scholarly journals Reliability of Five Rapid D-Dimer Assays Compared to ELISA in the Exclusion of Deep Venous Thrombosis

1997 ◽  
Vol 77 (02) ◽  
pp. 262-266 ◽  
Author(s):  
M C H Janssen ◽  
A E Heebels ◽  
M de Metz ◽  
H Verbruggen ◽  
H Wollersheim ◽  
...  
Keyword(s):  
Venous Thrombosis ◽  
Deep Venous Thrombosis ◽  
Negative Predictive Value ◽  
Degradation Product ◽  
Predictive Value ◽  
Clinical Management ◽  
Screening Test ◽  
Latex Agglutination ◽  
Fibrin Degradation Product ◽  
D Dimer

SummaryStudies measuring the fibrin degradation product D-Dimer (DD) using enzyme-linked immunosorbent assays (ELISA) in patients with venographically proven deep venous thrombosis (DVT) suggest that it is possible to exclude DVT when DD level is below a certain cut-off level. However, ELISA methods are time-consuming and not available in all laboratories. Different rapid latex-agglutination assays have been investigated, but their sensitivity is considerably lower.In the present study we compared the value of four novel latex DD tests (Tinaquant®, Minutex®, Ortho® and SimpliRed®) and one rapid ELISA (VIDAS®) to a classical ELISA DD assay (Organon Mab Y18®) in 132 patients suspected of DVT.The VIDAS®, a new quantitative automated ELISA, had a sensitivity of 100% and a negative predictive value of 100% for both proximal and distal DVT at a cut-off level of 500 ng/ml. The Tinaquant® assay, a new quantitative latex method, had a sensitivity of 99% and a negative predictive value of 93% for both proximal and distal DVT at a cut-off level of 500 ng/ml. For proximal DVT only, both assays had a sensitivity and negative predictive value of 100%. VIDAS® and Tinaquant® correlated well with ELISA (correlation of r = 0.96 and r = 0.98 respectively). Sensitivities of the semi-quantitative latex assays Minutex®, Ortho® and SimpliRed® were considerably lower (77%, 51 % and 61 % respectively).These results suggest that VIDAS® and Tinaquant® may be used instead of ELISA DD in the exclusion of DVT. Tinaquant® can be performed within 20 min and VIDAS® within 35 min. Both assays might be used as a routine screening test and should be evaluated in large clinical management studies.

scholarly journals The D-Dimer Test for Deep Venous Thrombosis: Gold Standards and Bias in Negative Predictive Value

2003 ◽  
Vol 49 (4) ◽  
pp. 570-574 ◽  
Author(s):  
John T Philbrick ◽  
Steven Heim
Keyword(s):  
Venous Thrombosis ◽  
Deep Venous Thrombosis ◽  
Negative Predictive Value ◽  
Predictive Value ◽  
Gold Standard ◽  
English Language ◽  
False Negative ◽  
True Negative ◽  
Language Studies ◽  
D Dimer

Abstract Background: Because venous ultrasound (US) fails to fully image the calf veins, there is the potential for US gold standard studies to classify patients with calf deep venous thrombosis (DVT) in the nondiseased category, causing bias in test index calculations. A false increase in negative predictive value (NPV) is especially likely because calf DVT false-negative tests will be counted in the numerator along with the true-negative tests in NPV calculations. We verified the presence and magnitude of this bias for the d-dimer test. Methods: We abstracted data on overall (calf and thigh) and thigh-only test sensitivity, specificity, and NPV from the six English language studies published between March 1995 and October 2001 that compared d-dimer to a gold standard (GS) capable of imaging both thigh and calf veins and that also stratified results by thigh and calf location. Thigh specificity and NPV were calculated classifying calf DVT patients as free of disease. Results: The six studies included 81–214 participants and provided 26 comparisons of 16 different d-dimer assays to the GS. Thigh sensitivity was higher than overall sensitivity in 22 of 26 comparisons (range, −0.3 to 8.6); thigh specificity was lower than overall specificity in all comparisons (range, −0.7 to −7.8); and thigh NPV was higher than overall NPV in 22 of 26 comparisons and unchanged in 4 comparisons (range, 0.0–9.2). NPV was >95% in 20 of the thigh results but >95% in only 8 of the overall results. Conclusions: Different GS can produce clinically significant differences in test indices. Care must be taken in interpreting DVT studies that evaluate d-dimer as a rule-out test and that use US as a GS, because missed calf DVT can falsely increase the NPV.

