Method for measuring cystatin c in human body fluid

Details Method for measuring cystatin c in human body fluid Method for measuring cystatin c in human body fluid

G - Physics

01

N

G01N 33/53 (2006.01) G01N 33/543 (2006.01) G01N 33/577 (2006.01)

Patent

CA 2745610

There is provided a particle-enhanced immunoassay method for cystatin C in a human body fluid, which has higher specificity and is easily automatable at low cost as compared with conventional assay methods that use large amounts of polyclonal antibodies having low specificity or monoclonal antibodies having high specificity but having poor agglutinability. Disclosed is an assay method specific to cystatin C in a human body fluid, which is a particle-enhanced immunoassay method utilizes a combination of antibody-coated particles in which some insoluble carrier particles are coated with anti-human cystatin C monoclonal antibodies of one type which have high affinity and in which some other insoluble carrier particles are coated with anti-human cystatin C monoclonal antibodies of one type which recognize an epitope different from that of the monoclonal antibody of the first-mentioned type and which have relatively low affinity, wherein the binding amount of the anti-human cystatin C monoclonal antibodies relative to the total weight of the particles being coated with the corresponding antibodies is less than 5% by weight.

La présente invention concerne un procédé d'immunoessai sur particule pour la cystatine C dans un fluide corporel humain, qui a une spécificité supérieure, est plus économique, et peut être automatisé plus aisément comparé à des procédés d'essai conventionnels dans lesquels des anticorps polyclonaux ayant une faible spécificité ou des anticorps monoclonaux ayant une spécificité élevée mais ayant une faible aptitude à l'agrégation ont été utilisés en grandes quantités. Le procédé d'immunoessai sur particule utilise une combinaison d'une particule sensibilisée par anticorps comprenant une particule porteuse insoluble et un anticorps monoclonal anti-cystatine C humaine ayant une affinité supérieure et lié à la particule et une particule sensibilisée par anticorps comprenant la particule porteuse insoluble et un anticorps monoclonal anti-cystatine C humaine ayant un site de reconnaissance différent de celui de l'anticorps monoclonal mentionné ci-dessus et ayant une affinité relativement élevée, où la quantité de chacun des anticorps monoclonaux anti-cystatine C humaine liés à la particule porteuse insoluble est inférieure à 5 % en poids par rapport au poids de la particule sensibilisée par anticorps.

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