System for detecting bacteria in blood, blood products, and fluids of tissues

Abstract

The invention provides methods for screening for the presence of a clinically relevant amount of bacteria in donor blood or a blood product from a donor mammal, particularly blood or a blood product that will be transferred from the donor mammal to a recipient mammal. The method comprises contacting a sample of the donor blood or a blood product with a set of binding agents that comprises binding agents that specifically bind to Gram-negative bacterial antigen and/or binding agents that specifically bind to Gram-positive bacterial antigen, and determining binding of the set of binding agents to the sample, wherein binding indicates the presence of a clinically relevant amount of Gram-positive bacteria and/or Gram-negative bacteria in the donor blood or blood product and no binding indicates the absence of a clinically relevant amount of Gram-positive bacteria and/or Gram-negative bacteria in the donor blood or blood product. The invention further provides methods and kits for screening for the presence of a clinically relevant amount of Gram-positive bacteria, Gram-negative bacteria, or both Gram-positive and Gram-negative bacteria in a donor tissue by screening the fluid in which the donor tissue is stored.

1 . A method for screening for the presence of a clinically relevant amount of bacteria in donor blood or blood product from a donor mammal for transfer to a recipient mammal comprising contacting a sample of the donor blood or blood product with a set of binding agents, wherein the set of binding agents comprises binding agents that specifically bind to a Gram-negative bacterial antigen and binding agents that specifically bind to a Gram-positive bacterial antigen, and determining binding of the set of binding agents to the sample, wherein binding indicates the presence of a clinically relevant amount of bacteria in the donor blood or blood product and no binding indicates the absence of a clinically relevant amount of bacteria in the donor blood or blood product. 
     
     
         2 . The method of  claim 1 , wherein the donor blood or blood product from the donor mammal determined to have an absence of a clinically relevant amount of bacteria is transferred to the recipient mammal. 
     
     
         3 . The method of  claim 1 , wherein the donor blood or blood product is selected from the group consisting of whole blood, leukocytes, hematopoietic stem cells, platelets, red blood cells, plasma, and serum. 
     
     
         4 . The method of  claim 1 , wherein the binding agents that specifically bind to the Gram-negative bacterial antigen specifically bind to the lipopolysaccharide structure of the Gram-negative bacteria. 
     
     
         5 . The method of  claim 1 , wherein the binding agents that specifically bind to the Gram-positive bacterial antigen specifically bind to the lipotechoic acid structure of the Gram-positive bacteria. 
     
     
         6 . The method of  claim 1 , wherein the set of binding agents is immobilized on a solid-phase support. 
     
     
         7 . A method for screening for the presence of a clinically relevant amount of Gram-positive bacteria in donor blood or blood product from a donor mammal for transfer to a recipient mammal comprising contacting a sample of the donor blood or blood product with a set of binding agents, wherein the set of binding agents comprises binding agents that specifically bind to a Gram-positive bacterial antigen, and determining binding of the set of binding agents to the sample, wherein binding indicates the presence of a clinically relevant amount of Gram-positive bacteria in the donor blood or blood product and no binding indicates the absence of a clinically relevant amount of Gram-positive bacteria in the donor blood or blood product 
     
     
         8 . A method for screening for the presence of a clinically relevant amount of Gram-negative bacteria in donor blood or blood product from a donor mammal for transfer to a recipient mammal comprising contacting a sample of the donor blood or blood product with a set of binding agents, wherein the set of binding agents comprises binding agents that specifically bind to a Gram-negative bacterial antigen, and determining binding of the set of binding agents to the sample, wherein binding indicates the presence of a clinically relevant amount of Gram-negative bacteria in the donor blood or blood product and no binding indicates the absence of a clinically relevant amount of Gram-negative bacteria in the donor blood or blood product. 
     
     
         9 . A kit for screening for the presence of a clinically relevant amount of bacteria in donor blood or blood product from a donor mammal for transfer to a recipient mammal comprising a set of binding agents, wherein the set of binding agents comprises binding agents that specifically bind to a Gram-negative bacterial antigen and binding agents that specifically bind to a Gram-positive bacterial antigen, and a means for detecting binding of the set of binding agents to a sample of the donor blood or blood product, wherein binding indicates the presence of a clinically relevant amount of bacteria in the donor blood or blood product and no binding indicates the absence of a clinically relevant amount of bacteria in the donor blood or blood product. 
     
     
         10 . The kit of  claim 9 , wherein the donor blood or blood product from the donor mammal determined to have an absence of a clinically relevant amount of bacteria is transferred to the recipient mammal. 
     
     
         11 . The kit of  claim 9 , wherein the set of binding agents is immobilized on a solid-phase support. 
     
     
         12 . A kit for screening for the presence of a clinically relevant amount of Gram-positive bacteria in donor blood or blood product from a donor mammal for transfer to a recipient mammal comprising a set of binding agents, wherein the set of binding agents comprises binding agents that specifically bind to a Gram-positive bacterial antigen, and a means for detecting binding of the set of binding agents to a sample of the donor blood or the donor blood product, wherein binding indicates the presence of a clinically relevant amount of Gram-positive bacteria in the donor blood or blood product and no binding indicates the absence of a clinically relevant amount of Gram-positive bacteria in the donor blood or blood product. 
     
