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KR960029790A - 면역크로마토그래피 스트립 상에서의 분석물의 정량적 측정방법 - Google Patents

면역크로마토그래피 스트립 상에서의 분석물의 정량적 측정방법 Download PDF

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KR960029790A
KR960029790A KR1019960001777A KR19960001777A KR960029790A KR 960029790 A KR960029790 A KR 960029790A KR 1019960001777 A KR1019960001777 A KR 1019960001777A KR 19960001777 A KR19960001777 A KR 19960001777A KR 960029790 A KR960029790 A KR 960029790A
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analyte
binding partner
region
labeled binding
strip
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지. 솜머 로날드
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프랭클린 이. 브렉켄릿지
바이엘 코포레이션
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    • 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
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • G01N33/54386—Analytical elements
    • G01N33/54387—Immunochromatographic test strips
    • G01N33/54388—Immunochromatographic test strips based on lateral flow
    • 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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/90—Plate chromatography, e.g. thin layer or paper chromatography
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    • Y10S435/00—Chemistry: molecular biology and microbiology
    • Y10S435/805—Test papers
    • 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
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    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00—Chemistry: molecular biology and microbiology
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    • 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
    • Y10S435/97—Test strip or test slide
    • 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
    • Y10S436/00—Chemistry: analytical and immunological testing
    • Y10S436/807—Apparatus included in process claim, e.g. physical support structures
    • Y10S436/81—Tube, bottle, or dipstick

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Abstract

포획된 분석물／표지된 결합 파트너 복합체로부터의 시그날을 장치적 수단, 예를 들면, 방사 분광광도계에 의해 정량적으로 측정함을 포함하여, 면역크로마토그래피 기술에 의해 시험 유체중의 분석물 농도를 측정하는 개선된 방법이 기술되어 있다. 바람직한 양태에 있어, 반사 판독은 면역크로마토그래피 스트립의 별개 영역중에 포획된 비복합체화된 표지된 결합 파트너와 포획된 복합체에 대해 측정하고, 이들 반사치의 비를 사용하여 검정 방법에 대해 부가적 정량화가 이루어진다.

Description

면역크로마토그래피 스트립 상에서의 분석물의 정량적 측정방법
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음
제3도는 본 발명의 또다른 양태의 면역크로마토그래피 스트립을 나타내는 도면이다.

Claims (17)

