Assesment of Important Analytical Parameters of Peptest Immunoassay for its use in Diagnosis of Esophageal Reflux Disease

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F65269705%3A_____%2F18%3A00069910" target="_blank" >RIV/65269705:_____/18:00069910 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216224:14110/18:00106970

Výsledek na webu

<a href="https://www.gastrojournal.org/article/S0016-5085(18)31830-4/fulltext" target="_blank" >https://www.gastrojournal.org/article/S0016-5085(18)31830-4/fulltext</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/S0016-5085(18)31830-4" target="_blank" >10.1016/S0016-5085(18)31830-4</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Assesment of Important Analytical Parameters of Peptest Immunoassay for its use in Diagnosis of Esophageal Reflux Disease

Popis výsledku v původním jazyce

Introduction: Gastroesophageal reflux disease (GERD) can lead to esophageal and extraesophageal symptomatology. Extraesophageal reflux (EER) is a condition where refluxate penetrate above the upper esophageal sphincter into the oral cavity, pharynx, upper and lower respiratory tract. Prolonged or repeated exposure to gastric contents leads to mucosal damage and pathological changes. Experimental studies suggested that the damage caused by reflux is not only due to acidic nature of the refluxate, but is caused also by pepsin and bile acids. Methods: A recently developed noninvasive rapid salivary pepsin lateral flow device (Peptest, RDBiomed, Hull, UK) was introduced as a commercially available method to diagnose reflux. In this work, we have evaluated basic analytical parameters of the Peptest assay, such as time dependence of the signal, repeatability, reproducibility and longitudinal signal dependence that are all important for standardizing sampling and analysis procedure. We tried to evaluate the sensitivity and specificity in the study with 32 patients (19 women, 13 men, mean age of 51 years (age range, 30 to 65 years)) with asthma or chronic cough. All patients underwent MII-pH and Peptest. The group of 13 healthy volunteers (4 women, 9 men, mean age of 44 years (age range, 30 to 65 years) served as the controls and they underwent only Peptest without MII-pH for ethical reasons. Saliva samples were collected immediately after waking and were processed exactly as recommended by the producer. The pepsin concentration was obtained by a standard LFD reader. Results: The study showed that the readout time of 15 minutes needs to be exactly followed, because there is about 50% increase of the signal in additional 15 minutes. The LFD reader provides reasonable precision, ranging from 1.2 to 12.9% RSD using the same LF device. However, the reproducibility of individual LF devices is poor, especially for low concentration of pepsin. The difference between individual LF devices on the same saliva sample can be as high as 35 ng/ml, so we suggest to rise the positivity cut-off value to 35 ng/ml. Using this cut off value, the sensitivity of the Peptest assay was 42.1 % in the group with acid reflux and 12.5% in the group with weakly acid reflux was. The specificity at 35 ng/ml was 58.3%. Conclusion: The repeatability, reproducibility, sensitivity and specificity values of Peptest are low. They could be improved by taking multiple samples, but the cost of the testing will increase significantly with only moderate improvement in the assay performance. Without changes in the assay protocol of Peptest cannot be recommended for use in primary care.

Název v anglickém jazyce

Assesment of Important Analytical Parameters of Peptest Immunoassay for its use in Diagnosis of Esophageal Reflux Disease

Popis výsledku anglicky

Introduction: Gastroesophageal reflux disease (GERD) can lead to esophageal and extraesophageal symptomatology. Extraesophageal reflux (EER) is a condition where refluxate penetrate above the upper esophageal sphincter into the oral cavity, pharynx, upper and lower respiratory tract. Prolonged or repeated exposure to gastric contents leads to mucosal damage and pathological changes. Experimental studies suggested that the damage caused by reflux is not only due to acidic nature of the refluxate, but is caused also by pepsin and bile acids. Methods: A recently developed noninvasive rapid salivary pepsin lateral flow device (Peptest, RDBiomed, Hull, UK) was introduced as a commercially available method to diagnose reflux. In this work, we have evaluated basic analytical parameters of the Peptest assay, such as time dependence of the signal, repeatability, reproducibility and longitudinal signal dependence that are all important for standardizing sampling and analysis procedure. We tried to evaluate the sensitivity and specificity in the study with 32 patients (19 women, 13 men, mean age of 51 years (age range, 30 to 65 years)) with asthma or chronic cough. All patients underwent MII-pH and Peptest. The group of 13 healthy volunteers (4 women, 9 men, mean age of 44 years (age range, 30 to 65 years) served as the controls and they underwent only Peptest without MII-pH for ethical reasons. Saliva samples were collected immediately after waking and were processed exactly as recommended by the producer. The pepsin concentration was obtained by a standard LFD reader. Results: The study showed that the readout time of 15 minutes needs to be exactly followed, because there is about 50% increase of the signal in additional 15 minutes. The LFD reader provides reasonable precision, ranging from 1.2 to 12.9% RSD using the same LF device. However, the reproducibility of individual LF devices is poor, especially for low concentration of pepsin. The difference between individual LF devices on the same saliva sample can be as high as 35 ng/ml, so we suggest to rise the positivity cut-off value to 35 ng/ml. Using this cut off value, the sensitivity of the Peptest assay was 42.1 % in the group with acid reflux and 12.5% in the group with weakly acid reflux was. The specificity at 35 ng/ml was 58.3%. Conclusion: The repeatability, reproducibility, sensitivity and specificity values of Peptest are low. They could be improved by taking multiple samples, but the cost of the testing will increase significantly with only moderate improvement in the assay performance. Without changes in the assay protocol of Peptest cannot be recommended for use in primary care.

Druh

O - Ostatní výsledky

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

2018

Kód důvěrnosti údajů

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