scholarly journals The Diagnostic Efficacy of Age-Adjusted D-Dimer Cutoff Value and Pretest Probability Scores for Deep Venous Thrombosis

2019 ◽  
Vol 25 ◽  
pp. 107602961982631 ◽  
Author(s):  
Junxun Li ◽  
Fan Zhang ◽  
Chujia Liang ◽  
Zhuangjian Ye ◽  
Shaoqian Chen ◽  
...  
Keyword(s):  
Positive Predictive Value ◽  
Venous Thrombosis ◽  
Deep Venous Thrombosis ◽  
Negative Predictive Value ◽  
Predictive Value ◽  
Diagnostic Efficacy ◽  
Predictive Values ◽  
Cutoff Value ◽  
Wells Score ◽  
D Dimer

This study seeks to evaluate the diagnostic value of D-Dimer Plus and Innovance D-Dimer as well as the age-adjusted cutoff value for D-dimer detection in combination with 4 pretest probability (PTP) scores for deep venous thrombosis (DVT). A total of 688 patients referred for lower extremity vascular compression venous ultrasonography for suspected DVT from January 2016 to May 2018 in the First Affiliated Hospital of Sun Yat-sen University underwent D-dimer tests combining with 4 PTP scores. The diagnostic efficacy of the Wells score was the highest of the 4 PTP scores. The diagnostic efficacy of Innovance D-Dimer for DVT was greater than that of D-Dimer Plus, with better sensitivity and negative predictive value, which were both greater than 98%. If the cutoff values were adjusted by age, the Innovation D-Dimer could further improve both the specificity and the positive predictive value, providing better diagnostic performance. When the 2 D-dimer detections were used in combination with 4 PTP scores for DVT diagnosis, separately, both the positive predictive value and the negative predictive value significantly improved for D-Dimer Plus, and the positive predictive values significantly improved for Innovance D-Dimer. However, the sensitivity, specificity, and negative predictive values did not obviously change. For our patients, Wells score had the best diagnostic efficacy for our patients with suspected DVT among the 4 PTP scores. Innovance D-Dimer in combination with age-adjusted cutoff values exhibited increased sensitivity and negative predictive value for DVT diagnosis and was equivalent to the diagnostic efficacy of the Innovance D-Dimer in combination with PTP scores.

D-Dimer Test and Diagnosis of Deep Vein Thrombosis: A Comparative Study of 7 Assays

1996 ◽  
Vol 76 (04) ◽  
pp. 518-522 ◽  
Author(s):  
A Elias ◽  
I Aptel ◽  
B Huc ◽  
J J Chale ◽  
F Nguyen ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Negative Predictive Value ◽  
Predictive Value ◽  
Latex Agglutination ◽  
Lower Limbs ◽  
First Episode ◽  
Lower Sensitivity ◽  
Vein Thrombosis ◽  
Deep Vein ◽  
D Dimer

