# US 4,400,353 A · Electro-optical system for use in evaluating immunological reactions

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- Number: US 4,400,353 A
- Document ID: US4400353A
- Status: Granted
- Kind: A
- Application number: 06/097,196
- Filed: 1979-11-26
- Granted: 1983-08-23
- Earliest claimed: 1977-09-23
- Assignees: Akro-Medic Engineering, Inc.
- Inventors: Peter M. Meserol; Jesse L. Acker
- Web page: https://patentgrep.com/patent/US4400353A

## CPC

- G01N 33/5302: {Apparatus specially adapted for immunological test procedures}
- G01N 21/5911: {of the scanning type (scanning per se G02B)}
- G01N 35/00029: {provided with flat sample substrates, e.g. slides (G01N35/028 takes precedence)}
- G01N 21/03: Cuvette constructions
- G01N 21/82: producing a precipitate or turbidity
- G01N 33/48: Biological material, e.g. blood, urine (G01N33/02, G01N33/26, G01N33/44, G01N33/46 take precedence); Haemocytometers (counting blood corpuscules distributed over a surface by scanning the surface G06M11/02)
- G01N 33/53: Immunoassay; Biospecific binding assay; Materials therefor
- G01N 2035/00099: {Characterised by type of test elements}
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

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 imaging the light beams transmitted therethrough on the image sensor, the dark areas formed on the surface of the image sensor are measured, preferably electronically. This procedure is repeated for a reference specimen 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 immunoreactive 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 unknown 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.

## Claims

### Claim 1

An electro-optical system for use in evaluating immunological reactions, said system comprising:
(a) an image cell comprising a pair of opposed planar surfaces, each surface having a generally circular groove such that when said surfaces are bonded together, said grooves form a reaction zone confined between said planar surfaces, one of said grooves including an aperture through which a biological fluid and a reagent therefore are introduced into said reaction zone,
(b) a light source from which beams of radiant energy impinge on said reaction zone,
(c) an image sensor having a photosensitive surface consisting of photosensitive elements, said image sensor being electrically connected to a display means,
(d) an imaging lens for focusing the light transmitted through said reaction zone of said image cell on the surface of said image sensor wherein dark imaged area appear corresponding to agglutinated particles in said reaction zone,
(e) focusing means operably connected to said imaging lens for adjusting the focus plane in said reaction zone, and,
(f) a threshold comparator and particle counter for rejecting dark imaged areas smaller than predetermined threshold levels and counting dark imaged areas greater than said threshold level.

### Claim 2 (depends on 1)

An electro-optical system as in claim 1 further including a digital computer cooperating with said threshold comparator, means for storing the output of said computer and means for printing said computer output.

### Claim 3 (depends on 1)

An electro-optical system as in claim 1 further including a temperature control for controlling the temperature of the content of said image cell.

### Claim 4 (depends on 3)

An electro-optical system as in claim 3 further including a digital computer cooperating with said threshold comparator, means for storing the output of said computer and means for printing said computer output.

### Claim 5 (depends on 3)

An electro-optical system as in claim 3 further including a display screen operatively associated with said image sensor for visual display of the content of said image cell.

### Claim 6 (depends on 5)

An electro-optical system as in claim 5 further including a digital computer cooperating with said threshold comparator, means for storing the output of said computer and means for printing said computer output.