US2015330993A1PendingUtilityA1

Diagnostic, prognostic, therapeutic and screening protocols

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Assignee: MACFARLANE BURNET INST FOR MEDICAL RES & PUBLIC HEALTH LTDPriority: Nov 8, 2012Filed: Nov 8, 2013Published: Nov 19, 2015
Est. expiryNov 8, 2032(~6.3 yrs left)· nominal 20-yr term from priority
Inventors:David Andrew AndersonMary Louise GarciaNadine Carmel BarnesKhayriyyah Mohd HanafiahAlan Lee Landay
G01N 2333/08G01N 2333/16G01N 33/6854G01N 2333/10G01N 2333/70535C07K 14/70503G01N 2800/06C07K 2319/00G01N 33/56983G01N 2469/20
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Claims

Abstract

The specification describes an antibody capture process comprising (i) obtaining a biological sample comprising antibodies, (ii) contacting the biological sample with recombinant pIgR or a dIgA-binding variant, wherein the pIgR or variant binds dIgA and forms a pIgR-dIgA complex. The process may further comprise (iii) directly or indirectly assessing the level of the pIgR-dIgA complex or the level of a complex between pIgR-dIgA and an antigen of interest. There is also an antibody capture process for determining gut wall integrity in a test subject, wherein the level or ratio of SIgA to dIgA is compared to a corresponding level or ratio from a control subject. The specification provides kits embodying the process and recombinant pIgR when used for, or for use, in capturing or detecting dIgA and/or IgM.

Claims

exact text as granted — not AI-modified
1 . An antibody capture process comprising (i) obtaining a biological sample comprising antibodies, (ii) contacting the biological sample with recombinant pIgR or a dIgA-binding variant, wherein the pIgR or variant binds dIgA and forms a pIgR-dIgA complex. 
     
     
         2 . The process of  claim 1 , further comprising (iii) directly or indirectly assessing the level of the pIgR-dIgA complex or the level of a complex between pIgR-dIgA and an antigen of interest. 
     
     
         3 . The antibody capture process of  claim 1  or  claim 2  wherein the pIgR or a dIgA-binding variant binds dIgA and substantially fails to bind IgM or wherein the pIgR or variant binds dIgA and IgM. 
     
     
         4 . The antibody capture process of  claims 1  to  3  wherein the biological sample is a blood or serum sample. 
     
     
         5 . The antibody capture process of any one of  claims 1  to  4  wherein the biological sample is obtained from a subject. 
     
     
         6 . The antibody capture process of  claim 5  wherein the subject is human or primate. 
     
     
         7 . The antibody capture process of  claim 5  wherein the subject is a mammalian or avian animal species other than a primate or human species. 
     
     
         8 . The antibody capture process of any one of  claims 1  to  7  wherein the pIgR is recombinant HpIgA or RpIgR. 
     
     
         9 . The antibody capture process of any one of  claims 1  to  7  wherein the recombinant pIgR or dIgA-binding variant has the transmembrane domain and/or the cytoplasmic domain deleted. 
     
     
         10 . The antibody capture process of any one of  claims 1  to  9  wherein the recombinant pIgR comprises a heterologous detection or binding domain. 
     
     
         11 . The antibody capture process of any one of  claims 1  to  0  wherein the recombinant pIgR or IgA-binding variant is recombinantly produced in a glycan deficient cell. 
     
     
         12 . The antibody capture process of any one of  claims 1  to  11  wherein the recombinant pIgR is bound to a solid support. 
     
     
         13 . The antibody capture process of any one of  claims 1  to  12  wherein the biological sample is depleted of IgM or dIgA antibodies prior to use in the process. 
     
     
         14 . The process of any one of  claims 2  to  13  wherein the antigen of interest is an antigen of an infectious agent or an antigen associated with a condition of a subject that affects a mucosal surface or associated tissues. 
     
     
         15 . The process of  claim 13  wherein the infectious agent is selected from HIV, leprosy, syphilis, hepatitis, dengue virus, measles and rubella. 
     
     
         16 . The process of any one of  claims 1  to  14  process further comprising contacting the biological sample with an anti-SC binding agent or anti-SC antibody wherein the anti-SC binding agent or anti-SC antibody binds SIgA and forms an SIgA-binding agent/antibody complex. 
     
     
         17 . The process of any one of  claims 1  to  14 , further comprising contacting a sample comprising the pIgR-dIgA complex with a denaturing solution to remove any SIgA from the complex and measuring the ratio of SIgA and dIgA in the biological sample. 
     
