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 ◽  
...  

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.

1991 ◽  
Vol 65 (01) ◽  
pp. 028-032 ◽  
Author(s):  
B Boneu ◽  
G Bes ◽  
H Pelzer ◽  
P Sié ◽  
H Boccalon

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.


2017 ◽  
Vol 33 (7) ◽  
pp. 458-463 ◽  
Author(s):  
Efrem Gómez-Jabalera ◽  
Sergio Bellmunt Montoya ◽  
Eva Fuentes-Camps ◽  
José Román Escudero Rodríguez

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.


2018 ◽  
Vol 146 (5-6) ◽  
pp. 303-308
Author(s):  
Dragan Markovic ◽  
Dragan Vasic ◽  
Jelena Basic ◽  
Slobodan Tanaskovic ◽  
Slobodan Cvetkovic ◽  
...  

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.


1992 ◽  
Vol 68 (03) ◽  
pp. 257-260 ◽  
Author(s):  
Giancarlo Agnelli ◽  
Raul Volpato ◽  
Stefano Radicchia ◽  
Franca Veschi ◽  
Paolo Di Filippo ◽  
...  

SummaryThe aim of this study was to prospectively evaluate the accuracy of real-time B-mode ultrasonography in the diagnosis of asymptomatic proximal deep vein thrombosis (DVT) in hip surgery patients. Venography was adopted as the gold standard. We studied 100 consecutive patients undergoing hip surgery: 60 patients for hip fracture and 40 patients for elective hip replacement. Bilateral real-time B-mode ultrasonography was performed prior to bilateral venography. The two diagnostic procedures were performed on the same day by different investigators unaware of the assigned prophylatic regimen for DVT Compressibility of the vein segment was adopted as the single criterion for DVT. Venography was performed and judged by radiologists unaware of the ultrasonography results. In 13 limbs venography was either impossible to perform or not adequate for judgement. Ultrasonography and an adequate venography was obtained in 187 limbs. A venography proven DVT was observed in 49 limbs (26.2%) and a proximal DVT in 21 limbs (11.2%). All the patients were asymptomatic for DVT. The sensitivity and specificity of real time B-mode ultrasonography for proximal DVT were 57% (95% confidence interval: C. I. 36–80) and 99% (C. I. 99–100), respectively and the positive and negative predictive values were 93% (C.I. 73–100) and 95% (C.I. 91–97), respectively. The sensitivity and specificity for overall DVT were 25% (C.I. 11–38) and 99% (C.I. 97–100), respectively and the positive and negative predictive values were 92% (C. I. 73–100) and 79% (C.I. 76–85), respectively. Our data indicate that realtime B-mode ultrasonography for its high specificity could make venography unnecessary in patients with positive results. However, because of its low sensitivity it cannot be used for the screening of DVT in asymptomatic patients, nor can it replace venography for outcome measurements in clinical trials on DVT prophylaxis.


Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 1982-1982 ◽  
Author(s):  
Yu Chen Barrett ◽  
Jessie Wang ◽  
Zhigang Yu ◽  
Andrew Shenker ◽  
Robert Knabb ◽  
...  

