Analytical performance of the new D‐dimer and antithrombin assay on Roche cobas t 711 analyzer

Abstract

while it was 0.91 (95% CI, 0.84-0.99; P < 0.001) for samples with DD values <1000 ng/L and 0.94 (95% CI, 0.88-1.00; P < 0.001) for those with DD values ≥1000 ng/L, respectively. Using the cutoff value provided by IL (230 ng/mL fibrinogen equivalent units; FEU), the best analytical cutoff of cobas t 711 DD was 470 ng/L (0.91 sensitivity and 0.91 specificity, respectively).The new generation of coagulation analyzers is increasingly designed to meet most of the essential needs of modern clinical laboratories, 9 thus including fully automated functioning, cap piercing, and large test menus (including a vast array of clotting, chromogenic, and immunoturbidimetric assays). Overall, the analytical performance of cobas t 711 analyzer was found to be optimal for routine use. The imprecision data are aligned with, or even better than, those of other commercially available coagulation analyzers, reported in previous studies. 5 Linearity of cobas t 711 analyzer was also excellent over the clinically relevant range of values of both DD and AT, with correlation coefficients of 0.999. Method comparison studies also showed that DD and AT values obtained with cobas t 711 analyzer are substantially aligned to those obtained on paired samples with ACL TOP (Figure 1), displaying correlation coefficients always >0.96, albeit the DD unit reported differed slightly, thus further supporting the continued need for major standardization of this assay . 10In conclusion, the results of this analytical evaluation of cobas t 711 analyzer DD and AT reagents expand previous reports on this instrument, showing that these tests display excellent performance for both routine and stat laboratories. ACK N OWLED G EM ENTSThe manufacturer provided in-kind support in the form of equipment and consumables for the evaluation of the equipment. The manufacturer had no role in directing the study or influencing the study outcomes.

COVID‐19 and renin‐angiotensin system inhibition: role of angiotensin converting enzyme 2 (ACE2) ‐ Is there any scientific evidence for controversy?

“…Moreover, ACE2 cleaves other peptides and plays a central role in inactivating des-arginine(9)-bradykinin (des-Arg(9)-BK), a potent metabolite of the kininkallikrein system that increases vascular permeability, thus promoting angioedema, acting on B1 type receptors, which are, in turn, upregulated by inflammatory cytokines [38,39]. According to some authors, the leakage of plasma in the subendothelial compartment in conjunction with the inflammatory response triggered by the host-virus interaction may have a central pathogenetic role in the endotheliitis and disseminated intravascular coagulation that have been documented to occur in COVID-19 patients [39][40][41]. ACE2 plays an important role in heart failure, in diabetic microvascular or macrovascular disease [42] and in inflammatory lung disease [43], and ACEIs/ ARBs-mediated increase in ACE2 exerts a protective role in many conditions such as atherosclerosis, myocardial infarction, myocardial dysfunction, heart failure, diabetes mellitus and acute lung injury (ALI).…”

System performance evaluation of the cobas t 711 and cobas t 511 coagulation analyzers in routine laboratory settings

“…The potential advantages include increased precision and accuracy compared with pipetting when manually reconstituting reagents, increased walkaway time for operators and efficiencies in scheduling sample runs [26]. Assays used for routine coagulation testing with the cobas t 711 and 511 analyzers include three different aPTT reagents (aPTT, aPTT Lupus, aPTT Screen), AT, D-Dimer, Fibrinogen, PTderived Fibrinogen, PT Owren and PT Rec (recombinant human thromboplastin reagent); their analytical performance has been described in detail previously [26][27][28][29].…”

Performance of 6 routine coagulation assays on the new Roche Cobas t711 analyzer

“…The aims of this study were first to reproduce previous results on imprecision and method comparison [[4], [5], [6], [7]], second to evaluate the performance of the anti-Xa assay (not previously published), third to determine whether the aPTT can be used to monitor UFH therapy, fourth to investigate a fast centrifugation protocol in order to shorten turn-around time, and finally to study sample stability over time, since this is known to be method and reagent dependent [8].…”