Detailed Information on Publication Record
2019
Evaluation of Important Analytical Parameters of the Peptest Immunoassay that Limit its Use in Diagnosing Gastroesophageal Reflux Disease
DOLINA, Jiří, Štefan KONEČNÝ, Pavol ĎURČ, Júlia LAČNÁ, Michal GREGUŠ et. al.Basic information
Original name
Evaluation of Important Analytical Parameters of the Peptest Immunoassay that Limit its Use in Diagnosing Gastroesophageal Reflux Disease
Authors
DOLINA, Jiří (203 Czech Republic, belonging to the institution), Štefan KONEČNÝ (703 Slovakia, belonging to the institution), Pavol ĎURČ (703 Slovakia, belonging to the institution), Júlia LAČNÁ (703 Slovakia, belonging to the institution), Michal GREGUŠ (703 Slovakia, belonging to the institution), František FORET (203 Czech Republic, belonging to the institution), Jana SKŘIČKOVÁ (203 Czech Republic, belonging to the institution), Martina DOUBKOVÁ (203 Czech Republic, belonging to the institution), Dagmar KINDLOVÁ (203 Czech Republic, belonging to the institution), Eva POKOJOVÁ (203 Czech Republic, belonging to the institution) and Petr KUBÁŇ (203 Czech Republic, belonging to the institution)
Edition
Journal of clinical gastroenterology, PHILADELPHIA, LIPPINCOTT WILLIAMS & WILKINS, 2019, 0192-0790
Other information
Language
English
Type of outcome
Článek v odborném periodiku
Field of Study
30219 Gastroenterology and hepatology
Country of publisher
United States of America
Confidentiality degree
není předmětem státního či obchodního tajemství
References:
Impact factor
Impact factor: 2.973
RIV identification code
RIV/00216224:14740/19:00108449
Organization unit
Central European Institute of Technology
UT WoS
000464986600012
Keywords in English
GERD; noninvasive test; pepsin; peptest; saliva
Tags
International impact, Reviewed
Změněno: 3/3/2020 15:30, Mgr. Pavla Foltynová, Ph.D.
Abstract
V originále
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.
Links
| NV17-31945A, research and development project |
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