Abstract
Background: A high number of US citizens experience gastroesophageal reflux disease (GERD) symptoms at least once a month. These symptoms have a great impact on an individual’s quality of life and present a huge burden on healthcare systems. Diagnosis of GERD like symptoms is not straight forward and many individuals do not have a diagnosis with current tests being invasive, expensive and often with low patient compliance. To speed the diagnosis process up there are many individuals seeking self-diagnosis and it became apparent that an easily accessible, rapid, non-invasive and cost-effective diagnostic test would be well received by individuals.
Methods: Seven hundred and ninety-three self-referral individuals experiencing reflux like symptoms provided up to three saliva samples. The first on waking, the other two samples provided either post-prandial or post-symptom. All saliva samples were sent to a central laboratory for pepsin analysis using a lateral flow device containing two unique human monoclonal antibodies (Peptest). Following analysis, the pepsin concentration in each saliva sample was determined using a PepCube reader and expressed in ng/ml.
Results: A total of 1834 saliva samples were analysed for pepsin. Sixty-two percent of individuals tested had one or more saliva sample pepsin positive and 38% of individuals had all samples pepsin negative. The highest pepsin concentrations were seen in post-prandial samples with the lowest pepsin concentrations significantly lower (p=0.0127) in the on waking samples. The US interstate pepsin concentration data is limited due to low numbers of self-diagnosing individuals tested to date. There was no difference in pepsin concentrations between genders.
Conclusion: The individuals self-diagnosing their reflux like symptoms were mostly those aged 40 to 70 years. The availability of a simple easy to use non-invasive test for self-diagnosis is now widely accessible across all states of the US.