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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Validation of the Blood Test MACK-3 for the Noninvasive Diagnosis of Fibrotic Nonalcoholic Steatohepatitis: An International Study With 1924 Patients
Clinical Gastroenterology and Hepatology, Volume 21, No. 12, Year 2023
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Description
Background & Aims: Drug development in nonalcoholic steatohepatitis (NASH) is hampered by a high screening failure rate that reaches 60% to 80% in therapeutic trials, mainly because of the absence of fibrotic NASH on baseline liver histology. MACK-3, a blood test including 3 biomarkers (aspartate aminotransferase, homeostasis model assessment, and cytokeratin 18), recently was developed for the noninvasive diagnosis of fibrotic NASH. We aimed to validate the diagnostic accuracy of this noninvasive test in an international multicenter study. Methods: A total of 1924 patients with biopsy-proven nonalcoholic fatty liver disease from 10 centers in Asia, Australia, and Europe were included. The blood test MACK-3 was calculated for all patients. FibroScan–aspartate aminotransferase score (FAST), an elastography-based test for fibrotic NASH, also was available in a subset of 655 patients. Fibrotic NASH was defined as the presence of NASH on liver biopsy with a Nonalcoholic Fatty Liver Disease Activity Score of 4 or higher and fibrosis stage of F2 or higher according to the NASH Clinical Research Network scoring system. Results: The area under the receiver operating characteristic of MACK-3 for fibrotic NASH was 0.791 (95% CI 0.768–0.814). Sensitivity at the previously published MACK-3 threshold of less than 0.135 was 91% and specificity at a greater than 0.549 threshold was 85%. The MACK-3 area under the receiver operating characteristic was not affected by age, sex, diabetes, or body mass index. MACK-3 and FAST results were well correlated (Spearman correlation coefficient, 0.781; P < .001). Except for an 8% higher rate of patients included in the grey zone, MACK-3 provided similar accuracy to that of FAST. Both tests included 27% of patients in their rule-in zone, with 85% specificity and 35% false positives (screen failure rate). Conclusions: The blood test MACK-3 is an accurate tool to improve patient selection in NASH therapeutic trials. © 2023 The Authors
Authors & Co-Authors
Zheng, Minghua
China, Wenzhou
The First Affiliated Hospital of Wenzhou Medical University
Vonghia, Luisa
Belgium, Edegem
Universitair Ziekenhuis Antwerpen
Belgium, Antwerpen
Universiteit Antwerpen
George, Jacob
Australia, Sydney
Westmead Hospital
Armandi, Angelo
Italy, Turin
Università Degli Studi Di Torino
Adams, Leon Anton
Australia, Perth
The University of Western Australia
Blanchet, Odile
France, Angers
Chu Angers
Moal, Valérie
France, Angers
Chu Angers
Younes, Ramy
Italy, Turin
Università Degli Studi Di Torino
Chan, Wah Kheong
Malaysia, Kuala Lumpur
Universiti Malaya
Stürm, Nathalie
France, Grenoble
Centre Hospitalier Universitaire de Grenoble
Eslam, Mohammed
Australia, Sydney
Westmead Hospital
Bugianesi, Elisabetta
Italy, Turin
Università Degli Studi Di Torino
Dufour, Jean-Francois François J.
Unknown Affiliation
Francque, Sven M.A.
Belgium, Edegem
Universitair Ziekenhuis Antwerpen
Belgium, Antwerpen
Universiteit Antwerpen
Yki-Jar̈vinen, Hannele
Finland, Helsinki
Helsinki University Hospital
Finland, Helsinki
Minerva Foundation Institute for Medical Research Helsinki
Zheng, Kenneth I.
China, Wenzhou
The First Affiliated Hospital of Wenzhou Medical University
Boursier, Jérôme
France, Angers
Chu Angers
France, Angers
Université D’angers
Statistics
Authors: 17
Affiliations: 14
Identifiers
Doi:
10.1016/j.cgh.2023.03.032
ISSN:
15423565
Research Areas
Health System And Policy
Noncommunicable Diseases