US2011053140A1PendingUtilityA1

Methods and reagents for diagnosing hantavirus infection

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Assignee: NOVARTIS VACCINES & DIAGNOSTICPriority: Jun 18, 2004Filed: Jun 17, 2010Published: Mar 3, 2011
Est. expiryJun 18, 2024(expired)· nominal 20-yr term from priority
Inventors:Steve H. NguyenSergio Pichuantes
C07K 14/175C07K 16/10C07K 14/005G01N 33/56983C12N 2760/12122C12Q 1/70G01N 33/569G01N 33/53G01N 33/68
48
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Claims

Abstract

Novel methods and immunodiagnostic test kits for the detection of hantavirus infection are disclosed. The methods and kits employ combinations of recombinant N and/or G1 antigens from at least six different hantavirus serotypes, including Hantann (HTNV), Puumala (PUUV), Seoul (SEOV), Dobrava (DOBV), Sin Nombre (SNV) and Andes (ANDV). Additional hantavirus antigens from these and other hantavirus types may also be present. The methods provide for highly accurate results and allow the detection of infection so that treatment can be administered and death avoided.

Claims

exact text as granted — not AI-modified
1 . A method of detecting hantavirus antibodies in a biological sample, comprising:
 (a) contacting said biological sample with at least six hantavirus recombinant antigens, wherein the at least six hantavirus recombinant antigens comprise a combination of G1 and/or N antigens from hantavirus serotypes Hantaan (HTNV), Puumala (PUUV), Seoul (SEOV), Dobrava (DOBV), Sin Nombre (SNV) and Andes (ANDV) wherein at least one recombinant antigen from each of the serotypes is present, said contacting performed under conditions which allow hantavirus antibodies, when present in the biological sample, to bind to at least one of said G1 or N antigens to form an antibody/antigen complex; and   (b) detecting the presence or absence of said antibody/antigen complex, thereby detecting the presence or absence of hantavirus antibodies in said sample.   
     
     
         2 . The method of  claim 1 , wherein said G1 antigen(s) comprises an amino acid sequence corresponding to the amino acid sequence of SEQ ID NO:40. 
     
     
         3 . The method of  claim 2 , wherein said G1 antigen(s) is one or more antigens comprising an amino acid sequence selected from the group consisting of SEQ ID NO:14, SEQ ID NO:16, SEQ ID NO:18, SEQ ID NO:20, SEQ ID NO:22, SEQ ID NO:24, SEQ ID NO:42, SEQ ID NO:43, SEQ ID NO:44, SEQ ID NO:45, SEQ ID NO:46 and SEQ ID NO:47. 
     
     
         4 . The method of  claim 1 , wherein the at least six hantavirus recombinant antigens comprise a combination of G1 and N antigens, and wherein said N antigen(s) comprises an amino acid sequence corresponding to the amino acid sequence of SEQ ID NO:39. 
     
     
         5 . The method of  claim 4 , wherein said N antigen(s) is one or more antigens comprising an amino acid sequence selected from the group consisting of SEQ ID NO:26, SEQ ID NO:28, SEQ ID NO:30, SEQ ID NO:32, SEQ ID NO:34, SEQ ID NO:36, SEQ ID NO:48, SEQ ID NO:49, SEQ ID NO:50, SEQ ID NO:51, SEQ ID NO:52 and SEQ ID NO:53. 
     
     
         6 . The method of  claim 1 , wherein the at least six hantavirus recombinant antigens comprise a combination of G1 and N antigens, and wherein said G1 antigen(s) comprises an amino acid sequence corresponding to the amino acid sequence of SEQ ID NO:40 and said N antigen(s) comprises an amino acid sequence corresponding to the amino acid sequence of SEQ ID NO:39. 
     
     
         7 . The method of  claim 6 , wherein said G1 antigen(s) is one or more antigens comprising an amino acid sequence selected from the group consisting of SEQ ID NO:14, SEQ ID NO:16, SEQ ID NO:18, SEQ ID NO:20, SEQ ID NO:22, SEQ ID NO:24, SEQ ID NO:42, SEQ ID NO:43, SEQ ID NO:44, SEQ ID NO:45, SEQ ID NO:46 and SEQ ID NO:47, and said N antigen(s) is one or more antigens comprising an amino acid sequence selected from the group consisting of SEQ ID NO:26, SEQ ID NO:28, SEQ ID NO:30, SEQ ID NO:32, SEQ ID NO:34, SEQ ID NO:36, SEQ ID NO:48, SEQ ID NO:49, SEQ ID NO:50, SEQ ID NO:51, SEQ ID NO:52 and SEQ ID NO:53. 
     
     
         8 . The method of  claim 1 , wherein at least one G1 antigen is present from each of hantavirus serotypes HTNV, PUUV, SEOV, DOBV, SNV and ANDV, and at least one N antigen is present from each of hantavirus serotypes HTNV, PUUV, SEOV, DOBV, SNV and ANDV. 
     
