US3876503A - Method and instrument for the detection of neisseria gonorrheae without culture - Google Patents

Method and instrument for the detection of neisseria gonorrheae without culture Download PDF

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Publication number
US3876503A
US3876503A US193739A US19373971A US3876503A US 3876503 A US3876503 A US 3876503A US 193739 A US193739 A US 193739A US 19373971 A US19373971 A US 19373971A US 3876503 A US3876503 A US 3876503A
Authority
US
United States
Prior art keywords
pledget
specimen
swab
ampul
tube
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
US193739A
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English (en)
Inventor
Frederick C Mennen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
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Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to US193739A priority Critical patent/US3876503A/en
Priority to CA149,145A priority patent/CA972267A/en
Priority to GB3882572A priority patent/GB1371417A/en
Priority to DK436272AA priority patent/DK142823B/da
Priority to NO3205/72A priority patent/NO138578C/no
Priority to FI2787/72A priority patent/FI55266C/fi
Priority to IT30390/72A priority patent/IT986857B/it
Priority to FR7237807A priority patent/FR2158269B1/fr
Priority to SE7213927A priority patent/SE414410B/sv
Priority to DE19722252957 priority patent/DE2252957C3/de
Priority to US05/537,593 priority patent/US4018653A/en
Priority to US05/561,707 priority patent/US3954564A/en
Priority to US05/563,300 priority patent/US3954563A/en
Application granted granted Critical
Publication of US3876503A publication Critical patent/US3876503A/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/02—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving viable microorganisms
    • C12Q1/04—Determining presence or kind of microorganism; Use of selective media for testing antibiotics or bacteriocides; Compositions containing a chemical indicator therefor
    • C12Q1/12—Nitrate to nitrite reducing bacteria
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5029—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures using swabs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0096—Casings for storing test samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0291—Instruments for taking cell samples or for biopsy for uterus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B2010/0003—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements including means for analysis by an unskilled person
    • A61B2010/0006—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements including means for analysis by an unskilled person involving a colour change
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/10—Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/16—Reagents, handling or storing thereof
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/069—Absorbents; Gels to retain a fluid
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0809—Geometry, shape and general structure rectangular shaped
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00—Chemistry: molecular biology and microbiology
    • Y10S435/81—Packaged device or kit
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00—Chemistry: molecular biology and microbiology
    • Y10S435/8215—Microorganisms
    • Y10S435/822—Microorganisms using bacteria or actinomycetales
    • Y10S435/871—Neisseria

Definitions

  • the present invention involves the use of a reagent from the group of oxidase testing reagents known as phenylenediamines, including-the following: 'p-Amino Dimethylaniline Oxalate, N, N-Dimethyl-p- Phenylenediamine Dihydrochloride. N,'N-Dimethyl-p- Phenylenediamine Oxalate, N., vN-Dimethyl-p- Phenylenediamine.Monohydrochloride and N, N, N, N, N
  • the wall structure of the plastic tube is flexible, it has sufficient rigidity normally to maintain a generally cylindrical shape and to permit easy insertion of the swab after a specimen of exudate has been taken.
  • the ampul contains a suitable wetting agent, as described herein, and is sufficiently frangible that it can readily be broken when the sides of the flexible tube are pressed inwardly between the thumb and forefinger. whereupon the ampul shatters and permits its fluid contents to wet the material impregnated in the pledget, which normally is pushed into the fluid and fragmented glass when the swab is inserted in the tube.
  • reaction between the specimen on the swab and the reagent in the pledget commences immediately and, if gonococci are present, the specimen on the swab changes color, normally to purple, red-orange, or dark gray, depending upon the reagent used in the pledget, thus indicating a positive test.
  • the reaction time to indicate a positive specimen usually falls within the range of from 30 to 120 seconds.
  • a physiological saline solution is prepared by adding 0.85 grams of Sodium Chloride to 99 ml distilled water and the pH adjusted to 7.0. This solution becomes the wetting agent. Frangible ampuls containing /2 ml of this solution are prepared, as this is the quantity necessary to adequately wet the /1 inch X 9/16 inch pledget.
  • a sterile dacron swab, mounted on a plastic stick approximately mm long is packaged together with the reagent system and this combination becomes the diagnostic instrument.
  • This swab is separately contained in its own sterile glassine envelope.
  • the above procedure is repeated and a culture of Neisseria gonorrheae is used as being representative of the exudate in the foregoing example.
  • the swab is used to pick a few colonies from a petri dish culture.
  • the identical procedure is used with the instrument.
  • a distinct purple coloration of the bacteria on the swab will be observed within 1 minute.
  • the nearly colorless pledget and the white background of the dacron swab make the identification of the organisms on the swab clear and distinct, just as it is with the exudate directly from a patient.

