WO2000060353A1 - Composition pour une preparation a base d'un echantillon preleve sur un patient - Google Patents

Composition pour une preparation a base d'un echantillon preleve sur un patient Download PDF

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Publication number
WO2000060353A1
WO2000060353A1 PCT/US1999/007573 US9907573W WO0060353A1 WO 2000060353 A1 WO2000060353 A1 WO 2000060353A1 US 9907573 W US9907573 W US 9907573W WO 0060353 A1 WO0060353 A1 WO 0060353A1
Authority
WO
WIPO (PCT)
Prior art keywords
composition
amino
salt
mixtures
group
Prior art date
Application number
PCT/US1999/007573
Other languages
English (en)
Inventor
Raymond Chan
Original Assignee
Genzyme Corporation
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 Genzyme Corporation filed Critical Genzyme Corporation
Priority to JP2000609792A priority Critical patent/JP2002541456A/ja
Priority to AU34752/99A priority patent/AU3475299A/en
Priority to EP99916432A priority patent/EP1166111A1/fr
Priority to PCT/US1999/007573 priority patent/WO2000060353A1/fr
Priority to CA002368007A priority patent/CA2368007A1/fr
Publication of WO2000060353A1 publication Critical patent/WO2000060353A1/fr

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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
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/5306—Improving reaction conditions, e.g. reduction of non-specific binding, promotion of specific binding

Definitions

  • Enteric stool specimens are frequently collected in a 10% formalin or sodium acetate-acetic acid-formalin (SAF) transport medium which serves to inactivate the infectivity and preserve the morphology of parasitic organisms in the sample. These media may have adverse effects on the function of antibodies in diagnostic immunoassays.
  • SAF sodium acetate-acetic acid-formalin
  • Formalin also known as formaldehyde, binds to amino groups on proteins, potentially altering their structure and functional activity.
  • Low pH such as from the acetic acid in SAF, is inhibitory to antigen-antibody binding.
  • the object of the present invention is to claim a composition which when added to a patient sample containing a target antigen in an acidic or formalin- containing transport medium neutralizes the acid and formalin while preserving immunoreactivity of the antigen allowing its detection.
  • the composition comprises an amino glycol buffer, an amino acid, a salt, and a non-ionic detergent.
  • a further object of the present invention is to claim a method of processing a sample by adding a composition comprising an amino glycol buffer, an amino acid, a salt, and a non-ionic detergent.
  • the present invention is based on the discovery that a composition comprising an amino glycol buffer, an amino acid, a salt, and a non-ionic detergent can, when added to a patient sample containing a target antigen in an acidic or formalin-containing transport medium, allow for the neutralization of the acid and formalin while preserving immunoreactivity of the antigen allowing its detection.
  • composition of the present invention includes an amino glycol buffer.
  • Suitable amino gylcol buffers include 2-amino-2hydroxymethyl-l,3-propanediol (Tris buffer), 2-amino-2-methyl-l,3-propanediol.
  • the present composition further includes an amino acid.
  • Suitable amino acids include glycine, lysine and arginine.
  • the composition further includes a salt.
  • Suitable salts include sodium salts such as sodium chloride and potassium salts such as potassium chloride.
  • the composition of the present invention further includes a non-ionic detergent.
  • Suitable non-ionic detergents include polyoxyethylenes such as t- octylphenoxypolyethoxyethanol (Triton X-100) and (octylphenoxyl)- polyethoxyethanol (Nonidet P-40).
  • the composition of the present invention may further include serum. It is believed that serum serves to prevent or reduce non-specific binding of antibodies that may be subsequently used in an immunoassay when non-specific binding is a problem.
  • Suitable serums include normal mammalian serum of any kind, such as that derived from humans. Other mammalian serums include bovine, porcine, equine and murine. Formulation:
  • the key elements of the treatment buffer formulation are the use of an amino acid in a basic buffer medium.
  • glycine as the amino acid
  • Tris base as the basic buffer .
  • Triton X-100 which appears to help extract antigens relevant to our specific assay from the stool matrix
  • sodium chloride to help mimic physiological salt conditions which are theoretically ideal for antigen-antibody binding to occur
  • sodium azide which is added as an anti-microbial preservative.
  • normal bovine serum was added to block non-specific binding.
  • the final formulation consists of 1 M Tris, 1 M glycine, 0.9% sodium chloride, 0.5% Triton X-100, and 0.01% sodium azide.
  • the sources of the chemicals we have used to develop the treatment buffer are the Sigma Chemical Company (St. Louis, Mo USA) and the J.T. Baker Chemical Company
  • Tris Base also known as Trizma Base
  • Glycine also known as Trizma Base
  • Sodium chloride Baker 3624-07
  • Triton X-100 Sigma T-6878
  • Sodium azide Sigma S-2002.
  • the data shown in the table below illustrates the suppressive effects of SAF on control line signal development in a lateral flow assay.
  • These assays utilize goat anti-mouse IgG antibody striped onto a membrane, which in turn captures a particulate-labeied mouse IgG antibody to generate a visible signal.
  • the use of the sample treatment buffer (STB) restores the control line signal to approximately the same intensity as the control level.

