公开(公告)号：WO1993007298A1

公开(公告)日：1993-04-15

申请号：PCT/US1992008035

申请日：1992-09-22

Applicant: ABBOTT LABORATORIES

Inventor： ABBOTT LABORATORIES ,  JOU, Yi-Her ,  STROUPE, Stephen, D. ,  ADAMCZYK, Janina ,  SAFFORD, John

IPC: C12Q01/70

CPC classification number: G01N33/538 ,  G01N33/54366 ,  G01N33/56983 ,  G01N33/57473 ,  Y10S435/969 ,  Y10S435/971 ,  Y10S436/811 ,  Y10S436/823

Abstract: The present invention includes novel rubella assays employing a Rubella virus capture reagent and a solid phase material containing a reaction site comprising a polymeric cation substance. A test sample suspected of containing Rubella antibody may be contacted with the capture reagent to form a capture reagent/analyte complex. The complex is then contacted to the positively charged solid phase to attract, attach, and immobilize the capture reagent/analyte complex.

Abstract translation: 本发明包括使用风疹病毒捕获试剂的新型风疹试验和含有包含聚合物阳离子物质的反应位点的固相材料。 怀疑含有风疹抗体的测试样品可以与捕获试剂接触以形成捕获试剂/分析物复合物。 然后将络合物与带正电的固相接触以吸引，附着和固定捕获试剂/分析物复合物。

公开(公告)号：WO1992021772A1

公开(公告)日：1992-12-10

申请号：PCT/US1992002996

申请日：1992-04-10

Applicant: ABBOTT LABORATORIES

Inventor： ABBOTT LABORATORIES ,  ADAMCZYK, Janina ,  BERRY, Daniel, S. ,  JOU, Yi-Her ,  STROUPE, Stephen, Denham

IPC: C12Q01/25

CPC classification number: G01N33/538 ,  G01N33/54353 ,  G01N33/548

Abstract: The present invention includes novel assays employing a capture reagent, involving a first binding member conjugated to a polymeric anion such as carboxymethylamylose, and a solid phase material containing a reaction site comprising a polymeric cation substance. A test sample suspected of containing the analyte of interest may be contacted with the capture reagent to form a charged capture reagent/analyte complex. The complex is then contacted to the oppositely charged solid phase to attract, attach, and immobilize the capture reagent/analyte complex. The use of carboxymethylamylose to prepare a suitably charged capture reagent provides a superior capture reagent that is capable of binding and retaining the analyte on the solid phase even in the presence of polyanionic non-specific binding blockers.

Abstract translation: 本发明包括采用捕获试剂的新试验，涉及与聚合阴离子缀合的第一结合成员例如羧甲基纤维素，以及含有包含聚合物阳离子物质的反应位点的固相材料。 怀疑含有感兴趣的分析物的测试样品可以与捕获试剂接触以形成带电的捕获试剂/分析物复合物。 然后将络合物与相反电荷的固相接触以吸引，附着和固定捕获试剂/分析物复合物。 使用羧甲基纤维素来制备适当带电的捕获剂提供了一种优异的捕获试剂，即使在聚阴离子非特异性结合阻断剂存在下也能将分析物结合并保留在固相上。

公开(公告)号：WO1992021770A1

公开(公告)日：1992-12-10

申请号：PCT/US1992002980

申请日：1992-04-10

Applicant: ABBOTT LABORATORIES

Inventor： ABBOTT LABORATORIES ,  ADAMCZYK, Janina ,  BERRY, Daniel, S. ,  FICO, Rosario ,  JOU, Yi-Her ,  STROUPE, Stephen, D.

IPC: C12Q01/00

CPC classification number: G01N33/538

Abstract: This invention presents novel assay methods employing a capture reagent, involving a first binding member typically conjugated to a polymeric anion substance, and a solid phase material containing a reaction site comprising a polymeric cation substance having a nitrogen content of at least about two percent. In one embodiment a test sample suspected of containing the analyte of interest may be contacted with the capture reagent to form a charged capture reagent/analyte complex. The complex is then contacted to the oppositely charged solid phase to attract, attach, and immobilize the capture reagent/analyte complex. The use of a polycationic substance, having a nitrogen content of at least about two percent (excluding the counter ions), to prepare a suitably charged solid phase provides a solid phase that can be subjected to a greater extent of manipulation, such as multiple washes, without losing the capability to attract and retain the capture reagent.