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • General Health & Medical Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • Analytical Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Physics & Mathematics (AREA)
  • Toxicology (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Biotechnology (AREA)
  • General Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Genetics & Genomics (AREA)
  • Hematology (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)
  • Measuring And Recording Apparatus For Diagnosis (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Investigating Or Analysing Materials By The Use Of Chemical Reactions (AREA)
US193739A 1971-10-29 1971-10-29 Method and instrument for the detection of neisseria gonorrheae without culture Expired - Lifetime US3876503A (en)

Priority Applications (13)

Application Number Priority Date Filing Date Title
US193739A US3876503A (en) 1971-10-29 1971-10-29 Method and instrument for the detection of neisseria gonorrheae without culture
CA149,145A CA972267A (en) 1971-10-29 1972-08-10 Method and instrument for the detection of neisseria gonorrheae without culture
GB3882572A GB1371417A (en) 1971-10-29 1972-08-21 Method and assembly for the detection of neisseria gonorrheae without culture
DK436272AA DK142823B (da) 1971-10-29 1972-09-04 Fremgangsmåde og instrument til hurtig undersøgelse af en mandlig patient for Neisseria gonorrheae.
NO3205/72A NO138578C (no) 1971-10-29 1972-09-08 Instrument til bruk av direkte paavisning av neisseria gonorrheae uten dyrkning
FI2787/72A FI55266C (fi) 1971-10-29 1972-10-09 Foerfarande och anordning foer diagnostisering av neisseria gonorrhea utan odling
IT30390/72A IT986857B (it) 1971-10-29 1972-10-12 Strumento per rilevare la neisseria gonorrheae senza coltura
FR7237807A FR2158269B1 (sv) 1971-10-29 1972-10-25
SE7213927A SE414410B (sv) 1971-10-29 1972-10-27 Medel for pavisande av neisseria gonorrheae genom dess oxidasaktivitet
DE19722252957 DE2252957C3 (de) 1971-10-29 1972-10-28 Vorrichtung zur direkten, ohne Züchtung möglichen Erkennung akuter Gonorrhoe
US05/537,593 US4018653A (en) 1971-10-29 1974-12-30 Instrument for the detection of Neisseria gonorrhoeae without culture
US05/561,707 US3954564A (en) 1971-10-29 1975-03-25 Instrument for the detection of neisseria gonorrhoeae and the like
US05/563,300 US3954563A (en) 1971-10-29 1975-03-28 Apparatus especially useful for detection of neisseria gonorrhoeae and the like in females

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US193739A US3876503A (en) 1971-10-29 1971-10-29 Method and instrument for the detection of neisseria gonorrheae without culture

Related Child Applications (3)

Application Number Title Priority Date Filing Date
US05/537,593 Division US4018653A (en) 1971-10-29 1974-12-30 Instrument for the detection of Neisseria gonorrhoeae without culture
US05/561,707 Continuation-In-Part US3954564A (en) 1971-10-29 1975-03-25 Instrument for the detection of neisseria gonorrhoeae and the like
US05/563,300 Continuation-In-Part US3954563A (en) 1971-10-29 1975-03-28 Apparatus especially useful for detection of neisseria gonorrhoeae and the like in females

Publications (1)

Publication Number Publication Date
US3876503A true US3876503A (en) 1975-04-08

Family

ID=22714821

Family Applications (1)

Application Number Title Priority Date Filing Date
US193739A Expired - Lifetime US3876503A (en) 1971-10-29 1971-10-29 Method and instrument for the detection of neisseria gonorrheae without culture

Country Status (9)

Country Link
US (1) US3876503A (sv)
CA (1) CA972267A (sv)
DK (1) DK142823B (sv)
FI (1) FI55266C (sv)
FR (1) FR2158269B1 (sv)
GB (1) GB1371417A (sv)
IT (1) IT986857B (sv)
NO (1) NO138578C (sv)
SE (1) SE414410B (sv)

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3968010A (en) * 1975-12-08 1976-07-06 Miles Laboratories, Inc. Microbiological culturing method and means
US4017420A (en) * 1975-12-22 1977-04-12 Smithkline Corporation Stable oxidase reagent solutions
US4067776A (en) * 1975-11-25 1978-01-10 Research Foundation Of Children's Hospital Method for differential diagnosis of meningitis with a limulus lysate test
US4082614A (en) * 1975-12-10 1978-04-04 Bio-Syn, Inc. Means for conveying pathological specimens safely to places of identification
US4108729A (en) * 1977-05-16 1978-08-22 U.S. Packaging Corp. Paper booklet for presumptive diagnosis of Neisseria Gonorrhoeae in the male
US4196167A (en) * 1978-12-26 1980-04-01 California Medical Developments, Inc. Drug detection device
US4223093A (en) * 1978-08-25 1980-09-16 Precision Dynamics Corporation Culture collection and transport device
US4376634A (en) * 1980-05-30 1983-03-15 Mallinckrodt, Inc. Assay kit having syringe, dilution device and reagents within sealed container
US5264346A (en) * 1991-06-03 1993-11-23 Chen Kirk C S Colorimetric method for beta-lactamase assay and its applications
WO2002039942A1 (fr) * 2000-11-15 2002-05-23 Zhendong Wu Tampon
US20040214316A1 (en) * 2003-04-24 2004-10-28 O'connell David Personal cell sampling kit
WO2017180909A1 (en) * 2016-04-13 2017-10-19 Nextgen Jane, Inc. Sample collection and preservation devices, systems and methods

