Salivary Pepsin Lacks Sensitivity as a Diagnostic Tool to Evaluate Extraesophageal Reflux Disease.

Objectives To determine the sensitivity of salivary pepsin compared with multichannel intraluminal impedance with pH testing (pH-MII), endoscopy, and gastroesophageal reflux disease (GERD) questionnaires. Study design We prospectively recruited 50 children from Boston Children's Hospital who were undergoing pH-MII to evaluate for GERD. The patients completed 24-hour pH-MII testing, completed symptom and quality of life questionnaires, and provided a saliva specimen that was analyzed using the PepTest lateral flow test. A subset of patients also underwent bronchoscopy and esophagogastroduodenoscopy. Receiver operating characteristic curve analyses were performed to determine the sensitivity of salivary pepsin compared with each reference standard. Results Twenty-one of the 50 patients (42%) were salivary pepsin-positive, with a median salivary pepsin concentration of 10 ng/mL (IQR, 10-55 ng/mL). There was no significant difference in the distributions of acid, nonacid, total reflux episodes, full column reflux, or any other reflux variable in patients who were pepsin-positive compared with those who were pepsin-negative ( P  > .50). There was no significant correlation between the number of reflux episodes and pepsin concentration ( P  > .10). There was no positive relationship between salivary pepsin positivity, any extraesophageal symptoms or quality of life scores, or inflammation on bronchoscopy or esophagogastroduodenoscopy ( P  > .30). Conclusion Salivary pepsin measurement has a low sensitivity for predicting pathological gastroesophageal reflux in children.