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

Kód výsledku v 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>

Nalezeny alternativní kódy

RIV/65269705:_____/19:00070714

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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.

Název v anglickém jazyce

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

Popis výsledku anglicky

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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30219 - Gastroenterology and hepatology

Projekt

<a href="/cs/project/NV17-31945A" target="_blank" >NV17-31945A: Vývoj neinvazivní diagnostiky extraezofageálních projevů refluxní choroby jícnu</a><br>

Návaznosti

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

Rok uplatnění

2019

Kód důvěrnosti údajů

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

Název periodika

Journal of clinical gastroenterology

ISSN

0192-0790

e-ISSN

—

Svazek periodika

53

Číslo periodika v rámci svazku

5

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

6

Strana od-do

355-360

Kód UT WoS článku

000464986600012

EID výsledku v databázi Scopus

2-s2.0-85048294657