STA Liatest Research Articles

Performance of the automated and rapid STA Liatest D-dimer on the STA-R analyzer

Objective The aim of the present study was to investigate the accuracy indices of the new automated and rapid microlatex D-dimer assay, STA Liatest D-Di, on the STA-R analyzer and to compare it with established D-dimer assays. Methods D-dimer testing has been performed in 103 consecutive outpatients with suspected deep venous thrombosis (DVT). Diagnosis of DVT was established by contrast venography or color-coded duplex ultrasonography. D-dimers plasma concentrations were measured with the STA Liatest D-Di on the STA-R coagulation analyzer, with a reference ELISA technique (Asserachrom®), with an automated quantitative latex-based immunoassay (Tinaquant®) and with the VIDAS® D-dimer test. Results In total, 103 eligible outpatients entered the current study and DVT was detected in 46 patients (44.6%). Two duplicate D-dimer measurement with the STA Liatest D-Di revealed excellent correlation ( r S=0.996) and almost identical sensitivity (each 98%), specificity (49% and 50%), negative predictive value (NPV; each 97%), positive predictive value (PPV; 61% and 62%) and exclusion rate (27% and 28%), respectively. Comparison of the STA Liatest D-Di with the other D-dimer tests revealed highly significant correlations ( r S=0.951–0.979), highly comparable regression and excellent agreement in clinical interpretation of the test results (kappa coefficients 0.812–0.856). Moreover, sensitivity, specificity, NPV, PPV and exclusion rate at a cut-off level of 500 ng/ml were in the same range for the STA Liatest D-Di when compared with the other D-dimer tests. Conclusion The Liatest D-Di performed on the coagulation analyzer STA-R compares favorable with the VIDAS®, Tinaquant® and Asserachrom® D-dimer tests and is suitable for the safe exclusion of DVT in symptomatic outpatients. The test can be included in an algorithm for DVT diagnosis including other diagnostic tools.

Analytic Validation and Clinical Evaluation of the STA LIATEST Immunoturbidimetric D-Dimer Assay for the Diagnosis of Disseminated Intravascular Coagulation

To evaluate the diagnostic performance of a quantitative, immunoturbidimetric D-dimer assay and compare it with other components of the proposed International Society on Thrombosis and Haemostasis disseminated intravascular coagulation (DIC) diagnostic algorithm, we retrospectively analyzed the D-dimer, platelet count, prothrombin time, and fibrinogen results for all eligible hospitalized patients (n = 241) who had a D-dimer assay ordered during a 12-month period. A receiver operating characteristic (ROC) curve constructed from the maximum D-dimer measurement for all patients was significant (P < .001) with an area under the curve (AUC) of 0.94. The ROC curves of the other tests were each significant (P < .001), but the AUCs of the prothrombin time (0.74), fibrinogen level (0.70), and platelet count (0.67) did not approach that of the D-dimer. A D-dimer cutoff of 8.2 μg/mL (8,200 μg/L) optimized sensitivity and negative predictive value for the total population and patients with a predisposing condition. Validation against 286 additional patients in a separate analysis verified the diagnostic performance of the aforementioned cutoff. A sensitive, immunoturbidimetric D-dimer assay, by itself, provides excellent sensitivity and negative predictive value for the diagnosis of DIC.

The predictive characteristics of D-dimer testing in outpatients with suspected venous thromboembolism: a Bayesian approach

Background: Despite the widespread use of quantitative methods to measure D-dimer, clinical decisions commonly are based only on binary test information (positive/negative). This study aimed to determine the significance of quantitative D-dimer results in the evaluation of venous thromboembolism (VTE) by means of a differentiated Bayesian approach. Methods: Prospective study in 118 outpatients referred for workup of suspected pulmonary embolism ( n=75) or deep vein thrombosis ( n=43). The sensitivity and specificity of D-dimer results obtained by DD VIDAS (Biomerieux, France), STA Liatest (Diagnostica Stago, France), and D-dimer plus (Dade, US) were assessed for five different cut-offs. Further, predictive values and multilevel likelihood ratios were calculated in order to assess the operative test characteristics in excluding or confirming VTE. Results: At a cut-off of 500 ng/ml and pretest probabilities <47%, the VIDAS provides a negative predictive value (NPV) >95%, whereas a positive predictive value (PPV) >95% is obtained in patients with a D-dimer >10,000 ng/ml and pretest probabilities >50%. At a cut-off of 500 ng/ml and pretest probabilities <33%, the Liatest exhibits a NPV >95%, whereas a PPV >95% is obtained in patients with a D-dimer >10,000 ng/ml and pretest probabilities >37%. Finally, with the D-dimer plus, a NPV >95% is seen at a cut-off of 150 ng/ml and pretest probabilities <30%, whereas a PPV >95% is obtained at a cut-off >1000 ng/ml and pretest probabilities >67%. Conclusions: D-dimer measurements in outpatients cannot only allow for exclusion but, in some situations, also for confirmation of venous thromboembolism. It is therefore advisable to conduct a quantitative interpretation of D-dimer results.

