公开(公告)号：EP0632896A4

公开(公告)日：1995-03-22

申请号：EP93909171

申请日：1993-03-24

Applicant: ABBOTT LAB

Inventor： CLARK FREDERIC L ,  CLIFT GILBERT ,  HENDRICK KENDALL B ,  LAGOCKI PETER A ,  MARTIN RICHARD R ,  MITCHELL JAMES E ,  MOORE LARRY W ,  PENNINGTON CHARLES D ,  WALKER EDNA S ,  SMITH JANE B ,  TAYI APPARAO ,  VAUGHT JAMES A ,  YOST DAVID A ,  KANEWSKE WILLIAM J III

IPC: G01N21/64 ,  B01L3/00 ,  B01L3/08 ,  B01L9/06 ,  B29C45/00 ,  G01N1/00 ,  G01N21/03 ,  G01N21/25 ,  G01N21/27 ,  G01N21/49 ,  G01N21/59 ,  G01N33/53 ,  G01N33/537 ,  G01N33/538 ,  G01N33/542 ,  G01N33/543 ,  G01N35/00 ,  G01N35/02 ,  G01N35/04 ,  G01N35/10 ,  H01J49/04

CPC classification number: H01J49/04 ,  B01L3/08 ,  B01L3/5025 ,  B01L3/5085 ,  B01L3/50853 ,  B01L9/06 ,  B01L2200/142 ,  B01L2300/042 ,  B01L2300/043 ,  B29C45/00 ,  B29K2995/0032 ,  B29L2023/22 ,  G01N21/03 ,  G01N21/253 ,  G01N33/5302 ,  G01N33/537 ,  G01N33/538 ,  G01N33/542 ,  G01N33/54313 ,  G01N35/0092 ,  G01N35/0099 ,  G01N35/025 ,  G01N35/1065 ,  G01N2001/007 ,  G01N2035/00168 ,  G01N2035/00287 ,  G01N2035/00356 ,  G01N2035/00386 ,  G01N2035/00455 ,  G01N2035/00475 ,  G01N2035/00495 ,  G01N2035/00524 ,  G01N2035/00752 ,  G01N2035/0093 ,  G01N2035/0405 ,  G01N2035/0436 ,  G01N2035/0441 ,  G01N2035/0443 ,  G01N2035/0444 ,  G01N2035/0448 ,  G01N2035/0453 ,  G01N2035/0465 ,  G01N2035/1025 ,  G01N2035/1076 ,  G01N2035/1086 ,  Y10S435/809 ,  Y10S436/807 ,  Y10T436/11 ,  Y10T436/113332 ,  Y10T436/114165 ,  Y10T436/114998 ,  Y10T436/119163 ,  Y10T436/2575

Abstract: An automated, continuous and random access analytical system (18), having apparatus and methodology capable of simultaneously performing multiple assays of liquid samples using different assay methodologies, and providing continuous and random access while performing a plurality of different assays on the same or different samples during the same time period, is disclosed. A method is also disclosed of operating an automated continuous and random access analytical system (18) capable of simultaneously effecting multiple assays of a plurality of liquid samples wherein scheduling of various assays of the plurality of liquid samples is followed by creating a unit dose disposable and separately transferring a first liquid sample (26) and reagents (30) to a reaction vessel (34) without initiation of an assay reaction sequence, followed by physical transfer of the unit dose disposable to a processing workstation (52), whereby a mixture of the unit dose disposable reagents and sample (34) are achieved during incubation. The system (18) is capable of performing more than one scheduled assay in any order, and assays where more than such scheduled assays are presented. The automated, continuous and random access analytical system (18) is also capable of analyzing the incubated reaction mixtures independently and individually by at least two assay procedures.

