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Validation in China of a non-invasive salivary pepsin biomarker containing two unique human pepsin monoclonal antibodies to diagnose gastroesophageal reflux disease.

Abstract：

OBJECTIVES:Peptest 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. METHODS:Patients 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. RESULTS:Altogether 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. CONCLUSION:The 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.

journal_name

J Dig Dis

journal_title

Journal of digestive diseases

authors

Wang YF,Yang CQ,Chen YX,Cao AP,Yu XF,Yu Y,Zhang ZY,Shen XZ,Liu F,Zhong L,Wang YX,Liu ZJ,Shi YH,Zhong J,Li JN,Lan Y,Lenham RK,Woodcock AD,Dettmar PW,Fang JY

doi

10.1111/1751-2980.12783

subject

Has Abstract

pub_date

2019-06-01 00:00:00

pages

278-287

issue

eissn

1751-2972

issn

1751-2980

journal_volume

pub_type

杂志文章,多中心研究

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Validation in China of a non-invasive salivary pepsin biomarker containing two unique human pepsin monoclonal antibodies to diagnose gastroesophageal reflux disease.