Manufacturing method for laminated immunodiagnostic test device
First Claim
1. A process of preparing a biphasic laminated substrate for use in an immunodiagnostic test device, the process comprises the steps of:
- providing a liner material, a release medium, and a capture medium, wherein the capture medium comprises a micorporous hydrophilic polymeric material disposed on a polymer film;
aligning the release medium with the capture medium in side-by-side, single edge only, overlapping relation to form a single release/capture media layer such that a sequential liquid flow path is formed therethrough;
aligning the liner material in vertical, parallel alignment with the release/capture media layer; and
bonding the liner material to a side of the release/capture media layer including the polymer film to form a laminate.
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Accused Products
Abstract
The invention relates to a method of making a laminated substrate for use in an immunodiagnostic device and a machine or apparatus for marking the substrate with reagent. The method of forming the laminated substrate creates a rollable chromatographic medium. The chromatographic medium can be biphasic or multiphasic. The biphasic chromatographic medium comprises a capture medium precast onto a plastic backing and a release medium. The release and capture media are bonded to a liner material such as a plastic film. The multiphasic chromatographic medium comprises a capture medium precast onto a plastic backing, a release medium, and a sample absorbent medium. The capture medium, the release medium and the sample absorbent medium are disposed on a liner material such as a plastic film. The biphasic and multiphasic laminates are prepared for use as immunoassays by a specially adapted machine or apparatus. The machine includes a leader, an unwind system, a reagent dispensing system, a substrate reject marking system, a drying system, and a rewind system. In one exemplary embodiment, the machine applies four reagents to the substrate. The particular reagents used in the machine will vary depending upon the immunoassay to be performed.
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Citations
8 Claims
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1. A process of preparing a biphasic laminated substrate for use in an immunodiagnostic test device, the process comprises the steps of:
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providing a liner material, a release medium, and a capture medium, wherein the capture medium comprises a micorporous hydrophilic polymeric material disposed on a polymer film; aligning the release medium with the capture medium in side-by-side, single edge only, overlapping relation to form a single release/capture media layer such that a sequential liquid flow path is formed therethrough; aligning the liner material in vertical, parallel alignment with the release/capture media layer; and bonding the liner material to a side of the release/capture media layer including the polymer film to form a laminate. - View Dependent Claims (2, 3, 4)
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5. A process of preparing a multiphasic laminated substrate for use in an immunodiagnostic test device, the process comprising the steps of:
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providing a liner material, a release medium, a sample absorbent medium, and a capture medium, wherein the capture medium comprises a microporous hydrophilic polymeric material disposed on a polymer film; aligning the release medium with the capture medium in side-by-side, single edge only, overlapping relation; aligning the sample absorbent medium with an opposite edge of the capture medium in side-by-side, single edge only, overlapping relation, forming a single multimedia layer having a sequential flow path therein, the multimedia layer including the release, capture, and aligning the liner material in vertical, parallel alignment with the multimedia layer; and bonding the liner material to a side of the multimedia layer including the polymer film to form a laminate. - View Dependent Claims (6, 7, 8)
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Specification