Abstract translation: 具有能够使用不同的测定方法同时执行液体样品的多个测定的设备和方法，并且在对相同或不同样品执行多个不同测定的同时提供连续和随机访问的自动化，连续和随机访问分析系统（18） 在同一时间段内披露。 还公开了一种操作自动化连续随机进入分析系统（18）的方法，该系统能够同时实现多个液体样品的多次测定，其中调度多个液体样品的各种测定之后是生成单位剂量一次性和 在不启动分析反应序列的情况下将第一液体样品（26）和试剂（30）分开地转移至反应容器（34），随后将单位剂量物理转移至处理工作站（52），由此得到 单位剂量一次性试剂和样品（34）在孵化期间实现。 系统（18）能够以任何顺序执行多于一个计划的测定，并且能够进行多于这种计划的测定的测定。 自动化，连续和随机进入分析系统（18）还能够通过至少两个分析程序独立且单独分析孵育的反应混合物。

公开(公告)号：EP0634016A4

公开(公告)日：1997-06-04

申请号：EP93908561

申请日：1993-03-24

Applicant: ABBOTT LAB

Inventor： SCHMIDT LINDA S ,  SPRONK ADRIAN M ,  CLARK FREDERIC L ,  CLIFT GILBERT ,  HENDRICK KENDALL B ,  KANEWSKE WILLIAM J III ,  LAGOCKI PETER A ,  MITCHELL JAMES E ,  MARTIN RICHARD R ,  MOORE LARRY E ,  PENNINGTON CHARLES D ,  WALKER EDNA S ,  SMITH JANE B ,  TAYI APPARAO ,  VAUGHT JAMES A ,  YOST DAVID A

IPC: B01L3/00 ,  B01L3/08 ,  B01L9/06 ,  G01N1/00 ,  G01N21/25 ,  G01N33/53 ,  G01N33/536 ,  G01N33/537 ,  G01N33/538 ,  G01N33/542 ,  G01N33/543 ,  G01N35/00 ,  G01N35/02 ,  G01N35/04 ,  G01N35/10 ,  H01J49/04

CPC classification number: B01L3/50853 ,  B01L3/08 ,  B01L3/5025 ,  B01L3/5085 ,  B01L9/06 ,  B01L2200/142 ,  B01L2300/042 ,  B01L2300/043 ,  G01N21/253 ,  G01N33/53 ,  G01N33/5302 ,  G01N33/537 ,  G01N33/538 ,  G01N33/542 ,  G01N33/54313 ,  G01N35/0092 ,  G01N35/025 ,  G01N2001/007 ,  G01N2035/00752 ,  G01N2035/0093 ,  G01N2035/0405 ,  G01N2035/0441 ,  G01N2035/0443 ,  G01N2035/0444 ,  G01N2035/0453 ,  G01N2035/1025 ,  H01J49/04

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.

公开(公告)号：EP0637283A4

公开(公告)日：1995-12-13

申请号：EP93908570

申请日：1993-03-24

Applicant: ABBOTT LAB

Inventor： KANEWSKE WILLIAM J III ,  VAUGHT JAMES A ,  VICKSTROM RICHARD L ,  CLARK FREDERIC L ,  CLIFT GILBERT ,  HENDRICK KENDALL B ,  LAGOCKI PETER A ,  MARTIN RICHARD E ,  MITCHELL JAMES E ,  MOORE LARRY E ,  PENNINGTON CHARLES D ,  WALKER EDNA S ,  SMITH JANE B ,  TAYI APPARAO ,  YOST DAVID A

IPC: B01L3/00 ,  B01L3/08 ,  B01L9/06 ,  B29C45/00 ,  B29C45/26 ,  B29C45/42 ,  B29D11/00 ,  B29D23/00 ,  G01N1/00 ,  G01N21/03 ,  G01N21/25 ,  G01N33/53 ,  G01N33/537 ,  G01N33/538 ,  G01N33/542 ,  G01N33/543 ,  G01N35/00 ,  G01N35/02 ,  G01N35/04 ,  G01N35/10 ,  H01J49/04 ,  B29D23/24 ,  G01N21/64

