Claims for Patent: 4,123,509

Summary for Patent: 4,123,509

Title:	Pregnancy test
Abstract:	A simple, sensitive, reliable and safe method and device for detecting pregnancy is disclosed. The test involves concentration by ultrafiltration of a sample of urine or serum from a subject; followed by determining the presence of human chorionic gonadotropin or of its .beta.-subunit in the concentrated sample.
Inventor(s):	Banik; Upendra K. (Pierrefonds, CA), Givner; Morris L. (Pierrefonds, CA)
Assignee:	American Home Products Corporation (New York, NY)
Application Number:	05/786,721
Patent Claims:	1. A pregnancy test method suitable for detection of the human chorionic gonadotropin of pregnancy in urine at a concentration as low as about 40 m.i.u./ml of urine and capable of detecting pregnancy as early as day 26 of a regular 28 day menstrual cycle which comprises (a) clarifying a sample of the urnine to be tested; (b) subjecting about 5 to 50 ml of the clarified urine sample to absorbent induced ultrafiltration through an ultrafiltration membrane, said membrane having been prewashed with 0.1 to 5% aqueous solution of a protein selected from the group consisting of bovine serum albumin, rabbit serum albumin, human serum albumin, bovine gamma globulin, human gamma globulin, myoglobin, fibrinogen, human hemoglobin, and keyhold limpet hemocyanin so that adsorption of human chorionic gonadotropin from the sample onto the membrane is substantially reduced, and said membrane having a molecular weight cut-off from about 15,000 to about 35,000, whereby human chorionic gonadotropin is retained in the sample; (c) continuing the ultrafiltration until the retentate sample is one-tenth to one-five hundredth its original volume; (d) diluting the retentate sample with sufficient water to provide a retentate sample of about 0.5 ml; and (e) contacting the retentate sample with the appropriate amount of an immunological reagent for detecting the presence of human chorionic gonadotropin in the retentate sample. 2. The method of claim 1 wherein said ultrafiltration membrane is of the anisotropic type. 3. The method of claim 1 wherein the concentration of said solution of protein is from 0.1 to 1.0%. 4. The method of claim 1 wherein said clarifying step comprises filtration through a filter and which further comprises prewashing said filter with the aqueous solution of a protein. 5. The method of claim 4 wherein said ultrafiltration membrane is of the anisotropic type and wherein the concentration of the aqueous solution of protein is from 0.1 to 1.0%, said membrane being backed by a layer of absorbent capable of sorbing urine. 6. A pregnancy test method suitable for detection of the human chorionic gonadotropin of pregnancy in urine at a concentration as low as about 40 m.i.u./ml of urine and capable of detecting pregnancy as early as day 26 of a regular 28 day menstrual cycle which comprises: (a) clarifying a sample of the urine to be tested; (b) contacting the urine sample before or after clarification with a sufficient amount of a protein selected from the group consisting of bovine serum albumin, rabbit serum albumin, human serum albumin, bovine gamma globulin, human gamma globulin, myoglobin, fibrinogen, human hemoglobin, and keyhold limpet hemocyanin to give a concentration of the protein in the urine of from 0.001 to 1.0% so that absorption of human chorionic gonadotropin from the sample onto the membrane is substantially reduced; (c) subjecting about 5 to 50 ml of the clarified urine sample to absorbent induced ultrafiltration through an ultrafiltration membrane having a molecular weight cut-off from about 15,000 to about 35,000, whereby human chorionic gonadotropin is retained in the sample; (d) continuing the ultrafiltration until the retentate sample is one-tenth to one-five hundredth its original volume; (e) diluting the retentate sample with sufficient water to provide a retentate sample of about 0.5 ml; and (f) contacting the retentate sample with the appropriate amount of an immunological reagent for detecting the presence of human chorionic gonadotropin in the retentate sample. 7. The method of claim 6 wherein said membrane is of the anisotropic type and the concentration of said protein in the urine is from 0.01 to 1.0%. 8. The method of claim 7 in which said membrane is of the anisotropic type and wherein the concentration of said solution of protein is from 0.1 to 1.0%. 9. A pregnancy test method suitable for detection of the human chorionic gonadotropin of pregnancy in urine at a concentration as low as about 40 m.i.u./ml of urine and capable of detecting pregnancy as early as day 26 of a regular 28 day menstrual cycle which comprises: (a) clarifying a sample of the urine to be tested through a filter, said filter having been pretreated with an 0.1 to 5.0% aqueous solution of a protein selected from the group consisting of bovine serum albumin, rabbit serum albumin, human serum albumin, bovine gamma globulin, human gamma globulin, myoglobin, fibrinogen, human hemoglobin, and keyhold limpet hemocyanin so that absorption of human chorionic gonadotropin from the sample onto the membrane is substantially reduced; (b) subjecting about 5 to 50 ml of the clarified urine sample to absorbent induced ultrafiltration through an ultrafiltration membrane having a molecular weight cut-off from about 15,000 to about 35,000, whereby human chorionic gonadotropin is retained in the sample; (c) continuing the ultrafiltration until the retentate sample is one-tenth to one-five hundredth its original volume; (d) diluting the retentate sample with sufficient water to provide a retentate sample of about 0.5 ml; and (e) contacting the retentate sample with the appropriate amount of an immumological reagent for detecting the presence of human chorionic gonadotropin in the retentate sample.

Details for Patent 4,123,509

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	01/15/1974		1995-10-31
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	12/27/1984		1995-10-31
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	02/15/1985		1995-10-31
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	02/16/1990		1995-10-31
Bel-mar Laboratories, Inc.	CHORIONIC GONADOTROPIN	chorionic gonadotropin	Injection	017054	03/26/1974		1995-10-31
Fresenius Kabi Usa, Llc	CHORIONIC GONADOTROPIN	chorionic gonadotropin	For Injection	017067	03/05/1973		1995-10-31