Development and validation of nonalcoholic fatty liver disease test: a simple sensitive and specific marker for early diagnosis of nonalcoholic fatty liver disease

Author:

Omran Mohamed1,Omr Mona2,Mohamed Amal A.3,Abdelghafour Reem A.4,Muharram Nashwa M.5,Hassan Mohamed B.6,Fangry Abobakrelsedik7,Emran Tarek8,Arab Juan P.910,Arnold Jorge9,Diaz Luis Antonio9,Zheng Ming-Hua1011,El-Kassas Mohamed7

Affiliation:

1. Chemistry Department, Faculty of Science, Helwan University, Cairo

2. Chemistry Department, Faculty of Science, Damietta University, Damietta

3. Biochemistry Department, National Hepatology Tropical Medicine Research Institute, Cairo

4. Internal Medicine Department, Damnohour Teaching Hospital, Damnohour

5. Medical Biochemistry and Molecular Biology, Faculty of Medicine, Menoufia University, Shebin ElKom

6. Internal Medicine Department, Faculty of Medicine, Cairo University, Cairo

7. Endemic Medicine Department, Faculty of Medicine, Helwan University, Cairo

8. Clinical Pathology Department, Faculty of Medicine, Al-Azhar University, Damietta, Egypt

9. Departamento de Gastroenterología, Escuela de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile

10. Division of Gastroenterology, Department of Medicine, Schulich School of Medicine, Western University & London Health Sciences Centre, London, Ontario, Canada

11. Key Laboratory of Diagnosis and Treatment for the Development of Chronic Liver Disease in Zhejiang Province, Wenzhou, China

Abstract

Aim This study aimed to develop a noninvasive test for identifying patients with nonalcoholic fatty liver disease (NAFLD) based on clinical and routine laboratory data. Methods The developed model ‘NAFLD test’ was compared to the most commonly used NAFLD scores and then validated in three groups of NAFLD patients from five centers in Egypt, China, and Chile. Patients were divided into the discovery cohort (n = 212) and the validation study (n = 859). The ROC curve and stepwise multivariate discriminant analysis were used to develop and validate the NAFLD test and evaluate its diagnostic performance, which was then compared to other NAFLD scores. Results Elevated C-reactive protein (CRP), cholesterol, BMI, and alanine aminotransferase (ALT) levels were significantly associated with NAFLD (P < 0.0001). NAFLD test is depicted as (−0.695 + 0.031 × BMI + 0.003 × cholesterol + 0.014 × ALT + 0.025 × CRP) to discriminate patients with NAFLD from healthy individuals. The area under the ROC curve (AUC) of the NAFLD test was 0.92 [95% confidence interval (CI): 0.88–0.96]. The NAFLD test was the most accurate diagnostic indicator of NAFLD when compared to widely used NAFLD indices. Upon validating the NAFLD test, its AUC (95% CI) for distinguishing patients with NAFLD from healthy individuals was 0.95 (0.94–0.97), 0.90 (0.87–0.93), and 0.94 (0.91–0.97) in Egyptian, Chinese, and Chilean patients with NAFLD respectively. Conclusion The NAFLD test is a new validated diagnostic biomarker that can be utilized for the early diagnosis of NAFLD with high diagnostic performance.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Gastroenterology,Hepatology

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