CPC classification number: B01L3/08 ,  B01L3/5025 ,  B01L3/5085 ,  B01L3/50853 ,  B01L9/06 ,  B01L2200/142 ,  B01L2300/042 ,  B01L2300/043 ,  B29C45/00 ,  B29K2995/0032 ,  B29L2023/22 ,  G01N21/03 ,  G01N21/253 ,  G01N33/5302 ,  G01N33/537 ,  G01N33/538 ,  G01N33/542 ,  G01N33/54313 ,  G01N35/0092 ,  G01N35/0099 ,  G01N35/025 ,  G01N35/1065 ,  G01N2001/007 ,  G01N2035/00168 ,  G01N2035/00287 ,  G01N2035/00356 ,  G01N2035/00386 ,  G01N2035/00455 ,  G01N2035/00475 ,  G01N2035/00495 ,  G01N2035/00524 ,  G01N2035/00752 ,  G01N2035/0093 ,  G01N2035/0405 ,  G01N2035/0436 ,  G01N2035/0441 ,  G01N2035/0443 ,  G01N2035/0444 ,  G01N2035/0448 ,  G01N2035/0453 ,  G01N2035/0465 ,  G01N2035/1025 ,  G01N2035/1076 ,  G01N2035/1086 ,  H01J49/04

Abstract: A plastic assay cuvette (506) having the desired optical properties for the analysis of a test sample or reaction mixture thereof, and a method for making such a plastic assay cuvette (506), are described. The optical properties of the plastic assay cuvette (506) are substantially the same as the optical properties of glass wherein low birefringence throughout the optical read region (516) thereof is provided. When used for the analysis of a test sample or reaction mixture thereof, such as in fluorescence polarization assays and absorbance assays, the plastic assay cuvette (506) provides accurate and reproducible disposable assay cuvette which can be used in place of conventional glass assay cuvettes.

Abstract translation: 描述了具有用于分析测试样品或其反应混合物的所需光学性质的塑料分析比色杯（506）以及制备这种塑料分析比杯（506）的方法。 塑料分析试管（506）的光学性质基本上与玻璃的光学性质相同，其中提供了其整个光学读取区域（516）的低双折射。 当用于分析测试样品或其反应混合物时，例如在荧光偏振测定和吸光度测定中，塑料分析比色皿（506）提供可用于代替常规玻璃分析比色皿的精确和可重复的一次性分析比色皿。

公开(公告)号：ES2271941T3

公开(公告)日：2007-04-16

申请号：ES93908571

申请日：1993-03-24

Applicant: ABBOTT LAB

Inventor： CLARK FREDERIC L ,  CLIFT GILBERT ,  HENDRICK KENDALL B ,  KANEWSKE WILLIAM J III ,  LAGOCKI PETER A ,  MARTIN RICHARD R

IPC: G01N21/64 ,  G01N35/02 ,  B01L3/00 ,  B01L3/08 ,  B01L9/06 ,  B29C45/00 ,  G01N1/00 ,  G01N21/03 ,  G01N21/25 ,  G01N21/27 ,  G01N21/49 ,  G01N21/59 ,  G01N33/53 ,  G01N33/537 ,  G01N33/538 ,  G01N33/542 ,  G01N33/543 ,  G01N35/00 ,  G01N35/04 ,  G01N35/10 ,  H01J49/04

Abstract: SE PRESENTA UN SISTEMA ANALITICO AUTOMATICO DE ACCESO CONTINUO Y ALEATORIO, QUE TIENE UN APARATO Y UNA METODOLOGIA CAPACES DE REALIZAR SIMULTANEAMENTE ANALISIS MULTIPLES DE MUESTRAS DE LIQUIDOS UTILIZANDO DIFERENTES METODOLOGIAS DE ANALISIS, Y SUMINISTRANDO UN ACCESO CONTINUO Y ALEATORIO MIENTRAS QUE REALIZA UNA PLURALIDAD DE ANALISIS SOBRE LA MISMA O DIFERENTES MUESTRAS DURANTE EL MISMO PERIODO DE TIEMPO. TAMBIEN SE PRESENTA UN METODO PARA UTILIZAR UN SISTEMA ANALITICO AUTOMATICO DE ACCESO CONTINUO Y ALEATORIO CAPAZ DE EFECTUAR SIMULTANEAMENTE ANALISIS MULTIPLES DE UNA PLURALIDAD DE MUESTRAS DE LIQUIDO EN DONDE LA CATALOGACION DE LOS DIFERENTES ANALISIS DE LA PLURALIDAD DE MUESTRAS DE LIQUIDO SE SIGUE CREANDO UNA DOSIS UNITARIA DESECHABLE Y SEPARADAMENTE TRANSFIRIENDO UNA PRIMERA MUESTRA DE LIQUIDO (26), REACTIVOS (30) A UN VASO DE REACCION (34) SIN LA INICIALIZACION DE UNA SECUENCIA DE REACCION DE ANALISIS, SIGUIENDO CON LA TRANSFERENCIA FISICA DE LA DOSIS UNITARIA DESECHABLE (34) A UNA ESTACION DE TRABAJO DE PROCESAMIENTO, EN DONDE SE CONSIGUE UNA MEZCLA DE LA DOSIS UNITARIA DESECHABLE, LOS REACTIVOS Y LA MUESTRA (34) DURANTE LA INCUBACION. EL SISTEMA ES CAPAZ DE REALIZAR MAS DE UN ANALISIS CATALOGADO EN CUALQUIER ORDEN, Y LOS ANALISIS EN LOS QUE ESTAN PRESENTES MAS DE UN ANALISIS PROGRAMADO. EL SISTEMA ANALITICO AUTOMATICO, DE ACCESO CONTINUO Y ALEATORIO ES TAMBIEN CAPAZ DE ANALIZAR LAS MEZCLAS DE REACCION INCUBADAS INDEPENDIENTEMENTE E INDIVIDUALMENTE MEDIANTE AL MENOS DOS PROCEDIMIENTOS DE ENSAYO.

