Importance

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Abstract

The present invention provides a test strip for detecting, in a sample from a human subject, the presence of an antigenic substance which comprises a solid support, an antibody directed against the antigenic substance bound to a first discrete area on the solid support, an anti-human antibody bound to a second discrete area on the solid support as a positive control, and an antibody directed against an antigen which does not naturally occur in human subjects bound to a third discrete area on the solid support as a negative control. The present invention also provides a test strip for detecting, in a sample from a human subject, the presence of an antibody which comprises a solid support, an antigenic substance bound to a first discrete area on the solid support, an anti-human antibody bound to a second discrete area on the solid support as a positive control, and a negative control bound to a third discrete area on the solid support. The invention further provides a test strip for detecting the presence of an antibody and antigenic substance, which may additionally comprise an antibody-based reagent directed against the antigenic substance in an immune complex and native human antibody thereto. The invention also provides a method for detecting in a sample from a human subject the presence of an antigenic substance or antibody or both using the aforementioned test strips.

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First Claim