METHODS OF PERFORMING ULTRA-SENSITIVE IMMUNOASSAYS

摘要

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.