Interrupted flow testing device and method for immunological confirmatory tests

摘要

A self-contained device using a gravitationally encouraged, interrupted downward and programmed flow of fluid to provide for rapid confirmatory immunological testing ("RCIT") in a point-of-care setting. A fluid specimen such as blood, saliva or urine is deposited into a first chamber and premixed with a first measured, reactive mix buffer solution carried within an openable tank. The mix buffer carries a colloidal conjugate of antigens and/or antibodies pathogenically specific to the condition being tested. The premixture flows out of the first chamber toward chromatographic test strips having a single layer of uniformly dispersed porous matrix material such as polyethylene and inclined in a downward flow orientation. The flow is interrupted by a holding reservoir which is drained by siphoning, gravity and capillary forces. The delayed and regulated flow provides an incubation time for a better affinity binding of the specimen. In one embodiment, after a waiting period a bladder containing a stop-wash buffer solution is opened to flow into the reservoir and onto the strips. An absorbant pad collects excess fluid at the bottom end of the strips. It is a rapid confirmatory immunological test device having an analytical panel which can provide profile diagnostic results.