scholarly journals Sensitivity and specificity of D-dimer tests comparing to the ultrasound examination of deep vein thrombosis

2018 ◽  
Vol 146 (5-6) ◽  
pp. 303-308
Author(s):  
Dragan Markovic ◽  
Dragan Vasic ◽  
Jelena Basic ◽  
Slobodan Tanaskovic ◽  
Slobodan Cvetkovic ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Sensitivity And Specificity ◽  
Predictive Values ◽  
Vein Thrombosis ◽  
Wells Score ◽  
Examination Methods ◽  
False Diagnosis ◽  
Deep Vein ◽  
D Dimer ◽  
Compression Ultrasonography

Introduction/Objective. Untreated deep vein thrombosis (DVT) is associated with a high risk of pulmonary embolism (PE), and false diagnosis of DVT results in unnecessary anticoagulant therapy, with a risk of bleeding. Accurate diagnosis of DVT and prompt therapy are essential to reduce the risk of thromboembolic complications. The aim of our study was to evaluate the sensitivity and specificity of three D-dimer tests (DD PLUS, HemosIL, and VIDAS) comparing to compression ultrasonography (CUS) examination. Methods. We observed 350 patients, some with different risk factors. The patients underwent the same protocol (evaluation of the patient?s history, physical examination, and D-dimer testing), and CUS was used as a reference for all the patients. According to Wells score, the patients were divided into groups with low, moderate, and high pretest probability (PTP). Results. Most of the examined patients were with moderate PTP. The CUS showed that there was the highest number of examined patients without DVT. Most of the examined patients with a positive CUS finding had proximal iliac and femoral DVT. VIDAS test was positive in the highest percentage in the group of patients with CUS-documented thrombosis. Conclusion. All three D-dimer tests used in our study had similar sensitivity and specificity. However, VIDAS test had higher levels of positive and negative predictive values comparing to the others. The comparison of three D-dimer tests by an ROC curve showed that VIDAS test has the highest overall statistical accuracy of all three D-dimer tests.

D-Dimers, Thrombin Antithrombin III Complexes and Prothrombin Fragments 1 + 2: Diagnostic value in Clinically Suspected Deep Vein Thrombosis

1991 ◽  
Vol 65 (01) ◽  
pp. 028-032 ◽  
Author(s):  
B Boneu ◽  
G Bes ◽  
H Pelzer ◽  
P Sié ◽  
H Boccalon
Keyword(s):  
Deep Vein Thrombosis ◽  
Antithrombin Iii ◽  
High Sensitivity ◽  
Diagnostic Value ◽  
Predictive Values ◽  
Vein Thrombosis ◽  
High Negative Predictive Value ◽  
Deep Vein ◽  
D Dimer ◽  
Mercury Strain Gauge

SummaryThis study was performed to determine the accuracy of D-Dimer fibrin derivatives, thrombin-antithrombin III (TAT) complexes and prothrombin fragments 1 + 2 (F 1 + 2) determinations for the diagnosis of deep vein thrombosis (DVT). One hundred and sixteen consecutive patients referred to the angiology unit of our hospital for a clinically suspected DVT were investigated. They were submitted to mercury strain gauge plethysmography and to ultrasonic duplex scanning examination; in cases of inconclusive results or of proximal DVT (n = 35), an ascending phlebography was performed. After these investigations were completed, the diagnosis of DVT was confirmed in 34 and excluded in 82. One half of the patients were already under anticoagulant therapy at the time of investigation. The 3 biological markers were assayed using commercially available ELISA techniques and the D-Dimer was also assayed with a fast latex method. The normal distribution of these markers was established in 40 healthy blood donors. The most accurate assay for the diagnosis of DVT was the D-Dimer ELISA which had both a high sensitivity (94%) and a high negative predictive value (95%). The D-Dirner latex, TAT complexes and F 1 + 2 were far less sensitive and provided negative predictive values which ranged between 78 and 85%. In spite of positive and significant correlations between the levels of ihe 3 markers, their association did not improve their overall accuracy for detecting D\/L Therefore, with the exception of the D-Dimer ELISA, these markers were of little value for the diagnosis of DVT in this specific population.

