US 5,635,364 AGranted

Assay verification control for an automated analytical system

AssigneeAbbott Laboratories

InventorsFrederick L. Clark, Kendall B. Hendrick, Richard R. Martin, Larry W. Moore, William J. Raymoure, Paul R. Schrier, Edna S. Walker, Donny R. Walker, Gary E. Winter, Kevin M. Cloonan, David A. Yost, John M. Clemens, William J. Kanewske, III, Douglas D. McDowell, Carl M. Oleksak, William D. Rumbaugh, B. Jane Smith, James A. Vaught, Apparao Tayi, Robert A. Wohlford, James E. Mitchell, Robert B. Hance, Peter A. Lagocki, Richard A. Merriam, Charles D. Pennington, Linda S. Schmidt, Adrian M. Spronk, Richard L. Vickstrom, William E. Watkins, III, Gilbert Clift, Alyn K. Stanton, David B. Hills

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Abstract

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.

Claims19

Dependent claims

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.

4 more elements

A method for verifying a result in a heterogeneous immunoassay for determining the presence or amount of an analyte present in a test sample, wherein said heterogeneous assay is a competitive immunoassay, comprising the steps of:

(a) forming a mixture comprising said test sample and a labeled reagent comprising said analyte or an analog of said analyte labeled with a detectable moiety;
(b) dividing said mixture 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 comprising the steps of (I) contacting said mixture with a solid phase material, said solid phase material having a substance that specifically binds to said analyte or said labeled reagent to form a bound species of said labeled reagent and a free species of said labeled reagent and (ii) correlating the amount of said bound species of said labeled reagent or said free species of said labeled reagent to the amount or presence of said analyte present 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) contacting said mixture with a solid phase material, said solid phase material having a substance that specifically binds to said analyte or said labeled reagent to form a bound species of said labeled reagent and a free species of said labeled reagent and (ii) correlating the amount of said bound species of said labeled reagent or said free species of said labeled reagent 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.

4 more elements

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 said 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, 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 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 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 present in said test sample;
(e) adding assay verification sample to said independently analyzed first portion of said reaction mixture 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.

4 more elements

A method for verifying a result in a heterogeneous immunoassay for determining the presence or amount of an analyte present in a sample, wherein said heterogeneous immunoassay is a competitive heterogeneous immunoassay, comprising the steps of:

(a) forming a mixture comprising said test sample and a labeled reagent comprising said analyte or an analog of said analyte labeled with a detectable moiety;
(b) dividing said mixture 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 comprising the steps of (I) contacting said mixture with a solid phase material, said solid phase material having a substance that specifically binds to said analyte or said labeled reagent to form a bound species of said labeled reagent and a free species of said labeled reagent and (ii) correlating the amount of said bound species of said labeled reagent or said free species of said labeled reagent to the amount or presence of said analyte present 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) contacting said mixture with a solid phase material, said solid phase material having a substance that specifically binds to said analyte or said labeled reagent to form a bound species of said labeled reagent and a free species of said labeled reagent and (ii) correlating the amount of said bound species of said labeled reagent or said free species of said labeled reagent 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.

4 more elements

Dependencies are inferred from the claim text.

Facts

Application: 08/176,173Filed 3 Jan 1994 · continuation in part
Priority: 27 Mar 1992
Granted: 3 Jun 1997
Term ends: Not estimatedThe source records don’t support an estimate.

Classification65 codes

B01F 31/24
Mixing the contents of independent containers, e.g. test tubes: the containers being submitted to a rectilinear movement
B01L 3/08
Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers: flasks
B01L 3/5025
With fluid transport, e.g. in multi-compartment structures: for parallel transport of multiple samples
B01L 3/50853
For multiple samples, e.g. microtitration plates: with covers or lids

Family

Serial859,218Parent of this continuation-in-part · filed 27 Mar 1992
Serial915,162Parent of this continuation-in-part · filed 20 Jul 1992
Serial915,163Parent of this continuation-in-part · filed 20 Jul 1992
Serial915,164Parent of this continuation-in-part · filed 20 Jul 1992
Serial915,166Parent of this continuation-in-part · filed 20 Jul 1992
Serial915,167Parent of this continuation-in-part · filed 20 Jul 1992
Serial915,168Parent of this continuation-in-part · filed 20 Jul 1992
Serial916,425Parent of this continuation-in-part · filed 20 Jul 1992
Serial916,551Parent of this continuation-in-part · filed 20 Jul 1992
Serial916,556Parent of this continuation-in-part · filed 20 Jul 1992
Serial916,737Parent of this continuation-in-part · filed 20 Jul 1992
Serial917,253Parent of this continuation-in-part · filed 20 Jul 1992
Serial917,634Parent of this continuation-in-part · filed 20 Jul 1992
Serial27,268Parent of this continuation-in-part · filed 18 Mar 1993
Serial27,270Parent of this continuation-in-part · filed 18 Mar 1993
Serial27,387Parent of this continuation-in-part · filed 18 Mar 1993
Serial27,388Parent of this continuation-in-part · filed 18 Mar 1993
Serial27,481Parent of this continuation-in-part · filed 18 Mar 1993
Serial27,269Parent of this continuation-in-part · filed 18 Mar 1993
Serial27,482Parent of this continuation-in-part · filed 18 Mar 1993
Serial126,411Parent of this continuation-in-part · filed 24 Sep 1993
US 5,376,313 AParent of this continuation-in-part
US 5,451,528 AParent of this continuation-in-part
Serial000,000Parent doc
US 5,635,364 AThis patent

From the US filing history. Foreign family members aren’t listed.