CUSTOMIZED QUALITY CONTROLS FOR ANALYTICAL ASSAYS

摘要

Solid beads each containing a selected quantity of analyte are combined and a liquid base matrix that contains attributes of a biological fluid that is to be assayed, together constitute a kit from which a laboratory technician can, at the point of use, prepare a liquid control for a particular analyte, and preferably a series of such controls at different levels of the same analyte customized for a particular assay.

主权项

1. A kit for preparation of a customized control for a diagnostic assay, said kit comprising:
an aqueous liquid matrix comprising a salt and a buffer at a pH of from about 4.0 to about 9.0; and a plurality of solid water-soluble beads, wherein the solid water-soluble beads are prepared by lyophilization of an aqueous solution ranging in volume from about 5 μL to about 1,000 μL, and the solid water-soluble beads comprise at least one said analyte, a bulking agent, a salt, and a buffer,
wherein said beads are configured for 1) dissolving different quantities of the one or more solid water-soluble bead in separate aliquots of said aqueous liquid matrix, wherein the aliquots have equal volume; or 2) dissolving the same quantities of the one or more solid water-soluble bead in separate aliquots of said aqueous liquid matrix, wherein the aliquots have different volume.