公开(公告)号：US20150024416A1

公开(公告)日：2015-01-22

申请号：US14380074

申请日：2013-02-15

Applicant: THE BINDING SITE GROUP LIMITED ,  THE UNIVERSITY OF WARWICK

Inventor： Stephen Harding ,  Richard Hughes ,  Anne Bevins ,  Richard Keir ,  Michael Chappell ,  Neil Evans ,  Colin Hutchinson

IPC: G01N33/68

CPC classification number: G01N33/6857 ,  G01N2800/50

Abstract: The invention provides a method of estimating free light chain production (FLC) in a subject comprising (i) determining an amount of FLC in a sample from the subject; and (ii) correcting the amount of FLC in the sample for FLC cleared from the source of the sample by glomerular filtration and by reticuloendothelial (RE) clearance.

Abstract translation: 本发明提供一种估计受试者中游离轻链产生（FLC）的方法，包括（i）确定来自受试者的样品中FLC的量; 和（ii）校正通过肾小球滤过和网状内皮（RE）清除从样品来源清除的FLC样品中FLC的量。

公开(公告)号：US20150173685A1

公开(公告)日：2015-06-25

申请号：US14415884

申请日：2013-07-10

Applicant: THE BINDING SITE GROUP LIMITED

Inventor： Richard Hughes ,  Stephen Harding

IPC: A61B5/00 ,  G01N33/68 ,  A61B5/16 ,  A61B5/20 ,  A61B5/0205 ,  A61B5/145

CPC classification number: A61B5/7275 ,  A61B5/02055 ,  A61B5/021 ,  A61B5/024 ,  A61B5/0816 ,  A61B5/14542 ,  A61B5/165 ,  A61B5/208 ,  A61B5/4824 ,  A61B2505/01 ,  A61B2505/03 ,  G01N33/6857 ,  G01N33/6893 ,  G01N2333/47 ,  G01N2333/76 ,  G01N2800/56

Abstract: The application discloses a method of determining the severity of symptoms in a patient comprising (i) producing a triage score, such as an early warning score (EWS) modified early warning score (MEWS), paediatric early warning score (PEWS), NHS early warning score (NEWS), simple clinical score (SCS), rapid emergency score (REMS) or mortality in emergency department sepsis score for the patient, (ii) measuring an amount of free light chains (FLC), preferably combined free light chains (cFLC), in a sample from the patient, and (iii) using the triage score and the amount of FLC measured to assess the severity of symptoms in the patient. This also allows patients to be triaged to provide better treatment of them.

Abstract translation: 该应用公开了一种确定患者症状严重程度的方法，包括（i）产生分类评分，例如早期预警评分（EWS）修改的早期预警评分（MEWS），儿科早期预警评分（PEWS），早期NHS 警告评分（NEWS），简单临床评分（SCS），快速紧急评分（REMS）或患者急诊部败血症评分死亡率，（ii）测量游离轻链（FLC）的量，优选组合游离轻链 cFLC），以及（iii）使用分类评分和测量的FLC量来评估患者症状的严重程度。 这也使患者能够被分类，以更好地治疗他们。

公开(公告)号：US20230391851A1

公开(公告)日：2023-12-07

申请号：US18454967

申请日：2023-08-24

Applicant: The Binding Site Group Limited

Inventor： Gregg Wallis ,  Jamie Ashby ,  Stephen Harding

IPC: C07K16/06 ,  G01N33/68 ,  C07K16/00 ,  A61K47/68 ,  A61K51/10

CPC classification number: C07K16/065 ,  G01N33/6854 ,  C07K16/00 ,  G01N33/6857 ,  A61K47/6877 ,  A61K51/1087 ,  A61K51/1093 ,  C07K2317/94 ,  A61K2123/00 ,  C07K2317/24 ,  C07K2317/52 ,  C07K2317/54 ,  C07K2317/624

Abstract: A method for analyzing protein(s) in a sample using an immunoassay kit includes creating protein-reducing and/or protein-denaturing conditions by contacting the sample with a reducing and/or denaturing agent provided in the immunoassay kit, to provide a partially or fully denatured protein population. One or both of a presence and an amount of one or more protein-associated analytes are determined under the created protein-reducing and/or protein-denaturing conditions by contacting the partially or fully denatured protein population with one or more specific antibodies or binding fragments thereof provided in the immunoassay kit. The one or more specific antibodies or binding fragments thereof include one or more chemically-introduced non-disulfide cross-links between at least one heavy chain or binding fragment thereof and at least one light chain or binding fragment thereof.