SummaryThe current D-Dimer ELISA methods provide high sensitivity and negative predictive value for the diagnosis of deep vein thrombosis but these methods are not suitable for emergency or for individual determination. We have evaluated the performance of 3 newly available fast D-Dimer assays (Vidas D-Di, BioMerieux; Instant IA D-Di, Stago; Nycocard D-Dimer, Nycomed) in comparison with 3 classic ELISA methods (Stago, Organon, Behring) and a Latex agglutination technique (Stago). One-hundred-and-seventy-one patients suspected of presenting a first episode of deep vein thrombosis were investigated. A deep vein thrombosis was detected in 75 patients (43.8%) by ultrasonic duplex scanning of the lower limbs; in 11 of them the thrombi were distal and very limited in size (<2 cm). We compared the performance of the tests by calculating their sensitivity, specificity, positive and negative predictive value for different cut-off levels and by calculating the area under ROC curves. The concordance of the different methods was evaluated by calculating the kappa coefficient. The performances of the 3 classic ELISA and of the Vidas D-Di were comparable and kappa coefficients indicated a good concordance between the results provided by these assays. Their sensitivity slightly declined for detection of the very small thrombi. Instant IA D-Di had a non-significantly lower sensitivity and negative predictive value than the 4 previous assays; however its performance was excellent for out-patients. As expected, the Latex assay had too low a sensitivity and negative predictive value to be recommended. In our hands, Nycocard D-Dimer also exhibited low sensitivity and negative predictive value, which were significantly improved when the plasma samples were tested by the manufacturer. Thus significant progress has been made, allowing clinical studies to be planned to compare the safety and cost-effectiveness of D-Dimer strategy to those of the conventional methods for the diagnosis of venous thrombosis.

Investigations into the Clinical Utility of Latex D-Dimer in the Diagnosis of Deep Venous Thrombosis

1993 ◽  
Vol 69 (01) ◽  
pp. 008-011 ◽  
Author(s):  
Cedric J Carter ◽  
D Lynn Doyle ◽  
Nigel Dawson ◽  
Shauna Fowler ◽  
Dana V Devine
Keyword(s):  
Venous Thrombosis ◽  
Deep Venous Thrombosis ◽  
Lower Limb ◽  
Clinical Utility ◽  
Rapid Test ◽  
Fibrin Degradation Product ◽  
Current Form ◽  
Non Invasive ◽  
Clinically Significant ◽  
D Dimer

SummaryThe serial use of non-invasive tests has been shown to be a safe method of managing outpatients who are suspected of having lower limb deep venous thrombosis (DVT). Objective testing has shown that the majority of these outpatients do not have venous thrombosis. A rapid test to exclude DVT in these patients, without the need for expensive and inconvenient serial non-invasive vascular testing, would have practical and economic advantages.Studies measuring the fibrin degradation product D-dimer using enzyme-linked immunoassays (EIA) in patients with veno-graphically proven DVT suggest that it should be possible to exclude this condition by the use of one of the rapid latex bead D-dimer tests.We have examined 190 patients with suspected DVT using both a latex and an EIA D-dimer assay. The latex D-dimer test used in this study was negative in 7 of the 36 proven cases of DVT. This sensitivity of only 80% is not sufficient to allow this type of assay, in its current form, to be used as an exclusion test for DVT. The same plasma samples were tested with an EIA assay. This information was used to mathematically model the effects of selecting a range of D-dimer discriminant cut off points for the diagnosis of DVT. These results indicate that 62% of suspected clinically significant DVT could have this diagnosis excluded, with a 98% sensitivity, if the rapid latex or equivalent D-dimer test could be reformulated to measure less than 185 ng/ml of D-dimer.

scholarly journals Performance of the Quantitative Latex Immunoturbidimetric D-dimer Assay for the Diagnosis of Acute Pulmonary Embolism at Rafik Hariri University Hospital

2020 ◽  
Vol 7 (3) ◽  
pp. 125-128
Author(s):  
Rida Salman ◽  
Mira Alsheikh ◽  
Rim Ismail
Keyword(s):  
Pulmonary Embolism ◽  
Negative Predictive Value ◽  
Ct Angiography ◽  
Sensitivity And Specificity ◽  
Predictive Value ◽  
Retrospective Chart Review ◽  
Latex Agglutination ◽  
University Hospital ◽  
Acute Pe ◽  
D Dimer

