were compared to those of two automated quantitative assays. Simplify D-dimer assay result was positive in all 47 patients in whom the diagnosis of PE was retained and in 219 of the 422 patients without PE (51.2%), leading to a sensitivity of 100% (95%CI, 92.5 to 100%), a specificity of 48.8% (95%CI, 44.0 to 53.6%) and a negative predictive value (NPV) of 100% (95%CI, 98.2 to 100%). These results compared favorably with those of the Vidas D-dimer New assay [sensitivity=100% (95%CI, 92.5 to 100), specificity=49.8% (95%CI, 45.0 to 54.6%) and NPV=100% (95%CI, 98.3 to 100%)] and the STA-Liatest D-DI assay [sensitivity=100% (95%CI, 92.5 to 100%), specificity=48.1% (95%CI, 43.3 to 52.9%) and NPV=100% (95%CI, 98.2 to 100%)]. The inter-observer (n=2) variability was very good with 1.7% discordant readings and a kappa coefficient (K) value=0.97 (95%CI, 0.93 to 1.00). In conclusion, the Simplify D-dimer assay could be a valuable tool for ruling out PE in out-patients but a specific learning course of those having to work with is required in order to minimize the number of ambiguous reading and to overcome the inter-observer variability. SN - 0049-3848 UR - https://www.unboundmedicine.com/medline/citation/18692869/Evaluation_of_a_rapid_qualitative_immuno_chromatography_D_dimer_assay__Simplify_D_dimer__for_the_exclusion_of_pulmonary_embolism_in_symptomatic_outpatients_with_a_low_and_intermediate_pretest_probability__Comparison_with_two_automated_quantitative_assays_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0049-3848(08)00207-7 DB - PRIME DP - Unbound Medicine ER -