Diagnostic Accuracy of a New d-Dimer Assay (Sclavo Auto d-Dimer) for Exclusion of Deep Vein Thrombosis in Symptomatic Outpatients

2016 ◽  
Vol 23 (3) ◽  
pp. 221-228 ◽  
Author(s):  
Cristina Legnani ◽  
Michela Cini ◽  
Mirella Frascaro ◽  
Giuseppina Rodorigo ◽  
Michelangelo Sartori ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Imaging Techniques ◽  
False Negative ◽  
High Specificity ◽  
Predictive Values ◽  
Cutoff Value ◽  
Vein Thrombosis ◽  
Number Of Patients ◽  
Deep Vein ◽  
D Dimer

In patients presenting non-high clinical pretest probability (PTP), a negative d-dimer can exclude venous thromboembolism without imaging tests. However, each d-dimer assay should be validated in prospective studies. We evaluated an automated d-dimer immunoassay using the Sclavo Auto d-dimer (Sclavo Diagnostics Int, Sovicille, Italy) provided by Dasit Diagnostica (Cornaredo, Milan, Italy). Three hundred two consecutive outpatients suspected of leg deep vein thrombosis (DVT) with non-high PTP were included. The Sclavo Auto d-dimer assay was evaluated on 2 analyzers (Sysmex CA-7000 and Sysmex CS-2100; Sysmex Corporation, Kobe, Japan, provided by Dasit). The cutoff value (200 ng/mL) was established a priori. Prevalence of DVT was 11.9%. Since no false-negative patients were detected, the sensitivity and negative predictive values (NPVs) were 100% (sensitivity = CA-7000: 100% [95% confidence interval, CI: 93.3-100], CS-2100: 100% [95% CI: 93.3-100]; NPV = CA-7000: 100% [95% CI: 97.9-100], CS-2100: 100% [95% CI: 98.0-100]). Specificity was 65.4% (95% CI: 59.4-71.1) and 69.2% (95% CI: 63.3-74.7) for CA-7000 and CS-2100, respectively. Specificity increased when a higher cutoff value (234 ng/mL) was used for patients aged ≥60 years without compromising the safety. Assay reproducibility was satisfactory at concentrations near the cutoff value (total coefficient of variations <10%). In conclusion, the Sclavo Auto d-dimer assay was accurate when used for DVT diagnostic workup in outpatients with non-high PTP. Based on its high sensitivity and NPV, it can be used as a stand-alone test in outpatients with non-high PTP. Given its high specificity, the number of patients in whom further imaging techniques can be avoided increased, improving the yield of the test.

Performance of five D-dimer assays for the exclusion of symptomatic distal leg vein thrombosis

2012 ◽  
Vol 107 (02) ◽  
pp. 369-378 ◽  
Author(s):  
Jan Schwonberg ◽  
Carola Hecking ◽  
Marc Schindewolf ◽  
Dimitrios Zgouras ◽  
Susanne Lehmeyer ◽  
...  
Keyword(s):  
High Sensitivity ◽  
Diagnostic Value ◽  
Vein Thrombosis ◽  
Clinical Probability ◽  
Wells Score ◽  
Deep Vein ◽  
Test Result ◽  
D Dimer ◽  
Rule Out ◽  
Compression Ultrasonography

SummaryThe diagnostic value of D-dimer (DD) in the exclusion of proximal deep-vein thrombosis (DVT) is well-established but is less well-known in the exclusion of distal (infrapopliteal) DVT. Therefore, we evaluated the diagnostic abilities of five DD assays (Vidas-DD, Liatest-DD, HemosIL-DD, HemosIL-DDHS, Innovance-DD) for excluding symptomatic proximal and distal leg DVT. A total of 243 outpatients whose symptoms were suggestive of DVT received complete compression ultrasonography (cCUS) of the symptomatic leg(s). The clinical probability of DVT (PTP) was assessed by Wells score. Thirty-eight proximal and 31 distal DVTs (17 tibial/fibular DVTs, 14 muscle DVTs) were diagnosed by cCUS. Although all assays showed high sensitivity for proximal DVT (range 97–100%), the sensitivity was poor for distal DVT (range 78–93%). None of the assays were individually able to rule out all DVTs as a stand-alone test (negative predictive value [NPV] 91–96%). However, a negative DD test result combined with a low PTP exhibited a NPV of 100% for all DVTs (including proximal, tibial/fibular, and muscle DVTs) with the HemosIL-DDHS and Innovance-DD. All proximal and tibial/fibular DVTs, but not all muscle DVTs, could be ruled out with this strategy using the Liatest-DD and Vidas-DD. The HemosIL-DD could not exclude distal leg DVT, even in combination with a low PTP. The combination of a negative DD with a low PTP showed a specificity of 32–35% for all DVTs. In conclusion, our study shows that when used in conjunction with a low PTP some DD assays are useful tools for the exclusion of distal leg DVT.

