Microparticle enhanced light scattering agglutination assay...

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G01N 33/543 (2006.01) C12Q 1/68 (2006.01) G01N 21/47 (2006.01) G01N 33/546 (2006.01)

Patent

CA 2244326

The invention relates to a new microparticle enhanced light scattering agglutination assay for determining the amount of an analyte, and a microparticle reagent for performing that assay. The microparticle enhanced light scattering agglutination tests are quasihomogeneous and do not need a separation and washing step. They thus meet the requirements for the automation with commonly used clinical chemistry analyzers or dedicated nephelometers. Such tests provide an increased sensitivity by a factor of 2 to 3 orders of magnitude (down to 10 -11 mol/l analyte) compared to direct agglutination tests not using microparticles and, in addition, less matrix interference and higher flexibility. The specification provides a microparticle enhanced light scattering agglutination assay for determining the amount of an analyte which comprises using a mixture of particles of strong light scattering properties carrying at least one binding partner of high reactivity for the analyte and particles of weak light scattering properties carrying at least one binding partner of low reactivity for the analyte. The assay of the invention shows an unexpectedly high dynamic range (DR).

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