Abstract translation: 本发明提出了使用捕获试剂的新型测定方法，其包括通常与聚合物阴离子物质结合的第一结合构件，以及含有含有至少约2％氮含量的聚合阳离子物质的反应位点的固相材料。 在一个实施方案中，怀疑含有感兴趣的分析物的测试样品可与捕获试剂接触以形成带电的捕获试剂/分析物复合物。 然后将络合物与相反电荷的固相接触以吸引，附着和固定捕获试剂/分析物复合物。 使用具有至少约2％的氮含量（不包括抗衡离子）的聚阳离子物质来制备适当带电的固相，提供可以进行更大程度操作的固相，例如多次洗涤 ，而不失去吸引和保留捕获试剂的能力。

公开(公告)号：WO1992021769A1

公开(公告)日：1992-12-10

申请号：PCT/US1992002979

申请日：1992-04-10

Applicant: ABBOTT LABORATORIES

Inventor： ABBOTT LABORATORIES ,  ADAMCZYK, Janina ,  BERRY, Daniel, S. ,  FICO, Rosario ,  JOU, Yi-Her ,  STROUPE, Stephen, D.

IPC: C12Q01/00

CPC classification number: G01N33/54393 ,  G01N33/538 ,  G01N33/54353 ,  G01N33/544

Abstract: The present invention includes novel assays and reagents using a capture reagent, involving a specific binding member attached to a polymeric anionic substance, and a solid phase material containing a capture or reaction zone including a polymeric cationic substance. A test sample suspected of containing the analyte of interest may be contacted with the capture reagent to form a charged capture reagent/analyte complex. The complex is then contacted to the oppositely charged solid phase to attract, attach, and immobilize the capture reagent/analyte complex. With an appropriate indicator reagent, sandwich, competitive and indirect assays can be performed. Preferably, the indicator reagent includes a nonspecific binding blocker to reduce the nonspecific binding between the indicator reagent and the solid phase, without interfering with the reaction between the capture reagent and the solid phase. Suitable nonspecific binding blockers include unbound or free polyanionic materials such as dextran sulfate, heparin, carboxymethyl dextran, carboxymethyl cellulose, pentosan polysulfate, inositol hexasulfate or beta -cyclodextrin sulfate.

Abstract translation: 本发明包括使用捕获试剂，包括连接到聚合阴离子物质的特异性结合成员的新型测定和试剂，以及含有包含聚合阳离子物质的捕获或反应区的固相材料。 怀疑含有感兴趣的分析物的测试样品可以与捕获试剂接触以形成带电的捕获试剂/分析物复合物。 然后将络合物与相反电荷的固相接触以吸引，附着和固定捕获试剂/分析物复合物。 使用适当的指示剂，夹心，可以进行竞争性和间接测定。 优选地，指示剂试剂包括非特异性结合阻断剂，以减少指示剂与固相之间的非特异性结合，而不干扰捕获试剂和固相之间的反应。 合适的非特异性结合阻断剂包括未结合或游离的聚阴离子材料，例如硫酸葡聚糖，肝素，羧甲基葡聚糖，羧甲基纤维素，戊聚糖多硫酸酯，六水合硫酸肌醇或硫酸β-环糊精。

公开(公告)号：EP0586605A1

公开(公告)日：1994-03-16

申请号：EP92914861.0

申请日：1992-04-10

Applicant: ABBOTT LABORATORIES

Inventor： ADAMCZYK, Janina ,  BERRY, Daniel, S. ,  FICO, Rosario ,  JOU, Yi-Her ,  STROUPE, Stephen, D.

