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Performance of two relatively new quantitative D-dimer assays (Innovance D-dimer and AxSYM D-dimer) for the exclusion of deep vein thrombosis.

Elf, Johan LU ; Strandberg, Karin LU and Svensson, Peter LU (2009) In Thrombosis Research 124. p.701-705
Abstract
INTRODUCTION: D-dimer assays are now widely used as the first-line test in the diagnostic algorithm of suspected deep vein thrombosis (DVT). The aim of this study was to evaluate the performance of two relatively new quantitative D-Dimer assays (Innovance and AxSYM(R)) by comparison with a clinical gold standard. PATIENTS AND METHODS: 311 samples from outpatients with clinical suspicion of DVT, included in a prospective management study, was analysed (prevalence of DVT 23%). The diagnostic workup included estimation of pre-test probability, D-dimer determination, objective imaging as well as 3 month clinical follow up of negative patients. RESULTS: No significant differences were seen in sensitivity and negative predictive values between... (More)
INTRODUCTION: D-dimer assays are now widely used as the first-line test in the diagnostic algorithm of suspected deep vein thrombosis (DVT). The aim of this study was to evaluate the performance of two relatively new quantitative D-Dimer assays (Innovance and AxSYM(R)) by comparison with a clinical gold standard. PATIENTS AND METHODS: 311 samples from outpatients with clinical suspicion of DVT, included in a prospective management study, was analysed (prevalence of DVT 23%). The diagnostic workup included estimation of pre-test probability, D-dimer determination, objective imaging as well as 3 month clinical follow up of negative patients. RESULTS: No significant differences were seen in sensitivity and negative predictive values between Innovance, AxSYM and the reference assays. The area under the ROC curve was slightly lower for the AxSYM assay and the correlation to the reference assays was only moderate (r<0.8) whereas the agreement with the Vidas assay was near excellent (kappa=0.8). The Innovance assay reached the highest AUC, showed a strong correlation with the reference assays (r>/=0.9) and a good agreement with the Vidas assay (kappa=0.76). In combination with a low pre-test probability score the Innovance assay reached a NPV of 100% (95% CI, 92-100) and the AxSYM assay 98% (95% CI, 87-100). CONCLUSION: The Innovance and AxSYM assays show an overall good and comparable performance for the exclusion of DVT when compared to the established assays. Our results for the AxSYM assay indicate that the optimal cut-off value needs to be further evaluated. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Thrombosis Research
volume
124
pages
701 - 705
publisher
Elsevier Ltd
external identifiers
  • wos:000272857500013
  • pmid:19682729
  • scopus:70449527569
ISSN
1879-2472
DOI
10.1016/j.thromres.2009.07.008
language
English
LU publication?
yes
id
fa185e27-a074-45bd-9f6f-022b500c74a4 (old id 1469691)
alternative location
http://www.ncbi.nlm.nih.gov/pubmed/19682729?dopt=Abstract
date added to LUP
2009-09-03 13:43:02
date last changed
2017-08-27 05:44:57
@article{fa185e27-a074-45bd-9f6f-022b500c74a4,
  abstract     = {INTRODUCTION: D-dimer assays are now widely used as the first-line test in the diagnostic algorithm of suspected deep vein thrombosis (DVT). The aim of this study was to evaluate the performance of two relatively new quantitative D-Dimer assays (Innovance and AxSYM(R)) by comparison with a clinical gold standard. PATIENTS AND METHODS: 311 samples from outpatients with clinical suspicion of DVT, included in a prospective management study, was analysed (prevalence of DVT 23%). The diagnostic workup included estimation of pre-test probability, D-dimer determination, objective imaging as well as 3 month clinical follow up of negative patients. RESULTS: No significant differences were seen in sensitivity and negative predictive values between Innovance, AxSYM and the reference assays. The area under the ROC curve was slightly lower for the AxSYM assay and the correlation to the reference assays was only moderate (r&lt;0.8) whereas the agreement with the Vidas assay was near excellent (kappa=0.8). The Innovance assay reached the highest AUC, showed a strong correlation with the reference assays (r&gt;/=0.9) and a good agreement with the Vidas assay (kappa=0.76). In combination with a low pre-test probability score the Innovance assay reached a NPV of 100% (95% CI, 92-100) and the AxSYM assay 98% (95% CI, 87-100). CONCLUSION: The Innovance and AxSYM assays show an overall good and comparable performance for the exclusion of DVT when compared to the established assays. Our results for the AxSYM assay indicate that the optimal cut-off value needs to be further evaluated.},
  author       = {Elf, Johan and Strandberg, Karin and Svensson, Peter},
  issn         = {1879-2472},
  language     = {eng},
  pages        = {701--705},
  publisher    = {Elsevier Ltd},
  series       = {Thrombosis Research},
  title        = {Performance of two relatively new quantitative D-dimer assays (Innovance D-dimer and AxSYM D-dimer) for the exclusion of deep vein thrombosis.},
  url          = {http://dx.doi.org/10.1016/j.thromres.2009.07.008},
  volume       = {124},
  year         = {2009},
}