Amelioration of heterophile antibody immunosensor interference

G - Physics – 01 – N

Patent

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G01N 33/53 (2006.01)

Patent

CA 2756355

The invention is directed to methods and devices for reducing interference from heterophile antibodies in an analyte immunoassay. In one embodiment, the invention is to a method comprising the steps of (a) amending a biological sample such as a whole blood sample with non-human IgM or fragments thereof by dissolving into said sample a dry reagent to yield a non-human IgM concentration of at least about 20 g/mL or equivalent fragment concentration; and (b) performing an electrochemical immunoassay on the amended sample to determine the concentration of said analyte in said sample. Preferably, the sample is amended with IgG or fragments thereof in addition to the IgM of fragments thereof.

L'invention concerne des procédés et des dispositifs visant à réduire l'interférence due aux anticorps hétérophiles dans un test immunologique d'un analyte. Un mode de réalisation de l'invention concerne un procédé comprenant les étapes suivantes : (a) addition à un échantillon biologique comme un échantillon de sang entier d'une IgM non humaine ou de fragments de celle-ci par dissolution dans ledit échantillon d'un réactif sec pour obtenir une concentration d'IgM non humaine d'au moins environ 20 µg/ml ou une concentration de fragments équivalente ; et (b) mise en uvre d'un test immunologique électrochimique sur l'échantillon amendé afin de déterminer la concentration dudit analyte dans ledit échantillon. De préférence, l'échantillon est additionné d'une IgG ou de fragments de celle-ci en plus de l'IgM ou de fragments de celle-ci.

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