     
         9 . An immunodiagnostic test kit for detecting hantavirus infection, said test kit comprising:
 (a) at least six hantavirus recombinant antigens, wherein the at least six hantavirus recombinant antigens comprise a combination of G1 and/or N antigens from hantavirus serotypes Hantaan (HTNV), Puumala (PUUV), Seoul (SEOV), Dobrava (DOBV), Sin Nombre (SNV) and Andes (ANDV) wherein at least one antigen from each of the serotypes is present;   (b) and instructions for conducting the immunodiagnostic test.   
     
     
         10 . The immunodiagnostic test kit of  claim 9 , wherein said G1 antigen(s) comprises an amino acid sequence corresponding to the amino acid sequence of SEQ ID NO:40. 
     
     
         11 . The immunodiagnostic test kit of  claim 10 , wherein said G1 antigen(s) is one or more antigens comprising an amino acid sequence selected from the group consisting of SEQ ID NO:14, SEQ ID NO:16, SEQ ID NO:18, SEQ ID NO:20, SEQ ID NO:22, SEQ ID NO:24, SEQ ID NO:42, SEQ ID NO:43, SEQ ID NO:44, SEQ ID NO:45, SEQ ID NO:46 and SEQ ID NO:47. 
     
     
         12 . The immunodiagnostic test kit of  claim 9 , wherein the at least six hantavirus recombinant antigens comprise a combination of G1 and N antigens, and wherein said N antigen(s) comprises an amino acid sequence corresponding to the amino acid sequence of SEQ ID NO:39. 
     
     
         13 . The immunodiagnostic test kit of  claim 12 , wherein said N antigen(s) is one or more antigens comprising an amino acid sequence selected from the group consisting of SEQ ID NO:26, SEQ ID NO:28, SEQ ID NO:30, SEQ ID NO:32, SEQ ID NO:34, SEQ ID NO:36, SEQ ID NO:48, SEQ ID NO:49, SEQ ID NO:50, SEQ ID NO:51, SEQ ID NO:52 and SEQ ID NO:53. 
     
     
         14 . The immunodiagnostic test kit of  claim 9 , wherein the at least six hantavirus recombinant antigens comprise a combination of G1 and N antigens, and wherein said G1 antigen(s) comprises an amino acid sequence corresponding to the amino acid sequence of SEQ ID NO:40 and said N antigen(s) comprises an amino acid sequence corresponding to the amino acid sequence of SEQ ID NO:39. 
     
     
         15 . The immunodiagnostic test kit of  claim 14 , wherein said G1 antigen(s) is one or more antigens comprising an amino acid sequence selected from the group consisting of SEQ ID NO:14, SEQ ID NO:16, SEQ ID NO:18, SEQ ID NO:20, SEQ ID NO:22, SEQ ID NO:24, SEQ ID NO:42, SEQ ID NO:43, SEQ ID NO:44, SEQ ID NO:45, SEQ ID NO:46 and SEQ ID NO:47, and said N antigen(s) is one or more antigens comprising an amino acid sequence selected from the group consisting of SEQ ID NO:26, SEQ ID NO:28, SEQ ID NO:30, SEQ ID NO:32, SEQ ID NO:34, SEQ ID NO:36, SEQ ID NO:48, SEQ ID NO:49, SEQ ID NO:50, SEQ ID NO:51, SEQ ID NO:52 and SEQ ID NO:53. 
     
     
         16 . The immunodiagnostic test kit of  claim 9 , wherein at least one G1 antigen is present from each of hantavirus serotypes HTNV, PUUV, SEOV, DOBV, SNV and ANDV, and at least one N antigen is present from each of hantavirus serotypes HTNV, PUUV, SEOV, DOBV, SNV and ANDV. 
     
     
         17 . A method of detecting hantavirus antigens in a biological sample, comprising:
 (a) contacting said biological sample with at least six different antibodies, wherein each of said antibodies is specific for at least one of six hantavirus antigens, wherein the six hantavirus antigens comprise a combination of G1 and/or N antigens from hantavirus serotypes Hantaan (HTNV), Puumala (PUUV), Seoul (SEOV), Dobrava (DOBV), Sin Nombre (SNV) and Andes (ANDV), wherein at least one antibody specific for at least one antigen from each of the serotypes is present, wherein said contacting is done under conditions which allow hantavirus antigens, when present in the biological sample, to bind to said antibodies to form an antibody/antigen complex; and   (b) detecting the presence or absence of said antibody/antigen complex, thereby detecting the presence or absence of hantavirus antigens in said sample.   
     
     
         18 . The method of  claim 17 , wherein said antibodies are monoclonal antibodies. 
     
     
         19 . An immunodiagnostic test kit for detecting hantavirus infection, said test kit comprising:
 (a) at least six different antibodies, wherein each of said antibodies is specific for at least one of six hantavirus antigens, wherein the six hantavirus antigens comprise a combination of G1 and/or N antigens from hantavirus serotypes Hantaan (HTNV), Puumala (PUUV), Seoul (SEOV), Dobrava (DOBV), Sin Nombre (SNV) and Andes (ANDV), wherein at least one antibody specific for at least one antigen from each of the serotypes is present; and   (b) instructions for conducting the immunodiagnostic test.   
     
