Diagnostic devices
First Claim
1. A platform comprising one or more dry porous membranes for detecting at least one component in a low volume liquid sample, the membranes providing a membrane channel through which the liquid sample flows by capillary action while reactions take place determinative of at least one component in the sample;
- the platform formed with sample application means and having top and bottom layers with hydrophilic surfaces to enclose and position the membranes, each layer having a top and bottom surface formed so that the bottom surface of the top layer and the top surface of the bottom layer may be brought into fixed face to face contact so that the layers enclose and hold the membranes in place and form a platform flow channel upstream of the membranes and downstream of the sample application means, and including at least one indent in at least one of the hydrophilic surfaces, the formed platform flow channel is configured to promote increased capillary force and uniform flow of the sample and is in fluid communication with the membranes to permit the liquid sample to flow by capillary action in a continuous pathway from the upstream sample application means through the platform flow channel and then to an edge of an upstream end of the membranes towards the distal end of said membranes.
1 Assignment
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Accused Products
Abstract
The present invention relates to analytical methods, platforms, and devices for the rapid and efficient immunochromatic determination of one or more components in fluid samples. The devices are especially useful for identifying analytes in small volumes of whole blood samples utilizing one membrane principally for separating particles such as red blood cells from plasma and a second membrane as the site for reactions to identify the analytes.
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Citations
39 Claims
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1. A platform comprising one or more dry porous membranes for detecting at least one component in a low volume liquid sample, the membranes providing a membrane channel through which the liquid sample flows by capillary action while reactions take place determinative of at least one component in the sample;
the platform formed with sample application means and having top and bottom layers with hydrophilic surfaces to enclose and position the membranes, each layer having a top and bottom surface formed so that the bottom surface of the top layer and the top surface of the bottom layer may be brought into fixed face to face contact so that the layers enclose and hold the membranes in place and form a platform flow channel upstream of the membranes and downstream of the sample application means, and including at least one indent in at least one of the hydrophilic surfaces, the formed platform flow channel is configured to promote increased capillary force and uniform flow of the sample and is in fluid communication with the membranes to permit the liquid sample to flow by capillary action in a continuous pathway from the upstream sample application means through the platform flow channel and then to an edge of an upstream end of the membranes towards the distal end of said membranes. - View Dependent Claims (2, 3, 4, 5, 36, 38, 39)
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6. A device for the rapid and efficient detection of at least one component in a low volume liquid sample, the device containing a membrane in which reactions take place determinative of the presence of at least one component in the sample;
the membrane being enclosed in a platform formed with sample application means and having top and bottom layers with hydrophilic surfaces fixed to each other through face to face contact of the bottom surface of the top layer and the top surface of the bottom layer to enclose and position the membrane, the surfaces in such face to face contact fork a platform flow channel upstream of the membrane and downstream of the sample application means, and including at least one indent in at least one of the hydrophilic surfaces, the formed platform flow channel being configured to promote increased capillary force and uniform flow of the sample and being in fluid communication with the membrane to permit the liquid sample to flow by capillary action in a continuous pathway from the upstream sample application means through the platform flow channel and then to an edge of an upstream end of the membrane towards the distal end of the membrane. - View Dependent Claims (7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 37)
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20. A device for the rapid and efficient detection of one or more components in a whole blood sample, the device containing an upstream detection membrane and a downstream capture membrane, the detection membrane constructed to filter substantially all of the red blood cells from the sample and containing a mobile labeled detecting reagent which will react with the one or more components to form a reaction product which moves downstream in the detection membrane;
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a capture membrane downstream of the detection membrane and containing a fixed, immobile capture reagent which will react with and concentrate the reaction product at a capture line, the downstream end of the detection membrane slightly overlapping the upstream end of the capture membrane; the membranes being enclosed in a platform formed with sample application means and having top and bottom layers with hydrophilic surfaces fixed to each other through face to face contact of the bottom surface of the top layer and the top surface of the bottom layer to enclose both membranes; the surfaces in face to face contact form a platform flow channel upstream of the detection membrane and downstream of the sample application means, and include at least one indent in at least one of the hydrophilic surfaces, and the formed platform flow channel is configured to promote increased capillary force and uniform flow of the sample and is in fluid communication with the upstream end of the detection membrane to permit the sample to flow by capillary action from the application means through the platform flow channel and to an edge of an upstream end of the detection membrane to the distal end of the capture membrane. - View Dependent Claims (21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35)
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Specification