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Performance of the SteatoTest, ActiTest, NashTest and FibroTest in a multiethnic cohort of patients with type 2 diabetes mellitus
  1. Fernando Bril1,2,
  2. Michael J McPhaul3,
  3. Michael P Caulfield3,
  4. Jean-Marie Castille4,
  5. Thierry Poynard4,
  6. Consuelo Soldevila-Pico5,
  7. Virginia C Clark5,
  8. Roberto J Firpi-Morell5,
  9. Jinping Lai6,
  10. Kenneth Cusi1,2
  1. 1 Division of Endocrinology, Diabetes and Metabolism, University of Florida, Gainesville, Florida, USA
  2. 2 Malcom Randall Veterans Administration Medical Center, Quest Diagnostics Nichols Institute, Gainesville, Florida, USA
  3. 3 Quest Diagnostics Nichols Institute, San Juan Capistrano, California, USA
  4. 4 Biopredictive, Paris, France
  5. 5 Gastroenterology, Hepatology, and Nutrition, University of Florida, Gainesville, Florida, USA
  6. 6 Department of Pathology, Immunology and Laboratory Medicine, University of Florida, Gainesville, Florida, USA
  1. Correspondence to Dr Kenneth Cusi, Division of Endocrinology, Diabetes and Metabolism, University of Florida, Gainesville Florida 32610, USA; kcusi{at}


Fibromax is a diagnostic tool composed of the combination of 4 non-invasive biomarker panels for the diagnosis of steatosis (SteatoTest), necrosis and inflammation (ActiTest and NashTest-2) and fibrosis (FibroTest). The purpose of this study was to assess the performance of these biomarker panels in patients with type 2 diabetes mellitus (T2DM). All patients underwent routine labs, a 75 g oral glucose tolerance test, a liver proton magnetic resonance spectroscopy (1H-MRS) to measure intrahepatic triglyceride content, and a percutaneous liver biopsy to establish the diagnosis of non-alcoholic steatohepatitis (NASH) and to grade and stage the disease in those patients with non-alcoholic fatty liver disease (NAFLD) by 1H-MRS. For determination of the scores, plasma samples were blindly provided to establish the SteatoTest, ActiTest, NashTest-2 and FibroTest scores. A total of 220 patients with T2DM were included in this study. When the ability of the SteatoTest to identify patients with T2DM with NAFLD by 1H-MRS was assessed, the overall performance expressed as the area under the receiver operating characteristic curve was 0.73 (95% CI 0.65 to 0.81). The performance of the ActiTest and NashTest-2 to diagnose definite NASH among patients with T2DM was 0.70 (95% CI 0.63 to 0.77) and 0.69 (95% CI 0.62 to 0.76), respectively. Regarding the FibroTest score, its performance to identify patients with moderate or advanced fibrosis was 0.67 (95% CI 0.58 to 0.76) and 0.72 (95% CI 0.61 to 0.83), respectively. Non-invasive panels for the diagnosis of steatosis, NASH and/or fibrosis, which were developed and validated in non-diabetic cohorts, underperformed when applied to a large cohort of patients with T2DM. Results from non-diabetic populations should not be extrapolated to patients with T2DM.

  • fatty liver
  • diabetes mellitus
  • insulin
  • hepatitis

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  • Contributors All authors have significantly contributed to this manuscript and have approved the final version.

  • Funding Funding was provided by Burroughs Wellcome Fund and the American Diabetes Association (1-08-CR-08 and 7-13-CE-10-BR).

  • Competing interests MJM and MPC are employees and stock holders of Quest Diagnostics. JMC is full employee of BioPredictive. TP is the inventor of the tests assessed in the study and founder of BioPredictive. The patents belong to the public organization Asssitance Publique Hôpitaux de Paris.

  • Patient consent Obtained.

  • Ethics approval University of Florida (UF) and University of Texas Health Sciense Center at San Antonio (UTHSCSA)’s institutional review boards.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Additional information, such as the statistical analysis may be available on request.

  • Correction notice This article has been corrected to publish as open access.

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