CN111965348A - Anti-backflow and anti-misjudgment detection test strip - Google Patents

Abstract

The invention relates to the technical field of immunochromatography diagnosis, in particular to a detection test strip for preventing backflow and misjudgment, the test strip adds the gravity action in the flowing process of the sample by arranging the inclined bottom plate (1), the side wings are arranged on the two sides of the water absorption pad (5), so that the area of the water absorption pad (5) is obviously increased compared with the water absorption pad without the side wings, the chromatographic force brought by the water absorption pad (5) is increased, the sample can only flow to the reaction pad (3) and the combination pad (4) due to the gravity and the chromatographic force, can effectively prevent the sample from flowing back, ensures the chromatography effect, has no obvious difference between the reaction time and the common test strip, and ensures that the sample has no obvious difference in the detection process, due to the setting of the first boundary line (8) and the second boundary line (9), the influence of ghost lines on the result interpretation is avoided, the accuracy of result reading is improved, and the sensitivity and the specificity are not obviously different.

Description

A detection test strip with anti-reflux and anti-misjudgment

technical field

The invention relates to the technical field of immunochromatographic diagnosis, in particular to a detection test strip with anti-reflux and anti-misjudgment.

Background technique:

Immunochromatography is a new type of immunoassay method that appeared in the early 1980s. It is a fast and convenient immunoassay technology based on immunopenetration. The principle is based on the action of the capillary, the sample moves along the nitrocellulose membrane to the area marked with the specific antibody. When the corresponding antigen and antibody in the sample are specifically combined, the area can display a certain color. Immunochromatographic test strips are widely used in various fields due to their advantages of rapidity, simplicity, low cost and easy portability.

At present, when the test strip is used for rapid detection, it is placed flat on the table, and then the sample is dropped on the sample pad. The sample moves forward to the binding pad and the reaction pad due to the chromatographic effect, and the detection result is displayed on the reaction pad. The chromatographic effect is mainly due to the water-absorbing pad located at the end of the test strip. However, the water-absorbing pad is far away from the sample pad, and the test samples are mostly body fluid samples. Due to individual differences, the body fluid may be viscous, so we only rely on the test paper. Due to the chromatographic effect of the strip, the sample may not be chromatographed to the absorbent pad area of the test strip or the chromatography may be incomplete, resulting in a deep background, insufficient reaction or unreadable results. In addition, in the actual detection process, the amount of sample added will affect the accuracy of the test results. If the amount of sample added is too small, the test result will not be displayed due to incomplete reaction. This can lead to conditions such as deep background or deposition of marker complexes, which in turn leads to misjudgment of results. The sample reflux is an important factor affecting the test results of the test strip, and solving the sample reflux is of great significance to the accuracy of the test results of the test strip. Patent CN201720434591.2 discloses a test strip for detection. The test strip can ensure that the test strip is facing upwards and cross-contamination will not occur, but it does not solve the phenomenon of sample backflow. Patent CN201621013716.6 discloses a fecal occult blood detection kit. By adding a ventilation window on the upper cover, the liquid chromatography effect is improved, and the phenomenon of sample backflow caused by the rapid evaporation of liquid at one end of the sample pad is avoided, but it does not solve the problem of the sample. Reflux phenomenon caused by adding too much.

In addition, the storage of test strips has certain requirements on the temperature and humidity of the environment, especially the humidity; if the humidity is too high, the activity of the antigen or antibody fixed on the binding pad and the detection and control strips of the reaction pad will be affected. At the same time, the reaction pad-nitrocellulose membrane will also be affected, so that ghost lines appear during the actual detection, that is, a light-colored band appears on the upper or lower edge of the actual detection zone or control zone. It is a non-specific band, which will mislead the interpretation of the result. In addition, even if the test strip is sealed and stored, if it is not used for a long time after opening, the outer packaging is damaged or stored for a long time, ghost lines may occur during the test, as shown in Figure 1, which affects the accuracy of the test results.

In view of the above technical problems, the inventor has developed a new way to prevent backflow and misjudgment. Inaccurate results caused by streaming. Mark the upper and lower edges of the detection strip and the control strip of the test strip. If the color strips outside the marking are non-specific strips, they are not included in the interpretation range, so that the interference caused by ghost lines can be eliminated. The test strip is aimed at the public without professional knowledge, and can also accurately interpret the test results, reduce the limiting factors in the use of the test strip, and can be popularized and used on a large scale.

