Application of a Novel and Rapid Whole Blood Assay for D-Dimer in Patients with Clinically Suspected Pulmonary Embolism

Ginsberg, Jeffrey S.; Wells, P. S.; Brill-Edwards, Patrick; Donovan, Dianne; Panju, Akbar; Beek, Edwin Jacques Rudolph van; Patel, Ameen

doi:10.1055/s-0038-1653722

Cited by 110 publications

(64 citation statements)

References 17 publications

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“…This SimpliRED method had a sensitivity of 93% for proximal DVT, but only 70% for distal DVT. Other investigators also reported high sensitivity and negative predictive value for this rapid whole blood assay in suspected pulmonary embolism 11 and suspected DVT. 12 In our study, selection bias may have resulted from excluding patients with symptoms exceeding 7 days' duration; however, the time lag between the thrombotic event and diagnostic procedures may result in a false-negative D-dimer result.…”

Section: Discussionmentioning

confidence: 81%

Evaluation of a New Rapid D-Dimer Assay for Clinically Suspected Deep Venous Thrombosis (Liatest D-Dimer)

Escoffre‐Barbe¹,

Oger²,

Leroyer³

et al. 1998

Am J Clin Pathol

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Several studies have evaluated D-dimer, a fragment that is specific for the degradation of fibrin, 1 in patients with clinically suspected d e e p v e n o u s thrombosis (DVT).2 Because of their long half-lives, D-dimers provide a better choice than markers with shorter half-lives (thrombin-antithrombin complexes and prothrombin fragments 1 + 2) in evaluating the DVTs. Two D-dimer techniques are currently available: an e n z y m e l i n k e d -i m m u n o s o r b e n t assay (ELISA) or a latex agglutination assay. In preliminary studies, the ELISA assay has been reported to have very high sensitivity and moderate specificity. ELISA is the more widely used method. However, because it is time consuming, it is not well adapted for emergency testing; in addition, ELISA formatting is not usually suitable for individual testing. Studies involving latex testing for the measurement of Ddimer have frequently reported insufficient sensitivity for the exclusion of DVT. The purpose of the present study was to determine the performance of a new, quantitative and automated rapid D-dimer assay in the diagnosis of s u s p e c t e d DVT in a cohort of patients in whom symptoms had developed within 7 days before admission to the hospital. METHODS PatientsData for all patients with a possible diagnosis of DVT w h o were a d m i t t e d to the D e p a r t m e n t of Pneumology and Internal Medicine were collected prospectively on a register from March 1992 to June 1995. Recent clinical symptoms of DVT (onset less than 7 days) had to be present. The clinical suspicion of DVT occurred before hospitalization, so patients were referred for diagnosis, or during the first clinical 748

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Section: Discussionmentioning

confidence: 81%

Evaluation of a New Rapid D-Dimer Assay for Clinically Suspected Deep Venous Thrombosis (Liatest D-Dimer)

Escoffre‐Barbe¹,

Oger²,

Leroyer³

et al. 1998

Am J Clin Pathol

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“…The diagnostic performance of the new test is identical to that of classical ELISA assays. Novel whole-blood bedside latex assays for D-dimer seem equally promising (30,31), but the experience with these tests is still limited, and the problem of interobserver variability inherent to the latex technique was not addressed in the studies in which it showed promise. Moreover, the latex assays do not provide quantitative results.…”