Repeat duplex ultrasound scanning in suspected Deep Vein Thrombosis (DVT): putting the onus back on the referring clinician

2016 ◽  
Vol 15 (2) ◽  
pp. 63-67
Author(s):  
Bryan Renton ◽  
S Thiru ◽  
CP Griffin
Keyword(s):  
Deep Vein Thrombosis ◽  
Duplex Ultrasound ◽  
Ultrasound Scanning ◽  
Nice Guideline ◽  
Vein Thrombosis ◽  
Dramatic Rise ◽  
Wells Score ◽  
Deep Vein ◽  
Repeat Scanning ◽  
D Dimer

Duplex scanning is utilised by many departments in the investigation of suspected Deep Vein Thrombosis (DVT). NICE Guideline CG144 recommended repeat scanning for patients in whom the initial Wells score was ‘likely’ in the presence of a raised D-Dimer, following a normal first scan. Following implementation of this recommendation in our department there was a dramatic rise in the number of repeat scans being undertaken, all of which were negative for DVT. Introduction of an electronic message to the report, placing the onus back on the referring clinician to arrange repeat scan if deemed appropriate resulted in a fall in the number of scans being undertaken without impacting on patient outcome.

scholarly journals Safety of a strategy combining D-dimer testing and whole-leg ultrasonography to rule out deep vein thrombosis

2020 ◽  
Vol 4 (20) ◽  
pp. 5002-5010
Author(s):  
Synne G. Fronas ◽  
Camilla T. Jørgensen ◽  
Anders E. A. Dahm ◽  
Hilde S. Wik ◽  
Jostein Gleditsch ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Pretest Probability ◽  
Vein Thrombosis ◽  
Venous Thromboembolic ◽  
Deep Vein ◽  
D Dimer ◽  
Rule Out ◽  
Compression Ultrasonography ◽  
High Pretest Probability

Abstract Guidelines for the diagnostic workup of deep vein thrombosis (DVT) recommend assessing the clinical pretest probability before proceeding to D-dimer testing and/or compression ultrasonography (CUS) if the patient has high pretest probability or positive D-dimer. Referring only patients with positive D-dimer for whole-leg CUS irrespective of pretest probability may simplify the workup of DVT. In this prospective management outcome study, we assessed the safety of such a strategy. We included consecutive outpatients referred to the Emergency Department at Østfold Hospital, Norway, with suspected DVT between February 2015 and November 2018. STA-Liatest D-Di Plus D-dimer was analyzed for all patients, and only patients with levels ≥0.5 µg/mL were referred for CUS. All patients with negative D-dimer or negative CUS were followed for 3 months to assess the venous thromboembolic rate. One thousand three hundred ninety-seven patients were included. Median age was 64 years (interquartile range, 52-73 years), and 770 patients (55%) were female. D-dimer was negative in 415 patients (29.7%) and positive in 982 patients (70.3%). DVT was diagnosed in 277 patients (19.8%). Six patients in whom DVT was ruled out at baseline were diagnosed with DVT within 3 months of follow-up for a thromboembolic rate of 0.5% (95% confidence interval, 0.2-1.2). A simple diagnostic approach with initial stand-alone D-dimer followed by a single whole-leg CUS in patients with positive D-dimer safely ruled out DVT. We consider this strategy to be a valuable alternative to the conventional workup of DVT in outpatients. This trial was registered at www.clinicaltrials.gov as #NCT02486445.

scholarly journals P001: Age-adjusted D-dimer and two-site compression point of care ultrasonography to rule out acute deep vein thrombosis - a pilot study

CJEM ◽  
2018 ◽  
Vol 20 (S1) ◽  
pp. S57-S57
Author(s):  
K. Alqaydi ◽  
J. Turner ◽  
L. Robichaud ◽  
D. Hamad ◽  
X. Xue ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Point Of Care ◽  
Screening Tools ◽  
Duplex Scan ◽  
Vein Thrombosis ◽  
Wells Score ◽  
Deep Vein ◽  
D Dimer ◽  
Rule Out