SUMMARY OF THE INVENTION

The purpose of the present invention is to provide an anti-reflux and anti-misjudgment detection test strip, including a sample pad 2, a binding pad 3, a reaction pad 4 and a water-absorbing pad 5. The sample pad 2, the binding pad 3, the reaction pad The width of the pad 4 and the absorbent pad 5 are equal, and they are connected in turn. The length of the sample pad 2 and the bond pad 3 is 1-2mm, the length of the bond pad 3 and the reaction pad 4 is 1-2mm, and the reaction pad 4 and the absorbent pad are connected with a length of 1-2mm. 5. The connecting length is 1-2mm; the reaction pad 4 is provided with a detection band 6 and a control band 7, the detection band 6 is arranged at one end close to the binding pad 3, and the control band 7 is arranged close to the water absorption. one end of the pad 5; the test strip is also provided with a bottom plate 1, the bottom plate 1 is inclined, and the sample pad 2, the binding pad 3, the reaction pad 4 and the water absorption pad 5 are sequentially arranged on the inclined surface of the bottom plate 1 cover the entire slope of the bottom plate 1, the sample pad 2 is arranged on the higher end of the slope of the bottom plate 1, and the water-absorbing pad 5 is arranged on the bottom end of the slope of the bottom plate 1 to form an inclined test strip, and the sample adheres to gravity and chromatography. , can only flow from the higher sample pad 2 to the lower absorbent pad 5, effectively preventing sample backflow. The preparation materials of the sample pad 2, the binding pad 3, the reaction pad 4 and the absorbent pad 5 are the same as those used for preparing test strips in the art, ensuring that the sample pad 2, the binding pad 3, the reaction pad 4 and the absorbent pad 5 can be achieve their respective effects. Preferably, the angle between the bottom surface of the bottom plate 1 and the inclined surface is 10°-30°, the sample can be moved downward at a constant speed by the action of gravity and chromatographic force, and the reaction will not be incomplete due to the flow too fast, resulting in the sample Inaccurate test results.

Preferably, the included angle between the bottom surface of the bottom plate 1 and the inclined surface is 15°-25°.

Preferably, the sloped portion of the bottom plate 1 is made of anti-leakage material, and the sample can only flow on the surface of the bottom plate 1 and cannot penetrate into the bottom plate 1 to prevent waste of the sample and also prevent the sample from infiltrating into the bottom plate 1 resulting in inaccurate results.

Preferably, the sloped portion of the bottom plate 1 is made of polyethylene material.

Preferably, extending first side wings 501 and second side wings 502 are provided on both sides of the absorbent pad 5 near the bottom end. The first side wings 501 and the second side wings 502 have the same size and are integrally formed with the absorbent pad 5 , the first side wings 501 and the second side wings 502 increase the overall area of the absorbent pad 5, thereby increasing the suction force of the absorbent pad 5, facilitating the flow of samples, and effectively draining excess samples.

Preferably, the test strip is further provided with a first dividing line 8 and a second dividing line 9, the first dividing line 8 is set at the end of the detection belt 6 away from the control belt 7, and the second dividing line 8 The boundary line 9 is set at the end of the control strip 7 away from the detection strip 6, and the results appearing within the first boundary line 8 and the second boundary line 9 are valid, and appearing outside the first boundary line 8 and the second boundary line 9 The result is invalid.

Preferably, the distance between the first demarcation line 8 and the detection zone 6 is 0.4-0.8 cm, and the distance between the second demarcation line 9 and the control zone 7 is 0.4-0.8 cm.

Preferably, the first demarcation line 8 and the second demarcation line 9 are arranged on the surface reaction pad 4 of the test strip, the back bottom plate 1 or the cross-section of the side bottom plate 1 and the reaction pad 4, as long as the detection strip 6 And the control strip 7 can be placed between the first dividing line 8 and the second dividing line 9 .

Preferably, the first demarcation line 8 and the second demarcation line 9 can be set to any one of a straight line, a curve, an arc, a polygon or a petal, and can cover a part or all of the width of the test strip, It is enough to be able to correctly decipher the results.

Preferably, the first demarcation line 8 and the second demarcation line 9 are set to be black, red, green, yellow, orange, purple, color or mosaic color.

The beneficial effects of the present invention are as follows: the anti-reflux test detection paper strip of the present invention adds gravitational action and greater chromatographic force during the flow of the sample, and the sample can only flow to the reaction pad 3 and the reaction pad 3 due to the gravitational force and the chromatographic force. The combination pad 4 can effectively prevent the backflow of the sample, ensure the chromatographic effect, and the reaction time is not significantly different from that of ordinary test strips; during the detection process of the sample, due to the setting of the first dividing line 8 and the second dividing line 9, It avoids the impact of ghost lines on the interpretation of results and increases the accuracy of reading results; there is no significant difference in sensitivity and specificity.

