Device for analysis of rapid agglutination of particles and method for using same

An agglutination assay for detecting the presence or amount of an analyte in a test sample, comprising the steps of:

• a) placing the test sample in a device comprising:
• i) a sample receiving well which accommodates the test sample when the device is in a horizontal position,
• ii) a reaction chamber having a first end and a second end, wherein said receiving well communicates with said first end of said reaction chamber such that the test sample passes from said receiving well and fills said reaction chamber when the device is placed at an angle to the horizontal but will not pass when the device is horizontal,
• iii) a reservoir communicating with said second end of said reaction chamber to collect excess test sample from said reaction chamber,
• iv) a vent communicating from said reservoir to the exterior of the device;
• and
• b) placing the device at an angle to the horizontal, thereby initiating an agglutination reaction between a suspension of particles and the analyte whereby gravity causes the downward movement of said particles through said filled reaction chamber to cause agglutination if the analyte is present at a threshold amount;
• and
• c) observing the agglutination reaction which occurs in said reaction chamber in the presence of analyte.