Apparatus and method for quantitative determination of...

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G01N 21/13 (2006.01) G01N 33/48 (2006.01)

Patent

CA 1139126

APPARATUS AND METHOD FOR QUALITATIVE AND QUANTITATIVE DETERMINATION OF IMMUNOLOGICAL REACTIONS Abstract of the Technical Disclosure An apparatus and a method are provided for qualitative and quantitative determinations of agglutination in immunore- active systems, and for determining the concentration of the immunocreactive components of such systems. The apparatus comprises a carriage assembly having a plurality of spaced, axially-disposed compartments for receiving image cells which are uniquely designed for holding the biological fluid test specimen and the reagent therefor. Means are provided for partially lifting each image cell successively out of its compartment and into an optical path. A monochromatic light source directs beams of radiant energy through the reaction zone in each image cell and the light beams transmitted through the reaction zone are focused, by means of an imaging lens, on the surface of an image sensor such as a "Charge-Coupled Device." The dark areas formed on the image sensor are measured electronically and also displayed on a display cathode ray tube. The method of this invention comprises introducing the fluid biological test specimen and the reagent (e.g., latex spheres) into a reaction zone in the image cell, evenly mixing and incubating the mixture thereby forming agglutinated particles. After transilluminating the reaction zone and imag- ing the light beams transmitted therethrough on the image sensor, the dark areas formed on the surface of the image sensor are measured, preferably electronically. -.alpha.- This procedure is repeated for a reference speciment and the total dark imaged area is compared with the total dark area obtained for the unknown specimen for qualitative determination. In order to obtain the concentration of the immunore- active component in the unknown specimen, the foregoing procedure is repeated for at least two specimens with known antibody concentrations, one of which may be a negative control. The concentration of the immunoreactive component of the un- known sample is then determined from the total dark imaged area thereof and the relationship between the total dark imaged areas of the known specimen and their respective concentrations. -b-

376917

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