Abstract: An assay device may include a first cylinder that includes a first end that is closed and a second, opposite end that is open. The first cylinder may include one or more reservoirs that are compressible and store one or more reagents. The device may include a test chamber to which the reservoirs are connected, and in which the sample can be inserted to perform the assay; and a second cylinder that includes a third end that is closed and a fourth, opposite end that is open. The fourth end may fit within the second end to enable the second cylinder to be attached to, and rotate within, the first cylinder. The third end may include a member that compresses the reservoirs, in a predetermined order, as the second cylinder is rotated within the first cylinder to cause the reagents to flow, to the test chamber, in the predetermined order.

Abstract: The present invention involves the reaction of a CD4 immuno-conjugate with a sample of patient whole blood. The CD4 immuno-conjugate consists of one or more antibodies with specificity for the CD4 surface receptor coupled to a signal moiety, or “label”, that is detectable by a flow cytometer. Such labels may generate a signal by such means as fluorescence properties, light scatter properties, electronic properties, or magnetic properties. The CD4 immuno-conjugate binds to both the CD4 positive lymphocytes (Helper T cells) and all monocytes. Differential detection means are employed to count immuno-conjugate labeled Helper T cells. The present invention distinguishes itself by simultaneously measuring the signal level from monocytes as a means to verify sufficient activity of the anti-CD4 antibody.

Abstract: This invention relates to the field of biological assays where cells can be classified and enumerated using flow cytometry optical instrumentation. The invention combines information from multi-angle, light scatter from the cell itself and multi-angle light scatter from small, optically resonant particles that are selectively bound to surface molecules on the cell to carry out classification and enumeration. This light scatter method enables an instrumentation system that is simple to use, inexpensive to build, and mechanically robust; making it suitable for use in remote clinical environments.