公开(公告)号：US20150051839A1

公开(公告)日：2015-02-19

申请号：US14383147

申请日：2013-03-06

Applicant: THE BINDING SITE GROUP LIMITED

Inventor： Stephen Harding ,  Richard Hughes ,  Hugh Carr-Smith

IPC: G01N33/68 ,  G06F19/00

CPC classification number: G01N33/6857 ,  G01N2800/22 ,  G16H50/30

Abstract: The invention provides a method for characterising a plasma cell associated disease in a patient comprising: (i) providing at least one sample from the patient; (ii) determining in the sample(s) two or more of; (a) the κ:λ free light chain (FLC) ratio; (b) the ratio of κ light chains bound to a class of heavy chain:λ light chain bound to the same class of heavy chain (HLCκ:HLC λ ratio); (c) the total amount of FLC in the samples and (d) the total amount of κ light chains bound to the heavy chain class plus λ light chains bound to the same heavy chain class (total HLC); (iii) comparing each ratio or amount from (a) (b), (c) and/or (d) to predetermined values and assigning a score to each amount or ratio; and (iv) using the scores to characterise the plasma cell associated disease. Apparatus configured to carry out the method of the invention are also provided. The invention also provides a kit comprising, in combination, (i) anti-κ FLC specific and anti-λ FLC specific antibodies or fragments thereof and (ii) anti-κ heavy chain class specific and anti-λ heavy chain class specific antibodies or fragments thereof, optionally mixed together.

Abstract translation: 本发明提供了一种用于表征患者中血浆细胞相关疾病的方法，包括：（i）从患者提供至少一种样品; （ii）在样本中确定两个或更多个样本; （a）＆kgr;：λ自由轻链（FLC）比; （b）比率＆kgr; 轻链与一类重链结合：λ轻链与同一类重链结合（HLC＆Kgr：HLCλ比）; （c）样品中FLC的总量和（d）总量＆kgr; 绑定到重链类的轻链加上与相同重链类（总HLC）结合的λ轻链; （iii）将（a）（b），（c）和/或（d）的每个比例或量与预定值进行比较，并将分数分配给每个量或比率; 和（iv）使用分数来表征浆细胞相关疾病。 还提供了用于实现本发明的方法的设备。 本发明还提供了一种试剂盒，其组合包含（i）抗 - FLC特异性抗体和抗-λFLC特异性抗体或其片段，和（ii）抗 - 重链类特异性和抗λ重链类特异性抗体或其片段，任选地混合在一起。

公开(公告)号：US20230184782A1

公开(公告)日：2023-06-15

申请号：US17924880

申请日：2021-05-12

Applicant: THE BINDING SITE GROUP LIMITED

Inventor： Stephen Harding ,  Dhananjay Sakrikar ,  Tara A. Krause ,  Gregg Wallis

IPC: G01N33/68 ,  G01N33/537

CPC classification number: G01N33/6854 ,  G01N33/6851 ,  G01N33/5375 ,  G01N2458/15

Abstract: The Invention provides a method of immunopurifying and characterising an analyte from a sample comprising: (i) providing a predetermined amount of a control substance bound to a substrate via a linkage cleavable by acidic pH and/or reducing agents and optionally additional analyte specific antibodies or fragments thereof bound to a substrate, wherein the control substance is specific for the analyte or is not specific for the analyte; (ii) allowing analyte when present in the sample to bind to the control substance or said optional additional analyte-specific antibodies or fragments, wherein the control substance bound to the substrate (i) may be provided after contacting the analyte with the optional additional analyte-specific antibodies (ii); (iii) washing unbound material away from the substrate; (iv) acid eluting the analyte bound thereto, from at least one substrate; (v) performing mass spectrometry to identify two or more peaks, at least one peak of which is associated with the presence of the analyte and at least a second peak which is associated with at least a portion of the control substance; and (vi) comparing the size or intensity of the second peak to a predetermined calibration value to allow the first peak associated with the analyte to be calibrated.