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...

Descripción completa

Detalles Bibliográficos
Autores: Loría Gutiérrez, Arlene, Blanco Barrantes, Jeimy, Ramirez Elizondo, Giovanni
Tipo de recurso: artículo
Fecha de publicación:2021
País:Costa Rica
Institución:Universidad de Costa Rica
Repositorio:Kérwá
Idioma: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
Access Level:acceso abierto
Palabra clave:Gliadins
Gluten
ELISA
Validation
Medicines
Cosmetics
id CR_edc28fa9036cb642b9d0c3812e4e2e98
oai_identifier_str oai:kerwa.ucr.ac.cr:10669/87101
network_acronym_str CR
network_name_str Costa Rica
repository_id_str
dc.title.es_ES.fl_str_mv Validation of an enzyme-linked inmunosorbent assay (ELISA) kit for the quantification of gliadins in medicines and cosmetics
title Validation of an enzyme-linked inmunosorbent assay (ELISA) kit for the quantification of gliadins in medicines and cosmetics
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_short 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_sort Validation of an enzyme-linked inmunosorbent assay (ELISA) kit for the quantification of gliadins in medicines and cosmetics
dc.creator.none.fl_str_mv Loría Gutiérrez, Arlene
Blanco Barrantes, Jeimy
Ramirez Elizondo, Giovanni
author Loría Gutiérrez, Arlene
author_facet Loría Gutiérrez, Arlene
Blanco Barrantes, Jeimy
Ramirez Elizondo, Giovanni
author_role author
author2 Blanco Barrantes, Jeimy
Ramirez Elizondo, Giovanni
author2_role author
author
dc.subject.es_ES.fl_str_mv Gliadins
Gluten
ELISA
Validation
Medicines
Cosmetics
topic Gliadins
Gluten
ELISA
Validation
Medicines
Cosmetics
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.
publishDate 2021
dc.date.issued.none.fl_str_mv 2021
dc.date.accessioned.none.fl_str_mv 2022-07-29T21:54:55Z
dc.date.available.none.fl_str_mv 2022-07-29T21:54:55Z
dc.type.es_ES.fl_str_mv artículo original
dc.type.none.fl_str_mv http://purl.org/coar/resource_type/c_2df8fbb1
info:eu-repo/semantics/article
format article
dc.identifier.citation.es_ES.fl_str_mv https://ijmpronline.com/home/article_abstract/389
dc.identifier.issn.none.fl_str_mv 2319-5878
dc.identifier.uri.none.fl_str_mv https://hdl.handle.net/10669/87101
url https://ijmpronline.com/home/article_abstract/389
https://hdl.handle.net/10669/87101
identifier_str_mv 2319-5878
dc.language.iso.es_ES.fl_str_mv eng
language eng
dc.rights.none.fl_str_mv acceso abierto
http://purl.org/coar/access_right/c_abf2
info:eu-repo/semantics/openAccess
rights_invalid_str_mv acceso abierto
http://purl.org/coar/access_right/c_abf2
eu_rights_str_mv openAccess
dc.source.es_ES.fl_str_mv International Journal of Modern Pharmaceutical Research; Vol. 5 Núm. 2: 2021 pp.17-21
dc.source.none.fl_str_mv reponame:Kérwá
instname:Universidad de Costa Rica
instacron:UCR
instname_str Universidad de Costa Rica
instacron_str UCR
institution UCR
reponame_str Kérwá
collection Kérwá
bitstream.url.fl_str_mv https://www.kerwa.ucr.ac.cr/bitstreams/fa3b1c29-a012-4ed3-83a6-61a5aecdf3b7/download
https://www.kerwa.ucr.ac.cr/bitstreams/b61eba0b-a059-4ed7-ba7b-6fda01ed97cc/download
https://www.kerwa.ucr.ac.cr/bitstreams/12a5ba49-395d-408f-a4e8-c154cbf0fcd3/download
