CN1512175A - Test strip for testing biochemical matter in blood and its producing method - Google Patents

Abstract

The test strip for testing biochemical matter in blood includes one insulating substrate, one enzyme reaction area on the substrate, work electrode and reference electrode with one end connected to the enzyme reaction area and other end connected to the test instrument, and one non-enzyme reaction area adjacent to the enzyme reaction area with also work electrode and reference electrode connected. The enzyme reaction area and the non-enzyme reaction area are separated with a separating band in the bottom and covered with one covering sheet to form one blood sucking passage with side port. Compared with available technology, the test strip has the advantages of high test accuracy, high test repeatability and micro sampling design.

Description

A kind of test-strips and production method thereof that is used to test blood mesophytization material

Technical field:

The present invention relates to a kind of test-strips and production method thereof that is used to test blood mesophytization material

Background technology:

The test-strips that is used to test blood mesophytization material at present is to be communicated with the enzyme reaction district by substrate, on-chip enzyme reaction district, an end, and working electrode that the other end links to each other with tester and reference electrode are formed.When adopting this test-strips to test, the blood sample amount that needs is bigger, usually be no less than the 3-4 microlitre, so must take mode with the broken finger of acupuncture, could satisfy requirement than the large sample amount, the normal like this pain that causes that blood count person is bigger, simultaneously because it has only an enzyme reaction district, thereby test result usually is subjected to other reducing substances in the blood sample, the interference of factor such as red blood cell and blood viscosity makes test result deviation occur, thereby influences test result accuracy and reappearance, in addition since its working electrode area greater than the area of reference electrode, thereby the less stable of test.

Summary of the invention:

At the prior art above shortcomings, it is few to the invention provides a kind of blood sample amount that needs, strong interference immunity, and stable testing is good, the test-strips and the production method thereof that are used to test blood mesophytization material that accuracy is high.

The present invention is used to test the test-strips of blood mesophytization material, comprise the working electrode and the reference electrode that communicate an insulating substrate, this on-chip enzyme reaction district, an end and enzyme reflection district the other end links to each other with tester, also comprise a non-enzyme reaction district adjacent with the enzyme reaction district, this non-enzyme reaction district is connected with working electrode and reference electrode, the bottom in enzyme reaction district and non-enzyme reaction district is separated by the isolation strip, the two top is covered by cover plate, forms a passage of sucking blood with wing passage mouth.

For making test result more stable, two working electrode areas preferably equate and all less than the area of reference electrode.

The processing step and the process conditions of producing above-mentioned test-strips method are followed successively by:

A. select substrate material, make substrate with good stability, smooth, nonhygroscopic insulating material;

B. on substrate, evenly cover conductive material;

C. use the laser scribing machine, to substrate and on electrode divide cutting stock by setting size;

D. adopt the plasma process aura to handle electrode;

E. with glue spreader gluing is carried out in the inoperative zone of electrode and cover, and isolate enzyme reaction district and non-enzyme reaction district;

F. add in the non-enzyme reaction district and do not contain enzyme reagent, and with adding the enzyme reaction district behind this reagent interpolation enzyme, dry then;

G. make cover plate (8) with good stability, smooth, nonhygroscopic insulating material, cover the top in enzyme reaction district and non-enzyme reaction district.

Because the present invention is provided with non-enzyme reaction district, an enzyme reaction district, these two reaction zones can produce different reaction signals during test, compare with these two kinds of reaction signals, the signal value in non-enzyme reaction district is rejected in enzyme reaction district signal, got rid of the interference of factors such as other reducing substances, red blood cell and blood viscosity thus, make the test result that obtains much more accurate, and reappearance and stability are all much better than prior art.Also drawing a result through repeatedly testing, is exactly to work as the area of the area of reference electrode greater than working electrode, and the stability of test is more better than existing technologies (the working electrode area is greater than the reference electrode area).In the present invention, blood-sample withdrawal utilizes the capillary siphoning principle by the automatic application of sample of passage contact blood sample of sucking blood, its blood volume that needs is usually about 1 microlitre, be no more than 2 microlitres at most, therefore testing blood sampling not only is confined to finger blood less owing to make blood using amount, also can be at arm, legs etc. locate to get blood, these local neural distributions are lacked, and tester's pain also reduces, and also avoids finger to get the susceptible phenomenon of blood simultaneously.

For reaching the purpose of Trace Blood test, need the test strip electrode area little, in very little scope, arrange three electrodes (two working electrodes, a reference electrode), in production technology of the present invention, adopt the method for cut to realize.For offsetting the problem that electrode area reduces the test susceptibility decline that causes, the present invention has adopted plasma aura PROCESS FOR TREATMENT electrode, has enlarged the specific surface area of electrode, thereby guarantees the sensitivity of test.

