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US 4,066,744 AGranted
Serological reagent, test slide and method for gonorrheal antibodies
AssigneeAkzona Incorporated
InventorsRichard T. Price, Rita C. Prodell
Life of this patent
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AssigneeAkzona Incorporated
InventorsRichard T. Price, Rita C. Prodell
Estimating the term…
Disclosed are a reagent and test slide used for serological detection of gonorrheal antibodies in human blood serum or synovial fluid. The reagent comprises latex particles having absorbed on their surfaces an inert protein, such as bovine serum albumin and a heat labile antigen derived from Neisseria gonorrhoeae bacteria exhibiting T.sub.1 colonial morphology. The reagent may be employed by several forms, for example, as a liquid suspension of the latex particles, or in the form of a dried deposit of the latex particles. Regardless of the form employed, the reagent is particularly useful as a routine screening test in hospitals and prenatal clinics to detect gonococcal infection in women and also in cases of complicated gonorrhea, e.g., gonorrheal arthritis where infection is not conveniently detectable by present means. The test slide may have dried thereon an absorbing antigen for heterophile antibodies. If desired, diagnosis made by the test of the invention can be subsequently confirmed by conventional more expensive and time consuming means, if this is thought to be desirable.
A reagent for the detection of gonorrheal antibodies in human blood serum or synovial fluid by the immunochemical reaction of the antibodies with gonorrheal antigens, consisting essentially of a supply of spheroidally-shaped latex particles having an average diameter of from 0.2 to 1.3 microns, said particles having adsorbed upon their surface
A test slide adapted for the performance on the surface thereof of an immunochemical test for detection of gonorrheal antibodies in human blood serum or synovial fluid, having as essential elements a substantially planar strip of substrate material having at least one test surface whereon is positioned (1) a deposit of solid dried latex particles having a generally spheroidal shape and having an average particle diameter of from 0.2 to 1.3 microns, said particles having adsorbed upon their surface, (a) a presensitizing protein which is a dispersing agent for the particles and which is inert thereto and does not participate in the immunochemical reaction and does not detrimentally influence the antigen and antibody involved in the reaction, and (b) a sensitizing soluble heat labile gonorrheal antigen from ruptured bacterial cells of an antigenic strain of Neisseria gonorrhoeae bacteria exhibiting T.sub.1 colonial morphology, (2) a second dried deposit of absorbing antigen capable of combining with heterophile antibodies in said serum or synovial fluid, said test deposits being positioned in close proximity on said test surfaces.
A method for preparing synthetic resin particles presensitized with inert protein and sensitized with gonorrheal antigen, comprising the steps of (a) presensitizing an aqueous suspension of spheroidal latex particles having a diameter of from 0.2 to 1.3 microns with an aqueous solution of inert protein which is a dispersing agent for the particles and which is inert thereto;
The method for detection of gonorrheal antibodies in human blood serum or synovial fluid by means of the immunochemical reaction of said antibodies with gonorrheal antigens, which comprises (1) admixing a sample of said serum or fluid with an absorbing antigen capable of combining with heterophile antibodies in said serum or synovial fluid, and (2) further admixing with mixture (1) a reagent having as its essential reactive component a supply of spheroidally shaped latex particles having an average diameter of from 0.2 to 1.3 microns, said particles having adsorbed on their surface (a) a presensitizing protein, which is a dispersing agent for the particles and which is inert to and does not participate in said immunochemical reaction and does not detrimentally influence the antigen and antibody involved in the reaction, and (b) a sensitizing soluble heat labile gonorrheal antigen from ruptured bacterial cells of an antigenic strain of Neisseria gonorrhoeae bacteria exhibiting T.sub.1 colonial morphology.
Dependencies are inferred from the claim text.