Method and device to optimize analyte and antibody substrate...

G - Physics – 01 – N

Patent

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G01N 33/543 (2006.01) G01N 33/552 (2006.01)

Patent

CA 2573931

The present invention provides a method of making an assay device for conducting an assay to detect a concentration of an analyte in a sample fluid. The assay devices would typically have a substantially planar surface having a series of site specific immobilized calibration spot arrays containing pre- determined quantities of the analyte printed thereon. In addition, a series of site specific immobilized test spot arrays, including capture antibody for binding the analyte protein is printed on the assay device. The method involves first modifying the planar surface to provide hydrophobic binding sites, hydrophilic linking and covalent bonding sites. Then the method requires printing the series of site specific immobilized test spot arrays and the series of site specific immobilized calibration spot arrays on the substantially planar surface. Applying the sample fluid to the assay device is the next step followed by testing a sensitivity of the assay and modulating ratios of the hydrophobic, hydrophilic and covalent binding sites in order to optimize the sensitivity of the assay.

L'invention concerne un procédé de fabrication d'un dispositif d'essai permettant d'effectuer un essai pour détecter une concentration d'un analyte dans un fluide échantillon. Ce dispositif d'essai possède typiquement une surface sensiblement plane sur laquelle est imprimée une série d'ensembles de points d'étalonnage immobilisés spécifiques à un site contenant des quantités prédéterminées de l'analyte. En outre, une série d'ensembles de points de test immobilisés spécifiques à un site, contenant un anticorps de capture pour lier la protéine de l'analyte, est imprimée sur le dispositif d'essai. Ce procédé consiste à tout d'abord modifier la surface plane pour obtenir des sites de liaison hydrophobe, des sites de liaison hydrophile et des sites de liaison covalente. Ensuite, le procédé consiste à imprimer la série d'ensembles de points de test immobilisés spécifiques à un site et la série d'ensembles de points d'étalonnage immobilisés spécifiques à un site sur la surface sensiblement plane. L'étape suivante est l'application du fluide échantillon sur le dispositif d'essai, suivie du test d'une sensibilité de l'essai et de la modulation des rapports entre les sites de liaison hydrophobe, hydrophile et covalente afin d'optimiser la sensibilité de l'essai.

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