IPC: G01N33

CPC classification number: G01N33/538

Abstract: Nouveaux procédés d'analyse faisant appel à un réactif de capture, mettant en jeu un premier membre de fixation normalement associé à une substance anionique polymérique, un matériau en phase solide contenant un lieu de réaction constitué d'une substance cationique polymérique d'une teneur en azote d'au moins environ 2 %. Dans un mode de réalisation, un échantillon à analyser dans lequel on soupçonne la présence de l'analyte recherché peut être mis en contact avec le réactif de capture pour former un complexe chargé contenant le réactif de capture et l'analyte. Le complexe est ensuite mis en contact avec la phase solide de charge opposée pour attirer, fixer et immobiliser le complexe réactif de capture/analyte. L'utilisation d'une substance polycationique, d'une teneur en hydrogène d'au moins environ 2 % (à l'exclusion des contre-ions), dans la préparation d'une phase solide correctement chargée fournit une phase solide qui peut être soumise à un plus grande nombre de manipulations, tels que les lavages multiples, sans perdre la capacité d'attirer et de retenir le réactif de capture.

公开(公告)号：EP0586590B1

公开(公告)日：1999-07-07

申请号：EP92913618.2

申请日：1992-04-10

Applicant: ABBOTT LABORATORIES

Inventor： ADAMCZYK, Janina ,  BERRY, Daniel, S. ,  FICO, Rosario ,  JOU, Yi-Her ,  STROUPE, Stephen, D.

IPC: C12Q1/00 ,  C12Q1/68 ,  G01N33/53 ,  G01N33/536 ,  G01N33/537 ,  G01N33/538 ,  G01N33/541 ,  G01N33/543 ,  G01N33/544 ,  G01N33/546 ,  G01N33/532 ,  G01N33/545

CPC classification number: G01N33/54393 ,  G01N33/538 ,  G01N33/54353 ,  G01N33/544

Abstract: The present invention includes novel assays and reagents using a capture reagent, involving a specific binding member attached to a polymeric anionic substance, and a solid phase material containing a capture or reaction zone including a polymeric cationic substance. A test sample suspected of containing the analyte of interest may be contacted with the capture reagent to form a charged capture reagent/analyte complex. The complex is then contacted to the oppositely charged solid phase to attract, attach, and immobilize the capture reagent/analyte complex. With an appropriate indicator reagent, sandwich, competitive and indirect assays can be performed. Preferably, the indicator reagent includes a nonspecific binding blocker to reduce the nonspecific binding between the indicator reagent and the solid phase, without interfering with the reaction between the capture reagent and the solid phase. Suitable nonspecific binding blockers include unbound or free polyanionic materials such as dextran sulfate, heparin, carboxymethyl dextran, carboxymethyl cellulose, pentosan polysulfate, inositol hexasulfate or beta -cyclodextrin sulfate.

公开(公告)号：EP0974060B1

公开(公告)日：2003-09-03

申请号：EP98910389.0

申请日：1998-03-13

Applicant: Abbott Laboratories

Inventor： LEE, Evelyn, Mok ,  WESTERBERG, David, A. ,  YAO, Haiou, H. ,  ADAMCZYK, Janina ,  CHRISTENSEN, Melissa, A.

IPC: G01N33/72 ,  G01N33/543

CPC classification number: G01N33/723 ,  Y10S435/96 ,  Y10S436/805 ,  Y10S436/824

Abstract: A glycated hemoglobin assay utilizes a simple procedure for the determination of DCCT Standardized %GHb in whole blood samples. First, a lysed whole blood sample is incubated with a solid phase that is coupled with boronic acid or similar boronate compound through covalent linkage chemistries known in the art. Next, a labeled antibody to human hemoglobin is added and the resulting signal is directly proportional to the %GHb in the sample. The advantages of measuring %GHb using a single determination include high precision and, since the assay is easily automatable, high throughput. With automation, this assay can also be consolidated with other testing on one analyzer. The method according to the various embodiments of the invention thus eliminates the need for two measurements: one for GHb and another for total hemoglobin (THb).

公开(公告)号：EP1212623A1

公开(公告)日：2002-06-12

申请号：EP00964939.3

申请日：2000-09-05

Applicant: ABBOTT LABORATORIES

Inventor： LEE, Evelyn, Mok ,  WESTERBERG, David, A. ,  YAO, Haiou, H. ,  ADAMCZYK, Janina ,  CHRISTENSEN, Melissa, A.