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0808557D0 (en) 2008-05-13 2008-06-18 3M Innovative Properties Co Sampling devices and methods of use
EP2869925A1 (en) 2012-07-06 2015-05-13 3M Innovative Properties Company Apparatus for detecting atp in a liquid sample
EP2870257B1 (en) 2012-07-06 2017-02-22 3M Innovative Properties Company Apparatus and methods for detecting atp in a liquid sample

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3360440A (en) * 1966-04-13 1967-12-26 Haab Walter Cold water reconstitutable microbiological medium, process for preparation and use, ad product
US3388043A (en) * 1965-06-01 1968-06-11 Nunc As Bacteriological sampling set
US3446596A (en) * 1965-04-02 1969-05-27 Mallinckrodt Chemical Works Analytical package and method
US3450129A (en) * 1966-07-06 1969-06-17 Medical Supply Co Swabbing unit
US3661717A (en) * 1970-05-08 1972-05-09 Minnesota Mining & Mfg Unitary sterility indicator and method
US3689224A (en) * 1966-04-13 1972-09-05 Westinghouse Electric Corp Chemical contaminant detection sampler

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3446596A (en) * 1965-04-02 1969-05-27 Mallinckrodt Chemical Works Analytical package and method
US3388043A (en) * 1965-06-01 1968-06-11 Nunc As Bacteriological sampling set
US3360440A (en) * 1966-04-13 1967-12-26 Haab Walter Cold water reconstitutable microbiological medium, process for preparation and use, ad product
US3689224A (en) * 1966-04-13 1972-09-05 Westinghouse Electric Corp Chemical contaminant detection sampler
US3450129A (en) * 1966-07-06 1969-06-17 Medical Supply Co Swabbing unit
US3661717A (en) * 1970-05-08 1972-05-09 Minnesota Mining & Mfg Unitary sterility indicator and method

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4067776A (en) * 1975-11-25 1978-01-10 Research Foundation Of Children's Hospital Method for differential diagnosis of meningitis with a limulus lysate test
US3968010A (en) * 1975-12-08 1976-07-06 Miles Laboratories, Inc. Microbiological culturing method and means
US4082614A (en) * 1975-12-10 1978-04-04 Bio-Syn, Inc. Means for conveying pathological specimens safely to places of identification
US4017420A (en) * 1975-12-22 1977-04-12 Smithkline Corporation Stable oxidase reagent solutions
US4108729A (en) * 1977-05-16 1978-08-22 U.S. Packaging Corp. Paper booklet for presumptive diagnosis of Neisseria Gonorrhoeae in the male
US4223093A (en) * 1978-08-25 1980-09-16 Precision Dynamics Corporation Culture collection and transport device
US4196167A (en) * 1978-12-26 1980-04-01 California Medical Developments, Inc. Drug detection device
US4376634A (en) * 1980-05-30 1983-03-15 Mallinckrodt, Inc. Assay kit having syringe, dilution device and reagents within sealed container
US5264346A (en) * 1991-06-03 1993-11-23 Chen Kirk C S Colorimetric method for beta-lactamase assay and its applications
WO2002039942A1 (fr) * 2000-11-15 2002-05-23 Zhendong Wu Tampon
US20040214316A1 (en) * 2003-04-24 2004-10-28 O'connell David Personal cell sampling kit
US7232681B2 (en) * 2003-04-24 2007-06-19 O'connell David Personal cell sampling kit
WO2017180909A1 (en) * 2016-04-13 2017-10-19 Nextgen Jane, Inc. Sample collection and preservation devices, systems and methods
US11446011B2 (en) 2016-04-13 2022-09-20 Nextgen Jane, Inc. Sample collection and preservation devices, systems and methods
US11864740B2 (en) 2016-04-13 2024-01-09 Nextgen Jane, Inc. Sample collection and preservation devices, systems and methods

Also Published As

Publication number Publication date
FI55266C (fi) 1979-06-11
FI55266B (fi) 1979-02-28
DK142823C (sv) 1981-09-21
NO138578C (no) 1978-09-27
SE414410B (sv) 1980-07-28
CA972267A (en) 1975-08-05
FR2158269A1 (sv) 1973-06-15
GB1371417A (en) 1974-10-23
DK142823B (da) 1981-02-02
DE2252957A1 (de) 1973-05-03
IT986857B (it) 1975-01-30
DE2252957B2 (de) 1976-07-15
FR2158269B1 (sv) 1977-01-14
NO138578B (no) 1978-06-19

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