| 摘要 |
The present invention is directed to improved method and device for detecting the presence of antigens in sample fluids which comprises bringing fluid to be tested for presence of antigens into contact with the device having first reactive zone (18), enzyme regulated fluid flow barrier (13), and second reactive zone (20). The first reactive zone (18) is composed of matrix layer (12) containing bacteria collagenase and enzyme-linked antibodies (24) which are capable of immunologically reacting with antigens being tested for. An enzyme regulated fluid flow barrier (13) is operably connected to first reactive zone (18) of the device and the barrier (13) is composed of sufficient amount of collagen to allow fluid flow when degraded by bacterial collagenase of first reactive zone. A second reactive zone (20), having two interconnecting matrix layers (14, 16), i.e. trapping layer (14) and substrate layer (16), is also operably connected to fluid flow barrier (13) of the device. The trapping layer (14) contains bound and immobilized antigens which are recognized by enzyme-linked antibodies (24) of first reactive zone (18), and substrate layer (16) contains material capable of reacting with enzyme linked to enzyme-linked antibodies (24) of first reactive zone (18) to produce a color forming reaction. After sufficient period of time for allowing the sample fluid to permeate the device, the presence or absence of any color change in the second reactive zone is observed to determine the presence of the antigens being tested for the sample fluid. |