Abstract Background: Elevated levels of coagulation markers such as D-dimer, prothrombin fragment 1+2 (F1+2), and thrombin antithrombin (TAT) have been associated with increased risk for thrombotic events. Apixaban, an oral, selective, direct inhibitor of factor Xa, was shown to be effective for the prevention and treatment of venous thromboembolism (VTE). Apixaban is also in development for stroke prevention in atrial fibrillation patients and secondary prevention in patients with acutre coronary syndrome. This study was conducted to assess changes in coagulation biomarkers after apixaban treatment. Methods: Approximately 1430 plasma samples (pre-dose, week 3 and week 12) were obtained from 520 patients who participated in a phase 2, randomized, parallel-arm, double-blind study of apixaban for the treatment of acute symptomatic deep-vein thrombosis. The study comprised 4 dose arms of approximately 130 patients each (apixaban 5 mg bid, 10 mg bid, 20 mg qd, and 1 active control arm, low molecular weight heparin [LMWH] followed by vitamin K antagonist [VKA] [target INR 2–3]). Five biomarkers, D-dimer, F1+2, TAT, modified prothrombin time (mPT), and anti-Xa activity were measured in plasma. Biomarker responses over treatment time were evaluated using an ANOVA mixed-effect model. Results: Biomarkers of thrombin generation and fibrin turnover, D-dimer, F1+2, and TAT, were significantly elevated at the time of trial randomization in all dose groups with approximately 95%, 46%, and 43% of patients showing values above the upper limit of normal range (ULN) for D-dimer, F1+2, and TAT values, respectively. The respective median biomarker values were 1662 ng/mL, 294 pmol/L, and 4.1 ng/mL. After 3 and 12 weeks of drug treatment, the biomarker values were significantly reduced in the majority of patients in all dose groups (Table). By the end of 12 weeks, the number of patients who continued to have marker values exceeding the ULN in the 4 dose groups ranged from 24% to 40%, 8% to 13%, and 7% to 12%, for D-dimer, F1+2, and TAT, respectively. Pharmacodynamic biomarkers mPT and anti-Xa activity increased with increasing apixaban exposure (R2 = 0.534 for mPT and 0.853 for anti-Xa activity). When comparing the accuracy and precision of mPT and anti-Xa assays in predicting apixaban plasma concentration, the difference between predicted and observed apixaban concentration was much lower for the anti-Xa assay compared to mPT. The median absolute error of the anti-Xa assay was 12% compared with 48% for mPT. Conclusion: 12 weeks of apixaban treatment results in pronounced reduction of coagulation activity as measured by D-dimer, F1+2, and TAT, which is consistent with the low number of thrombotic events observed in apixaban-treated patients in this study (symptomatic VTE rate of 2.5% in the combined apixaban group and the comparator group). The anti-Xa assay demonstrated very good accuracy and precision in predicting apixaban plasma concentration in this clinical trial. Table D-dimer (% Patients &gt; ULN) F1+2 (% Patients &gt; ULN) TAT (% Patients &gt; ULN) Treatment Groups Predose Week 3 Week 12 Predose Week 3 Week 12 Predose Week 3 Week 12 Apixaban 5 mg bid 93% 75% 32% 43% 19% 13% 36% 13% 12% Apixaban 10 mg bid 100% 74% 31% 41% 12% 8% 44% 7% 7% Apixaban 20 mg qd 93% 74% 40% 46% 21% 16% 43% 16% 12% LMWH/VKA 98% 72% 24% 54% 10% 10% 48% 11% 9%


2006 ◽  
Vol 96 (07) ◽  
pp. 79-83 ◽  
Author(s):  
Wolfgang Korte ◽  
Michael Schwab ◽  
Rainer Zerback ◽  
Menno Huisman ◽  
Carl-Erik Dempfle ◽  
...  

SummaryD-dimer assays are efficient in the exclusion diagnostics of deep vein thrombosis (DVT) in patients without severe concomitant diseases. We have determined diagnostic sensitivity and specificity of a new point-of-care rapid assay for quantitative determination of D-dimer in heparinized whole blood in outpatients with suspected DVT. In 19 participating centers, 637 patients were included in the study, of which 77 were excluded, the majority because of inadequate documentation of analytical quality control measures. DVT was diagnosed in 223 of the remaining 560 patients by duplex ultrasound examination. The POC D-dimer assay showed a high sensitivity of 96.9% for the diagnosis of DVT and a high specificity of 60.8% at a pre-specified cutoff of 0.5 µg/ml. For Tina-quant D-dimer, sensitivity was slightly lower at 94.9%, with a specificity of 64.8%.The VIDAS D-dimer assay showed a sensitivity of 98.2%, but specificity was 40.7%. The area under the curve (AUC ± standard error, 95% confidence interval) was 0.879 ± 0.019 (0.845–0.909) for POC D-dimer, 0.908 ± 0.016 (0.877–0.934) for Tina-quant D-dimer, and 0.895± 0.018 (0.862–0.922) forVIDAS D-dimer. Differences were not statistically significant. The new whole blood POC D-dimer assay isa reliable tool for exclusion of DVT in symptomatic outpatients, displaying a comparable diagnostic performance as VIDAS D-dimer and Tina-quant D-dimer assays.Roche CARDIAC and TINA-QUANT are tradenames of Roche.