     
         18 . An antibody capture process for determining gut wall integrity in a test subject, the process comprising (i) obtaining a biological sample comprising antibodies from the test subject, (ii) contacting the biological sample with recombinant pIgR or a dIgA-binding variant, wherein the pIgR or variant binds dIgA and forms a pIgR-dIgA complex, and (iii) contacting the biological sample with a specific anti-SIgA binding agent or anti-SC binding agent/antibody wherein the anti-SIgA binding agent or anti-SC binding agent/antibody binds SIgA and forms an SIgA-binding agent/antibody complex, and (iv) measuring and comparing the level of the complex formed in (ii) with the level of the complex formed in (iii), wherein the ratio of SIgA to dIgA is compared to a corresponding level or ratio from a control subject and provides a measure of gut integrity/leakage. 
     
     
         19 . A process of any one of  claims 16  to  18  wherein the level or ratio of SIgA2/dIgA2 and/or SIgA1/dIgA1 are determined. 
     
     
         20 . An antibody capture process comprising (i) obtaining a biological sample comprising antibodies, (ii) contacting the biological sample with recombinant pIgR or a dIgA or IgM-binding variant, wherein the pIgR or variant binds IgM and/or IgA and forms a pIgR-IgM and/or pIgR-dIgA complex. 
     
     
         21 . An antibody capture process comprising (i) obtaining a biological sample comprising antibodies, (ii) contacting the biological sample with recombinant pIgR wherein the pIgR or variant binds IgM and forms a pIgR-IgM complex. 
     
     
         22 . A process for detecting the presence of antigen-specific dIgA in a subject, the process comprising (i) obtaining a biological sample comprising antibodies from a subject, (ii) contacting the sample with R/HpIgR and antigen and (iii) measuring the level of antigen-specific dIgA. 
     
     
         23 . A process for detecting the presence of antigen-specific IgM in a subject, the process comprising (i) obtaining a biological sample comprising antibodies from a subject, (ii) contacting the sample with a HpIgR and antigen and (iii) measuring the level of antigen-specific IgM. 
     
     
         24 . A process for detecting the presence of antigen-specific IgM and dIgA in a subject, the process comprising (i) obtaining a biological sample comprising antibodies from a subject, (ii) contacting the sample with HpIgR and R/HpIgR and antigen and (iii) measuring the level of antigen-specific IgM and antigen specific dIgA. 
     
     
         25 . A kit for assessing immune status in a subject, the kit comprising, (a) an immunographic device comprising a porous membrane operably connected to a sample portion, a test portion, and optionally a control portion; and further comprising a sucker portion, portion comprising a recombinant pIgR molecule or dIgA-binding variant thereof, a portion comprising an antigen of interest and optionally a conjugate portion; and b) instructions for using the immunographic device to detect the presence of antigen specific dIgA antibody in the sample. 
     
     
         26 . The kit of  claim 25  wherein the pIgR is HpIgR and/or R/HpIgR. 
     
     
         27 . The kit of  claim 25  or  26  wherein the recombinant pIgR or dIgA-binding variant has the transmembrane domain and/or the cytoplasmic domain deleted. 
     
     
         28 . The kit of any one of  claims 25  to  27  wherein the recombinant pIgR comprises a heterologous detection or binding domain. 
     
     
         29 . The kit of any one of  claims 25  to  28  wherein the recombinant pIgR or IgA-binding variant is recombinantly produced in a glycan deficient cell. 
     
     
         30 . The kit of any one of  claims 25  to  29  wherein the recombinant pIgR is bound to a solid support. 
     
     
         31 . The kit of any one of  claims 25  to  30  wherein the antigen of interest is an antigen of an infectious agent or an antigen associated with a condition of a subject that affects a mucosal surface or associated tissues. 
     
     
         32 . The kit of  claim 31  wherein the infectious agent is selected from HIV, leprosy, syphilis, hepatitis, dengue virus, measles and rubella. 
     
     
         33 . The kit of any one of  claims 25  to  32  further comprising an anti-SIgA binding agent/antibody or anti-SC antibody, wherein the anti-SIgA binding agent/antibody or anti-SC antibody binds SIgA and forms an SIgA-binding agent/antibody complex. 
     
     
         34 . Recombinant pIgR when used for, or for use, in capturing or detecting dIgA and/or IgM. 
     
     
         35 . The recombinant pIgR of  claim 34 , which is R/HpIgR or HpIgR or a dIgA and/or IgM binding variant of R/HpIgR or HpIgR.

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