Validation of Peptest™ in Patients with Gastro-Esophageal Reflux Disease and Laryngopharyngeal Reflux Undergoing Impedance Testing

Background & Aims: Pepsin in the gastric refluxate is a marker for a prior reflux event and rapid detection might be achieved using the Peptest (TM), an in vitro diagnostic medical device. The aim of this study was to validate the use of Peptest (TM) to reliably diagnose reflux in patients with gastro-esophageal reflux disease (GERD) and laryngopharyngeal reflux (LPR) disease diagnosed with multichannel intraluminal impedance/pHmetry (MII-pH). Methods: 20 reflux patients were recruited of whom 10 had classical GERD and 10 had LPR. All patients underwent MII-pH and provided expectorated saliva samples when a MII-pH reflux event was observed, or reflux symptoms were experienced, and all were tested for the presence of pepsin using the Peptest (TM). Results: Pepsin was detected in 31 out of 45 samples (68.9%). At least 1 positive pepsin result was seen in 16 patients (80%) and this was the same, irrespective of the GERD or LPR diagnosis. Peptest (TM) had a positive predictive value of 69% to detect MII-pH reflux events. Conclusions: Peptest (TM) is a good first-line diagnostic procedure to use in reflux sufferers to confirm the presence of reflux.