ObjectivesPeptest is a new non‐invasive reflux diagnostic test based on lateral flow technology that containing two highly specific human pepsin monoclonal antibodies for detecting pepsin, a biomarker for reflux disease. The primary aim of this multicenter clinical study was to validate the efficacy of Peptest in patients diagnosed with gastroesophageal reflux and healthy controls in China.MethodsPatients with suspected gastroesophageal reflux underwent an endoscopy and were classified into non‐erosive reflux disease and erosive esophagitis subgroups. A healthy control group was also recruited. All participants were given a reflux disease questionnaire—patients scoring greater than 12 and controls scoring zero. All participants provided a postprandial saliva sample and most patients gave an additional post‐symptom sample for pepsin analysis.ResultsAltogether 1032 participants aged between 19 and 78 years were recruited. They consisted of 488 patients with non‐erosive reflux disease, 221 with erosive esophagitis and 323 healthy controls. The number of postprandial and post‐symptom samples analyzed totaled 1031 and 692, respectively. The results across all centers showed an overall pepsin‐positive sensitivity of 85%, a specificity of 60%, a positive predictive value of 82%, a negative predictive value of 65% and a positive likelihood ratio of 2.12.ConclusionThe sensitivity of Peptest was high, but the specificity achieved in some centers was low, resulting overall in only a moderate specificity. Further diagnostic investigative studies are warranted.
Questionnaires and invasive diagnostic tests are established for diagnosing gastro-esophageal reflux disease (GERD) but shown not to be sensitive or specific for diagnosing laryngopharyngeal reflux (LPR) where vast majority of reflux events are weakly acidic or non-acidic. The research question addressed in the current multicentre study was to determine if the measurement of salivary pepsin is a sensitive, specific and reliable diagnostic test for LPR. Five UK voice clinics recruited a total of 1011 patients presenting with symptoms of LPR and a small group of subjects (n = 22) recruited as asymptomatic control group. Twenty-six patients failed to provide demographic information; the total patient group was 985 providing 2927 salivary pepsin samples for analysis. Study participants provided 3 saliva samples, the first on rising with two samples provided post-prandial (60 min) or post-symptom (15 min). The control group provided one sample on rising and two post-prandial providing a total of 66 samples. Pepsin analysis was carried out using Peptest as previously described. High prevalence of pepsin in patient groups (75%) represents a mean pepsin concentration of 131 ng/ml. The greatest prevalence for pepsin was in the post-prandial sample (155 ng/ml) and the lowest in the morning sample (103 ng/ml). The mean pepsin concentration in the control group was 0 ng/ml. Patients across all 5 clinics showed high prevalence of salivary pepsin (ranging from 69 to 86%), and the overall sensitivity was 76.4% and specificity 100%. Pepsin was shown to be an ideal biomarker for detecting airway reflux and LPR.
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