Methods of performing ultra-sensitive immunoassays

Details Methods of performing ultra-sensitive immunoassays Methods of performing ultra-sensitive immunoassays

G - Physics

01

N

G01N 35/02 (2006.01) C40B 30/04 (2006.01) G01N 33/543 (2006.01) G01N 33/569 (2006.01)

Patent

CA 2700745

A method for improving the sensitivity of an immunoassay by a factor of at least 10 to about 25, and perhaps greater. Furthermore, in addition to increasing the sensitivity of the assay, the method of this invention also improves assay specificity. In order to match or improve upon sensitivity of 0.2 pg/mL for an analyte, this invention provides an immunoassay involving amplification of a signal, e.g., a chemiluminescent signal, a specific binding member, e.g., a monoclonal antibody, and microparticle separation, e.g., magnetic microparticle separation, from large volumes of sample (e.g., from about 0.2 to about 3 mL). Such an immunoassay can be carried out with an automated immunoassay analyzers, e.g., an automated immunoassay analyzer in the ARCHITECT® family of analyzers.

L'invention concerne un procédé pour améliorer la sensibilité d'un immunoessai d'un facteur d'au moins 10 à environ 25, et peut-être plus. En outre, non seulement le procédé de l'invention augmente la sensibilité de l'essai, ledit procédé améliore également la spécificité de l'essai. Pour égaler ou améliorer la sensibilité de 0,2 pg/ml d'une substance à analyser, l'invention propose un immunoessai qui entraîne l'amplification d'un signal, par exemple d'un signal chimioluminescent, un élément de liaison spécifique, par exemple un anticorps monoclonal, et une séparation de microparticule, par exemple une séparation de microparticule magnétique, à partir de grands volumes d'échantillon (par exemple d'environ 0,2 à environ 3 ml). Un tel immunoessai peut être effectué avec des analyseurs d'immunoessai automatisés, par exemple un analyseur d'immunoessai automatisé de la famille des analyseurs ARCHITECT®.

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