التفاصيل البيبلوغرافية
| العنوان: |
Diagnostic performance of circulating biomarkers for non-alcoholic steatohepatitis. |
| المؤلفون: |
Sanyal, Arun, Shankar, Sudha, Yates, Katherine, Bolognese, James, Daly, Erika, Dehn, Clayton, Neuschwander-Tetri, Brent, Kowdley, Kris, Vuppalanchi, Raj, Behling, Cynthia, Tonascia, James, Samir, Anthony, Sherlock, Sarah, Heymann, Helen, Kamphaus, Tania, Calle, Roberto, Loomba, Rohit, Sirlin, Claude, Fowler, Kathryn |
| المصدر: |
Nature Medicine, vol 29, iss 10 |
| بيانات النشر: |
eScholarship, University of California |
| سنة النشر: |
2023 |
| المجموعة: |
University of California: eScholarship |
| الوصف: |
There are no approved diagnostic biomarkers for at-risk non-alcoholic steatohepatitis (NASH), defined by the presence of NASH, high histological activity and fibrosis stage ≥2, which is associated with higher incidence of liver-related events and mortality. FNIH-NIMBLE is a multi-stakeholder project to support regulatory approval of NASH-related biomarkers. The diagnostic performance of five blood-based panels was evaluated in an observational (NASH CRN DB2) cohort (n = 1,073) with full spectrum of non-alcoholic fatty liver disease (NAFLD). The panels were intended to diagnose at-risk NASH (NIS4), presence of NASH (OWLiver) or fibrosis stages >2, >3 or 4 (enhanced liver fibrosis (ELF) test, PROC3 and FibroMeter VCTE). The prespecified performance metric was an area under the receiver operating characteristic curve (AUROC) ≥0.7 and superiority over alanine aminotransferase for disease activity and the FIB-4 test for fibrosis severity. Multiple biomarkers met these metrics. NIS4 had an AUROC of 0.81 (95% confidence interval: 0.78-0.84) for at-risk NASH. The AUROCs of the ELF test, PROC3 and FibroMeterVCTE for clinically significant fibrosis (≥stage 2), advanced fibrosis (≥stage 3) or cirrhosis (stage 4), respectively, were all ≥0.8. ELF and FibroMeter VCTE outperformed FIB-4 for all fibrosis endpoints. These data represent a milestone toward qualification of several biomarker panels for at-risk NASH and also fibrosis severity in individuals with NAFLD. |
| نوع الوثيقة: |
article in journal/newspaper |
| وصف الملف: |
application/pdf |
| اللغة: |
unknown |
| العلاقة: |
qt7qn730j0; https://escholarship.org/uc/item/7qn730j0Test |
| الإتاحة: |
https://escholarship.org/uc/item/7qn730j0Test |
| حقوق: |
public |
| رقم الانضمام: |
edsbas.B920ECFA |
| قاعدة البيانات: |
BASE |
