Delayed and diffused flow rapid confirmatory immunological testing apparatus and method

Abstract

A self-contained apparatus using a gravitationally encouraged, interrupted, downward, diffusive and programmed flow of fluid to provide for rapid confirmatory immunological testing ('RCIT') in, for example, a clinical, point-of-care setting. A fluid specimen such as blood, saliva or urine is deposited into a first chamber carrying a source of conjugate having mobilizable binding members such as immunographic antigens or antibodies specific to the condition being tested conjugated to a detectable label such as colloidal gold. The specimen is premixed with a first measured, reactive mix buffer solution carried within an openable tank. The specimen and solution are temporarily held within an incubation reservoir formed behind a dam made from porous, diffusive material. The delay and flow through the diffusive dam causes mixing of the specimen and solution to form a premixture which exhibits a more uniformly high degree of first affinity binding before flowing out of the first chamber toward one or more chromatographic test strips in a second chamber. In one embodiment, after a waiting period, a bladder containing a stop-wash buffer solution is opened to flow onto the strips. Additional embodiments provide one or more diffusive structures that can be pretreated with mixture enhancing chemicals such as surfactants. It is a rapid confirmatory immunological test apparatus having an analytical panel which can provide profile diagnostic results.