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

Abstract

La présente invention porte sur une composition qui, ajoutée à un échantillon prélevé sur un patient et contenant un antigène cible dans un milieu de transport acide ou formolé, neutralise l'acide et le formol tout en préservant la réactivité immunologique de l'antigène permettant sa détection. Ladite composition comprend un tampon amino-glycolique, un acide aminé, un sel et un détergent non ionique. La présente invention porte également sur un procédé permettant de traiter un échantillon en y ajoutant une composition contenant un tampon amino-glycolique, un acide aminé, un sel et un détergent non ionique.
PCT/US1999/007573 1999-04-06 1999-04-06 Composition pour une preparation a base d'un echantillon preleve sur un patient WO2000060353A1 (fr)

Priority Applications (5)

Application Number Priority Date Filing Date Title
JP2000609792A JP2002541456A (ja) 1999-04-06 1999-04-06 患者試料標本用組成物
AU34752/99A AU3475299A (en) 1999-04-06 1999-04-06 Composition for patient sample preparation
EP99916432A EP1166111A1 (fr) 1999-04-06 1999-04-06 Composition pour une preparation a base d'un echantillon preleve sur un patient
PCT/US1999/007573 WO2000060353A1 (fr) 1999-04-06 1999-04-06 Composition pour une preparation a base d'un echantillon preleve sur un patient
CA002368007A CA2368007A1 (fr) 1999-04-06 1999-04-06 Composition pour une preparation a base d'un echantillon preleve sur un patient

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US1999/007573 WO2000060353A1 (fr) 1999-04-06 1999-04-06 Composition pour une preparation a base d'un echantillon preleve sur un patient

Publications (1)

Publication Number Publication Date
WO2000060353A1 true WO2000060353A1 (fr) 2000-10-12

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1999/007573 WO2000060353A1 (fr) 1999-04-06 1999-04-06 Composition pour une preparation a base d'un echantillon preleve sur un patient

Country Status (5)

Country Link
EP (1) EP1166111A1 (fr)
JP (1) JP2002541456A (fr)
AU (1) AU3475299A (fr)
CA (1) CA2368007A1 (fr)
WO (1) WO2000060353A1 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2007261552A1 (en) * 2006-06-19 2007-12-27 Becton, Dickinson And Company Methods and compositions for obtaining amplifiable nucleic acids from tissues, cells, or viruses exposed to transport media
JP5916610B2 (ja) 2009-09-03 2016-05-11 ベクトン・ディキンソン・アンド・カンパニーＢｅｃｔｏｎ， Ｄｉｃｋｉｎｓｏｎ Ａｎｄ Ｃｏｍｐａｎｙ 直接的な化学的溶解のための方法および組成物

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5185264A (en) * 1990-11-09 1993-02-09 Abbott Laboratories Diluent buffer and method for diluting an assay component
JPH06284886A (ja) * 1993-04-01 1994-10-11 Amano Pharmaceut Co Ltd 酵素の溶液中での安定化方法
US5695928A (en) * 1993-12-10 1997-12-09 Novartis Corporation Rapid immunoassay for detection of antibodies or antigens incorporating simultaneous sample extraction and immunogenic reaction
US5958300A (en) * 1998-02-06 1999-09-28 Genzyme Corporation Composition for patient sample preparation

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5185264A (en) * 1990-11-09 1993-02-09 Abbott Laboratories Diluent buffer and method for diluting an assay component
JPH06284886A (ja) * 1993-04-01 1994-10-11 Amano Pharmaceut Co Ltd 酵素の溶液中での安定化方法
US5695928A (en) * 1993-12-10 1997-12-09 Novartis Corporation Rapid immunoassay for detection of antibodies or antigens incorporating simultaneous sample extraction and immunogenic reaction
US5958300A (en) * 1998-02-06 1999-09-28 Genzyme Corporation Composition for patient sample preparation

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
DATABASE WPI Section Ch Week 199445, Derwent World Patents Index; Class B04, AN 1994-362593, XP002124079 *

Also Published As

Publication number Publication date
AU3475299A (en) 2000-10-23
EP1166111A1 (fr) 2002-01-02
CA2368007A1 (fr) 2000-10-12
JP2002541456A (ja) 2002-12-03

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