Section: Discussionmentioning

confidence: 99%

D-dimer Testing for Suspected Pulmonary Embolism in Outpatients

Perrier

Desmarais

Goehring

et al. 1997

Am J Respir Crit Care Med

247

164

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The plasma level of D-dimer, a fibrin degradation product (FDP), is nearly always increased in the presence of acute pulmonary embolism (PE). Hence, a normal D-dimer level (below a cutoff value of 500 micrograms/L by enzyme-linked immunosorbent assay [ELISA]) may allow the exclusion of PE. To assess the negative predictive value of a D-dimer concentration below 500 micrograms/L in outpatients with suspected PE, and the safety of withholding anticoagulant treatment from such patients, we performed D-dimer assays, lower limb venous compression ultrasonography, and lung scans in 671 consecutive outpatients presenting in the Emergency Center of the Geneva University Hospital with suspected PE. Pulmonary angiography was reserved for patients with an inconclusive noninvasive workup. Patients with a normal D-dimer concentration were discharged without anticoagulant treatment and followed for 3 mo. The prevalence of PE was 29%, and D-dimer (using a cutoff of 500 micrograms/L) had a diagnostic sensitivity for PE of 99.5%. Overall diagnostic specificity of D-dimer was 41%, but it was lower among older patients. Of the 198 patients with a D-dimer concentration below the cutoff value, 196 were free of PE, one had a PE, and one had incomplete information because of loss to follow-up. Thus, the negative predictive value of D-dimer concentration fell between 197 of 198 and 196 of 198 cases of PE (99% [95% CI: 96.4 to 99.9]). Using a cutoff value of 4,000 micrograms/L, the overall specificity of D-dimer concentration for PE was 93.1%. In conclusion, a plasma D-dimer concentration below 500 micrograms/L allows the exclusion of PE in 29% of outpatients suspected of having PE. Withholding anticoagulation from such patients is associated with a conservative 1% risk of thromboembolic events during follow-up.

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“…Semiquantitative Latex agglutination assays are rapid, but their sensitivity is too low for them to be used as an exclusion test. New rapid D-Dimer assays have recently been developed, and pilot studies have proved promising; however, because of the limited number of patients tested, large confidence intervals of their diagnostic performances have been reported (18,19).…”

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confidence: 99%

Evaluation of a New, Rapid, and Quantitative D-Dimer Test in Patients with Suspected Pulmonary Embolism

Oger¹,

Leroyer²,

Bressollette³

et al. 1998

Am J Respir Crit Care Med

104

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Previous studies have suggested the utility of D-Dimer ELISA assays in eliminating a diagnosis of pulmonary embolism (PE). Our objectives were to evaluate the performance of a new, rapid, quantitative, and automated Liatest D-Dimer Assay in patients with suspected PE. Three hundred eighty-six consecutive patients referred to our institution between March 1992 and December 1996 for clinically suspected PE, with recent clinical signs not exceeding 1 wk, were included in this study. Diagnosis of PE was based on clinical evaluation, radionuclide lung imaging, lower limb examination, and, when required, pulmonary angiography. D-Dimer performances, for both Liatest D-Dimer and standard D-Dimer ELISA (Asserachrom DDi), assays, were assessed at the end of the study. Among the 386 patients tested, 146 (37.8%) were classified as PE-positive. Liatest D-Dimer assay had a 100% sensitivity (95% confidence interval, 97 to 100%) and a negative predictive value of 100% (95% confidence interval, 94 to 100%). A normal result, below the cutoff of 500 ng/ml, occurred in 83 of the 386 (21%) patients. There was a strong agreement between Liatest D-Dimer and Asserachrom DDi analyses. These findings suggest that this rapid, quantitative, and automated D-Dimer assay provides a useful diagnostic tool for the clinician with regard to exclusion of PE.

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Application of a Novel and Rapid Whole Blood Assay for D-Dimer in Patients with Clinically Suspected Pulmonary Embolism

Cited by 110 publications

References 17 publications

Evaluation of a New Rapid D-Dimer Assay for Clinically Suspected Deep Venous Thrombosis (Liatest D-Dimer)

Evaluation of a New Rapid D-Dimer Assay for Clinically Suspected Deep Venous Thrombosis (Liatest D-Dimer)

D-dimer Testing for Suspected Pulmonary Embolism in Outpatients

Evaluation of a New, Rapid, and Quantitative D-Dimer Test in Patients with Suspected Pulmonary Embolism

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