Table 1.

Summary of key points from the company-included studies accepted by the External Assessment Centre

Study	Patient population and country	Intervention and/or comparator	Study design	Main findings
Friedrich-Rust et al. [33]	Hepatitis C (n = 253) Germany, Netherlands, Romania	VTq vs. TE, LB	Crossover; international multicentre study Abstract	Compared AUROC values of both VTq vs. TE (intention to diagnose) and VTq vs. TE (per protocol) and found that the only significant comparison was VTq vs. TE (intention to diagnose) F ≥ 2 (p = 0.03) Found a significant correlation between VTq and TE with histological fibrosis stage
Friedrich-Rust et al. [32]	Hepatitis B (n = 114) Germany, Netherlands	VTq vs. TE, LB	Prospective, cohort, multicentre study. Receiver operating curves used for comparisons at different levels of severity based on histology (liver fibrosis) Full paper	Found no significant overall correlation; a highly significant correlation was found between VTq and liver fibrosis stage (Spearman r = 0.65, p < 0.001) Documented sensitivity and specificity values using AUROC for fibrosis stage with confidence intervals and when comparing VTq to TE, they found no significant difference for either intention to diagnose or per protocol between TE and VTq
Sporea et al. [34]	Hepatitis C (n = 914), 911 valid cases Japan, Romania, Germany, Italy, Austria	VTq vs. TE, LB	Retrospective cohort, multicentre study. Correlation used to assess reliability, using Spearman test A subgroup of 400 patients with chronic hepatitis C assessed by ARFI and TE Full paper	Concluded that TE was significantly better than VTq for predicting presence of liver cirrhosis (p = 0.01) and fibrosis (p = 0.01), but found no significant difference for predicting severe fibrosis

ARFI acoustic radiation force impulse, AUROC area under receiver operating characteristic, LB liver biopsy, TE transient elastography, VTq Virtual Touch™ Quantification