Patent ID: 6593079
Filing Date: 2003-07-15
Classification: C07K,G01N

Abstract:
An immunoassay method for the detection of at least one of antibodies and antigens of each of HIV1, HIV1-sub0 and HIV2 in a sample suspected of containing said antibodies and antigens, the method comprising:a) incubating binding partners R1 and R2 in a sample mixture comprising at least a portion of said sample, wherein R1 binds specifically to an antigen selected from the group consisting of the p24 antigen of HIV1, the p24 antigen of HIV1-Sub0 and the p26 antigen of HIV2, R1 being bound directly or indirectly to a first solid phase, and wherein R2 binds specifically to said antigen, R2 being bound to a first detectable label, and R2 recognizing an epitope different from that recognized by R1, whereby the antigen forms a sandwich with R1 and R2; b) incubating binding partners R3 and R4 in a sample mixture comprising at least a portion of said sample, wherein R3 binds specifically to a first antibody selected from the group consisting of antibodies against an antigen of the env region HIV1, HIV1-Sub0 and HIV2, R3 being bound directly or indirectly to a second solid phase, and wherein R4 binds specifically to the first antibody, R4 being bound to a second detectable label, whereby said first antibody forms a bridge between R3 and R4; c) incubating binding partners R5 and R6 in a sample mixture comprising at least a portion of said sample, wherein R5 binds specifically to a second antibody selected from the group consisting of antibodies against an antigen of the pol and gag regions of HIV1, HIV-Sub0 and HIV2, wherein the gag regions exclude sequences of p24 and p26, R5 being bound directly or indirectly to a third solid phase, and wherein R6 binds specifically to the second antibody, R6 being bound to a third detectable label, whereby the second antibody forms a bridge between R5 and R6; and d) determining the amount of the detectable labels bound to the solid phases or remaining unbound as a measure of the antibodies and the antigens of HIV1, HIV1-sub0, and HIV2 in the sample; wherein at least one of R1, R3, and R5 binds specifically to at least one of antibodies and antigens of HIV1; at least one of R1, R3, and R5 binds specifically to at least one of antibodies and antigens of HIV-Sub0; and at least one of R1, R3, and R5 binds specifically to at least one of antibodies and antigens of HIV2.