Manufacturing process for sample initiated assay device

• US 5,411,858 A
• Filed: 08/12/1993
• Issued: 05/02/1995
• Est. Priority Date: 05/17/1989
• Status: Expired due to Fees

• Current Assignee: ActiMed Laboratories, Inc.
• Original Assignee: ActiMed Laboratories, Inc.
• Inventors: Meluch, Timothy B., Ertingshausen, Gerhard, McGeehan, John K.
• Primary Examiner(s): Saunders, David
• Assistant Examiner(s): Chin, Christopher L.
• Application Number:
  US08/104,934
• Time in Patent Office: 628 Days
• Field of Search: 422/56-58, 427/2, 435/4, 435/970, 435/805, 436/514, 436/518, 436/528, 436/164, 436/169, 436/800, 436/805, 436/810
• US Class Current: 435/4
• CPC Class Codes: B01L 2200/12 Specific details about manufacturing devices
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: C12Q 1/00 Measuring or testing processes involving enzymes, nucleic acids or microorganisms measuring or testing apparatus with condition measuring or sensing means, e.g. colony counters, C12M1/34; Compositions therefor; Processes of preparing such compositions
• CPC Class Codes: G01N 2035/00168 Manufacturing or preparing test elements
• CPC Class Codes: G01N 33/5302 Apparatus specially adapted for immunological test procedures
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 436/80 Fluorescent dyes, e.g. rhodamine
• CPC Class Codes: Y10S 436/805 Optical property
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick

Abstract

A quantitative test device is manufactured using a feedback loop which allows one to modify continuously the dimensions of a reading scale printed on the device. The quantitative test device is manufactured by attaching the critical component of a two-component dye system to minute particles such as microcrystalline cellulose, silica, or latex, which particles are suspended in a solution of a polymeric binder. Additional non-immobilized components of the reaction system of the test device are optionally added to the polymer solution. The suspension of dyed particles in polymer solution is applied to a fabric as a coating, using conventional coating machines, to obtain a homogeneous distribution of immobilized dye throughout the fabric.

The device includes a measurement zone which is made from a film support made of a material having a lower melting point than the filter cloth fabric used in the measurement zone was used. By using a lower melting point material for the support film, impulse heat sealing is controlled to a degree such that the lower melting point support is made to melt and extrude through the mesh of the fabric on either side of a channel, forming a seal along the sides of the channel.

Claims

1. In a method for making a multilayer assaying device for fluid samples by assembling layers and sealing said layers together, said layers comprising elements corresponding to an assay initiation area and elements corresponding to a measurement zone to form an assaying device comprising a sample initiation area and a measurement zone, whereby a fluid sample to be assayed flows from the sample initiation zone through the measurement zone, the improvement comprising said measurement zone being produced by heat sealing a support material to a woven mesh material to form a seal along the sides of said measurement zone, wherein the material forming the support melts during heat sealing while the material forming the woven mesh does not melt during heat sealing whereby the melting points of the woven mesh material and the support material are chosen so that during heat sealing the material forming the support flows into the woven mesh, and that the amount of heat applied to the measurement zone determines how much support material flows into the mesh to define the volume of the measurement zone.

2. The method according to claim 1 wherein said support material is polyethylene and said woven mesh material is polyester.

3. The method according to claim 1 wherein said measurement zone is made by heat sealing together dye layer fabric, channel layer fabric and sealing film, and said measurement zone is inserted into a support tray.

4. The method according to claim 1 wherein said support material is polyethylene and said woven mesh material is nylon.

5. The method of claim 1, wherein said multilayer assaying device further comprises layers comprising elements corresponding to a draw zone.

6. In a method for making a multilayer assaying device for fluid samples by assembling layers and sealing said layers together, said layers comprising elements corresponding to an assay initiation area and elements corresponding to a measurement zone, to form an assaying device comprising an assay in initiation area and a measurement zone whereby a fluid sample to be assayed flows from the assay initiation area through the measurement zone, the improvement comprising said measurement zone being produced prior to assembling said layers by heat sealing a support material to a woven mesh material to form a seal along the sides of said measurement zone, wherein the material forming the support melts during heat sealing whereby the melting points of the woven mesh material and the support material are chosen so that during heat sealing the material forming the support flows into the woven mesh and the amount of heat applied to the measurement zone determines how much support material flows into the mesh to define the volume of the measurement zone and applying a two-part dye system along the length of the measurement zone;

said dye system applied by immobilizing a second dye component on particles;

suspending said particles in a binder;

mixing said binder and particles with a first dye component to form a dye mixture;

applying said dye mixture to the woven mesh material in said measurement zone.

7. The method according to claim 6 wherein said dye mixture is applied with an ink jet printer.

8. The method according to claim 6 wherein on an assembly line for making assaying devices according to claim 6, representative assaying devices are continuously sampled and tested by applying a standard solution with a known quantity of analyte to said assay devices wherein color bars are formed by said analyte, the lengths of color bars in said devices are continuously compiled and subjected to trend analysis, and the distance between divisions of a measurement scale on said measurement zone are automatically adjusted by a computer which controls an ink jet printer.

9. The method according to claim 6 wherein said particles are selected from the group consisting of microcrystalline cellulose, silica and latex.

10. The method according to claim 6 wherein said binder is selected from the group consisting of polyvinyl alcohol, polyvinyl acetate, and cellulose acetate.