- Patent Number:
4,186,182
- Appl. No:
05/831,128
- Application Filed:
September 07, 1977
- نبذة مختصرة :
Serological method for determining presence of Neisseria gonorrhoeae antibodies in human sera and products utilized in such testing.
- Inventors:
Gaafar, Hassan A. (Voorheesville, NY); D'Arcangelis, Dora (Albany, NY)
- Assignees:
Research Corporation (New York, NY)
- Claim:
What is claimed is
- Claim:
1. A serological method for determining the presence of Neisseria gonorrhoeae antibodies in human serum which comprises diluting the serum to be tested in physiological saline at a dilution of about 1:2 to 1:1000, heating the diluted serum at about 56.degree. C. to 65.degree. C. for from about 15 to 30 minutes and thereafter incubating with a composition containing a heat labile, species specific antigen produced from a growth culture of Neisseria gonorrhoeae to form an antigen-antibody conjugate when said antibodies are present and detecting the presence of said conjugate; the antigen being protein in nature and characterized as follows
- Claim:
1. partially inactivated by heating at about 56.degree. C. for about 30 minutes and completely inactivated by boiling for 1 h
- Claim:
2.
- Claim:
2. stable in an aqueous medium at pH values of 3-11
- Claim:
3. stable when incubated with the following enzymes
- Claim:
deoxynucleic acidase
- Claim:
ribonucleic acidase
- Claim:
dextransase
- Claim:
meuraminidase
- Claim:
lysosyme
- Claim:
4. inactivated when incubated with trypsin
- Claim:
5. isoelectric point of 4.+-.0.2
- Claim:
6. molecular weight of active subunits of 37,000-40,000 as determined by SDS-polyacrylamide gel
- Claim:
7. contains 1-10% carbohydrate and 2-3% organic phosphorus, and
- Claim:
8. soluble in acqueous media containing surface active agents, and
- Claim:
insoluble in methanol, chloroform, and acetone. 2. A serological method as in claim 1 wherein the presence of said conjugate is detected by reaction with an anti-human IgG labelled with a chemical which fluoresces when exposed to ultraviolet light.
- Claim:
3. A method as in claim 2 wherein the chemical is selected from the group consisting of fluorescein, rhodamine and auramine.
- Claim:
4. A method as in claim 2 wherein the antigen composition has an antigen unit value of at least 100 Ag. u./mg. of protein.
- Claim:
5. A method as in claim 2 wherein the antigen unit value is at least 1000.
- Claim:
6. A method as in claim 2 wherein the antigen is produced by a culture of Neisseria gonorrhoeae ATCC No. 21823.
- Claim:
7. A method as in claim 2 wherein the antigen is produced by a culture of Neisseria gonorrhoeae ATCC No. 21824.
- Claim:
8. A method as in claim 2 wherein the antigen is produced by a culture of Neisseria gonorrhoeae ATCC No. 21825.
- Claim:
9. A serological method as in claim 1 wherein the presence of said conjugate is detected by reaction with an antihuman IgG labelled with an enzyme.
- Claim:
10. A method as in claim 9 wherein the enzyme is selected from the group consisting of peroxidase, B-glucuronidase, B-D-glucosidase, B-D-galactosidase, urease, glucose oxidase plus peroxidase, galactose oxidase plus peroxidase, and acid phosphatase.
- Claim:
11. A method as in claim 9 wherein the antigen composition has an antigen unit value of at least 100 Ag. u./mg. of protein.
- Claim:
12. A method as in claim 9 wherein the value is at least 1000.
- Claim:
13. A method as in claim 9 wherein the antigen is produced by a culture of Neisseria gonorrhoeae ATCC No. 21823.
- Claim:
14. A method as in claim 9 wherein the antigen is produced by a culture of Neisseria gonorrhoeae ATCC No. 21824.
- Claim:
15. A method as in claim 9 wherein the antigen is produced by a culture of Neisseria gonorrhoeae ATCC No. 21825.
- Claim:
16. A serological method as in claim 1 wherein the presence of said conjugate is detected by reaction with an antihuman IgG labelled with a radioactive element.
- Claim:
17. A method as in claim 16 wherein the radioactive element is selected from the group consisting of .sup.14 C, .sup.125 I, .sup.131 I, and .sup.35 S.
- Claim:
18. A method as in claim 16 wherein the chemical is selected from the group consisting of fluorescein, rhodamine and auramine.
- Claim:
19. A method as in claim 16 wherein the antigen composition has an antigen unit value of at least 100 Ag. u./mg. of protein.
- Claim:
20. A method as in claim 16 wherein the antigen unit value is at least 1000.
- Claim:
21. A method as in claim 16 wherein the antigen is produced by a culture of Neisseria gonorrhoeae ATCC No. 21823.
- Claim:
22. A method as in claim 16 wherein the antigen is produced by a culture of Neisseria gonorrhoeae ATCC No. 21824.
- Claim:
23. A method as in claim 16 wherein the antigen is produced by a culture of Neisseria gonorrhoeae ATCC No. 21825.
- Current U.S. Class:
424/1; 260/112R; 424/12; 435/7; 435/37
- Current International Class:
G01N 3316; A61K 4300
- Other References:
Cohen, J. of Bacteriology, vol. 94, No. 1, Jul. 1967, pp. 141-148.
- Primary Examiner:
Padgett, Benjamin R.
- Assistant Examiner:
Nucker, Christine M.
- Attorney, Agent or Firm:
Cooper, Dunham, Clark, Griffin & Moran
- الرقم المعرف:
edspgr.04186182
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