Original Article
Copyright ©2013 Baishideng Publishing Group Co., Limited. All rights reserved.
World J Gastrointest Pharmacol Ther. Nov 6, 2013; 4(4): 113-119
Published online Nov 6, 2013. doi: 10.4292/wjgpt.v4.i4.113
Validation of methods to assess potential biomarkers in pediatric patients with esophageal eosinophilia
Jennifer M Colombo, Nancy A Neilan, Jennifer Verrill Schurman, Craig A Friesen
Jennifer M Colombo, Nancy A Neilan, Craig A Friesen, Divisions of Gastroenterology, Children’s Mercy Hospital and Clinics, University of Missouri at Kansas City School of Medicine, Kansas City, MO 64108, United States
Jennifer Verrill Schurman, Developmental and Behavioral Sciences, Children’s Mercy Hospital and Clinics, University of Missouri at Kansas City School of Medicine, Kansas City, MO 64108, United States
Author contributions: Colombo JM, Schurman JV and Friesen CA designed the research; Colombo JM and Neilan NA performed the research; Colombo JM, Schurman JV and Friesen CA analyzed the data; Colombo JM, Neilan NA, Schurman JV and Friesen CA participated in the drafting and editing of the manuscript; all authors approved of the final version to be published.
Correspondence to: Jennifer M Colombo, MD, Divisions of Gastroenterology, Children’s Mercy Hospital and Clinics, University of Missouri at Kansas City School of Medicine, 2401 Gillham Road, Kansas City, MO 64108, United States. jmcolombo@cmh.edu
Telephone: +1-816-2343016 Fax: +1-816-8551721
Received: June 13, 2013
Revised: August 9, 2013
Accepted: September 4, 2013
Published online: November 6, 2013
Processing time: 143 Days and 21.6 Hours
Abstract

AIM: To validate methods for determining mast cell density, extracellular major basic protein content, and presence of fibrosis in esophageal eosinophilia.

METHODS: Twenty specimens with > 20 eosinophils/high-power field (hpf) classified as high eosinophil density (HE) and 20 specimens with < 5 eosinophils/hpf classified as low esophageal density (LE) were identified. All 40 specimens underwent immunohistochemical staining and trichrome staining. Mast cell density, extracellular major basic protein (MBP) density, and presence of subepithelial fibrosis were assessed in a standardized manner. All specimens were evaluated by two separate observers and by a single observer on two separate occasions to evaluate reproducibility of the methods.

RESULTS: A strong inter-observer correlation was noted for both peak and mean mast cell counts (r = 0.725, P < 0.0001 and r = 0.823, P < 0.0001). A strong intra-observer correlation also was noted for both peak and mean mast cell counts (r = 0.752, P < 0.0001 and r = 0.878, P < 0.0001). A very strong inter-observer correlation was noted for both peak (τ = 0.867, P < 0.0001) and mean extracellular MBP densities (r = 0.925, P < 0.0001). A very strong intra-observer correlation was noted for both peak (τ = 0.875; P < 0.0001) and mean extracellular MBP densities (r = 0.956, P < 0.0001). Excellent inter-rater reliability was found for fibrosis (κ = 0.887). Mast cell and MBP densities, as well as presence of fibrosis, were significantly increased in HE vs LE. The HE group had significantly higher intraepithelial mast cell peak (29.35 ± 21.61 vs 12.45 ± 8.26, P = 0.002) and mean (19.84 ± 15.81 vs 6.35 ± 4.5, P = 0.001) densities than the LE group. The HE group had significantly higher peak extracellular MBP (2.35 ± 0.67 vs 0.45 ± 0.61, P < 0.001) and mean extracellular MBP (1.95 ± 0.76 vs 0.20 ± 0.29, P < 0.0001) densities than the LE group. Seventy-three percent of patients with HE (11/15) had fibrosis, whereas only 10% of patients with LE (1/10) had fibrosis (P < 0.01). MBP performed the best in predicting classification of HE vs LE, with mean MBP demonstrating 100% sensitivity and 95% specificity at the optimal cut point.

CONCLUSION: This study provides methodology and proof-of-concept for future evaluation of these biomarkers for differentiating esophageal eosinophilic diseases such as reflux esophagitis and eosinophilic esophagitis.

Keywords: Eosinophilia; Immunohistochemical staining; Tryptase; Major basic protein; Subepithelial fibrosis

Core tip: Esophageal mucosal eosinophilia challenges many clinicians and researchers. Biomarkers have been proposed to help clarify and better characterize eosinophil driven disease. This study provides validation of methods used previously to differentiate low eosinophil density from high eosinophil density. Eosinophilic major basic protein appears to be the best predictor for classification of eosinophilia at both extremes. This lays the ground work for future studies to examine varying degrees of eosinophilia using biomarkers.