Description of drawings

Figure 1: Ghost lines appearing during detection of test strips

Figure 2: A schematic diagram of a test strip for preventing backflow and preventing misjudgment

1. Bottom plate; 2. Sample pad; 3. Binding pad; 4. Reaction pad; 5. Absorbent pad; 501. First wing; 502. Second wing; The dividing line; 9. The second dividing line

Figure 3: A top view of a test strip with anti-reflux and anti-misjudgment

Figure 4: The main view of the comparison of the test results of the anti-reflux and anti-misjudgment test strips and ordinary test strips

1. Anti-reflux and anti-misjudgment test strips; 2. Ordinary test strips

Figure 5: The top view of the comparison of the test results of the anti-reflux and anti-misjudgment test strips and ordinary test strips

1. Anti-reflux and anti-misjudgment test strips; 2. Ordinary test strips

Figure 6: Plan view of the comparison of the test results of the anti-reflux and anti-misjudgment test strips and ordinary test strips

1. Anti-reflux and anti-misjudgment test strips; 2. Ordinary test strips

Detailed ways

The present invention will be further described below with reference to the accompanying drawings and specific embodiments, but the protection scope of the invention is not limited by the following embodiments.

Embodiment 1, a kind of anti-reflux, anti-misjudgment detection test strip composition

An anti-reflux and anti-misjudgment test strip, comprising a sample pad 2, a binding pad 3, a reaction pad 4 and a water-absorbing pad 5, the sample pad 2, the binding pad 3, the reaction pad 4 and the water-absorbing pad 5 The widths are equal, and they are connected in sequence. The length of the connection between the sample pad 2 and the binding pad 3 is 2 mm, the length of the connection between the binding pad 3 and the reaction pad 4 is 2 mm, and the length of the connection between the reaction pad 4 and the absorbent pad 5 is 2 mm; The pad 4 is provided with a detection strip 6 and a control strip 7, the detection strip 6 is arranged at one end close to the binding pad 3, and the control strip 7 is arranged at one end close to the water-absorbing pad 5; the test strip is also A bottom plate 1 is provided, the bottom plate 1 is inclined, and the sample pad 2, the binding pad 3, the reaction pad 4 and the water absorption pad 5 are sequentially arranged on the inclined surface of the bottom plate 1, covering the entire inclined surface of the bottom plate 1, and the sample pad 2 It is arranged at the higher end of the slope of the bottom plate 1, and the absorbent pad 5 is arranged at the bottom end of the slope of the bottom plate 1 to form an inclined test strip. The sample depends on gravity and chromatography, and can only flow from the higher sample pad 2 to the higher end. The low absorbent pad 5 effectively prevents the backflow of the sample. The preparation materials of the sample pad 2, the binding pad 3, the reaction pad 4 and the absorbent pad 5 are the same as those used in the preparation of test strips in the art, ensuring that the sample pad 2, the binding pad 3, the reaction pad 4 and the absorbent pad 5 can be achieve their respective effects. Preferably, the angle between the bottom surface of the bottom plate 1 and the inclined surface is 25°, and the sample can be moved downward at a uniform speed with the help of gravity and chromatographic force, and the reaction will not be incomplete due to too fast flow, which will lead to poor sample detection results. Inaccurate. The inclined surface part of the bottom plate 1 is made of polyethylene material, the sample can only flow on the surface part of the bottom plate 1, and cannot penetrate into the bottom plate 1, so as to prevent the waste of the sample, and it can also prevent the sample from infiltrating into the bottom plate 1 and cause the reaction The result is inaccurate. The water absorbent pad 5 is provided with extending first side wings 501 and second side wings 502 on both sides near the bottom end. The side wings 501 and the second side wings 502 can increase the suction force of the absorbent pad 5, which is beneficial to the flow of the sample and effectively drains the excess sample.

The test strip is also provided with a first dividing line 8 and a second dividing line 9, the first dividing line 8 is arranged at one end of the detection belt 6 away from the control belt 7, and the second dividing line 9 Set at the end of the control strip 7 away from the detection strip 6, the results appearing in the first dividing line 8 and the second dividing line 9 are valid, and the results appearing outside the first dividing line 8 and the second dividing line 9 are Invalid. The distance between the first demarcation line 8 and the detection zone 6 is 0.6 cm, and the distance between the second demarcation line 9 and the control zone 7 is 0.6 cm. The first demarcation line 8 and the second demarcation line 9 are arranged on the surface reaction pad 4 of the test strip, on the back bottom plate 1 or on the cross-section of the side bottom plate 1 and the reaction pad 4, as long as the detection strip and the control strip are placed. It is enough to be between the first dividing line 8 and the second dividing line 9 . The first dividing line 8 and the second dividing line 9 can be set as straight lines, which can cover part or all of the width of the test strip, as long as the results can be correctly interpreted. The first dividing line 8 and the second dividing line 9 are set to be black.