Introduction: Deep vein thrombosis (DVT) can lead to significant morbidity and mortality if not diagnosed and treated promptly. Currently, few methods aside from venous duplex scanning can rule out DVT in patients presenting to the Emergency Department (ED). Current screening tools, including the use of the subjective Wells score, frequently leads to unnecessary investigations and anticoagulation. In this study, we sought to determine whether two-site compression point-of-care ultrasound (POCUS) combined with a negative age-adjusted D-dimer test can accurately rule out DVT in ED patients irrespective of the modified Wells score. Methods: This is a single-center, prospective observational study in the ED of the Jewish General Hospital in Montreal. We are recruiting a convenience sample of patients presenting to the ED with symptoms suggestive of DVT. All enrolled patients are risk-stratified using the modified Wells criteria for DVT, then undergo two-site compression POCUS, and testing for age-adjusted D-dimer. Patients with DVT unlikely according to modified Wells score, negative POCUS and negative age-adjusted D-dimer are discharged home and receive a three-month phone follow-up. Patients with DVT likely according to modified Wells score, a positive POCUS or a positive age-adjusted D-dimer, will undergo a venous duplex scan. A true negative DVT is defined as either a negative venous duplex scan or a negative follow-up phone questionnaire for patients who were sent home without a venous duplex scan. Results: Of the 42 patients recruited thus far, the mean age is 56 years old and 42.8% are male. Twelve (28.6%) patients had DVT unlikely as per modified Wells score, negative POCUS and negative age-adjusted D-dimer and were discharged home. None of these patients developed a DVT on three-month follow-up. Thirty patients (71.4%) had either a DVT likely as per modified Wells score, a positive POCUS or a positive age-adjusted D-dimer and underwent a venous duplex scan. Of those, six patients had a confirmed DVT (3 proximal & 3 distal). POCUS detected all proximal DVTs, while combined POCUS and age-adjusted D-dimer detected all proximal and distal DVTs. None of the patients with a negative POCUS and age-adjusted D-dimer were found to have a DVT. Conclusion: Two-site compression POCUS combined with a negative age-adjusted D-dimer test appears to accurately rule out DVT in ED patients without the need for follow-up duplex venous scan. Using this approach would alleviate the need to calculate the Wells score, and also reduce the need for radiology-performed duplex venous scan for many patients.

scholarly journals Predicting Venous Thromboembolic Events in Patients with Coronavirus Disease 2019 Requiring Hospitalization: an Observational Retrospective Study by the COVIDIC Initiative in a Swiss University Hospital

2020 ◽  
Vol 2020 ◽  
pp. 1-11 ◽  
Author(s):  
Eleftheria Kampouri ◽  
Paraskevas Filippidis ◽  
Benjamin Viala ◽  
Marie Méan ◽  
Olivier Pantet ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Retrospective Study ◽  
University Hospital ◽  
Thromboembolic Events ◽  
Vein Thrombosis ◽  
Venous Thromboembolic Events ◽  
Venous Thromboembolic ◽  
Wells Score ◽  
Deep Vein ◽  
D Dimer

Background. Coronavirus disease 2019 (COVID-19) can result in profound changes in blood coagulation. The aim of the study was to determine the incidence and predictors of venous thromboembolic events (VTE) among patients with COVID-19 requiring hospital admission. Subjects and Methods. We performed a retrospective study at the Lausanne University Hospital with patients admitted because of COVID-19 from February 28 to April 30, 2020. Results. Among 443 patients with COVID-19, VTE was diagnosed in 41 patients (9.3%; 27 pulmonary embolisms, 12 deep vein thrombosis, one pulmonary embolism and deep vein thrombosis, one portal vein thrombosis). VTE was diagnosed already upon admission in 14 (34.1%) patients and 27 (65.9%) during hospital stay (18 in ICU and nine in wards outside the ICU). Multivariate analysis revealed D-dimer value > 3,120   ng / ml ( P < 0.001 ; OR 15.8, 95% CI 4.7-52.9) and duration of 8 days or more from COVID-19 symptoms onset to presentation ( P 0.020; OR 4.8, 95% CI 1.3-18.3) to be independently associated with VTE upon admission. D-dimer value ≥ 3,000   ng / l combined with a Wells score for PE ≥ 2 was highly specific (sensitivity 57.1%, specificity 91.6%) in detecting VTE upon admission. Development of VTE during hospitalization was independently associated with D-dimer value > 5,611   ng / ml ( P < 0.001 ; OR 6.3, 95% CI 2.4-16.2) and mechanical ventilation ( P < 0.001 ; OR 5.9, 95% CI 2.3-15.1). Conclusions. VTE seems to be a common COVID-19 complication upon admission and during hospitalization, especially in ICU. The combination of Wells ≥ 2 score and D − dimer ≥ 3,000   ng / l is a good predictor of VTE at admission.