Background and aims: The diagnostic workup for pulmonary embolism (PE) includes D-dimer assay and computed tomographic angiography. Several D-dimer assays have been approved for PE diagnosis with different sensitivity and specificity. We aimed to study the sensitivity and specificity of the quantitative latex agglutination D-dimer assay used in a referral teaching hospital in Lebanon for the diagnosis of acute PE. Methods: Using a retrospective chart review, we studied 300 patients who had D-dimer test at Rafik Hariri University Hospital in the period between January 1, 2012 and December 31, 2013. Accordingly, 93 patients had a CT angiography after being suspected to have acute PE. A statistical table 2*2 was used to compare the results of CT angiography and D-dimer test. Results: Thirteen patients (13.97%) had PE and 60 patients (64.51%) had positive D-dimer test. Quantitative latex agglutination D-dimer assay had a sensitivity of 69%, specificity of 36%, and negative predictive value of 88%. False positive ratio was also 64%. Moreover, the receiver operating characteristic (ROC) curve was obtained with an area under the curve measuring 0.527. Conclusion: Quantitative latex agglutination D-dimer assay has a high negative predictive value; thus, it can exclude a PE diagnosis if it is associated with low clinical pretest probability.

Diagnostic Value of a New Sensitive Membrane Based Technique for Instantaneous D-Dimer Evaluation in Patients with Clinically Suspected Deep Venous Thrombosis

1997 ◽  
Vol 77 (04) ◽  
pp. 637-640 ◽  
Author(s):  
Christophe Leroyer ◽  
Martine Escoffre ◽  
Emmanuelle Le Moigne ◽  
Marc Grimaux ◽  
Olivier Cagnioncle ◽  
...  
Keyword(s):  
Venous Thrombosis ◽  
Deep Venous Thrombosis ◽  
Predictive Value ◽  
Clinical Signs ◽  
High Sensitivity ◽  
Diagnostic Value ◽  
Lower Sensitivity ◽  
Predictive Values ◽  
Study Results ◽  
D Dimer

SummaryBackground: Plasma D-Dimer analysis, using ELISA assays, has demonstrated in previous studies a high sensitivity, suggesting its utility in excluding deep venous thrombosis (DVT). Aim: To assess the performance of a new rapid plasma D-Dimer ELISA measurement in suspected DVT patients with recent clinical signs, not exceeding one week. Methods: A prospective study of patients admitted for a suspected recent DVT. Contrast venography or compression ultrasonography were performed within 24 h of admission. A new membrane based ELISA technique, which uses an immunofiltration and two complementary monoclonal antibodies was tested. Results were expressed as positive or negative. A standard plasma D-Dimer ELISA measurement was also performed. D-Dimer performances were assessed at the end of the study. Results: 265/448 patients had a proven DVT (72 distal, 193 proximal). The sensitivity of the instantaneous method in the diagnosis of overall DVT is 92 ± 3.4% (95% Cl), and specificity is 36.6 ± 6.9%. Positive predictive value is 67.7 ± 4.8% and negative predictive value is 76.1 ± 8.9%. Sensitivity and negative predictive values reach 97.9 and 94.3% in the diagnosis of proximal DVT, but only 76.3 and 79.7% in the diagnosis of distal DVT. Similar results are observed with the standard ELISA method. Conclusion: This new rapid plasma D-Dimer measurement appears highly sensitive, and could substitute the older ELISA methods. Both methods provide lower sensitivity in the case of a distal DVT location.

PLASMA CROSSLINKED FIBRIN DEGRADATION PRODUCTS FRACTION D (D-DIMER) IN PATIENTS UNDERGOING ELECTIVE MAJOR ABDOMINAL SURGERY AND IN HEALTHY VOLUNTEERS

1987 ◽  
Author(s):  
O Hauch ◽  
H Nerstrøm ◽  
T R Kølle ◽  
L N Jørgensen ◽  
P Wille-Jørgensen ◽  
...  
Keyword(s):  
Plasma Level ◽  
Abdominal Surgery ◽  
Venous Thrombosis ◽  
Deep Venous Thrombosis ◽  
Healthy Volunteers ◽  
Screening Test ◽  
Degradation Products ◽  
Blood Samples ◽  
Before And After ◽  
D Dimer

