Integrated filtration bioanalyzer

摘要

The present invention relates to an in vitro assay method and device that provides for detection and measurement of entities in a fluid sample that can be captured and concentrated in a unitized self-contained enclosed filter apparatus that is analyzed in an optical detection instrument for indications of the entity. It provides for analysis of biological material including cells, their enzymes, or other constituents thereof, that can be identified based on an indicator-generating means. The analysis provided for include detection of the presence of the entity, and changes in the entity over time, such as associated with growth and increasing metabolic activity with an expanding population of cells, or decreasing metabolic activity, for example, due to presence of inhibitory or toxic agents.

主权项

1. An in vitro method for determining the presence and/or activity of biological material in a liquid sample, comprising the steps of:
(i) filtering a liquid sample through an enclosed filter apparatus capable of trapping said biological material in said filter apparatus, whereby said biological material present in said liquid sample is retained in said filter apparatus; (ii) administering a reaction fluid into and/or through said filter apparatus, said reaction fluid comprising:
i. components to support and/or affect the biological activity of said biological material and/or,ii. an indicator means for indicating the presence and/or activity of said biological material; (iii) incubating said filter apparatus, said biological material retained and said reaction fluid in a measurement apparatus; (iv) performing one or more measurements by optical means of said indicator means and/or said biological material concurrent with incubation of said biological material in said filter apparatus using said measurement apparatus; and (v) performing analysis of said measurements of the said indictor means and/or said biological material to determine activity of the said biological material,
wherein steps (i)-(v) are performed within the enclosed filter apparatus.