| abstract |
The invention consists of devices for use in assaying fluid test samples for analyte of interest wherein the samples contain or are suspected of containing cells and cellular components. The devices of the invention each include a hydrophilic cell trap (1) for separation of the cellular fraction from the noncellular fraction of the test sample. The latter fraction migrates through porous, absorbent or bibulous membranes (3, 15, 20) of the device which are impregnated with reagents in at least three separate zones comprising a dye zone (15), a test zone (21) and a control zone (22). Formation of a distinctive visual pattern in the control zone indicates that the test was competently performed while formation or relative intensity of the visual pattern in the test zone indicates presence or absence of analyte in the test sample. The devices of the invention are particularly suited for assaying ligands in whole blood without prior separation of erythrocytes and other cells from the blood and without need to measure reflectance in the liquid phase. A method for performing the inventive assays is also disclosed. |