Multicenter evaluation of a new quantitative highly sensitive D-dimer assay, the Hemosil® D-dimer HS 500, in patients with clinically suspected venous thromboembolism

Legnani, Cristina; Cini, Michela; Scarvelis, Dimitrios; Toulon, Pierre; Wu, Jaclyn; Palareti, Gualtiero

doi:10.1016/j.thromres.2009.07.013

Cited by 38 publications

(39 citation statements)

References 23 publications

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“…[19] In another multicenter study of 747 patients with suspected VTE, the D-dimer assay proved to have 100% sensitivity and 100% NPV, and could be used to exclude VTE in patients with LCP. [20] In a prospective cohort study of 2206 patients with suspected PE who received follow-up for 3 months, the combination of negative D-dimer and PE was observed in 1057 patients (32.0%), of whom 1028 were not treated with anticoagulants; subsequent nonfatal VTE occurred in 5 patients (0.5%). [21]…”

Section: D-dimermentioning

confidence: 99%

Effectiveness of D-dimer as a screening test for venous thromboembolism: An update

2014

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Venous thromboembolism (VTE) is the leading cause of morbidity and mortality among hospitalized patients. We searched the PubMed database and reviewed the articles published until June 2011. Articles related to the D-dimer and VTE were considered to write this paper. Many factors play a key role in changing the sensitivity and specificity of D-dimer testing, including the extent of thrombosis and fibrinolytic activity, duration of symptoms, anticoagulant therapy, comorbidity due to surgical or medical illnesses, inflammatory diseases, cancer, elderly age, pregnancy and the postpartum period, and previous VTE. Many previous studies have shown that the D-dimer test is highly sensitive (>95%) in acute deep venous thrombosis or pulmonary embolism, usually with a cut-off value of 500 μg FEU/l, which reasonably rules out acute VTE, particularly in patients with low clinical probability (LCP) or intermediate clinical probability. Patients with high D-dimer levels upon presentation may prompt a more intense diagnostic approach, irrespective of pretest probability. Studies performed after a negative D-dimer for 3 months proved the high negative predictive value (NPV) of D-dimer testing together with LCP in patients with suspected VTE. Among oncology patients, D-dimer testing has the highest sensitivity and NPV in excluding VTE. The new cutoff values of D-dimer testing were analyzed in a recent prospective study of pregnant women; they are 286 ng DDU/ml, 457 ng DDU/ml, and 644 ng DDU/ml for the first, second, and third trimesters, respectively.

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Section: D-dimermentioning

confidence: 99%

Effectiveness of D-dimer as a screening test for venous thromboembolism: An update

2014

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“…12 In the original study, management 12 In all patients clinical probability was assessed using the Wells score. 13 DVT was ruled out based on: (i) a low clinical probability in combination with a normal D-dimer STALiatest (cut-off <500 mg/L FEU), (ii) a normal result on CUS or impedance plethysmography in patients with an abnormal Ddimer test and/or a high clinical probability of DVT.…”

Section: Cohortmentioning

confidence: 99%

Using an age-dependent D-dimer cut-off value increases the number of older patients in whom deep vein thrombosis can be safely excluded

et al. 2012

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BackgroundD-dimer testing to rule out deep vein thrombosis is less useful in older patients because of a lower specificity. An age-adjusted D-dimer cut-off value increased the proportion of older patients (>50 years) in whom pulmonary embolism could be excluded. We retrospectively validated the efficacy of this cut-off combined with clinical probability for the exclusion of deep vein thrombosis. Design and MethodsFive management study cohorts of 2818 consecutive outpatients with suspected deep vein thrombosis were used. Patients with non-high or unlikely probability of deep vein thrombosis were included in the analysis; four different D-dimer tests were used. The proportion of patients with a normal D-dimer test and the failure rates were calculated using the conventional (500 mg/L) and the age-adjusted D-dimer cut-off (patient's age x 10 mg/L in patients >50 years). ResultsIn 1672 patients with non-high probability, deep vein thrombosis could be excluded in 850 (51%) patients with the age-adjusted cut-off value versus 707 (42%) patients with the conventional cut-off value. The failure rates were 7 (0.8; 95% confidence interval 0.3-1.7%) for the age-adjusted cut-off value and 5 (0.7%, 0.2-1.6%) for the conventional cut-off value. The absolute increase in patients in whom deep vein thrombosis could be ruled out using the ageadjusted cut-off value was largest in patients >70 years: 19% among patients with non-high probability. ConclusionsThe age-adjusted cut-off of the D-dimer combined with clinical probability greatly increases the proportion of older patients in whom deep vein thrombosis can be safely excluded.

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“…To our knowledge, this is the first international management study conducted after the publication of the CLSI guideline and in compliance with CLSI and FDA recommendations with the purpose of evaluating the pulmonary embolism exclusion diagnosis performances of a D-dimer assay used in combination with a validated PTP. This study involved nine sites between Europe and North America and enrolled the largest study population to date (>1100 patients) [17,21,22]. …”

Section: Discussionmentioning

confidence: 99%

Validation of STA-Liatest D-Di assay for exclusion of pulmonary embolism according to the latest Clinical and Laboratory Standard Institute/Food and Drug Administration guideline. Results of a multicenter management study

Pernod

Maistre

et al. 2017

Blood Coagulation &Amp; Fibrinolysis

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Combined clinical pretest probability (PTP) and D-dimer testing have great diagnostic value for pulmonary embolism exclusion. To harmonize performance levels of D-dimer assays available on the market, the Clinical and Laboratory Standard Institute (CLSI) has published a guideline, endorsed by the US Food and Drug Administration (FDA). Such guideline specifies the ideal D-dimer assay characteristic and target population. This study was conducted following the CLSI guideline to upgrade the assay-intended use and obtain FDA clearance of STA-Liatest D-Di assay for pulmonary embolism exclusion in patient with low/moderate PTP. This was an international, multicenter, prospective nonrandomized, noninterventional clinical outcome management study conducted in a standard of care setting. D-dimer assay was performed in consecutive, ambulatory outpatients suspected of pulmonary embolism, with low/moderate PTP, and without medical conditions or in clinical settings known to alter default D-dimer values regardless of the presence of thrombosis using a threshold of 0.5 μg/ml (fibrinogen equivalent units) for venous thromboembolism exclusion. Results were used to determine test performance. Of 1141 patients who underwent D-dimer testing, 1060 had valid results and completed study as planned. STA-Liatest D-Di assay performance has exceeded the CLSI/FDA guidance requirements, with a sensitivity of 97.6% (95% confidence interval: 91.7–99.7%) and a negative predictive value of 99.7% (95% confidence interval: 99.0–100%). STA-Liatest D-Di assay has an excellent performance when used in combination with a PTP score in relevant patients and has the potential to minimize the economic healthcare burden avoiding unnecessary and expensive imaging tests.

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Multicenter evaluation of a new quantitative highly sensitive D-dimer assay, the Hemosil® D-dimer HS 500, in patients with clinically suspected venous thromboembolism

Cited by 38 publications

References 23 publications

Effectiveness of D-dimer as a screening test for venous thromboembolism: An update

Effectiveness of D-dimer as a screening test for venous thromboembolism: An update

Using an age-dependent D-dimer cut-off value increases the number of older patients in whom deep vein thrombosis can be safely excluded

Validation of STA-Liatest D-Di assay for exclusion of pulmonary embolism according to the latest Clinical and Laboratory Standard Institute/Food and Drug Administration guideline. Results of a multicenter management study

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