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Application of a novel and rapid whole blood assay for D-dimer in patients with clinically suspected pulmonary embolism.
Thromb Haemost. 1995 Jan; 73(1):35-8.TH

Abstract

STUDY OBJECTIVE

To determine the clinical utility of a novel whole blood assay for D-dimer (SimpliRED) in patients with clinically suspected pulmonary embolism (PE).

DESIGN

Prospective cohort.

PATIENTS

Eighty-six consecutive patients with clinically suspected PE.

INTERVENTION

All patients had the SimpliRED D-dimer assay performed and underwent ventilation/perfusion (V/Q) lung scanning and bilateral impedance plethysmography (IPG); pulmonary angiography was performed in two patients. Patients were classified as: 1) PE-positive; positive pulmonary angiography or high probability V/Q scan or non-high probability V/Q scan and either abnormal IPG (either at presentation or upon serial testing and confirmed by contrast venography) or symptomatic thromboembolic event within three months of presentation or 2) PE-negative; normal V/Q scan or normal pulmonary angiography or non-high probability V/Q scan and normal serial IPG and absence of symptomatic venous thromboembolism within three months of follow up. Sixteen (19%) patients were classified as PE-positive and 70 (81%) patients were classified as PE-negative. MEASUREMENTS AND RESULT: The sensitivities, specificities, positive predictive values, and negative predictive values of the D-dimer assay were calculated for all patients and for the subgroup of patients without comorbid conditions that independently can cause elevated D-dimer levels. The D-dimer showed a sensitivity of 94%, a negative predictive value of 98%, a specificity of 66%, and a positive predictive value of 38%. In the subgroup of patients without comorbid conditions, the specificity increased to 98% and the positive predictive value to 83%, but because only six patients had an abnormal D-dimer level, the 95% confidence interval on the observed positive predictive value is wide (36-100%).

CONCLUSIONS

This study demonstrates that the SimpliRED D-dimer assay, which can be performed and interpreted at the bedside within five minutes, has potential clinical utility as an exclusionary test in patients with clinically suspected PE. The assay should be evaluated in large clinical management studies.

Authors+Show Affiliations

Department of Medicine, McMaster University, Hamilton, Canada.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

7740493

Citation

Ginsberg, J S., et al. "Application of a Novel and Rapid Whole Blood Assay for D-dimer in Patients With Clinically Suspected Pulmonary Embolism." Thrombosis and Haemostasis, vol. 73, no. 1, 1995, pp. 35-8.
Ginsberg JS, Wells PS, Brill-Edwards P, et al. Application of a novel and rapid whole blood assay for D-dimer in patients with clinically suspected pulmonary embolism. Thromb Haemost. 1995;73(1):35-8.
Ginsberg, J. S., Wells, P. S., Brill-Edwards, P., Donovan, D., Panju, A., van Beek, E. J., & Patel, A. (1995). Application of a novel and rapid whole blood assay for D-dimer in patients with clinically suspected pulmonary embolism. Thrombosis and Haemostasis, 73(1), 35-8.
Ginsberg JS, et al. Application of a Novel and Rapid Whole Blood Assay for D-dimer in Patients With Clinically Suspected Pulmonary Embolism. Thromb Haemost. 1995;73(1):35-8. PubMed PMID: 7740493.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Application of a novel and rapid whole blood assay for D-dimer in patients with clinically suspected pulmonary embolism. AU - Ginsberg,J S, AU - Wells,P S, AU - Brill-Edwards,P, AU - Donovan,D, AU - Panju,A, AU - van Beek,E J, AU - Patel,A, PY - 1995/1/1/pubmed PY - 1995/1/1/medline PY - 1995/1/1/entrez SP - 35 EP - 8 JF - Thrombosis and haemostasis JO - Thromb. Haemost. VL - 73 IS - 1 N2 - STUDY OBJECTIVE: To determine the clinical utility of a novel whole blood assay for D-dimer (SimpliRED) in patients with clinically suspected pulmonary embolism (PE). DESIGN: Prospective cohort. PATIENTS: Eighty-six consecutive patients with clinically suspected PE. INTERVENTION: All patients had the SimpliRED D-dimer assay performed and underwent ventilation/perfusion (V/Q) lung scanning and bilateral impedance plethysmography (IPG); pulmonary angiography was performed in two patients. Patients were classified as: 1) PE-positive; positive pulmonary angiography or high probability V/Q scan or non-high probability V/Q scan and either abnormal IPG (either at presentation or upon serial testing and confirmed by contrast venography) or symptomatic thromboembolic event within three months of presentation or 2) PE-negative; normal V/Q scan or normal pulmonary angiography or non-high probability V/Q scan and normal serial IPG and absence of symptomatic venous thromboembolism within three months of follow up. Sixteen (19%) patients were classified as PE-positive and 70 (81%) patients were classified as PE-negative. MEASUREMENTS AND RESULT: The sensitivities, specificities, positive predictive values, and negative predictive values of the D-dimer assay were calculated for all patients and for the subgroup of patients without comorbid conditions that independently can cause elevated D-dimer levels. The D-dimer showed a sensitivity of 94%, a negative predictive value of 98%, a specificity of 66%, and a positive predictive value of 38%. In the subgroup of patients without comorbid conditions, the specificity increased to 98% and the positive predictive value to 83%, but because only six patients had an abnormal D-dimer level, the 95% confidence interval on the observed positive predictive value is wide (36-100%). CONCLUSIONS: This study demonstrates that the SimpliRED D-dimer assay, which can be performed and interpreted at the bedside within five minutes, has potential clinical utility as an exclusionary test in patients with clinically suspected PE. The assay should be evaluated in large clinical management studies. SN - 0340-6245 UR - https://www.unboundmedicine.com/medline/citation/7740493/Application_of_a_novel_and_rapid_whole_blood_assay_for_D_dimer_in_patients_with_clinically_suspected_pulmonary_embolism_ L2 - http://www.diseaseinfosearch.org/result/2504 DB - PRIME DP - Unbound Medicine ER -