https://www.kerwa.ucr.ac.cr/bitstreams/b9bf04ad-083e-4275-b504-84388521debe/download
bitstream.checksum.fl_str_mv ea57b4cf0818c436720bd01382a61b21
44ae5839bc6497e3c892c5ee8e4284f1
9d7888232e72a85115b9434798a9ce09
14b60a62c8dad4954f49a2b399efae3d
bitstream.checksumAlgorithm.fl_str_mv MD5
MD5
MD5
MD5
repository.name.fl_str_mv Kérwá - Universidad de Costa Rica
repository.mail.fl_str_mv meilyn.garro@ucr.ac.cr
_version_ 1849325634565701632
spelling Loría Gutiérrez, Arleneb128d966-0a03-4642-a7f0-c004d40dc89f600Blanco Barrantes, Jeimyaa5f881e-1d17-4a03-93af-013b86657f7e600Ramirez Elizondo, Giovanni522b7e2b-5f27-4f4f-832a-5084dfd3dd3c2022-07-29T21:54:55Z2022-07-29T21:54:55Z2021https://ijmpronline.com/home/article_abstract/3892319-5878https://hdl.handle.net/10669/87101Celiac 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)engacceso abiertohttp://purl.org/coar/access_right/c_abf2info:eu-repo/semantics/openAccessInternational Journal of Modern Pharmaceutical Research; Vol. 5 Núm. 2: 2021 pp.17-21reponame:Kérwáinstname:Universidad de Costa Ricainstacron:UCRGliadinsGlutenELISAValidationMedicinesCosmeticsValidation of an enzyme-linked inmunosorbent assay (ELISA) kit for the quantification of gliadins in medicines and cosmeticsartículo originalhttp://purl.org/coar/resource_type/c_2df8fbb1info:eu-repo/semantics/articleORIGINALValidation of an enzyme-linked inmunosorbent assay (ELISA) kit for the quantification of gliadins in medicines and cosmetics..pdfValidation of an enzyme-linked inmunosorbent assay (ELISA) kit for the quantification of gliadins in medicines and cosmetics..pdfapplication/pdf281035https://www.kerwa.ucr.ac.cr/bitstreams/fa3b1c29-a012-4ed3-83a6-61a5aecdf3b7/downloadea57b4cf0818c436720bd01382a61b21MD51LICENSElicense.txtlicense.txttext/plain; charset=utf-83585https://www.kerwa.ucr.ac.cr/bitstreams/b61eba0b-a059-4ed7-ba7b-6fda01ed97cc/download44ae5839bc6497e3c892c5ee8e4284f1MD52TEXTValidation of an enzyme-linked inmunosorbent assay (ELISA) kit for the quantification of gliadins in medicines and cosmetics..pdf.txtValidation of an enzyme-linked inmunosorbent assay (ELISA) kit for the quantification of gliadins in medicines and cosmetics..pdf.txtExtracted texttext/plain22799https://www.kerwa.ucr.ac.cr/bitstreams/12a5ba49-395d-408f-a4e8-c154cbf0fcd3/download9d7888232e72a85115b9434798a9ce09MD53THUMBNAILValidation of an enzyme-linked inmunosorbent assay (ELISA) kit for the quantification of gliadins in medicines and cosmetics..pdf.jpgValidation of an enzyme-linked inmunosorbent assay (ELISA) kit for the quantification of gliadins in medicines and cosmetics..pdf.jpgIM Thumbnailimage/jpeg11701https://www.kerwa.ucr.ac.cr/bitstreams/b9bf04ad-083e-4275-b504-84388521debe/download14b60a62c8dad4954f49a2b399efae3dMD5410669/871012024-06-25 10:11:04.505open.accessoai:kerwa.ucr.ac.cr:10669/87101https://www.kerwa.ucr.ac.crInstitucionalhttp://www.kerwa.ucr.ac.crUniversidadhttp://www.ucr.ac.crhttps://kerwa.ucr.ac.cr/oai/requestmeilyn.garro@ucr.ac.crCosta RicaNo aplicaNo aplicaNo aplicaopendoar:18712025-03-29T18:09:46.892Kérwá - Universidad de Costa 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
score 15,81155