Document Detail


Performances of a new, automated latex assay for the exclusion of venous thromboembolism.
MedLine Citation:
PMID:  11414638     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The performance of a new latex-enhanced turbidimetric assay, D-Dimer PLUS, has been evaluated with two analyzers performing various coagulation assays: the BCS Analyzer and the BCT Analyzer. A precision study showed total coefficients of variation ranging from 2.7 to 11.1% with the BCS Analyzer and from 2.5 to 6.6% with the BCT Analyzer. We investigated the ability of D-Dimer PLUS to exclude venous thromboembolism in 312 outpatients suspected of either pulmonary embolism or deep venous thrombosis. Three months follow-up was available for all patients. With the BCS Analyzer, we determined a cut-off value of 190 ng/ml, which gave a sensitivity of 97.9% [95% confidence interval (CI), 92.6-99.7%], a specificity of 37.9% (95% CI, 30.9-43.8%) and a negative predictive value of 97.6% (95% CI, 91.7-99.7%). With the BCT Analyzer, at a cut-off value of 130 ng/ml, sensitivity was 96.8% (95% CI, 91.0-99.3%), specificity was 45.2% (95% CI, 38.5-51.2%) and the negative predictive value was 97% (95% CI, 91.6-99.4). This new assay is fast and fully automated, and its performance is suitable to exclude venous thromboembolism. Management studies should be performed to assess its utility.
Authors:
G Reber; H Bounameaux; A Perrier; P de Moerloose
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Publication Detail:
Type:  Comparative Study; Evaluation Studies; Journal Article    
Journal Detail:
Title:  Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis     Volume:  12     ISSN:  0957-5235     ISO Abbreviation:  Blood Coagul. Fibrinolysis     Publication Date:  2001 Apr 
Date Detail:
Created Date:  2001-06-20     Completed Date:  2001-12-04     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  9102551     Medline TA:  Blood Coagul Fibrinolysis     Country:  England    
Other Details:
Languages:  eng     Pagination:  217-20     Citation Subset:  IM    
Affiliation:
Division of Angiology and Haemostasis, Geneva University Hospital, Switzerland. guido.reber@hcuge.ch
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Aged, 80 and over
Antibodies, Monoclonal / immunology
Calibration
Female
Fibrin Fibrinogen Degradation Products / analysis*
Humans
Latex Fixation Tests* / instrumentation*
Male
Middle Aged
Nephelometry and Turbidimetry / instrumentation*
Predictive Value of Tests
Prevalence
Pulmonary Embolism / blood,  diagnosis*,  epidemiology
ROC Curve
Random Allocation
Reference Values
Sensitivity and Specificity
Venous Thrombosis / blood,  diagnosis*,  epidemiology
Chemical
Reg. No./Substance:
0/Antibodies, Monoclonal; 0/Fibrin Fibrinogen Degradation Products; 0/fibrin fragment D

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