An increased plasma level of D-dimer has been suggested as an indicator of postoperative thromboembolism (TE). We studied the D-dimer level in patients undergoing major elective abdominal surgery and in healthy volunteers to evaluate a possible value of D-dimer as a screening test for TE. 18 patients and 5 healthy volunteers were studied. The patients received low molecular weight heparin (Logiparin TM) subcutaneously once . daily for 7 days. The 125 I-fibrinogen uptake test (FUT) was done in all patients. Blood samples were taken preoperatively, postoperatively and on the postoperative day 1, 3, 4, 5 and 6. The volunteers had blood samples taken before and 4 hours after subcutaneous Logiparin injection. D-dimer was assayed by enzyme-immunoassay (Boehringer Mannheim, Elisa D-dimer, Cat.no. 998117). Results are given as median with 95% confidence limits in brackets.One patient developed deep venous thrombosis verified by phlebography. Two patients had abnormal FUT but normal phlebography. The plasma level for D-dimer in the 15 patients with normal FUT was 500 ng/ml (300-800) preoperatively. The D-dimer level increased postoperatively to 1700 ng/ml (900-3300) (p < 0.001). The following days the D-dimer level increased steadily to 4800 ng/ml (2600-6800) 6 days postoperatively. The plasma level of D-dimer in the volunteers were less than 110 ng/ml both before and after injection of Logiparin. The plasma level of D-dimer in the patient with deep venous thrombosis and the 2 patients with abnormal FUT were within the range of the patients with normal FUT.The postoperative D-dimer level was as high as that reported in patients with diagnosed thromboembolism.In conclusion, the D-dimer test does not seem to be a potential screening test for postoperative thromboembolism.

scholarly journals Assessment of D-dimer for ruling out peripherally inserted central catheter-associated upper extremity venous thrombosis: a diagnostic accuracy study

2020 ◽  
Author(s):  
Wanli Liu ◽  
Lianxiang He ◽  
Wenjing Zeng ◽  
Liqing Yue ◽  
Jie Wei ◽  
...  
Keyword(s):  
Venous Thrombosis ◽  
Negative Predictive Value ◽  
Upper Extremity ◽  
Predictive Value ◽  
Diagnostic Marker ◽  
Color Doppler ◽  
Peripherally Inserted Central Catheter ◽  
Central Catheter ◽  
Wells Score ◽  
D Dimer

Abstract Background: With the extensive use of peripherally inserted central catheter (PICC), PICC-associated venous thrombosis (VT) has become one of the most important complications in the hospital. To reduce unnecessary color Doppler ultrasound (CDU) or imaging tests, D-dimer values are usually used to exclude VT. There is little evidence for the usefulness of the D-dimer level as an independent diagnostic marker for excluding PICC-associated VT.Objectives: To examine the effectiveness of D-dimer concentration to be used as an independent diagnostic marker for excluding PICC-associated UEVT. Design: A retrospective case cohort study. Settings: One teaching hospital in Hunan, China. Participants: In total, 281 subjects who underwent CDU and D-dimer values after PICC placement were eligible.Methods:The patients were categorized into the DVT unlikely group (<2 points) and the DVT likely group (≥2 points) according to their modified Wells score post PICC placement, before extubation. After the Wells score was determined, the patients underwent a D-dimer test and CDU within 7 days after D-dimer test.Results: 281 patients were included in the final analysis. Of them, 180 patients had D-dimer value <0.5 mgL-1. There were 39 patients with upper extremity venous thrombosis identified via CDU and 78.3% with negative predictive value of D-dimer for PICC-associated VT (95% CI: 71.7–83.7%). The negative predictive value of D-dimer for SVT was 91.0% (95% CI: 85.4–94.6%), which was higher than that for DVT (84.9%, 95% CI: 78.7–89.6%) and for VT in the cancer population (80.0%, 95% CI: 73.2–85.4%) and the non-cancer population (60.0%, 95% CI: 35.7–80.2%).Conclusion: the D-dimer concentration should not be used as a diagnostic index to rule out PICC-associated VT to avoid missed diagnosis of PICC-related venous thrombosis, which may cause adverse consequences or may even be life-threatening.

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