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

J 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.

Základní údaje

Originální název

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

Autoři

DOLINA, Jiří (203 Česká republika, domácí), Štefan KONEČNÝ (703 Slovensko, domácí), Pavol ĎURČ (703 Slovensko, domácí), Júlia LAČNÁ (703 Slovensko, domácí), Michal GREGUŠ (703 Slovensko, domácí), František FORET (203 Česká republika, domácí), Jana SKŘIČKOVÁ (203 Česká republika, domácí), Martina DOUBKOVÁ (203 Česká republika, domácí), Dagmar KINDLOVÁ (203 Česká republika, domácí), Eva POKOJOVÁ (203 Česká republika, domácí) a Petr KUBÁŇ (203 Česká republika, domácí)

Vydání

Journal of clinical gastroenterology, PHILADELPHIA, LIPPINCOTT WILLIAMS & WILKINS, 2019, 0192-0790

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30219 Gastroenterology and hepatology

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 2.973

Kód RIV

RIV/00216224:14740/19:00108449

Organizační jednotka

Středoevropský technologický institut

DOI

http://dx.doi.org/10.1097/MCG.0000000000001066

UT WoS

000464986600012

Klíčová slova anglicky

GERD; noninvasive test; pepsin; peptest; saliva

Štítky

14110215, podil, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 3. 3. 2020 15:30, Mgr. Pavla Foltynová, Ph.D.

Anotace

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.

Návaznosti

NV17-31945A, projekt VaV

Název: Vývoj neinvazivní diagnostiky extraezofageálních projevů refluxní choroby jícnu

Citovat

DOLINA, Jiří, Štefan KONEČNÝ, Pavol ĎURČ, Júlia LAČNÁ, Michal GREGUŠ, František FORET, Jana SKŘIČKOVÁ, Martina DOUBKOVÁ, Dagmar KINDLOVÁ, Eva POKOJOVÁ a Petr KUBÁŇ. Evaluation of Important Analytical Parameters of the Peptest Immunoassay that Limit its Use in Diagnosing Gastroesophageal Reflux Disease. Journal of clinical gastroenterology. PHILADELPHIA: LIPPINCOTT WILLIAMS & WILKINS, 2019, roč. 53, č. 5, s. 355-360. ISSN 0192-0790. Dostupné z: https://dx.doi.org/10.1097/MCG.0000000000001066.

@article{1492818,
   author = {Dolina, Jiří and Konečný, Štefan and Ďurč, Pavol and Lačná, Júlia and Greguš, Michal and Foret, František and Skřičková, Jana and Doubková, Martina and Kindlová, Dagmar and Pokojová, Eva and Kubáň, Petr},
   article_location = {PHILADELPHIA},
   article_number = {5},
   doi = {http://dx.doi.org/10.1097/MCG.0000000000001066},
   keywords = {GERD; noninvasive test; pepsin; peptest; saliva},
   language = {eng},
   issn = {0192-0790},
   journal = {Journal of clinical gastroenterology},
   title = {Evaluation of Important Analytical Parameters of the Peptest Immunoassay that Limit its Use in Diagnosing Gastroesophageal Reflux Disease},
   url = {https://journals.lww.com/jcge/Abstract/publishahead/Evaluation_of_Important_Analytical_Parameters_of.97867.aspx},
   volume = {53},
   year = {2019}
}

TY  - JOUR
ID  - 1492818
AU  - Dolina, Jiří - Konečný, Štefan - Ďurč, Pavol - Lačná, Júlia - Greguš, Michal - Foret, František - Skřičková, Jana - Doubková, Martina - Kindlová, Dagmar - Pokojová, Eva - Kubáň, Petr
PY  - 2019
TI  - Evaluation of Important Analytical Parameters of the Peptest Immunoassay that Limit its Use in Diagnosing Gastroesophageal Reflux Disease
JF  - Journal of clinical gastroenterology
VL  - 53
IS  - 5
SP  - 355-360
EP  - 355-360
PB  - LIPPINCOTT WILLIAMS & WILKINS
SN  - 01920790
KW  - GERD
KW  - noninvasive test
KW  - pepsin
KW  - peptest
KW  - saliva
UR  - https://journals.lww.com/jcge/Abstract/publishahead/Evaluation_of_Important_Analytical_Parameters_of.97867.aspx
L2  - https://journals.lww.com/jcge/Abstract/publishahead/Evaluation_of_Important_Analytical_Parameters_of.97867.aspx
N2  - 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.
ER  -

DOLINA, Jiří, Štefan KONEČNÝ, Pavol ĎURČ, Júlia LAČNÁ, Michal GREGUŠ, František FORET, Jana SKŘIČKOVÁ, Martina DOUBKOVÁ, Dagmar KINDLOVÁ, Eva POKOJOVÁ a Petr KUBÁŇ. Evaluation of Important Analytical Parameters of the Peptest Immunoassay that Limit its Use in Diagnosing Gastroesophageal Reflux Disease. \textit{Journal of clinical gastroenterology}. PHILADELPHIA: LIPPINCOTT WILLIAMS \&{} WILKINS, 2019, roč.~53, č.~5, s.~355-360. ISSN~0192-0790. Dostupné z: https://dx.doi.org/10.1097/MCG.0000000000001066.

Podrobný výpis o publikaci