| 主权项 |
1. A lateral flow immunoassay device for qualitative or quantitative analysis of an analyte of interest in a whole blood sample, the device comprising:
a base member; and a horizontal array disposed on said base member, the horizontal array comprising: (i) a sample receiving pad
being located on one end of the base member,having pores having an average pore size of 30 to 150 micrometers, which receive a whole blood sample, andwhich comprises a polycation which separates a red blood cell from the whole blood sample, thereby impeding passage of the red blood cell; (ii) a conjugate pad
being distinct from the sample receiving pad,being in contact with the sample receiving pad,having pores having an average pore size of 6 to 11 micrometers, andcomprising a diffusively bound conjugate, which forms a first immuno-complex with an analyte of the blood in the conjugate pad, the conjugate comprising
a first binder specific to the analyte, anda label; (iii) a flow delaying pad
being distinct from the conjugate pad,being in contact with the conjugate pad,having pores having an average pore size of 2 to 5 micrometers, andwhich receives from the conjugate pad the blood containing the analyte and the conjugate which are not yet combined each other, and the first immuno-complex; and (iv) a wicking membrane
being in contact with the flow delaying pad, andhaving a second binder, which is immobilized in a test line of the wicking membrane, is specific to the analyte, and which combines with the first immuno-complex to form a second immuno-complex fixed to the test line, andwhich receives the blood from the flow delaying pad; and wherein a relation between average pore size (P1) of the sample receiving pad, average pore size (P2) of the conjugate pad, and average pore size (P3) of the flow delaying pad is as follows: P1>P2>P3. |
