In vitro detection of presence and/or concentration of an antigen or particular antibody in a blood sample by immuno-chromatographic test, comprises applying blood sample and migration buffer to an absorbent element having marker

摘要

The in vitro detection of presence and/or concentration of an antigen or particular antibody in a blood sample by immuno-chromatographic test, comprises applying blood sample and migration buffer to an absorbent element (100) having a marker. The absorbent element is placed on a distal part of a reactive band of an analytical test device by immuno-chromatographic test. The migration buffer is applied to the absorbent element that allows the migration of a specifically marked binding reactant towards a detection zone (103) of a porous support (102). The in vitro detection of presence and/or concentration of an antigen or particular antibody in a blood sample by immuno-chromatographic test, comprises applying blood sample and migration buffer to an absorbent element (100) having a marker. The absorbent element is placed on a distal part of a reactive band of an analytical test device by immuno-chromatographic test. The migration buffer is applied to the absorbent element that allows the migration of a specifically marked binding reactant towards a detection zone (103) of a porous support (102), which is directly/indirectly connected to the absorbent element. The detection zone is immobilized to allow specifically non-marked binding reactant. The antigen or particular antibody present in the blood sample is determined by observing a level of the specifically marked binding reactant, which is immobilized on the detection zone. The applying step of migration buffer is carried out by contacting the absorbent element with cotton/celluloid matrix soaked with the migration buffer while placing the absorbent element in a tube/receptor. The porous support comprises a nitrocellulose layer and a control zone (106), which allows the user to determine the test function. The specifically marked binding reactant is directly/indirectly coupled with a latex colored particle marker. The specifically marked binding reactant is maintained to a dry state in a macroporous body having a porous size, which is ten times higher than the size of the latex colored particle marker. The macroporous body of the blood sample is crossed before the migration of the porous support with the absorbent element. The latex colored particle marker is indirectly coupled with the specifically marked binding reactant. The indirect coupling is obtained by the specifically marked binders, which are coupled with the binding reagent and the latex colored particle marker. The latex colored particle marker is coupled with a first binder, which is maintained to a dry state in the macroporous body. The specifically marked binder reactant is coupled with a second binder that is present in the migration buffer. Absorbent layer (105) is directly placed in the distal zone of the analytical test device with the porous support in which the layer has an absorption capacity to absorb excess binding reactant in the detection zone. Independent claims are included for: (1) an analytical immuno-chromotographic test device; and (2) an analytical immuno-chromotographic test kit.