[54] METHOD FOR QUALITATIVE AND QUANTITATIVE DETERMINATION OF IMMUNOLOGICAL REACTIONS
[75] Inventors: Peter M. Meserol, Montville; Jesse L. Acker, Rockaway, both of NJ.
[73] Assignee: Akro-Medic Engineering, Inc., Whippany, N.J.
[21] Appl. No.: 835,996
[22] Filed: Sep. 23,1977
[51] Int. C1.2 COIN 33/16; G01N 21/24
[52] U.S. CI 23/230 B; 250/574;
356/39; 356/246; 422/73; 422/104; 424/12
[58] Field of Search 23/230 B; 73/64.1;
424/12; 356/39; 250/574
[56] References Cited
U.S. PATENT DOCUMENTS
3,395,210 7/1968 Lenahan et al 23/230 B
3,463,614 8/1969 Leslie 23/230 B
3,520,609 7/1970 Lion 250/574 X
3,617,222 11/1971 Matte 23/230 R
3,770,380 11/1973 Smith 424/12X
3,803,299' 4/1974 Nouel 23/230 B X
3,819,271 6/1974 Beug 356/39
3,826,613 7/1974 Parikh et al 23/230 B
3,905,767 9/1975 Morris 424/12 X
3,915,640 10/1975 Turner et al 23/230 B
3,932,141 1/1976 Beall et al 23/230 B X
3,967,901 7/1976 Rodriguez 250/574 X
3,984,533 10/1976 Uzgiris 424/12
3,990,851 11/1976 Gross 424/12 X
4,003,988 1/1977 Hoff et al 23/230 B X
4,027,973 6/1977 Kaye 250/574 X
4,043,669 8/1977 Gehatia 356/246 X
4,050,895 9/1977 Hardy 424/12 X
4,052,010 10/1977 Baker et al. .. 23/230 B X
4,080,264 3/1978 Cohen 424/12 X
4,097,149 6/1978 Aladjem 356/72
4,118,192 10/1978 Sawai 424/12
4,136,953 1/1979 Klein : 250/574 X
Primary Examiner— Sidney Marantz
[57] ABSTRACT
A method for qualitative and quantitative determination of agglutination in immunoreactive systems, and for determining the concentration of the immunoreactive components of such system, which method comprises introducing a fluid biological test specimen and a reagent therefor (e.g., latex spheres) into a reaction zone in an image cell and evenly mixing and incubating the mixture thereby forming agglutinated particles. The reaction zone is then transilluminated and the light beams transmitted therethrough are imaged on an image sensor. Dark areas are formed on the surface of the image sensor which 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 concentrat ion 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.
24 Claims, 17 Drawing Figures
