Analytical Validation of a New Enzymatic and Automatable Method for d-Xylose Measurement in Human Urine Samples

Autor: Carmen Hermida, Eduardo García-Junceda, Luis Illa, Israel Sánchez-Moreno, Guillermo Manuel Muñoz, Carmen Monsalve-Hernando, Alfonso Fernández-Mayoralas, Jose Luis R. Martin, Ana Godino, A.A. Diaz, María Jesús Gaspar
Přispěvatelé: VenterPharma
Jazyk: angličtina
Rok vydání: 2017
Předmět:
Zdroj: BioMed Research International
Digital.CSIC. Repositorio Institucional del CSIC
instname
BioMed Research International, Vol 2017 (2017)
Repositorio Institucional de la Consejería de Sanidad de la Comunidad de Madrid
Consejería de Sanidad de la Comunidad de Madrid
ISSN: 2314-6141
2314-6133
Popis: Hypolactasia, or intestinal lactase deficiency, affects more than half of the world population. Currently, xylose quantification in urine after gaxilose oral administration for the noninvasive diagnosis of hypolactasia is performed with the hand-operated nonautomatable phloroglucinol reaction. This work demonstrates that a new enzymatic xylose quantification method, based on the activity of xylose dehydrogenase from Caulobacter crescentus, represents an excellent alternative to the manual phloroglucinol reaction. The new method is automatable and facilitates the use of the gaxilose test for hypolactasia diagnosis in the clinical practice. The analytical validation of the new technique was performed in three different autoanalyzers, using buffer or urine samples spiked with different xylose concentrations. For the comparison between the phloroglucinol and the enzymatic assays, 224 urine samples of patients to whom the gaxilose test had been prescribed were assayed by both methods. A mean bias of -16.08 mg of xylose was observed when comparing the results obtained by both techniques. After adjusting the cut-off of the enzymatic method to 19.18 mg of xylose, the Kappa coefficient was found to be 0.9531, indicating an excellent level of agreement between both analytical procedures. This new assay represents the first automatable enzymatic technique validated for xylose quantification in urine.
The authors thank IgorMart´ın for his support with statistical analysis, Jos´e Claros and Ricardo Jara from Immunostep for their work in the kit development, and Guillermo Corrales for his technical assistance. The work presented in this manuscript was funded by Venter Pharma S.L., Madrid, Spain.
Databáze: OpenAIRE