     
         13 . A kit for screening for the presence of a clinically relevant amount of Gram-negative bacteria in donor blood or blood product from a donor mammal for transfer to a recipient mammal comprising a set of binding agents, wherein the set of binding agents comprises binding agents that specifically bind to a Gram-negative bacterial antigen, and a means for detecting binding of the set of binding agents to a sample of the donor blood or blood product, wherein binding indicates the presence of a clinically relevant amount of Gram-negative bacteria in the donor blood or blood product and no binding indicates the absence of a clinically relevant amount of Gram-negative bacteria in the donor blood or blood product. 
     
     
         14 . A method for screening for the presence of a clinically relevant amount of bacteria in a donor tissue from a donor mammal for transfer to a recipient mammal, wherein the donor tissue is stored in a fluid, comprising contacting a sample of the fluid with a set of binding agents, wherein the set of binding agents comprises binding agents that specifically bind to a Gram-negative bacterial antigen and binding agents that specifically bind to a Gram-positive bacterial antigen, and determining binding of the set of binding agents to the sample, wherein binding indicates the presence of a clinically relevant amount of bacteria in the donor tissue and no binding indicates the absence of a clinically relevant amount of bacteria in the donor tissue. 
     
     
         15 . The method of  claim 14 , wherein the donor tissue determined to have an absence of a clinically relevant amount of bacteria is transferred to the second mammal 
     
     
         16 . The method of  claim 14 , wherein the donor tissue is selected from the group consisting of lung, heart, liver, skin, kidney, pancreas, spleen, and bone marrow. 
     
     
         17 . A method for screening for the presence of a clinically relevant amount of Gram-positive bacteria in a donor tissue from a donor mammal for transfer to a recipient mammal, wherein the donor tissue is stored in a fluid, comprising contacting a sample of fluid with a set of binding agents, wherein the set of binding agents comprises binding agents that specifically bind to a Gram-positive bacterial antigen, and determining binding of the set of binding agents to the sample, wherein binding indicates the presence of a clinically relevant amount of Gram-positive bacteria in the donor tissue and no binding indicates the absence of a clinically relevant amount of Gram-positive bacteria in the donor tissue. 
     
     
         18 . A method for screening for the presence of a clinically relevant amount of Gram-negative bacteria in a donor tissue from a donor mammal for transfer to a recipient mammal, wherein the donor tissue is stored in a fluid, comprising contacting a sample of the fluid with a set of binding agents, wherein the set of binding agents comprises binding agents that specifically bind to a Gram-negative bacterial antigen, and determining binding of the set of binding agents to the sample, wherein binding indicates the presence of a clinically relevant amount of Gram-negative bacteria in the donor tissue and no binding indicates the absence of a clinically relevant amount of Gram-negative bacteria in the donor tissue. 
     
     
         19 . A kit for screening for the presence of a clinically relevant amount of bacteria in a donor tissue from a donor mammal for transfer to a recipient mammal, wherein the donor tissue is stored in a fluid, comprising a set of binding agents, wherein the set of binding agents comprises binding agents that specifically bind to a Gram-negative bacterial antigen and binding agents that specifically bind to a Gram-positive bacterial antigen, and a means for detecting binding of the set of binding agents to a sample of the fluid, wherein binding indicates the presence of a clinically relevant amount of bacteria in the donortissue and no binding indicates the absence of a clinically relevant amount of bacteria in the donor tissue. 
     
     
         20 . The kit of  claim 19 , wherein the donor tissue determined to have an absence of a clinically relevant amount of bacteria is transferred to a recipient mammal. 
     
     
         21 . A kit for screening for the presence of a clinically relevant amount of Gram-positive bacteria in a donor tissue from a donor mammal for transfer to a recipient mammal, wherein the donor tissue is stored in a fluid, comprising a set of binding agents, wherein the set of binding agents comprises binding agents that specifically bind to a Gram-positive bacterial antigen, and a means for detecting binding of the set of binding agents to a sample of the fluid, wherein binding indicates the presence of a clinically relevant amount of Gram-positive bacteria in the donor tissue and no binding indicates the absence of a clinically relevant amount of Gram-positive bacteria in the donor tissue. 
     
     
         22 . A kit for screening for the presence of a clinically relevant amount of Gram-negative bacteria in a donor tissue from a donor mammal for transfer to a recipient mammal, wherein the donor tissue is stored in a fluid, comprising a set of binding agents, wherein the set of binding agents comprises binding agents that specifically bind to a Gram-negative bacterial antigen, and a means for detecting binding of the set of binding agents to a sample of the fluid, wherein binding indicates the presence of a clinically relevant amount of Gram-negative bacteria in the donor tissue and no binding indicates the absence of a clinically relevant amount of Gram-negative bacteria in the donor tissue.