Evidence for Safe Exclusion of Deep Vein Thrombosis (DVT) by a Rapid ELISA D-Dimeer Test at Cut-Off Levels of 500 and 1000 Ng/Ml in 1046 Consecutive Outpatients with Suspected DVT.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 1059-1059
Author(s):  
Jan Jacques Michels ◽  
Jan Hermssen ◽  
Paul H. Trienekens
Keyword(s):  
Deep Vein Thrombosis ◽  
Negative Predictive Value ◽  
Predictive Value ◽  
Clinical Score ◽  
Large Prospective Study ◽  
Vein Thrombosis ◽  
Persistent Symptoms ◽  
Deep Vein ◽  
D Dimer ◽  
Compression Ultrasonography

Abstract Introduction.A normal compression ultrasonography (CUS) safely excludes proximal deep vein thrombosis (DVT) with a negative predictive value of 97% indicating the need to repeat CUS testing within one week. In 3 studies, the rapid ELISA D-dimer assay at a cut-off of 500 ng/ml did have a sensitivity of 100% for the exclusion of venographically documented distal and proximal DVT irrespective of clinical score. To test this hypothesis we performed a large prospective study in outpatients with suspected DVT. Methods. CUS and a rapid ELISA D-Dimer test (VIDAS, BioMérieux L’Etoile, France) were performed in patients with suspected DVT. A negative CUS with a D-Dimer result of <500 ng/ml exclude DVT, and with a D-Dimer result of >500 ng/ml was followed by a second CUS within one week. Results. The prevalence of DVT 1046 consecutive out patients with suspected DVT was 23,4%. The first CUS was positive in 228 with a rapid ELISA D-Dimer of >500 ng/ml in 227 and of <500 ng/ml in one case, indicating a sensitivity of 99,6% irrespective of clinical score. The first CUS was negative in 818. The rapid ELISA D-dimer test Was <500 ng/ml in 297 of which 296 had a negative first CUS indicating a negative predictive value of 99.7% at a specificity of 37% irrespective of the clinicl score. The negative predictive value of a negative CUS plus a rapid ELISA D-Dimer result of less than 1000 ng/ml is 99.5% at a specificity of 67,9% irrespective of clinical score. The prevalence of DVT in patients with negative first CUS and a ELISA D-Dimer of >1000 ng/ml was 5.6% as documented by CUS repeat within on week. Conclusion.A normal rapid ELISA D-dimer test, <500 ng/ml, in outpatients with suspected DVT safely excludes DVT irrespective of clinical score. After a negative rapid ELISA result (<500 ng/ml), CUS is still indicated for safety reasons in patients with suspected DVT and persistent symptoms in search for an alternative diagnosis, or for a rare case of DVT. A negative CUS plus and ELISA D-Dimer result of <1000 ng/ml safely exclude DVT without the need to repeat CUS in 2/3 of patients with a negative first CUS.

Age-adjusted D-dimer for the diagnosis of deep vein thrombosis

2017 ◽  
Vol 33 (7) ◽  
pp. 458-463 ◽  
Author(s):  
Efrem Gómez-Jabalera ◽  
Sergio Bellmunt Montoya ◽  
Eva Fuentes-Camps ◽  
José Román Escudero Rodríguez
Keyword(s):  
Deep Vein Thrombosis ◽  
False Negative ◽  
Intermediate Risk ◽  
Vein Thrombosis ◽  
Clinical Probability ◽  
Specificity And Sensitivity ◽  
Wells Score ◽  
Risk Patients ◽  
Deep Vein ◽  
D Dimer

Objective In the diagnosis of deep vein thrombosis, new D-dimer cut-off values were defined by multiplying 10 µg/L × age. The objective of the present study is to define a more specific age-adjusted value, including the pre-test Wells score, without worsening sensitivity. Methods We designed a case–control study in patients attended in the emergency department with clinically suspected deep vein thrombosis. Demographics, Wells score, D-dimer and ultrasound data were collected. In low and intermediate clinical probability cases for deep vein thrombosis, we determined the specificity and sensitivity (false-negative rates) for the following cut-off values of D-dimer: age × 10 µg/L, age × 15 µg/L, age × 20 µg/L, age × 25 µg/L and age × 30 µg/L. The cut-off value with maximum specificity without any false-negative result (sensitivity 100%) was identified. Results We included 138 consecutive patients, 39.9% were men and the mean age was 71.6 years. Deep vein thrombosis was diagnosed in 16.7% of patients and the Wells score was low in 69.6%, intermediate in 21% and high in 9.4% of patients. Applying the conventional cut-off value of 500 µg/L, the specificity was 21.1% with a sensitivity of 100%. Maintaining 100% sensitivity, the highest specificity was reached with a cut-off value for D-dimer equivalent to the age × 25 µg/L in low-risk patients (67.1% specificity) and the age × 10 µg/L (50% specificity) in intermediate-risk patients. Conclusions In patients with low Wells score, the cut-off value can be raised to age × 25 µg/L in order to rule out deep vein thrombosis without jeopardizing safety. In intermediate-risk patients, the D-dimer cut-off value could be raised to age × 10 µg/L as previously suggested.

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