Test strip and method for manufacturating test strips

1. A test strip, comprising:

a base layer;

an intermediate layer overlaid on the base layer;

a blood retaining layer comprising a slit and a blood retaining region fluidly commuted with the slit and overlaid on the intermediate layer;

an upper layer overlaid on the blood retaining layer;

a reagent disposed on a surface of the intermediate layer and exposed in the slit, wherein there are a predetermined depth and a actual depth from an interface between the slit and the upper layer to an upper surface of the reagent; and

a classification mark representing a correction factor and disposed on an upper surface of the upper layer or a lower surface of the base layer;

wherein the correction factor is the product of a difference between the predetermined depth and the actual depth and a reciprocal of the predetermined depth.

2. The test strip according to claim 1 , wherein the base layer comprises an opening, and the opening is aligned with reagent.

3. The test strip according to claim 1 , wherein the predetermined depth is between 40 μm and 50 μm.

4. The test strip according to claim 1 , wherein each of the base layer, the intermediate layer, and the upper layer respectively comprises a through hole, and the three through holes are aligned with the blood retaining region.

5. The test strip according to claim 1 , wherein the base layer is a black polyethylene terephthalate film layer.

6. The test strip according to claim 1 , wherein the intermediate layer is a transparent film layer.

7. The test strip according to claim 1 , wherein the blood retaining layer is a transparent film layer formed of an adhesive material.

8. The test strip according to claim 1 , wherein the upper layer is a transparent polyethylene terephthalate film layer.

9. The test strip according to claim 1 , wherein a thickness of the blood retaining layer is 54 μm.

10. A method for manufacturing a test strip, comprising:

providing a sheet-shaped article which is composed of a plurality of test strips, wherein each of the test strips comprises a base layer, an intermediate layer, a blood retaining layer, an upper layer, and a reagent, the blood retaining layer comprises a slit and a blood retaining region fluidly commuted with the slit, and the reagent is disposed on a surface of the intermediate layer and exposed in the slit;

providing a predetermined depth from an interface between the slit and the upper layer to an upper surface of the reagent for the test strips;

measuring an actual depth from the interface between the slit and the upper layer to the upper surface of the reagent for each of the test strips;

performing calculation to respectively obtain a correction factor for each of the test strips according to the actual depth and the predetermined depth for each of the test strips;

labeling a corresponding one of a plurality of classification marks on each of the test strips according to the correction factor associated with each of the test strips; and

dividing the sheet-shaped article and cutting the test strips into each individual unit;

wherein the correction factor is the product of a difference between the predetermined depth and the actual depth and a reciprocal of the predetermined depth.

11. The method for manufacturing a test strip according to claim 10 , wherein the actual depth is measured by an optical measuring instrument.

12. The method for manufacturing a test strip according to claim 11 , wherein the optical measuring instrument measure the actual depth for each test strip along an S-like path.

13. The method for manufacturing a test strip according to claim 10 , wherein the corresponding one of the plurality of classification mark is labeled on the upper surface of the upper layer by a laser marker or an inkjet printer.

14. The method for manufacturing a test strip according to claim 10 , wherein the corresponding one of the plurality of classification mark is labeled on the lower surface of the base layer by a laser marker or an inkjet printer.

15. The method for manufacturing a test strip according to claim 10 , wherein the corresponding one of the plurality of classification mark is distinguished by different patterns with different gray levels for various groups.

16. The method for manufacturing a test strip according to claim 10 , wherein the corresponding one of the plurality of classification mark is distinguished by different dot symbols with different gray levels for various groups.

17. The method for manufacturing a test strip according to claim 10 , wherein the corresponding one of the plurality of classification mark is used to correct an error resulted from a difference between the predetermined depth and the actual depth in a colorimetric analysis.

18. The method for manufacturing a test strip according to claim 17 , wherein the colorimetric analysis calculates a concentration of a reaction product between blood and the reagent based on a formula of Beer-Lambert Law.

19. The method for manufacturing a test strip according to claim 18 , wherein the difference between predetermined depth and the actual depth causes a variation in an optical path length of the formula of Beer-Lambert Law.

20. The method for manufacturing a test strip according to claim 19 , wherein the corresponding one of the plurality of classification mark is used to correct an error of the calculated concentration of the reaction product caused from the variation.