2020 ◽  
Vol 26 ◽  
pp. 107602962095321 ◽  
Author(s):  
Yuan Yu ◽  
Jie Tu ◽  
Bingxin Lei ◽  
Huaqing Shu ◽  
Xiaojing Zou ◽  
...  

Deep vein thrombosis (DVT) is prevalent in patients with coronavirus disease 2019 (COVID-19). However, the risk factors and incidence rate of DVT remains elusive. Here, we aimed to assess the incidence rate and risk factors of DVT. All patients diagnosed with COVID-19 and performed venous ultrasound by ultrasound deparment between December 2019 and April 2020 in Wuhan Jin Yin-tan hospital were enrolled. Demographic information and clinical features were retrospectively collected. Notably, a comparison between the DVT and the non-DVT groups was explored. The incidence rate of venous thrombosis was 35.2% (50 patients out of 142). Moreover, the location of thrombus at the proximal extremity veins was 5.6% (n = 8), while at distal extremity veins was 35.2% (n = 50) of the patients. We also noted that patients with DVT exhibited a high level of D-dimer (OR 10.9 (95% CI, 3.3-36.0), P < 0.001), were admitted to the intensive care unit (OR 6.5 (95% CI, 2.1-20.3), P = 0.001), a lower usage of the anticoagulant drugs (OR 3.0 (95% CI, 1.1-7.8), P < 0.001). Finally, this study revealed that a high number of patients with COVID-19 developed DVT. This was observed particularly in critically ill patients with high D-dimer levels who required no anticoagulant medication.


2021 ◽  
Author(s):  
Kexin Zhang ◽  
Yanbin Zhu ◽  
Yunxu Tian ◽  
Miao Tian ◽  
Xiuting Li ◽  
...  

Abstract Objective: This study aimed to describe the characteristics of plasma D-dimer level with increasing age and establish a new age-adjusted D-dimer cutoff value for excluding preoperative lower limb deep vein thrombosis (DVT) in elderly patients with hip fractures.Methods: This was a retrospective study of elderly patients who presented with acute hip fracture in our institution between June 2014 and May 2020. All patients underwent D-dimer test and duplex ultrasound. Patients were divided into six 5-year-apart age groups. The optimal cutoff value for each group was calculated by using receiver operating characteristic (ROC) curves, whereby the new age-adjusted D-dimer cutoff value was determined. The sensitivity, specificity, positive predictive values (PPV) and negative predictive values (NPV) were calculated and compared when different D-dimer cutoff values were applied, i.e. conventional 0.5mg/L, previously well-established age-adjusted cutoff value (age*0.01 mg/L) and the new age-adjusted D-dimer cutoff value herein. Results: There were 2759 included, 887 males and 1872 females, with an average age of 77.8 years. 280 patients were diagnosed with preoperative DVT. The optimal cutoff values for the six age groups were 0.715 mg/L, 1.170 mg/L, 1.620 mg/L, 1.665 mg/L, 1.690 mg/L and 1.985 mg/L, respectively and the calculated age-adjusted coefficient was 0.02 mg/L. With this new coefficient applied, the specificity was 61.3%, clearly higher than those for conventional threshold (0.5mg/L, 36.9%) or previously established age-adjusted D-dimer threshold (age*0.01 mg/L, 22.2%). In contrast, the sensitivity was lower than that (58.9% vs 85.0% or 77.1%) when D-dimer threshold of 0.5 mg/L or age-adjusted cutoff value (age*0.01 mg/L) was used. The other indexes as PPV (14.7%, 11.0% and 12.1%) and NPV (93.0%, 92.9% and 93.5%) were comparable when three different D-dimer thresholds were applied. Conclusions: The use of the new age-adjusted D-dimer threshold increased the proportion of elderly hip fracture patients in whom preoperative lower limb deep vein thrombosis could be safely excluded.


