Idexx Laboratories, Inc.

Point Care Technologies

Peter W Hansen

John W Roche

Harold Richardson Crews

Harold C Flynn, Jr

Michelle L Coleman

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.

Cell classification system

The present invention is a flow cytometry-based hematology system useful in the analysis of biological samples, particularly whole blood or blood-derived samples. The system is capable of determining at least a complete blood count (CBC), a five-part white blood cell differential, and a reticulocyte count from a whole blood sample. The system preferably uses a laser diode that emits a thin beam to illuminate cells in a flow cell and a lensless optical detection system to measure one or more of axial light loss, low-angle forward scattered light, high-angle forward scattered light, right angle scattered light, and time-of-flight measurements produced by the cells. The lensless optical detection system contains no optical components, other than photoreactive elements, and does not include any moving parts. Finally, the system uses a unique system of consumable reagent tubes that act as reaction chambers, mixing chambers, and waste chambers for the blood sample analyses. The consumable tubes incorporate reference particles, which act as internal standards to ensure that the dilutions made during processing of the samples have been carried out correctly, and to ensure that the instrument is working properly. The present invention also relates to methods for using the system.

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Canaan, NY, United States of America

Peter W Hansen