Diagnostic tape unit

• US 8,449,823 B2
• Filed: 11/05/2010
• Issued: 05/28/2013
• Est. Priority Date: 05/06/2008
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Seelig, Peter, Leininger, Helmut
• Primary Examiner(s): SIEFKE, SAMUEL P
• Application Number:
  US12/940,368
• Publication Number:
  US 20110273715A1
• Time in Patent Office: 935 Days
• Field of Search: 422/66, 422/63, 422/68.1
• US Class Current: 422/66
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: B01L 2300/0654 Lenses; Optical fibres
• CPC Class Codes: B01L 2300/0812 Bands; Tapes
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0841 Drums
• CPC Class Codes: B01L 3/505 flexible containers not provided for above
• CPC Class Codes: B01L 9/523 for multisample carriers, e.g. used for microtitration plates
• CPC Class Codes: G01N 21/55 Specular reflectivity
• 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 33/48764 Test tape taken off a spool
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose

Abstract

The invention concerns a diagnostic tape unit with a test tape that can be wound onto a spool which comprises a transport tape and a plurality of test elements mounted thereon, where the test elements have an analytical reagent layer, a carrier foil supporting the reagent layer and a piece of adhesive tape connecting the carrier foil with the transport tape, and where the front side of the reagent layer facing away from the carrier foil is designed for the application of a sample substance. According to the invention it is proposed that the test elements in combination with the light transmitting transport tape in each case form an optical multi-layer system for a rear-side reflection-photometric measurement of the reagent layer.

Claims

1. A diagnostic tape unit comprising a tape cassette for blood sugar tests, the tape cassette having a test tape that is wound onto or can be wound onto a spool as a tape reel, the test tape comprising a light-transmitting transport tape and a plurality of spaced-apart test elements mounted thereon, the test elements each comprising an analytical reagent layer supported on a carrier foil layer, and further including an adhesive tape layer comprising a liner foil having adhesive on opposite sides and connecting the carrier foil layer adhered on the one side with the transport tape adhered on the opposite side, wherein a front side of the reagent layer faces away from the carrier foil layer and is configured for the application of a sample substance, the test elements in combination with the transport tape in each case forming an optical multi-layer system for a rear-side reflection-photometric measurement of the reagent layer, wherein the transport tape, the adhesive tape layer and the carrier foil layer of each test element each have optical properties comprising refractive index, transmission and haze, and wherein at least one optical property of the transport tape, adhesive tape layer and carrier foil layer are matched within predetermined tolerances.

2. The diagnostic tape unit according to claim 1, wherein the refractive index of the transport tape, the carrier tape and the adhesive tape layer is in each case between about 1.4 and 1.7.

3. The diagnostic tape unit according to claim 2, wherein the refractive index of the transport tape, the carrier tape and the adhesive tape layer is in each case between about 1.5 and 1.6.

4. The diagnostic tape unit according to claim 1, wherein the individual layers of the multi-layer system have a maximum refractive index difference of about 0.2.

5. The diagnostic tape unit according to claim 4, wherein the individual layers of the multi-layer system have a refractive index difference of less than about 0.1.

6. The diagnostic tape unit according to claim 1, wherein the total refractive index of the multi-layer system is about 1.5.

7. The diagnostic tape unit according to claim 1, wherein the transport tape, the adhesive tape layer and the carrier foil layer each have a transmission in the visible wavelength range of more than 80%.

8. The diagnostic tape unit according to claim 7, wherein the transport tape, the adhesive tape layer and the carrier foil layer each have a transmission in the visible wavelength range of between about 85% and 92%.

9. The diagnostic tape unit according to claim 1, wherein the total transmission of the multi-layer system in the visible wavelength range is at least about 80%.

10. The diagnostic tape unit according to claim 1, wherein the transmission tolerance is less than about 5% for the entirety of the test elements of a test tape.

11. The diagnostic tape unit according to claim 1, wherein the optical haze of the carrier foil layer and of the adhesive tape layer in the visible wavelength range is less than about 10%.

12. The diagnostic tape unit according to claim 11, wherein the optical haze of the carrier foil layer and of the adhesive tape layer in the visible wavelength range is less than about 8%.

13. The diagnostic tape unit according to claim 1, wherein the optical haze of the transport tape in the visible wavelength range is less than about 3%.

14. The diagnostic tape unit according to claim 13, wherein the optical haze of the transport tape in the visible wavelength range is less than about 2.5%.

15. The diagnostic tape unit according to claim 1, wherein the total optical haze of the multi-layer system in the visible wavelength range is less than about 20%.

16. The diagnostic tape unit according to claim 15, wherein the total optical haze of the multi-layer system in the visible wavelength range is less than about 15%.

17. The diagnostic tape unit according to claim 1, wherein the haze of the multi-layer system decreases in a time interval in particular of between about 1 and 2 weeks after its manufacture, and wherein subsequently the haze remains relatively constant.

18. The diagnostic tape unit according to claim 1, wherein the haze tolerance for the entirety of the multi-layer systems of a test tape is less than about 5%.

19. The diagnostic tape unit according to claim 1, wherein the adhesive tape layer comprises a transparent foil substrate furnished on both sides with an adhesive layer.

20. The diagnostic tape unit according to claim 1, wherein the transport tape and the carrier foil layer each comprise a PET film.

21. The diagnostic tape unit according to claim 1, wherein an analyte contained in a sample substance in the form of a body fluid can be determined by a relative reflectance measurement, wherein calibration data are assigned to the test elements which define the concentration of the analyte as a function of the measured reflectance.