CJEM ◽  
2018 ◽  
Vol 20 (S1) ◽  
pp. S105-S105 ◽  
Author(s):  
S. Sharif ◽  
C. Kearon ◽  
M. Eventov ◽  
M. Li ◽  
R. Jiang ◽  
...  

Introduction: Diagnosing pulmonary embolism (PE) can be challenging because the signs and symptoms are often non-specific. Studies have shown that evidence-based algorithms are not always adhered to in the Emergency Department (ED) and are often not used correctly, which leads to unnecessary CT scanning. The YEARS diagnostic algorithm, consisting of three items (clinical signs of deep vein thrombosis, hemoptysis, and whether pulmonary embolism is the most likely diagnosis) and D-dimer, is a novel and simplified way to approach suspected acute PE. The purpose of this study was to 1) evaluate the use of the YEARS algorithm in the ED and 2) to compare the rates of testing for PE if the YEARS algorithm was used. Methods: This was a health records review of ED patients investigated for PE at two emergency departments over a two-year period (April 2013-March 2015). Inclusion criteria were ED physician ordered CT pulmonary angiogram, ventilation-perfusion scan, or D-dimer for investigation of PE. Patients under the age of 18 and those without a D-dimer test were excluded. PE was considered to be present during the emergency department visit if PE was diagnosed on CT or VQ (subsegmental level or above), or if the patient was subsequently found to have PE or deep vein thrombosis during the next 30 days. Trained researchers extracted anonymized data. The rate of CT/VQ imaging and the false negative rate was calculated. Results: There were 1,163 patients that were tested for PE and 1,083 patients were eligible for our analysis. Of the total, 317/1,083 (29.3%; 95%CI 26.6-32.1%) had CT/VQ imaging for PE, and 41/1,083 (3.8%; 95%CI 2.8-5.1%) patients were diagnosed with PE at baseline. Three patients had a missed PE, resulting in a false negative rate of 0.4% (95%CI 0.1-1.2%). If the YEARS algorithm was used, 211/1,083 (19.5%; 95%CI 17.2-22.0%) would have required imaging for PE. Of the patients who would not have required imaging according to the YEARS algorithm, 8/872 (0.9%; 95%CI 0.5-1.8%) would have had a missed PE. Conclusion: If the YEARS algorithm was used in all patients with suspected PE, fewer patients would have required imaging with a small increase in the false negative rate.


1981 ◽  
Author(s):  
J J Rodzynek ◽  
P L Schoenfeld ◽  
T Martin ◽  
P Léautaud ◽  
P Wettendorff ◽  
...  

Citrated whole blood thrombo-elastogram (TEG) and its several parameters (r, k, am, IPT), Ethanol gel test (EGT), Fibrinogen degradation products (FDP) and Raby’s transfer test (RTT) were studied in 52 healthy volunteers acting as normal controls, in 211 consecutive patients admitted in a general hospital for non thrombotic pathologies (group 1), in 59 consecutive patients admitted for deep vein thrombosis (group 2) and in 45 consecutive patients addmitted for pulmonary thrombo embolism, confirmed at scintigraphy (group 3).In conclusion: l. TEG (r, k, am, IPT) offers little help in the early diagnosis of deep vein thrombosis as well as pulmonary thrombo embolism. 2. EGT although offering a high specificity (6.6% false positive), lacks of sensitivity for the diagnosis of deep vein thrombosis (56.6% false negative). 3. RTT appears as a highly sensitive detector of deep vein thrombosis (positive in 96.6% of cases) and of pulmonary embolism (positive in 97.7% of cases) as well as reasonably specific (12.3% false positive tests). 4. Negativity of FDP and RTT appears as a strong argument against the diagnosis of thrombotic disease.


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