公开(公告)号：DE69330785D1

公开(公告)日：2001-10-25

申请号：DE69330785

申请日：1993-03-24

Applicant: ABBOTT LAB

Inventor： SCHMIDT LINDA S ,  SPRONK ADRIAN M ,  CLARK FREDERIC L ,  CLIFT GILBERT ,  HENDRICK KENDALL B ,  KANEWSKE III ,  LAGOCKI PETER A ,  MITCHELL JAMES E ,  MARTIN RICHARD R ,  MOORE LARRY E ,  PENNINGTON CHARLES D ,  WALKER EDNA S ,  SMITH JANE B ,  TAYI APPARAO ,  VAUGHT JAMES A ,  YOST DAVID A

IPC: B01L3/00 ,  B01L3/08 ,  B01L9/06 ,  G01N1/00 ,  G01N21/25 ,  G01N33/53 ,  G01N33/536 ,  G01N33/537 ,  G01N33/538 ,  G01N33/542 ,  G01N33/543 ,  G01N35/00 ,  G01N35/02 ,  G01N35/04 ,  G01N35/10 ,  H01J49/04 ,  G01N33/02 ,  G01N33/483

公开(公告)号：CA2650258A1

公开(公告)日：1995-03-30

申请号：CA2650258

申请日：1994-09-22

Applicant: ABBOTT LAB

Inventor： TAYI APPARAO ,  VAUGHT JAMES A ,  KANEWSKE WILLIAM J III ,  WALKER EDNA S ,  LAGOCKI PETER A ,  MARTIN RICHARD R ,  SMITH B JANE ,  YOST DAVID A ,  PENNINGTON CHARLES D ,  CLIFT GILBERT ,  MOORE LARRY W ,  HENDRICK KENDALL B ,  MITCHELL JAMES E ,  CLARK FREDERIC L

IPC: G01N33/483 ,  G01N35/02 ,  B01F11/00 ,  B01L3/00 ,  B29C45/00 ,  G01F23/22 ,  G01F23/26 ,  G01N1/00 ,  G01N21/25 ,  G01N21/64 ,  G01N21/76 ,  G01N21/78 ,  G01N33/53 ,  G01N33/542 ,  G01N33/543 ,  G01N33/553 ,  G01N35/00 ,  G01N35/04 ,  G01N35/10 ,  H01J49/04

Abstract: An automated, continuous and random access analytical system, having apparat us and methodology capable of simultaneously performing multiple assays of liqu id samples using different assay methodologies, and providing continuous and random access while performing a plurality of different assays on the same or different samples during the same time period, is disclosed. A method is also disclosed of operating an automated continuous and random access analytical system capable of simultaneously effecting multiple assays of a plurality of liquid samples wherein scheduling of vario us assays of the plurality of liquid samples is followed by creating a unit dose disposab le and separately transferring a first liquid sample and reagents to a reaction vessel without initiation of an assay reaction sequence, followed by physical transfer of t he unit dose disposable to a processing workstation, whereby a mixture of the unit dose disposable reagents and sample are achieved during incubation. The system is capable of performing more than one scheduled assay in any order, and assays where more than such scheduled assays are presented. The automated, continuous and random access analytical system is also capable of analyzing the incubated reaction mixtur es independently and individually by atleast two assay procedures.

