DRY TEST STRIP WITH CONTROLLED FLOW AND METHOD OF MANUFACTURING SAME

• US 20080112848A1
• Filed: 10/31/2007
• Published: 05/15/2008
• Est. Priority Date: 02/03/2004
• Status: Active Grant

• Current Assignee: Polymer Technology Systems Incorporated (Sinocare, Inc.)
• Original Assignee: Polymer Technology Systems Incorporated (Sinocare, Inc.)
• Inventors: Huffstodt, Kimberly Zinser, Crabtree, Emmanuel P., Hancock, John P., Sutor, James J., Huffstodt, Robert, Lawrence, Gregory M.
• Granted Patent: US 8,465,696 B2
• Time in Patent Office: Days
• US Class Current: 422/68.1
• CPC Class Codes: G01N 2021/8494 Measuring or storing parameters of the band
• CPC Class Codes: G01N 2021/8654 Mechanical support; Mounting of sheet
• CPC Class Codes: G01N 21/78 producing a change of colour
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 2201/0221 Portable; cableless; compact; hand-held
• CPC Class Codes: G01N 2800/044 Hyperlipemia or hypolipemia, e.g. dyslipidaemia, obesity
• CPC Class Codes: G01N 33/52 Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements immunological elements G01N33/54386; involving labelled immunochemicals G01N33/58; for haemoglobin or occult blood G01N33/72
• CPC Class Codes: G01N 33/526 the element being adapted for a specific analyte
• CPC Class Codes: G01N 33/92 involving lipids, e.g. cholesterol , lipoproteins, or their receptors steroid hormones G01N33/743
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A dry test strip assembly includes: a carrier base having a test port and a well adapted for receiving a dry test strip element, and a cover having a sample opening. The cover can be snapped onto the base with the sample opening aligned over the test port and with a test strip element compressed between the base and cover. A maximum dry test strip compression stop controls the maximum compression on the dry test strip, and a minimum dry test strip compression stop controls the minimum compression on the dry test strip. A rib between two test ports prevents fluid flow in the dry test strip element from one side of the rib to another, thereby separating the test strip element into a plurality of separate fluid compartments. A manufacturing system efficiently assembles the dry test strip assembly without handling by humans.

Claims

1. A carrier system for a diagnostic dry test strip for use in measuring an analyte in a fluid sample, said carrier system comprising:

a carrier base including a test strip well adapted for receiving a dry test strip and a test port communicating with said well and enabling said test strip to be observed;

a cover having a sample opening; and

engagement elements on said carrier base and said cover configured to engage said cover to said carrier body with said sample opening aligned over said test port and said dry test strip compressed between said carrier base and said cover;

wherein said engagement elements include;

a maximum dry test strip compression stop controlling the maximum compression on said dry test strip; and

a minimum dry test strip compression stop controlling the minimum compression on said dry test strip.

2. A carrier system as in claim 1 wherein said maximum dry test strip compression stop comprises a landing pad formed on said base or cover and adapted to contact a portion of the other of said base or cover.

3. A carrier system as in claim 1 wherein said engagement elements include a snap-on latch, and said minimum dry test strip compression stop comprises a lip on said latch.

4. A carrier system as in claim 1 wherein said carrier system includes a proximal end adapted to be grasped by a human hand and a distal end adapted to be inserted into an analyzer, said cover is attached to said base near said distal end by a living hinge, and said engagement elements include a snap-on latch.

5. A carrier system as in claim 1 wherein said cover is made of glass-filled polypropylene

6. A carrier system as in claim 1 wherein said cover has a tensile strength of between 10,000 pounds per square inch (psi) and 14,000 psi.

8. A carrier system as in claim 6 wherein said hinge is a living hinge.

7. A carrier system for a diagnostic dry test strip for use in measuring an analyte in a fluid sample, said carrier system comprising:

a carrier having a proximal end adapted to be grasped with human fingers and a distal end adapted to be inserted into an analyzer;

said carrier comprising a carrier base and a carrier cover connected by a hinge located near said distal end of said carrier;

said carrier base including a test port and said carrier cover including a sample opening, with said sample opening aligned over said test port when said cover is closed over said base;

wherein said hinge attaches to at least one of said base and cover at a location recessed from said distal end of said carrier.

9. A carrier system as in claim 7 wherein said hinge is a double living hinge.

10. A multi-analyte diagnostic dry test strip system, the dry test strip system comprising:

a carrier base including a plurality of test ports and a carrier cover including one or more sample openings, with said one or more sample openings aligned over said test ports when said cover is closed over said base; and

a dry test strip compressed between said base and cover and extending continuously over a plurality of said test ports; and

wherein at least one of said base and cover includes a raised rib located between two of said test ports and adapted to compress said dry test strip sufficiently so that essentially no fluid can flow in said dry test strip from one side of said rib to another, thereby separating said continuous dry test strip into a plurality of separate fluid compartments.

11. A dry test strip system as in claim 10 wherein there are three of said test ports spaced apart longitudinally on said base and two of said ribs, each rib located between the center one of said test ports and one of the end ones of said test ports.

12. A dry test strip system as in claim 10 wherein said ribs extend between 0.014 inches and 0.035 inches in height from the surface of said base.

13. A dry test strip system as in claim 12 wherein said ribs extend between 0.020 inches and 0.030 inches in height from the surface of said base.

14. A dry test strip system as in claim 10 wherein said carrier cover is made of glass-filled polypropylene.

15. A dry test strip system as in claim 14 wherein said polypropylene is 30% glass-filled polypropylene.

16. A dry test strip system as in claim 10 wherein said carrier cover has a tensile strength between 10,000 pounds per square inch (psi) and 14,000 psi.

17. A method of assembling a dry test strip assembly having a plurality of separate fluid compartments, said method comprising:

placing a continuous dry test strip element on a dry test strip carrier base having first and second test ports, said continuous dry test strip material covering said first and second test ports and having a first test strip element portion over said first test port and a second test strip element portion over said second test port; and

said continuous dry test strip element having reagent layers having essentially no breaks between the said first and second test strip element portions of said reagent layers; and

snapping a cover on said base while sufficiently compressing said dry test strip element between said cover and said base at a location between said first and second test ports so that fluid cannot flow between said first test strip element portion and said second test strip element portion, thereby dividing said continuous dry test strip into said plurality of separate fluid compartments.

18. A method of manufacturing a dry test strip assembly, said method comprising:

placing a dry test strip carrier base on a conveyer, said base having a well;

conveying said test strip carrier base on said conveyer to a cutting station and then to a cover station;

at said cutting station, cutting a dry test strip element from a dry test strip material and placing said cut dry strip element in said well in said base;

at said cover station, snapping a cover onto said base, thereby compressing said dry test strip element between said cover and said base to complete said dry test strip assembly;

wherein said placing, conveying, cutting, and snapping are all performed automatically by machinery without human handling.

19. A method as in claim 18 wherein said cutting comprises punching out or shearing said dry test strip element from a sheet of material or a ribbon of material.

20. A method as in claim 18, and further comprising loading a plurality of said dry test strips in a vial and capping said vial, wherein said loading and capping are also performed automatically by machinery without human handling.