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Background and Aims: Real-time shear wave elastography (2D-SWE) is a two-dimensional transient elastography and a competitor as a biomarker of liver fibrosis in comparison with the standard reference transient elastography by M probe (TE-M). The aims were to compare several criteria of applicability, and to assess inflammation and steatosis impact on elasticity values, two unmet needs. Methods: We took FibroTest as the fibrosis reference and ActiTest and SteatoTest as quantitative estimates of inflammation and steatosis. After standardization of estimates, analyses used curve fitting, quantitative Lin concordance coefficient [LCC], and multivariate logistic regression. Results: A total of 2,251 consecutive patients were included. We validated the predetermined 0.2 kPa cut-off as a too low minimal elasticity value identifying not-reliable 2D-SWE results (LCC with FibroTest = 0.0281[-0.119;0.175]. Other criteria, elasticity CV, body mass index and depth of measures were not sufficiently discriminant. The applicability of 2D-SWE (95%CI) 89.6%(88.2–90.8), was significantly higher than that of TE, 85.6%(84.0–87.0; P<0.0001). In patients with non-advanced fibrosis (METAVIR F0F1F2), elasticity values estimated by 2D-SWE was less impacted by inflammation and steatosis than elasticity value estimated by TE-M: LCC (95%CI) 0.039 (0.021;0.058) vs 0.090 (0.068;0.112;P<0.01) and 0.105 (0.068;0.141) vs 0.192 (0.153;0.230; P<0.01) respectively. The three analyses methods gave similar results. Conclusions: Elasticity results including very low minimal signal in the region of interest should be considered not reliable. 2D-SWE had a higher applicability than TE, the reference elastography, with less impact of inflammation and steatosis especially in patients with non-advanced fibrosis, as presumed by blood tests. Trial Registration: ClinicalTrials.gov [ABSTRACT FROM AUTHOR]

Background & Aims: Real-time shear wave elastography (SWE) is a new two-dimensional transient elastography which had no assessment of factors associated with reliability, and had limited comparisons with other validated fibrosis biomarkers. The aim was to assess the applicability and performances of SWE for the diagnosis of fibrosis as compared with FibroTest (FT) and liver stiffness measurement (LSM) by transient elastography using two probes (TE-M and TE-XL). Methods: Without a gold standard, the strength of concordance, discordance analysis and latent class analysis (LCM) were applied. Results: 422 patients were included. The applicability of SWE (90.0%) was significantly lower than that of FT (97.9%; p <0.0001) and did not differ from those of TE-M (90.5%) and TE-XL (90.3%); it was higher though for SWE (86%) in 22 patients with ascites vs. 55% using TE-M (p =0.04). For the diagnosis of all fibrosis stages as presumed by FT, the performance of SWE was highly significant (Obuchowski measure 0.807±0.013 [m±se]), but lower than those of TE-M (0.852; p =0.0007) and TE-XL (0.834; p =0.046). SWE had a low performance for discrimination between F0 and F1. For the diagnosis of cirrhosis using LCM, SWE specificities were all equal to 99%, and SWE sensitivities ranged from 0.47 to 0.64. For the diagnosis of non-cirrhotic stages, the results were heterogeneous. Conclusions: The performance of SWE for the diagnosis of cirrhosis was similar to those of FT and TE. SWE applicability was lower than that of FT, but greater than that of TE in patients with ascites. [Copyright &y& Elsevier]