公开(公告)号：CA2538953A1

公开(公告)日：1993-10-14

申请号：CA2538953

申请日：1993-03-24

Applicant: ABBOTT LAB

Inventor： WALKER DONNY RAY ,  VAUGHT JAMES A ,  YOST DAVID A ,  MERRIAM RICHARD A ,  CLEMENS JOHN M ,  CLARK FREDERIC L ,  RUMBAUGH WILLIAM ,  KANEWSKE WILLIAM J III ,  HENDRICK KENDALL B ,  TAYI APPARAO ,  CLIFT GILBERT ,  WALKER EDNA S ,  LOGOCKI PETER A ,  MARTIN RICHARD R ,  MITCHELL JAMES E ,  MOORE LARRY W ,  PENNINGTON CHARLES D ,  SMITH B JANE

IPC: G01N35/02 ,  B01L3/00 ,  B01L3/08 ,  B01L9/06 ,  B29C45/00 ,  B67D99/00 ,  C12M1/34 ,  G01F23/26 ,  G01F23/284 ,  G01N1/00 ,  G01N1/14 ,  G01N1/28 ,  G01N21/03 ,  G01N21/25 ,  G01N21/76 ,  G01N21/77 ,  G01N33/53 ,  G01N33/537 ,  G01N33/538 ,  G01N33/542 ,  G01N33/543 ,  G01N35/00 ,  G01N35/04 ,  G01N35/10 ,  G05D23/19 ,  H01J49/04 ,  H05B1/02

公开(公告)号：CA2132959A1

公开(公告)日：1993-10-14

申请号：CA2132959

申请日：1993-03-24

Applicant: ABBOTT LAB

Inventor： CLARK FREDERIC L ,  CLIFT GILBERT ,  HENDRICK KENDALL B ,  KANEWSKE WILLIAM J III ,  LOGOCKI PETER A ,  MARTIN RICHARD R ,  MITCHELL JAMES E ,  MOORE LARRY W ,  PENNINGTON CHARLES D ,  WALKER EDNA S ,  SMITH B JANE ,  TAYI APPARAO ,  VAUGHT JAMES A ,  YOST DAVID A ,  RUMBAUGH WILLIAM ,  WINTER GARY E ,  HANCE ROBERT B ,  STANTON ALYN K ,  OLEKSAK CARL M ,  WATKINS WILLIAM E III ,  VICKSTROM RICHARD L ,  CLOONAN KEVIN M ,  WOHLFORD ROBERT A ,  HILLS DAVID B JR ,  SCHRIER PAUL R

IPC: B01L3/00 ,  B01L3/08 ,  B01L9/06 ,  G01N1/00 ,  G01N1/14 ,  G01N1/28 ,  G01N21/03 ,  G01N21/25 ,  G01N33/53 ,  G01N33/537 ,  G01N33/538 ,  G01N33/542 ,  G01N33/543 ,  G01N35/00 ,  G01N35/02 ,  G01N35/04 ,  G01N35/10 ,  G05D23/00 ,  H01J49/04 ,  H02P8/00 ,  H05B41/00 ,  G01F11/04 ,  G01M11/00 ,  G05D23/19 ,  H04B15/00 ,  H05B39/04 ,  H05B41/36

Abstract: 2132959 9320441 PCTABS00027 An automated, continuous and random access analytical system, having apparatus and methodology capable of simultaneously performing multiple assays of liquid samples using different assay methodologies, and providing continuous and random access while performing a plurality of different assays on the same or different samples during the same time period, is disclosed. A method is also disclosed of operating an automated continuous and random access analytical system capable of simultaneously effecting multiple assays of a plurality of liquid samples wherein scheduling of various assays of the plurality of liquid samples is followed by creating a unit dose disposable and separately transferring a first liquid sample (26), reagents (30) to a reaction vessel (34) without initiation of an assay reaction sequence, followed by physical transfer of the unit dose disposable (34) to a process work station, whereby a mixture of the unit dose disposable reagents and sample (34) are achieved during incubation. The system is capable of performing more than one scheduled assay in any order, and assays where more than such scheduled assays are presented. The automated, continuous and random access analytical system is also capable of analyzing the incubated reaction mixtures independently and individually by at least two assay procedures.