Valor diagnóstico del dímero-D en pacientes con baja probabilidad clínica de trombosis venosa profunda en miembros inferiores

We aimed to assess the accuracy of a diagnostic strategy including broth clinical assessment and determination of D-dimer (DD) in patients with clinically suspicion of low pretest probability of deep venous thrombosis (DVT). 149 outpatients (mean age 69; SD 16) with clinically suspected proximal DVT attending our Emergency Department and classified as low pretest probability were included in an observational prospective study. In patients with a DD (STA Liatest D-Di, Diagnostica Stago, Asnières sur Seine, France) concentration below the cut-off value (0.4 ng/ml) the diagnosis of DVT was readily ruled out, whereas those individuals with a positive DD result underwent compression Doppler venous ultrasound. A 3-month clinical follow-up was carried out in those patients in whom a diagnosis of DVT was initially excluded. Only 2 cases of DVT were confirmed (prevalence 1.3%; CI 95%, 0.2-5.3). In 47.6% of cases, a DD negativity ruled out the diagnosis of DVT. The rate of negative DD results was significantly lower in patients below 70 years of age as compared to older patients (73.6 versus 33.3%) (p < 0.001). Sensitivity, specificity, positive predictive value and negative predictive value of DD in our series were 100% (CI 95%,19.7-95.1), 48.3% (CI 95%, 40.0-56.7), 2.6% (CI 95%, 0.4-9.8) and 100% (CI 95%, 93.6-99.8) respectively, the latter being similar in the two age groups. No case of DVT was diagnosed during the follow-up period. In patients with a low pretest probability of DVT a negative DD result reliably and safely rules out such diagnosis. However, the diagnostic value of DD is lower in elderly patients (>= 70 years of age) due to a lower rate of negative results in these individuals.

Multicentre evaluation of a new point-of-care test for the quantitative determination of D-dimer

Imprecision studies, interference testing and multicentre method comparisons using patient samples were carried out with of a new point-of-care test for D-dimer (CARDIAC D-Dimer). The CV of the within-series and the day-to-day imprecision with blood samples and control materials were between 7% and 13%. Compared with Tina-quant D-Dimer, CARDIAC D-Dimer showed a good correlation and accuracy (n=353; r=0.91; y=1.06x−0.03), compared with STA LIATEST D-Dimer some poorer accuracy (n=304; r=0.91; y=1.12x−0.03). No interference was detected for different hematocrit values (16% to 51%) and in investigations with hemoglobin (up to 0.13 mmol/l), biotin (up to 30 μg/l), bilirubin (up to 340 μmol/l), intralipid (up to 31.1 mmol/l) and rheumatic factor (up to 79 IU/ml). Overdosing or underdosing by 10 μl did not affect the test result. The diagnostic sensitivity of CARDIAC D-Dimer for the detection of acute venous thromboembolic diseases was 100% in our study. With CARDIAC D-Dimer reliable quantitative D-dimer results can be easily obtained. Because of the good analytical and clinical agreement with Tina-quant D-Dimer, it should be suitable for ruling out venous thromboembolic diseases.

Preliminary Evaluation of two New Rapid Immunoturbidimetric D-dimer Assays in Patients with Clinically Suspected Venous Thromboembolism (VTE)

The practical utility and diagnostic accuracy of two new rapid, automated and quantitative immunoturbidimetric D-dimer methods have been evaluated in a population of 123 randomly selected patients with suspected VTE. The STA Liatest D-dimer and MDA D-dimer methods are based on the photo-optical measurement of the rate of agglutination of antibody-coated latex particles. The VIDAS D-dimer automated Elisa was used as the reference method. Diagnosis was confirmed in 51 patients (29 PE, 19 DVT, 3 DVT+PE). The immunoturbidimetric methods compared favorably with the VIDAS Elisa as judged from the correlation coefficients of linear regression lines (r = 0.82, MDA vs VIDAS; r = 0.75, STA vs VIDAS) and areas under the curve of ROC plots (VIDAS 0.83; STA 0.83; MDA 0.81). At a discriminant value of 500 ng/mL, all three D-dimer assays showed high sensitivity (96-98%), high NPV (93-97%) and moderate specificity (39-42%). Reproducibility of results around the cut-off is an important aspect of the diagnostic utility of D-dimer assays. CV's of duplicate determinations in this critical zone showed average values of 5.4% and 17.0% for MDA and STA, respectively. These data demonstrate that such rapid and automated latex-based methods for the quantitative measurement of D-dimer hold promise as reliable and cost-efficient approaches for the exclusion of VTE. Prospective patient management studies will be required to confirm this.