Evaluation of Important Analytical Parameters of the Peptest Immunoassay that Limit its Use in Diagnosing Gastroesophageal Reflux Disease

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216224%3A14740%2F19%3A00108449" target="_blank" >RIV/00216224:14740/19:00108449 - isvavai.cz</a>

Alternative codes found

RIV/65269705:_____/19:00070714

Result on the web

<a href="https://journals.lww.com/jcge/Abstract/publishahead/Evaluation_of_Important_Analytical_Parameters_of.97867.aspx" target="_blank" >https://journals.lww.com/jcge/Abstract/publishahead/Evaluation_of_Important_Analytical_Parameters_of.97867.aspx</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1097/MCG.0000000000001066" target="_blank" >10.1097/MCG.0000000000001066</a>

Result language

angličtina

Original language name

Evaluation of Important Analytical Parameters of the Peptest Immunoassay that Limit its Use in Diagnosing Gastroesophageal Reflux Disease

Original language description

Goal: To evaluate the analytical parameters of a lateral flow (LF) pepsin immunoassay (Peptest) and assess its suitability in the diagnostics of gastroesophageal reflux disease (GERD). Background: Peptest is a noninvasive assay to analyze pepsin in saliva, intended for use in GERD diagnostics. Although commercialized, fundamental studies on its performance are missing. The assay therefore requires basic analytical parameter evaluation to assess its suitability in clinical practice. Study: Assay reaction’s time dependence, reader device repeatability, and individual LF devices and longitudinal pepsin concentration reproducibility in individual subjects was evaluated. Salivary pepsin was analyzed in 32 GERD patients with extraesophageal reflux symptoms and 13 healthy individuals. Results: The assay’s signal increase is not completed at the recommend readout time and continues to increase for another 25 minutes. The relative standard deviation of measurement was good when using the same LF device, ranging from 2.3% to 12.9%, but the reproducibility of 10 different individual LF devices was poor. The random error when analyzing the same saliva sample on 10 LF devices was as high as 36ng/ml and this value is thus suggested as the positivity cut-off. Pepsin concentration in individual subjects during a 10-day period varied significantly. The sensitivity of the Peptest was 36.8% in the group with acid reflux and 23.1% in the group with weakly acid reflux. The specificity was 61.5%. Conclusions: The Peptest assay's sensitivity and specificity is low, the results are highly variable and it should not be used as a near-patient diagnostic method in primary care.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

30219 - Gastroenterology and hepatology

Project

<a href="/en/project/NV17-31945A" target="_blank" >NV17-31945A: Development of non-invasive diagnosis of extraesophageal symptoms of gastroesophageal reflux disease</a><br>

Continuities

P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)

Publication year

2019

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Journal of clinical gastroenterology

ISSN

0192-0790

e-ISSN

—

Volume of the periodical

53

Issue of the periodical within the volume

5

Country of publishing house

US - UNITED STATES

Number of pages

6

Pages from-to

355-360

UT code for WoS article

000464986600012

EID of the result in the Scopus database

2-s2.0-85048294657