  1. 검출영역에서 스그날을 측정할 수 있는 검출기가 있는 장치를 사용하여 표지로부터의 시그날을 측정함을 특징으로 하여, 유체를 면역크로마토그래피 매트릭스[여기서, 매트릭스는 분석물에 대한 표지된 결합 파트너를 함유하고, 표지된 결합 파트너가 함유하고 있는 표지를 검출함으로써 분석물이 검출되는 검출영역 하나 이상을 함유한다]에 적용시킴으로써 유체 시험 샘플이 모세관 현상에 의해 매트릭스를 따라 흐르게 하여 유체 시험 샘플중의 분석물을 측정하는 방법.
  2. a) 검출가능한 표지를 함유하고 분석물과 반응함으로써 분석물／표지된 결합 파트너 복합체를 형성할 수 있는, 분석물에 대한 이동성 특이적 결합 파트너를 함유하는 제1영역과, 고정된 분석물 또는 이의 동족체를 함유하는 하나 이상의 제2영역으로 이루어지는, 모세관 현상에 의해 유체 시험 샘플이 흐를 수 있는 매트릭스를 포함하는 시험 스트립을 제공하는 단계; b) 분석물을 함유하는 것으로 추정되는 유체 시험 샘플을 스트립에 적용시킴으로써 분석물이 이에 대한 이동성, 표지된 특이적 결합 파트너와 접촉하게 하여 유체 시험 샘플 중에 존재하는 분석물이 좀더 반응할 수 있는 과량의 비반응된 결합 파트너를 남겨 둔채 표지된 특이적 결합 파트너와 결합하여 복합체를 형성시키고, 유체 시험 샘플이 분석물／표지된 결합 파트너 복합체와 비반응된 표지된 결합 파트너를 모세관 현상에 의해 고정된 분석물 또는 이의 동족체를 함유하는 제2영역으로 스트립을 따라 운반시켜 여기서 비반응된 표지된 결합 파트너가 고정된 분석물과 유체 시험 샘플 중의 분석물 농도까지 역관계로 결합하도록 스트립을 전개시키는 단계; c) 검출가능한 표지로부터의 시그날을 측정할 수 있는 검출기를 갖는 장치 상에서 전개된 스트립을 판독하여 제2영역중의 표지된 결합 파트너의 농도를 측정하는 단계; 및 d) 단계 c)에서 측정된 검출가능한 표지로부터의 시그날을 공지된 농도의 분석물을 함유하는 유체 샘플을 사용하여 유사한 방식으로 작성된 시그날 측정치와 비교함으로써 유체 시험 샘플중의 분석물 농도를 측정하는 단계들을 포함하여, 유체 시험 샘플중의 분석물 하나 이상의 농도를 측정하는 방법.
  3. 제2항에 있어서, 분석물과 표지된 결합 파트너 사이에 형성된 복합체를 고정화시키고 제3영역내에 고정된 검출가능한 표지로부터의 시그날을 측정하기 위한 수단을 함유하는 스트립의 제3영역이 존재하여, 제2영역중에 고정화된 표지된 결합 파트너와 제3영역중에 고정된 복합체로부터의 시그날의 비를 측정하는 방법.
  4. 제2항에 있어서, 장치가 스트립 또는 검출기를 서로에 대해 이동시키기 위한 수단을 함유하여, 장치상에 정밀하게 위치하지 않을 수 있는 영역에 대해 정확한 정량화가 이루어지게 하는 방법.
  5. 제2항에 있어서, 스트립 상의 동일하거나 상이한 영역내에 둘 이상의 이동성 표지된 결합 파트너 및 고정된 분석물 또는 이의 동촉체를 함유하는 둘 이상의 영역의 존재함으로써, 둘 이상의 분석물이 단일 시험으로 측정될 수 있는 방법.
  6. 제2항에 있어서, 장치가 반사 분광광도계인 방법.
  7. 제2항에 있어서, 매트릭스가 비－흡수성 측위 유동성인 재료 또는 흡수성 재료로 구성되는 방법.
  8. 제2항에 있어서, 분석물이 사람 혈청 알부민(HSA)인 방법.
  9. 제2항에 있어서, 검출 가능한 표지가 발색중인 방법.
  10. 제9항에 있어서, 발색종이 골드 졸인 방법.
  11. 제2항에 있어서, 표지된 결합 파트너가 항체인 방법.
  12. a) 검출가능한 표지를 함유하고 분석물과 반응함으로써 분석물／표지된 결합 파트너 복합체를 형성할 수 있는, 분석물에 대한 이동성 특이적 결합 파트너를 함유하는 제1영역과, 고정된 분성물 또는 이의 동족체를 함유하는 하나 이상의 제2영역 및 분석물과 표지된 결합 파트너 사이에 형성된 복합체를 고정화시키기 위한 수단을 함유하는 하나 이상의 제3영역으로 이루어지는, 모세관 현상에 의해 유체 시험 샘플이 흐를 수 있는 매트릭스를 포함하는 시험 스트립을 제공하는 단계; b) 분석물을 함유하는 것으로 추정되는 유체 시험 샘플을 스트립에 적용시킴으로써 분석물이 이에 대한 이동성, 특이적 결합 파트너와 접촉하게 하여 유체 시험 샘플 중에 존재하는 분석물이 좀더 반응할 수 있는 과량의 비반응된 결합 파트너를 남겨 둔채 표지된 특이적 결합 파트너와 결합하여 복합체를 형성시키고, 유체 시험 샘플이 분석물／표지된 결합 파트너 복합체와 비반응된 표지된 결합 파트너를 모세관 현상에 의해 스트립을 따라 고정된 분석물 또는 이의 동족체를 함유하는 제2영역으로 운반시켜 여기서 비반응된 표지된 결합 파트너를 고정된 분석물과 유체 시험 샘플 중의 분석물 농도까지 역관계로 결합시키고, 분석물／표지된 결합 파트너 복합체를 모세관 현상에 의해 제3영역까지 운반시켜 여기서 고정화 수단에 의해 포획될 수 있도록 스트립을 전개시키는 단계; c) 검출가능한 표지로부터의 시그날을 측정할 수 있는 검출기를 갖는 장치 상에서 전개된 스트립의 제2영역을 판독하여 제2영역중의 표지된 결합 파트너의 농도를 측정하고 유사한 방식으로 전개된 스트립의 제3영역을 판독하여 스트립의 제3영역중의 표지된 결합 파트너로부터의 시그날을 측정하는 단계; 및 d) 제2영역중에 고정된 표지된 결합 파트너로부터의 시그날과 제3영역중의 표지된 결합 파트너로부터의 시그날의 비를 측정하는 단계; 및 e) 단계 c)에서 측정된 스그날과 공지된 농도의 분석물을 함유하는 유체 샘플을 사용하여 유사한 방식으로 측정된 스그날비의 측정치를 비교함으로써 유체 시험 샘플중의 분석물 농도를 측정하는 단계들을 포함하여, 유체 시험 샘플중의 분석물 하나 이상의 농도를 정량적으로 측정하는 방법.
  13. 제12항에 있어서, 측정 장치가 반사 분광광도계인 방법.
  14. 제12항에 있어서, 매트릭스가 비－흡수성 측위 유동성인 재료 또는 흡수성 재료로 구성되는 방법.
  15. 제12항에 있어서, 분석물이 사람 혈청 알부민(HSA)인 방법.
  16. 제12항에 있어서, 검출 가능한 표지가 골드 졸인 방법.
  17. 제12항에 있어서, 표지된 결합 파트너가 항체인 방법.
    ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.
KR1019960001777A 1995-01-30 1996-01-27 면역크로마토그래피 스트립 상에서의 분석물의 정량적 측정방법 KR960029790A (ko)

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US08/380,119 US5569608A (en) 1995-01-30 1995-01-30 Quantitative detection of analytes on immunochromatographic strips
US08/380,119 1995-01-30

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KR960029790A true KR960029790A (ko) 1996-08-17

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US (1) US5569608A (ko)
EP (1) EP0724157A2 (ko)
JP (1) JPH08240591A (ko)
KR (1) KR960029790A (ko)
CN (1) CN1146557A (ko)
AU (1) AU4222696A (ko)
CA (1) CA2166913A1 (ko)
ZA (1) ZA96357B (ko)

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