Embodiment 2, the use of a kind of anti-reflux, anti-misjudgment detection test strip and the result reading method

(1) prepare corresponding test strips according to the test strip composition described in embodiment one;

(2) When in use, drop the sample on the sample pad 1 of the test strip, then the sample is gradually chromatographed to the binding pad 3 based on the capillary action, the suction action of the absorbent pad 5 and the gravity action, and the labeled particles on the binding pad 3 After the binding reaction and the labeled particles are chromatographed to the reaction pad 4, they react with the substances coated on the detection line 6 and the quality control line 7 to develop color, and the excess sample and labeled particles are chromatographed to the water absorption pad 5.

(3) Read the test result, if the strip showing the result appears between the first dividing line 8 and the second dividing line 9, the result reading is valid, if the strip showing the result appears between the first dividing line 8 and the second dividing line 9 Outside the second dividing line 9, the result read is invalid. Embodiment 3, a kind of anti-reflux, anti-misjudgment detection test strip and the comparison of the detection results of ordinary test strips

(1) Take an anti-reflux, anti-misjudgment test strip and an ordinary test strip respectively, and place them on a horizontal desktop;

(2) Add samples to the sample pads of the anti-reflux and anti-misjudgment test strips and ordinary test strips, and let stand for 1 minute;

(3) Observing the test results, the results show that the anti-reflux and anti-misjudgment test strips develop normal color, while the ordinary test strips do not develop color. Especially when the sample volume is small, due to the backflow factor, the sample of the ordinary test strip cannot reach the detection line and the quality control line, and the detection line and the quality control line cannot develop color. The experimental results are shown in Figures 4, 5, and 6.

Claims (10)

1. An anti-reflux and anti-misjudgment detection test strip, comprising a sample pad (2), a binding pad (3), a reaction pad (4) and a water-absorbing pad (5), the sample pad (2) , the binding pad (3), the reaction pad (4) and the water absorbing pad (5) have the same width, and are connected in turn. ) and the reaction pad (4) are connected with a length of 1-2mm, and the reaction pad (4) and the water-absorbing pad (5) are connected with a length of 1-2mm; the reaction pad (4) is provided with a detection belt (6) and a control Belt (7), the detection belt (6) is arranged at one end close to the bonding pad (3), and the control belt (7) is arranged at one end close to the water absorbing pad (5); it is characterized in that: The test strip is also provided with a bottom plate (1), the bottom plate (1) is inclined, the sample pad (2), the binding pad (3), the reaction pad (4) and the water absorption pad ( 5) It is arranged on the inclined surface of the bottom plate (1) in turn, covering the entire inclined surface of the bottom plate (1), the sample pad (2) is arranged on the higher end of the inclined surface of the bottom plate (1), and the water absorption pad (5) is arranged on the inclined surface of the bottom plate (1) bottom end. 2 . The detection test strip according to claim 1 , wherein the angle between the bottom surface of the bottom plate ( 1 ) and the inclined surface is 10°-30°. 3 . 3 . The detection test strip according to claim 2 , wherein the angle between the bottom surface of the bottom plate ( 1 ) and the inclined surface is 15°-25°. 4 . 4. The detection test strip according to claim 2 or 3, characterized in that, the slope portion of the bottom plate (1) is made of leak-proof material. 5. The detection test strip according to claim 4, characterized in that, the slope part of the bottom plate (1) is made of polyethylene material. 6. detection test strip as claimed in claim 1, is characterized in that, described water-absorbing pad (5) is provided with the first side flap (501) and the second side flap (502) that extend near bottom end both sides, so The first side flap (501) and the second side flap (502) have the same size and are integrally formed with the absorbent pad (5). 7. detection test strip as claimed in claim 1, is characterized in that, described test strip is also provided with first dividing line (8) and second dividing line (9), described first dividing line (9) The boundary line (8) is arranged at the end of the detection band (6) away from the control band (7), and the second boundary line (9) is arranged at the end of the control band (7) away from the detection band (6). 8. detection test strip as claimed in claim 7 is characterized in that, the distance of described first dividing line (8) and detection zone (6) is 0.4-0.8cm, and described second dividing line ( 9) The distance from the control belt (7) is 0.4-0.8 cm. 9. detection test strip as claimed in claim 7 is characterized in that, described first dividing line (8) and second dividing line (9) are arranged on the surface reaction pad (4) of test strip, On the rear bottom plate (1) or on the cross-section of the side bottom plate (1) and the reaction pad (4). 10. detection test strip as claimed in claim 7, is characterized in that, described first dividing line (8) and second dividing line (9) can be set to linear, curved, arc, polygon or Any of the petal shapes can cover a part or all of the width of the test strip; the first dividing line (8) and the second dividing line (9) are set to black, red, green, yellow, orange, purple , Color, or Patch Color.

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