Test-strips remarkable advantage of the present invention in sum is its test high accuracy and the design of high reappearance and microsampling.

Description of drawings:

Fig. 1 is a front view of the present invention;

Fig. 2 is the cut-open view of Fig. 1.

Embodiment:

Test-strips of the present invention as can be seen from Figure 1 is provided with two reaction zones on substrate 1, one is non-enzyme reaction district 5 for 2, one in enzyme reaction district, and these two reaction zones are adjacent, its bottom is separated by isolation strip 7, and be connected with working electrode 3 and working electrode 6 respectively, the two area equates that reference electrode 4 is the public electrodes of the two, its area is greater than working electrode (one), we can see from figure, the lower end of the straight-through test-strips of these three electrodes, and this end is the connectivity port of test-strips and tester.

In conjunction with Fig. 2 as can be seen, the height of isolation strip 7 is lower than the height of above-mentioned two reaction zone up-and-down boundaries, be coated with cover plate 8 on this height, formed the passage 9 of sucking blood by the up-and-down boundary and the bottom of this cover plate and above-mentioned two reaction zones, side is the application of sample port, with this port contact blood sample, sharp capillary siphoning principle, blood sample is drawn in the passage 9 of sucking blood automatically, reacts by two reaction zones again, send signal and send into tester, show test results by tester.

The processing step and the process conditions of an embodiment in the manufacture method of the present invention are followed successively by:

A. with the Polyvinylchloride substrate material;

B. the even carbon coating of mode by serigraphy is starched on substrate material, 60-90 ℃ of drying;

C. use the laser scribing machine, to substrate and on electrode divide cutting stock by setting size, for example determine that every sizes of substrate wide is 6 millimeters, length is 38 millimeters, in three carbon electrodes, the width of two working electrodes is respectively 1.25mm, and the width of reference electrode is 1.5mm, carbon electrode thickness is not more than 0.03 millimeter, and spacing is not more than 0.5 millimeter and divides cutting stock between two adjacent electrodes;

D. adopt plasma aura PROCESS FOR TREATMENT electrode;

E. be coated with Polyurethane glue with the inoperative zone of glue spreader, isolate enzyme reaction district and non-enzyme reaction district electrode;

F. add the reagent that mixes by electronic conduction media and stabilizing agent in the non-enzyme reaction district, add by enzyme in the enzyme reaction district, the reagent that electronic mass media Jie and stabilizing agent mix is put into drying box then with 25-35 ℃, carries out dry fixating reagent in 10-20 minute;

G. make patch material with vinyl chloride, its thickness is not more than 0.1 millimeter, and cover plate is covered the top of enzyme reaction district and non-enzyme reaction, with the formation passage of sucking blood.

The substrate and the patch material that adopt when the present invention makes can be: Polyvinylchloride, poly terephthalic acid, polyethylene terephthalate, polycarbonate, macrogol ester; The material that electrode is used can be: gold, platinum, silver, carbon; The electrode material covering method can adopt: printing, plating, sputter.

Claims (3)

1. test-strips that is used to test blood mesophytization material, comprise an insulating substrate (1), enzyme reaction district (2) on this substrate (1), one end and enzyme reflection district (2) working electrode (3) and the reference electrode (4) that the other end links to each other with tester that communicate, it is characterized in that: also comprise a non-enzyme reaction district (5) adjacent with the enzyme reaction district, this non-enzyme reaction district (5) is connected with working electrode (6) and reference electrode (4), enzyme reaction district (2) is separated by isolation strip (7) with the bottom in non-enzyme reaction district (5), the two top is covered by cover plate (8), forms a passage of sucking blood (9) with wing passage mouth.

2. the test-strips of test blood mesophytization material according to claim 1 is characterized in that: the area of working electrode (3) and working electrode (6) equates, and all less than the area of reference electrode (4).

3. the production method of a test-strips as claimed in claim 1 comprises the processing step and the process conditions of following order:

A. select substrate material, make substrate (1) with good stability, smooth, nonhygroscopic insulating material;

B. go up at substrate (1) and evenly cover conductive material;

C. use the laser scribing machine, to substrate and on electrode divide cutting stock by setting size;

D. adopt the plasma process aura to handle electrode;

E. with glue spreader gluing is carried out in the inoperative zone of electrode and cover, and isolate enzyme reaction district and non-enzyme reaction district;

F. add in the non-enzyme reaction district and do not contain enzyme reagent, and with adding the enzyme reaction district behind this reagent interpolation enzyme, dry then;

G. make cover plate (8) with good stability, smooth, nonhygroscopic insulating material, cover the top in enzyme reaction district and non-enzyme reaction district.

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