公开(公告)号：CA2643126C

公开(公告)日：2010-05-04

申请号：CA2643126

申请日：1994-09-22

Applicant: ABBOTT LAB

Inventor： CLARK FREDERICK L ,  MOORE LARRY W ,  KANEWSKE WILLIAM J III ,  MCDOWELL DOUGLAS D ,  CLIFT GILBERT

IPC: G01N33/483 ,  G01N35/02 ,  B01F11/00 ,  B01J19/24 ,  B01L3/00 ,  B29C45/00 ,  G01F23/22 ,  G01F23/26 ,  G01N1/00 ,  G01N21/25 ,  G01N21/64 ,  G01N21/76 ,  G01N21/78 ,  G01N33/53 ,  G01N33/542 ,  G01N33/543 ,  G01N33/553 ,  G01N35/00 ,  G01N35/04 ,  G01N35/10 ,  H01J49/04

Abstract: A reaction vessel suitable for multiple assay utilization within an automated, continuous and random access analytical system which allows for kidding of sample and reagents and physical transfer of the kidded reaction vessel to a process carousel, comprises: multiple wells of various volume capacities, the multiple wells having openings on the same plane and depths extending from said plane, the reaction vessel having at least one curvette, the curvette extending substantially below the multiple wells, the curvette having an opening on the same plane as the multiple wells; and at a transfer projection on a well bottom portion of the well on a first end portion of the reaction vessel, the curvette projecting downward from a second end portion of the reaction vessel; the vessel may be employed in multiple assays, for example, in clinical analyzers.

公开(公告)号：CA2538953C

公开(公告)日：2009-09-29

申请号：CA2538953

申请日：1993-03-24

Applicant: ABBOTT LAB

Inventor： MOORE LARRY W ,  YOST DAVID A ,  MERRIAM RICHARD A ,  MITCHELL JAMES E ,  KANEWSKE WILLIAM J III ,  SMITH B JANE ,  PENNINGTON CHARLES D ,  CLARK FREDERIC L ,  WALKER DONNY RAY ,  TAYI APPARAO ,  VAUGHT JAMES A ,  CLIFT GILBERT ,  LOGOCKI PETER A ,  HENDRICK KENDALL B ,  MARTIN RICHARD R ,  WALKER EDNA S ,  CLEMENS JOHN M ,  RUMBAUGH WILLIAM

IPC: G01F23/284 ,  B01L3/00 ,  B01L3/08 ,  B01L9/06 ,  B29C45/00 ,  B67D99/00 ,  C12M1/34 ,  G01F23/26 ,  G01N1/00 ,  G01N1/14 ,  G01N1/28 ,  G01N21/03 ,  G01N21/25 ,  G01N21/76 ,  G01N21/77 ,  G01N33/53 ,  G01N33/537 ,  G01N33/538 ,  G01N33/542 ,  G01N33/543 ,  G01N35/00 ,  G01N35/02 ,  G01N35/04 ,  G01N35/10 ,  G05D23/19 ,  H01J49/04 ,  H05B1/02

Abstract: An automated, continuous and random access analytical system, having apparatus and methodology capable of simultaneously performing multip le assays of liquid samples using different assay methodologies, and providing continuous and random access while performing a plurality of different assay s on the same or different samples during the same time period, is disclosed. A method is also disclosed of operating an automated continuous and random access analytical system capable of simultaneously effecting multiple assays of a plurality of liquid samples wherein scheduling of various assays of the plurality of liquid samples is followed by creating a unit dose disposable and separately transferring a first liquid sample, reagents to a reaction vessel without initiation of a n assay reaction sequence, followed by physical transfer of the unit dose disposable to a process work station, whereby a mixture of the unit dose disposable reagents and sample are achieved during incubation. The system is capable of performing more than one scheduled assay in any order, and assays where more than such scheduled assays are presented. The automated, continuous and random access analytical system is also capable of analyzing the incubated reaction mixtures independently and individually by at least two assay procedures.