Classifications

• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
  • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
  • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
  • G01N33/74—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
  • G01N33/76—Human chorionic gonadotropin including luteinising hormone, follicle stimulating hormone, thyroid stimulating hormone or their receptors

Definitions

• a method of in vitro pregnancy detection comprises contacting a urine sample of a female with a diagnostic composition consisting essentially of Bromocresol purple or Chlorophenol Red and observing the color produced.
• This invention relates to a diagnostic dye indicator for in vitro pregnancy detection.
• HCG human chorionic gonadotrophin
• one aspect of the present invention is to provide an in vitro method of determining pregnancy in women and other female mammals which does not require any laboratory equipment or any special skills for interpretation of the results and which can be routinely carried out by a layman.
• Another aspect of the present invention is to provide in vitro diagnostic reagents which are characterized by a high degree of sensitivity and provide accurate results in substantially faster time than heretofore possible.
• An additional aspect of the present invention is to provide a diagnostic dye reagent for determining pregnancy which consists essentially of a buffered Bromocresol purple solution having a pH between about 5.5 and 7.
• a further aspect of the present invention relates to a process of producing diagnostic dye reagents of this invention.
• a preferred procedure for preparing the dye reagent is to include a buffering agent in the solution to increase the pH stability of the solution during extended periods of storage.
• the selection of the buffering agent is not critical. Suitable materials include phosphates, glycine, borates, etc.
• a Bromocresol buffered solution used in my invention may be prepared as follows: To 0.40 gram of Bromocresol purple in a glass mortar, there was added a .01 N sodium hydroxide solution in increments of about 10 ml. while vigorously stirring, until a total of 74 ml. has been added. Stirring is continued until solution is completed. Thereafter about 725 ml. of a phosphate buffer (pH 6) solution (250 ml. 0.2 M potassium phosphate monobasic solution mixed with 28 ml. 0.2 M sodium hydroxide solution and diluted to 1000 ml. with water) was thoroughly mixed with the Bromocresol dissolved in the sodium hydroxide to provide a buffered solution having a pH of about 6.
• a phosphate buffer (pH 6) solution 250 ml. 0.2 M potassium phosphate monobasic solution mixed with 28 ml. 0.2 M sodium hydroxide solution and diluted to 1000 ml. with water
• the in vitro diagnostic dye reagent may also be prepared by grinding 0.1 gram of Bromocresol purple in a mortar with 18.5 ccs. of 0.01 N sodium hydroxide to produce a homogenous mixture. Thereafter this mixture is diluted to 250 ccs. with distilled water to provide a red solution having a pH of about 6. It has been found that if the dye is added directly to the water and the sodium hydroxide separately added, the resulting dye solution will not produce a sufiiciently distinct color change when added to urine of a pregnant woman.
• the procedure for adding the diagnostic dye reagent to the urine sample is as follows: One to two drops of the diagnostic dye reagent are added to 3 to 5 ccs. of urine in a test tube which is shaken. The color development which takes place almost instantaneously is then observed. -As previously indicated a purple color indicates a positive reaction and a red to reddish-brown color a negative reaction.
• the quantity of diagnostic dye reagent used is not critical. Any substantial variation in the quantity of dye added to a given quantity of urine affects only the intensity of the color observed.
• the diagnostic dye reagent may be useful as a tool for the in vitro detection of steroids and therefore permit a female who is taking an oral contraceptive to readily determine whether she has missed taking a pill in the prescribed cycle.
• a method of in vitro pregnancy detection in a female which comprises adding to urine derived from said female a sufiicient quantity of a composition consisting essential- 1y of a Chlorophenol Red solution having a pH between about 6 and about 6.5 and observing the color produced in said urine.
• a method of in vitro pregnancy detection in a female which comprises adding to urine derived from said female a sufficient quantity of a composition consisting essentially of a Bromocresol purple solution having a pH between about 6 and about 6.5 and observing the color produced in said urine.
• a method of detecting pregnancy in a female which comprises contacting urine derived from said female with a diagnostic composition selected from the class consisting of Bromocresol purple and Chlorophenol Red and observing the color produced, said diagnostic composition having a pH between about 5.5 and about 6.5.
• diagnostic composition is in the form of an aqueous solution.
• a method of in vitro pregnancy detection in a female which comprises adding to urine derived from said female a sufiicient quantity of a composition consisting essentially of Bromocresol purple and a phosphate buffer, said composition having a pH of about 6, and observing the color produced in said urine.

Landscapes

• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Molecular Biology (AREA)
• Engineering & Computer Science (AREA)
• Urology & Nephrology (AREA)
• Chemical & Material Sciences (AREA)
• Biomedical Technology (AREA)
• Endocrinology (AREA)
• Immunology (AREA)
• Hematology (AREA)
• Physics & Mathematics (AREA)
• General Physics & Mathematics (AREA)
• Biotechnology (AREA)
• Reproductive Health (AREA)
• Food Science & Technology (AREA)
• Medicinal Chemistry (AREA)
• Biochemistry (AREA)
• Analytical Chemistry (AREA)
• Microbiology (AREA)
• General Health & Medical Sciences (AREA)
• Cell Biology (AREA)
• Pathology (AREA)
• Investigating Or Analysing Biological Materials (AREA)
• Ventilation (AREA)

Applications Claiming Priority (1)

Publications (1)

Family

ID=25091567

Family Applications (1)

Country Status (13)

Cited By (3)

• 1968
  • 1968-10-28 US US771363A patent/US3595620A/en not_active Expired - Lifetime
• 1969
  • 1969-10-07 GB GB49320/69A patent/GB1283782A/en not_active Expired
  • 1969-10-15 IL IL33186A patent/IL33186A/en unknown
  • 1969-10-15 DE DE19691952014 patent/DE1952014A1/de active Pending
  • 1969-10-22 CA CA065529A patent/CA938870A/en not_active Expired
  • 1969-10-22 AT AT996169A patent/AT294325B/de not_active IP Right Cessation
  • 1969-10-23 BE BE740668D patent/BE740668A/xx unknown
  • 1969-10-23 BR BR213554/69A patent/BR6913554D0/pt unknown
  • 1969-10-24 ES ES372841A patent/ES372841A1/es not_active Expired
  • 1969-10-27 NO NO694247A patent/NO130247B/no unknown
  • 1969-10-27 CH CH1605269A patent/CH510431A/fr not_active IP Right Cessation
  • 1969-10-27 NL NL6916198A patent/NL6916198A/xx unknown
  • 1969-10-28 FR FR6936940A patent/FR2021743A1/fr not_active Withdrawn

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