IPC: G01N33/72 ,  G01N33/543

CPC classification number: G01N33/723 ,  Y10S435/96 ,  Y10S436/805 ,  Y10S436/824

Abstract: A glycated hemoglobin assay utilizes a simple procedure for the determination of DCCT Standardized %GHb in whole blood samples. First, a lysed whole blood sample is incubated with a solid phase that is coupled with boronic acid or similar boronate compound through covalent linkage chemistries known in the art. Next, a labeled antibody to human hemoglobin is added and the resulting signal is directly proportional to the %GHb in the sample. The advantages of measuring %GHb using a single determination include high precision and, since the assay is easily automatable, high throughput. With automation, this assay can also be consolidated with other testing on one analyzer. The method according to the various embodiments of the invention thus eliminates the need for two measurements: one for GHb and another for total hemoglobin (THb).

公开(公告)号：EP0641388B1

公开(公告)日：1998-09-09

申请号：EP92912697.7

申请日：1992-04-10

Applicant: ABBOTT LABORATORIES

Inventor： ADAMCZYK, Janina ,  BERRY, Daniel, S. ,  JOU, Yi-Her ,  STROUPE, Stephen, Denham

IPC: C12Q1/00 ,  C12Q1/68 ,  G01N33/53 ,  G01N33/536 ,  G01N33/537 ,  G01N33/538 ,  G01N33/541 ,  G01N33/543 ,  G01N33/544 ,  G01N33/546 ,  G01N33/532 ,  G01N33/545

CPC classification number: G01N33/538 ,  G01N33/54353 ,  G01N33/548

Abstract: The present invention includes novel assays employing a capture reagent, involving a first binding member conjugated to a polymeric anion such as carboxymethylamylose, and a solid phase material containing a reaction site comprising a polymeric cation substance. A test sample suspected of containing the analyte of interest may be contacted with the capture reagent to form a charged capture reagent/analyte complex. The complex is then contacted to the oppositely charged solid phase to attract, attach, and immobilize the capture reagent/analyte complex. The use of carboxymethylamylose to prepare a suitably charged capture reagent provides a superior capture reagent that is capable of binding and retaining the analyte on the solid phase even in the presence of polyanionic non-specific binding blockers.

公开(公告)号：EP0586590A1

公开(公告)日：1994-03-16

申请号：EP92913618.0

申请日：1992-04-10

Applicant: ABBOTT LABORATORIES

Inventor： ADAMCZYK, Janina ,  BERRY, Daniel, S. ,  FICO, Rosario ,  JOU, Yi-Her ,  STROUPE, Stephen, D.

IPC: G01N33

CPC classification number: G01N33/54393 ,  G01N33/538 ,  G01N33/54353 ,  G01N33/544

Abstract: Nouveaux procédés d'analyse et réactif faisant appel à un réactif de capture, mettant en jeu un membre de fixation spécifique associé à une substance anionique polymère, et un matériau en phase solide contenant une zone de capture ou de réaction comportant une substance cationique polymère. Un échantillon à analyser dans lequel on soupçonne la présence de l'analyte recherché peut être mis en contact avec le réactif de capture pour former un complexe chargé contenant le réactif de capture et l'analyte. Le complexe est ensuite mis en contact avec la phase solide de charge opposée pour attirer, fixer et immobiliser le complexe réactif de capture/analyte. Avec un réactif indicateur approprié, on peut réaliser des analyses en sandwich, compétitives et indirectes. De préférence, le réactif indicateur comprend un inhibiteur de fixation non spécifique qui permet de réduire la fixation non spécifique entre les réactifs indicateurs et la phase solide, sans gêner la réaction entre le réactif de capture et la phase solide. Les inhibiteurs de fixation non spécifiques appropriés comprennent des matériaux polyanioniques non liés ou libres tels que le sulfate de dextrane, l'héparine, le dextrane de carboxyméthyle, la cellulose de carboxyméthyle, le polysulfate de pentosane, l'hexasulfate d'inositol ou le sulfate de beta-cyclodextrine.