Validation of an enzyme-linked inmunosorbent assay (ELISA) kit for the quantification of gliadins in medicines and cosmetics

Celiac disease is caused by intolerance to gluten and the only current treatment is a gluten-free diet. Gliadins are the alcohol-soluble proteins that make up the majority of gluten and are the ones that have the most harmful effect on patients with celiac disease. In recent years the issue of the p...

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Autores: Loría Gutiérrez, Arlene; Blanco Barrantes, Jeimy; Ramirez Elizondo, Giovanni
Tipo de documento: Artículo
Fecha de publicación:2021
País:Costa Rica
Institución:UCR
Repositorio:Kérwá
Lenguaje:Inglés
OAI Identifier:oai:kerwa.ucr.ac.cr:10669/87101
Acceso en línea:https://ijmpronline.com/home/article_abstract/389
https://hdl.handle.net/10669/87101
Nivel de acceso:Acceso abierto
Palabra clave:Gliadins
Gluten
ELISA
Validation
Medicines
Cosmetics
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author Loría Gutiérrez, Arlene
author2 Blanco Barrantes, Jeimy
Ramirez Elizondo, Giovanni
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author_browse Blanco Barrantes, Jeimy
Loría Gutiérrez, Arlene
Ramirez Elizondo, Giovanni
author_facet Loría Gutiérrez, Arlene
Blanco Barrantes, Jeimy
Ramirez Elizondo, Giovanni
author_role author
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description Celiac disease is caused by intolerance to gluten and the only current treatment is a gluten-free diet. Gliadins are the alcohol-soluble proteins that make up the majority of gluten and are the ones that have the most harmful effect on patients with celiac disease. In recent years the issue of the presence of gluten in medicines and cosmetics, has become relevant since it is present in many excipients that are used as lubricants or absorbents, to provide mass or volume, give shape, color and consistency. The quantification of gliadins was carried out using the ELISA technique based on the R5 antibody, with a RIDASCREEN® Gliadin kit from R-Biopharm and a microplate ELISA spectrophotometer. To validate the immunological analytical method, the specificity, intermediate precision, relative accuracy and range were measured according to the USP 41 specifications for biologic assays. Recovery percentages of gliadins in positive control samples higher than 65 % were obtained. The relative standard deviation resulting from the amount of gliadins recovered to determine the intermediate precision of the kit was 7,6 %. Then, when determining the relative accuracy, an average absolute error value of 9,5 % was obtained. The range established to accurately and precisely analyze a sample was from 5 mg/kg to 80 mg/kg. The analytical method validated in this project meets performance characteristics such as specificity, intermediate precision, relative accuracy and range, suitable for the determination of gliadin content in drugs and cosmetics.
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spelling Validation of an enzyme-linked inmunosorbent assay (ELISA) kit for the quantification of gliadins in medicines and cosmetics Loría Gutiérrez, Arlene Blanco Barrantes, Jeimy Ramirez Elizondo, Giovanni Gliadins Gluten ELISA Validation Medicines Cosmetics Celiac disease is caused by intolerance to gluten and the only current treatment is a gluten-free diet. Gliadins are the alcohol-soluble proteins that make up the majority of gluten and are the ones that have the most harmful effect on patients with celiac disease. In recent years the issue of the presence of gluten in medicines and cosmetics, has become relevant since it is present in many excipients that are used as lubricants or absorbents, to provide mass or volume, give shape, color and consistency. The quantification of gliadins was carried out using the ELISA technique based on the R5 antibody, with a RIDASCREEN® Gliadin kit from R-Biopharm and a microplate ELISA spectrophotometer. To validate the immunological analytical method, the specificity, intermediate precision, relative accuracy and range were measured according to the USP 41 specifications for biologic assays. Recovery percentages of gliadins in positive control samples higher than 65 % were obtained. The relative standard deviation resulting from the amount of gliadins recovered to determine the intermediate precision of the kit was 7,6 %. Then, when determining the relative accuracy, an average absolute error value of 9,5 % was obtained. The range established to accurately and precisely analyze a sample was from 5 mg/kg to 80 mg/kg. The analytical method validated in this project meets performance characteristics such as specificity, intermediate precision, relative accuracy and range, suitable for the determination of gliadin content in drugs and cosmetics. UCR::Vicerrectoría de Investigación::Unidades de Investigación::Ciencias de la Salud::Instituto de Investigaciones Farmacéuticas (INIFAR) https://ijmpronline.com/home/article_abstract/389 2319-5878 https://hdl.handle.net/10669/87101
spellingShingle Validation of an enzyme-linked inmunosorbent assay (ELISA) kit for the quantification of gliadins in medicines and cosmetics
Loría Gutiérrez, Arlene
Gliadins
Gluten
ELISA
Validation
Medicines
Cosmetics
title Validation of an enzyme-linked inmunosorbent assay (ELISA) kit for the quantification of gliadins in medicines and cosmetics
title_full Validation of an enzyme-linked inmunosorbent assay (ELISA) kit for the quantification of gliadins in medicines and cosmetics
title_fullStr Validation of an enzyme-linked inmunosorbent assay (ELISA) kit for the quantification of gliadins in medicines and cosmetics
title_full_unstemmed Validation of an enzyme-linked inmunosorbent assay (ELISA) kit for the quantification of gliadins in medicines and cosmetics
title_short Validation of an enzyme-linked inmunosorbent assay (ELISA) kit for the quantification of gliadins in medicines and cosmetics
title_sort Validation of an enzyme-linked inmunosorbent assay (ELISA) kit for the quantification of gliadins in medicines and cosmetics
topic Gliadins
Gluten
ELISA
Validation
Medicines
Cosmetics
topic_facet Gliadins
Gluten
ELISA
Validation
Medicines
Cosmetics
url https://ijmpronline.com/home/article_abstract/389
https://hdl.handle.net/10669/87101