[특허]Assay verification control for an automated analytical system

Assay verification control for an automated analytical system 원문보기

IPC분류정보
국가/구분	United States(US) Patent 등록
국제특허분류(IPC7판)	G01N-033/53 G01N-033/538 G01N-033/546 G01N-035/00
출원번호	US-0176173 (1994-01-03)
발명자 / 주소	Clark Frederick L. (Plano TX) Hendrick Kendall B. (Southlake TX) Martin Richard R. (Irving TX) Moore Larry W. (Plano TX) Raymoure William J. (Lake Blluff IL) Schrier Paul R. (Carrollton TX) Walker Ed
출원인 / 주소	Abbott Laboratories (Abbott Park IL 02)
인용정보	피인용 횟수 : 99 인용 특허 : 0

초록 ▼

A method for verifying that an assay methodology is properly performed, that assay reagents employed possess the necessary potency for accurately performing such assay methodology, and whether or not test samples or assay reagents have been tampered with or are adulterated, is described. The method is performed by employing an assay verification sample, comprising a positive analyte component and the test sample under analysis, wherein the assay verification sample is analyzed employing the same assay reagents and essentially the same assay methodology employed to analyze the test sample. The method is particularly useful for performing heterogeneous immunoassays on an automated continuous and random access analytical system.

대표청구항 ▼

A method for verifying a result in a heterogeneous immunoassay for determining the presence or amount of an analyte present in a test sample, comprising the steps of: (a) forming a reaction mixture comprising said test sample and a labeled reagent comprising a substance that specifically binds to said analyte labeled with a detectable moiety to form a bound species of said labeled reagent and a free species of said labeled reagent, wherein said bound species of said labeled reagent comprises said analyte and said labeled reagent and said free species of said labeled reagent does not contain said analyte; (b) dividing said reaction mixture containing said bound species and free species into a first portion and a second portion; (c) forming an assay verification sample comprising said second portion of said reaction mixture and a positive analyte component, in a known amount, capable of providing a detectable response as an indication of the presence or amount of said positive analyte component present in said assay verification sample; (d) independently analyzing said first portion of said reaction mixture to provide a first result indicative of the presence or amount of said analyte present in said test sample, said step of analyzing said first portion comprises the steps of (I) separating said free species from said bound species by means of a solid phase material, said solid phase material having a substance that specifically binds to said bound species but not capable of binding said free species, brought into contact with said reaction mixture and (ii) correlating the amount of labeled reagent in said free species or said bound species to the amount or presence of said analyte in said test sample; (e) independently analyzing said assay verification sample to provide a second result indicative of the presence or amount of said positive analyte component in said assay verification sample, said step of analyzing said assay verification sample comprising the steps of (I) separating said free species from said bound species by means of a solid phase material, said solid phase material having a substance that specifically binds to said bound species but not capable of binding said free species, brought into contact with said assay verification sample and (ii) correlating the amount of labeled reagent in said free species or said bound species to the amount or presence of said analyte present in said assay verification sample; and (f) determining if said second result is as expected, given knowledge that said assay verification sample contains said positive analyte component or said positive analyte component in said known amount, to verify said first result.

이 특허를 인용한 특허 (99)

Chow, Allan Tit-Shing; Devlin, Sr., William Jackson; Evers, Timothy Patrick; Thompson, David Russell, Automated analyzer.
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Ammann, Kelly G.; Burns, Ralph E.; Hansberry, Ernest V.; Horner, Glenn A.; Jakub, Cheryl A.; Kling, John E.; Nieglos, Donald J.; Schneider, Robert E.; Smith, Robert J., Automated process for detecting the presence of a target nucleic acid in a sample.
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Ammann,Kelly G.; Burns,Ralph E.; Hansberry,Ernest V.; Horner,Glenn A.; Jakub,Cheryl A.; Kling,John E.; Nieglos,Donald J.; Schneider,Robert E.; Smith,Robert J., Automated process for preparing and amplifying a target nucleic acid sequence.
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Ammann,Kelly G.; Burns,Ralph E.; Hansberry,Ernest V.; Horner,Glenn A.; Jakub,Cheryl A.; Kling,John E.; Nieglos,Donald J.; Schneider,Robert E.; Smith,Robert J., Automated system for isolating and amplifying a target nucleic acid sequence.
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Hirano, Masaaki; Nakamura, Kazuhiro, Automatic analytical device and method.
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Ammann, Kelly G.; Schneider, Robert E.; Smith, Robert J., System and method for incubating the contents of a reaction receptacle.
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Celentano, Michael J.; Groll, Henning; Pauley, James L.; Moore, Steven K., System and method for quality assurance of a biosensor test strip.
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Celentano, Michael J.; Groll, Henning; Pauley, James L.; Moore, Steven K., System and method for quality assurance of a biosensor test strip.
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Celentano, Michael J.; Groll, Henning; Pauley, James L.; Moore, Steven K., System and method for quality assurance of a biosensor test strip.
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Ammann, Kelly G.; Hansberry, Ernest V., System for agitating the fluid contents of a container.
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Ammann, Kelly G.; Schneider, Robert E.; Smith, Robert J., System for incubating the contents of a reaction receptacle.
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Knight, Byron J.; Li, Haitao, System for performing multi-formatted assays.
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Lair, Gary D.; Nguyen, Thanh N.; Li, Haitao; Li, Florence F.; Knight, Byron J.; Heinz, Robert E.; Macioszek, Jerzy A.; Davis, Christopher B.; Scalese, Robert F., System for performing multi-formatted assays.
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IPC	Description
A	생활필수품
A62	인명구조; 소방(사다리 E06C)
A62B	인명구조용의 기구, 장치 또는 방법(특히 의료용에 사용되는 밸브 A61M 39/00; 특히 물에서 쓰이는 인명구조 장치 또는 방법 B63C 9/00; 잠수장비 B63C 11/00; 특히 항공기에 쓰는 것, 예. 낙하산, 투출좌석 B64D; 특히 광산에서 쓰이는 구조장치 E21F 11/00)
A62B-1/08	.. 윈치 또는 풀리에 제동기구가 있는 것

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저장형식	Text(ASCII format) Excel format PIAS분석(.xls)
메일정보	받는사람 (필수) @ 보내는사람 (선택) @ 제목 내용 KISTI 검색결과 이메일 서비스
안내	총 건의 자료가 검색되었습니다. 다운받으실 자료의 인덱스를 입력하세요. (1-10,000) 검색결과의 순서대로 최대 10,000건 까지 다운로드가 가능합니다. 데이타가 많을 경우 속도가 느려질 수 있습니다.(최대 2~3분 소요) 다운로드 파일은 UTF-8 형태로 저장됩니다. 파일의 내용이 제대로 보이지 않을실 때는 웹브라우저 상단의 보기 -> 인코딩 -> 자동선택 여부를 확인하십시오. ~ Text(ASCII format) Excel format

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Assay verification control for an automated analytical system 원문보기

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Assay verification control for an automated analytical system 원문보기

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