[PubMed] [Google Scholar] 16

[PubMed] [Google Scholar] 16. any effect up to 10?g/L hemoglobin and 300?mg/L bilirubin. Lipemia seemed to generate an underestimation of D\dimer concentration when the Intralipid concentration was 5?g/L. RF and HAMAs did not BRD-IN-3 have any effect. The Passing\Bablok and Bland\Altman analyses showed small differences with other available D\dimer assays, which were more pronounced with increasing values. Conclusions Its analytical performances and main technical features indicate that the new Yumizen G DDi 2 assay is suitable for the rapid quantification of D\dimer in clinical hemostasis laboratories. at room temperature for 15?minutes, and was analyzed within 4?hours of collection. As the remaining plasma was used for Yumizen G DDi 2 testing, no blood sample was specifically collected for this study. This study was approved by the South\East VI Ethics Committee (France, AU765). 2.2. Method description \ immunoturbidimetry D\dimer concentration was measured using the Yumizen G DDi 2 assay and the Yumizen G800 coagulation analyzer (HORIBA Medical) according to the manufacturers instructions. This is a fully automated immunoturbidimetric assay for the quantitative determination PPP3CC of D\dimer, based on the time\fixed determination of the D\dimer concentration by photometric measurement of the antigen\antibody reaction between antiCD\dimer antibodies carried by latex particles and the D\dimer molecules present in the plasma sample. The kit includes the D\dimer reagent (Yumizen G DDi 2 Buffer and Yumizen G DDi 2 Latex), control plasma samples (G CTRL DDi I and II), and buffer (Yumizen G Imidazol). Two quality controls (low and high concentration) were performed daily. To 20 L of plasma, 115 L of Yumizen G DDi 2 Buffer were added and incubated for 120?seconds at 37C. The degree of agglutination was measured after the addition of 45 L of Yumizen G DDi 2 Latex in relation to the decrease of transmitted light at 570?nm. Results are available in 3?minutes if no rerun is performed. D\dimer concentrations 4000?ng/mL fibrinogen\equivalent units (FEU) are obtained after automatic sample dilution (1:4) in the buffer Yumizen G Imidazol. The ready\to\use liquid format minimizes the preparation time, and the reagent is precalibrated, removing the need of a costly and time\consuming calibration step. 2.3. Analytical evaluation 2.3.1. Precision Precision was evaluated using manufactured human plasmaCbased quality controls at low and high concentration (Yumizen G CTRL DDi I and II). Within\run imprecision was assessed in BRD-IN-3 30 sequential runs and between\run imprecision by measuring the same controls in 15 different series twice per day, by using an identical lot of reagents. The final results were reported as a coefficient of variation (CV). 2.3.2. Limit of blank, limit of detection, and limit of quantification These parameters were assessed according to the Clinical and Laboratory Standards Institute (CLSI) EP17\A2?standard. 17 The LoB, defined as the highest measurement result that can be reliably measured in a blank sample, was estimated by measuring 30 replicates of a sample without D\dimer molecules, and calculated with the following formula: LoB?=?meanblank?+?1.645 SDblank. The dilution buffer (Yumizen G Imidazol) was the blank. The LoD, defined as the lowest D\dimer concentration likely to be reliably detected by the assay was obtained from 10 measurements in one run of a plasma sample having a D\dimer concentration of 2LoB, and was identified with the following method: LoD?=?LoB?+?1.645 SDsample. The LoQ, defined as BRD-IN-3 the smallest value with an acceptable level of confidence and known uncertainty, BRD-IN-3 was estimated by measuring 11 samples with mean D\dimer concentrations from 33 to 333?ng/mL FEU (10 repeated measurements), and a nonlinear relationship calculated between the measurement error (CV%, axis) and the D\dimer concentration (ng/mL FEU, axis). 2.3.3. Linearity A patient plasma with high D\dimer concentration (32?700?ng/mL FEU) was.