Method and test kit for neutralization/immunoinhibition assay

G - Physics – 01 – N

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150/15

G01N 33/573 (2006.01) G01N 33/542 (2006.01)

Patent

CA 1320114

ABSTRACT OF THE DISCLOSURE Method and test kit suitable for determination of the level of a diagnostically relevant isoenzyme in a biological fluid sample. This method and test kit are based upon the determination of residual enzyme activity of a biological fluid sample subsequent to inhibition of the diagnostically relevant isoenzyme within the sample. Such neutralization/immunoinhibition of the enzyme is accomplished with a relatively impure, low avidity anti-serum which is specific for the isoenzyme. This assay is unique in that the anti-serum which is employed in the neutralization/immunoinhibition of the isoenzyme is only effective in the neutralization/immunoinhibition of from at least about 50% to up to about 85% of the original enzymatic activity of the isoenzymes within the sample, This method provides the unique ability to determine the level of diagnostically relevant isoenzyme from rate data which is inclusive of high residual enzymatic activity of the diagnostically relevant isoenzymes and other interferents, This method is suitable for determination of CK-MB levels and, thus, provides a diagnostic tool for the exclusion of acute myocardial infarction as the cause of patient distress.

566474

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