     
         20 . The immunodiagnostic test kit of  claim 19 , wherein said antibodies are monoclonal antibodies. 
     
     
         21 . A solid support comprising at least six hantavirus recombinant antigens, wherein the at least six hantavirus recombinant antigens comprise a combination of G1 and/or N antigens from hantavirus serotypes Hantaan (HTNV), Puumala (PUUV), Seoul (SEOV), Dobrava (DOBV), Sin Nombre (SNV) and Andes (ANDV) wherein at least one antigen from each of the serotypes is present. 
     
     
         22 . The solid support of  claim 21 , wherein said G1 antigen(s) comprises an amino acid sequence corresponding to the amino acid sequence of SEQ ID NO:40. 
     
     
         23 . The solid support of  claim 22 , wherein said G1 antigen(s) is one or more antigens comprising an amino acid sequence selected from the group consisting of SEQ ID NO:14, SEQ ID NO:16, SEQ ID NO:18, SEQ ID NO:20, SEQ ID NO:22, SEQ ID NO:24, SEQ ID NO:42, SEQ ID NO:43, SEQ ID NO:44, SEQ ID NO:45, SEQ ID NO:46 and SEQ ID NO:47. 
     
     
         24 . The solid support of  claim 21 , wherein the at least six hantavirus recombinant antigens comprise a combination of G1 and N antigens, and wherein said N antigen(s) comprises an amino acid sequence corresponding to the amino acid sequence of SEQ ID NO:39. 
     
     
         25 . The solid support of  claim 24 , wherein said N antigen(s) is one or more antigens comprising an amino acid sequence selected from the group consisting of SEQ ID NO:26, SEQ ID NO:28, SEQ ID NO:30, SEQ ID NO:32, SEQ ID NO:34, SEQ ID NO:36, SEQ ID NO:48, SEQ ID NO:49, SEQ ID NO:50, SEQ ID NO:51, SEQ ID NO:52 and SEQ ID NO:53. 
     
     
         26 . The solid support of  claim 21 , wherein the at least six hantavirus recombinant antigens comprise a combination of G1 and N antigens, and wherein said G1 antigen(s) comprises an amino acid sequence corresponding to the amino acid sequence of SEQ ID NO:40 and said N antigen(s) comprises an amino acid sequence corresponding to the amino acid sequence of SEQ ID NO:39. 
     
     
         27 . The solid support of  claim 26 , wherein said G1 antigen(s) is one or more antigens comprising an amino acid sequence selected from the group consisting of SEQ ID NO:14, SEQ ID NO:16, SEQ ID NO:18, SEQ ID NO:20, SEQ ID NO:22, SEQ ID NO:24, SEQ ID NO:42, SEQ ID NO:43, SEQ ID NO:44, SEQ ID NO:45, SEQ ID NO:46 and SEQ ID NO:47, and said N antigen(s) is one or more antigens comprising an amino acid sequence selected from the group consisting of SEQ ID NO:26, SEQ ID NO:28, SEQ ID NO:30, SEQ ID NO:32, SEQ ID NO:34, SEQ ID NO:36, SEQ ID NO:48, SEQ ID NO:49, SEQ ID NO:50, SEQ ID NO:51, SEQ ID NO:52 and SEQ ID NO:53. 
     
     
         28 . The solid support of  claim 21 , wherein at least one G1 antigen is present from each of hantavirus serotypes HTNV, PUUV, SEOV, DOBV, SNV and ANDV, and at least one N antigen is present from each of hantavirus serotypes HTNV, PUUV, SEOV, DOBV, SNV and ANDV. 
     
     
         29 . The solid support of  claim 21 , wherein the solid support is a nitrocellulose strip. 
     
     
         30 . An immunodiagnostic test kit for detecting hantavirus, said test kit comprising:
 (a) a solid support according to  claim 21 ; and   (b) instructions for conducting the immunodiagnostic test.   
     
     
         31 . A method of detecting the presence of hantavirus antibodies in a biological sample, said method comprising:
 (a) providing a biological sample;   (b) providing a solid support according to  claim 21 ;   (c) contacting said biological sample with said solid support, under conditions which allow hantavirus antibodies, if present in the biological sample, to bind with at least one of the hantavirus antigens to form an antibody/antigen complex; and   (d) detecting the presence of the antibody/antigen complex, thereby detecting the presence of hantavirus antibodies in the biological sample.   
     
     
         32 . The method of  claim 31 , further comprising:
 (e) removing unbound hantavirus antibodies;   (f) providing one or more moieties capable of associating with said antibody/antigen complex; and   (g) detecting the presence of said one or more moieties, thereby detecting the presence of hantavirus antibodies in the biological sample.   
     
     
         33 . The method of  claim 32 , wherein said one or more moieties comprises a detectably labeled hantavirus antigen. 
     
     
         34 . The method of  claim 33 , wherein the detectable label is an enzyme. 
     
     
         35 . The method of any one of  claims 1 ,  17 , and  31 , wherein said biological sample is from a human blood sample.

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