Device and method for detecting blood group antigens by means of an incomplete antibody

Abstract

A device for determining a cellular-bound analyte in a liquid sample includes a separation matrix with at least one indicator zone. The indicator zone includes a first antibody directed against the cellular-bound analyte or a fragment thereof and a binding element directed against the first antibody. The first antibody is an incomplete antibody. The separation matrix can be designed in the form of the membrane of a lateral flow assay device or as a gel matrix. For example, the device can include a membrane with a charging zone for applying the liquid sample, at least one indicator zone which can interact with the cellular-bound analyte, and at least one absorption region, which absorbs the liquid after passing the indicator zone. The indicator zone lies between the charging zone and the absorption region. The indicator zone can include an antibody directed against the cellular-bound analyte or a fragment thereof and a binding element directed against the first antibody.

What is claimed is: 
     
         1 . A device for determining the presence of at least one blood group antigen in a liquid sample, the device comprising:
 a separating matrix comprising tubes filled with gel material,   wherein the gel material comprises at least one indicator zone, the indicator zone comprising:   a first antibody, or a fragment thereof, directed against the blood group antigen, and   a binding element directed against the first antibody, the first antibody being an incomplete antibody.   
     
     
         2 . The device of  claim 1 , wherein the blood group antigen is selected from the group consisting of A, B, AB, D, C, E, c, e, Cw, K, k, Jka, Jkb, Fya, Fyb, M, N, S, s, P1, Kpa, Kpb, Lua, Lub, Lea, Leb, Mia, Dia, Jsa, Jsb, Coa, Cob, Wra and Xga. 
     
     
         3 . The device of  claim 1 , wherein the first antibody is an antibody of the IgG or IgA type. 
     
     
         4 . The device of  claim 1 , wherein the binding element directed against the first antibody is selected from an antibody directed against the first antibody, or a fragment thereof, and a lectin or a fragment thereof. 
     
     
         5 . The device of  claim 1 , wherein the binding element directed against the first antibody is selected from an anti IgG antibody directed against the first antibody, or a fragment thereof, an anti-IgA antibody directed against the first antibody, or a fragment thereof, protein A, or a fragment thereof, and protein G, or a fragment thereof. 
     
     
         6 . A method for producing the device of  claim 1 , comprising:
 applying a first antibody, or a fragment thereof, directed against the at least one blood group antigen and a binding element directed against the first antibody in the indicator zone, wherein the first antibody is an incomplete antibody.   
     
     
         7 . A method for producing the device of  claim 1 , wherein the first antibody and the binding element are applied separately from one another or as a mixture. 
     
     
         8 . A method for determining at least one blood group antigen in a liquid sample, comprising:
 i) applying the sample to the device of  claim 1 ,   wherein said sample is present in an amount sufficient to cause the sample liquid to flow through the indicator zone of the device such that the at least one blood group antigen in the sample liquid forms a complex in the indicator zone, and   ii) detecting the formation of the complex in the indicator zone.   
     
     
         9 . The method of  claim 8 , wherein the liquid sample preferably consists of blood or constituents of blood, preferably of whole blood, erythrocyte concentrate, coagulated blood or test liquid, such as control blood 
     
     
         10 . The method of  claim 8 , wherein the sample is diluted with a buffer before it is applied to the device. 
     
     
         11 . A device for simultaneously determining at least a first and a second blood group antigens in a liquid sample, comprising:
 a plurality of tubes filled with gel material, the gel material comprising at least one indicator zone,
 wherein:
 (i) the at least one indicator zone of the gel material of a first tube of the plurality of tubes comprises:
 (a) a first antibody, or a fragment thereof, directed against the first blood group antigen, the first antibody being an incomplete antibody, and 
 (b) a binding element directed against the first antibody; and 
 
 (ii) the at least one indicator zone of the gel material of a second tube of the plurality of tubes comprises:
 (a) a first antibody directed against the second blood group antigen, the first antibody being a complete antibody; or 
 (b) a first antibody directed against the second blood group antigen, the first antibody being incomplete, and a binding element directed against the first antibody. 
 
 
   
     
     
         12 . The device of  claim 11 , wherein the first antibody, or a fragment thereof, directed against the first blood group antigen is an anti-IgG antibody and the first antibody, or a fragment thereof, directed against the second blood group antigen is an anti-IgM antibody. 
     
     
         13 . A method for producing the device of  claim 11 , comprising:
 applying a first antibody, or a fragment thereof, directed against the first blood group antigen, and a binding element directed against the first antibody in the indicator zone of the first tube of the plurality of tubes, wherein the first antibody is an incomplete antibody.   
     
     
         14 . A method for producing the device of  claim 11 , wherein the first antibody and the binding element in the indicator zone of the first tube of the plurality of tubes, are applied separately from one another or as a mixture.