Validation of an enzyme-linked inmunosorbent assay (ELISA) kit for the quantification of gliadins in medicines and cosmetics
Fecha
2021
Tipo
artículo original
Autores
Loría Gutiérrez, Arlene
Blanco Barrantes, Jeimy
Ramirez Elizondo, Giovanni
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Resumen
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.
Descripción
Palabras clave
Gliadins, Gluten, ELISA, Validation, Medicines, Cosmetics