NTK Institute | Liquid Biopsy Accurate for Diagnosing NASH, Liver Fibrosis
Jul 18, 2022
Liquid Biopsy Accurate for Diagnosing NASH, Liver Fibrosis
A novel liquid biopsy is accurate, sensitive, and specific in diagnosing the presence and severity of non-alcoholic steatohepatitis (NASH) and/or liver fibrosis, and is more reliable than currently used biomarkers, according to a study published in the journal Gut.
Geltrude Mingrone, Università Cattolica del Sacro Cuore, Rome, Italy, and King's College London, London, United Kingdom, and colleagues identified 2 protein biomarkers -- PLIN2 and RAB14 -- that were used as part of an algorithm to identify people with NASH and/or liver fibrosis.
The machine learning-based algorithms gave impressive results, including a sensitivity of 88% to 95%, a specificity of 90% to 100%, and an overall accuracy of 92% to 93% for NASH. For fibrosis, they were even better, with a sensitivity of 99% to 100%, specificity of 90% to 96%, and accuracy of 98% to 99%.
"This blood test will allow us to define the real prevalence of NASH in large and small populations, including children and adolescents, avoiding the need for invasive liver biopsy," said Dr. Mingrone. "Importantly, it will also allow us to monitor the efficacy of NASH treatments over time, reducing screen failures and helping generate better drugs."
The multicentre study included a discovery cohort of 100 patients and a validation cohort of 150 patients with histologically proven non-alcoholic fatty liver disease or NASH, with or without fibrosis.
The algorithm for NASH using PLIN2 mean fluorescence intensity (MFI) combined with waist circumference, triglyceride, alanine aminotransferase (ALT), and presence/absence of diabetes as covariates had an accuracy of 93% in the discovery cohort and of 92% in the validation cohort. Sensitivity and specificity were 95% and 90% in the discovery cohort and 88% and 100% in the validation cohort, respectively. The area under the receiver operating characteristic (AUROC) for NASH level prediction ranged from 83.7% in the discovery cohort to 97.8% in the validation cohort.
The algorithm including RAB14 plus MFI, age, waist circumference, high-density lipoprotein cholesterol, plasma glucose, and ALT levels as covariates to predict the presence of liver fibrosis yielded an AUROC of 95.9% in the discovery cohort and 99.3% in the validation cohort, respectively. Accuracy was 99.25%, sensitivity 100%, and specificity 95.8% in the discovery cohort and 97.6%, 99%, and 89.6% in the validation cohort.
This novel biomarker was superior to currently used FIB4, non-alcoholic fatty liver disease fibrosis score, and aspartate aminotransferase -to-platelet ratio, and was comparable to ultrasound 2-dimensional shear wave elastography.
Reference:https://gut.bmj.com/content/early/2022/07/12/gutjnl-2022-327498
SOURCE: King's College London
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