WO2018068377A1

WO2018068377A1 - Liquid sample guiding device and test apparatus comprising same

Info

Publication number: WO2018068377A1
Application number: PCT/CN2016/109480
Authority: WO
Inventors: 赵天贤; 张仑; 曾庆; 许文文
Original assignee: 广州好芝生物科技有限公司
Priority date: 2016-10-11
Filing date: 2016-12-12
Publication date: 2018-04-19
Also published as: CN206756858U

Abstract

A liquid sample guiding device and a test apparatus comprising same. The guiding device comprises a cover plate (1) and a channel plate (2). One end of the cover plate (1) is provided with a sample inlet hole (11) and the other end is provided with an air outlet (12). The channel plate (2) is provided with a sample inlet cavity (21), a liquid flow channel (22), and a flow hole (23). The sample inlet cavity (21) is located below the sample inlet hole (11) and is connected to the flow hole (23) by means of the liquid flow channel (22). An extension conduit (24) extends from the end of the flow hole (23) in the channel plate (2) distant from the sample inlet cavity (21). When the cover plate (1) is stacked on the channel plate (2), a ventilation opening communicated with the outside is defined by the channel plate (2) by means of the air outlet (12). The ventilation opening is located on any point of the extension conduit (24), or is located at the distal end of the extension conduit (24) more distant from the sample inlet cavity (21). The test apparatus further comprises a base plate (3) that is stacked with the cover plate (1) and the channel plate (2) to form a test strip. In addition, also provided is a test instrument comprising the test strip.

Description

Liquid sample guiding device and detecting device containing the same

Technical field

The present invention relates to an instant blood detecting device, and in particular to a blood guiding device and a test strip, and a detection system including the test strip.

Background technique

Point-of-care testing (POCT) refers to rapid clinical testing performed next to a patient, usually not necessarily by a clinical examiner, but by a nurse, doctor, or even the patient himself. This is a new method of analyzing the samples immediately at the sampling site, eliminating the complicated processing procedures of specimens in laboratory tests, and quickly obtaining test results. By definition, POCT is a test method that is carried out at the sampling site and uses a portable analytical instrument and supporting reagents to quickly obtain test results.

In recent years, POCT has been widely used, including hospital departments, primary hospitals, community clinics and families, such as blood gas, blood electrolytes, and immediate detection of myocardial markers have been widely used in emergency rooms, ICUs and operating rooms; home blood glucose meters The widespread use is the most successful example of POCT.

Another example is the rapid detection of prothrombin time PT/INR. The INR-POCT system provides patients with a simple, fast, convenient and safe method to monitor the INR value. Fingertip blood test is adopted, and the operation is simple and easy to standardize. Accurate test results can be obtained in minutes or so, avoiding the delay from sample collection and transportation to detection. The existing INR-POCT system consists of an electrochemical analyzer and a single-use test strip.

The invention is applicable to the test strip for POCT, and can be used not only for rapid detection of blood but also for other liquid samples such as urine. Chinese patent CN2788184Y discloses a biological test strip which relates to a biological test strip for detecting blood ketone body concentration or glucose concentration in whole blood, which comprises: a substrate carrying an electrode, and a reaction zone space provided with a reaction reagent a hydrophilic cover plate, a spacer layer between the substrate and the hydrophilic cover plate; wherein the electrode comprises a working electrode and a reference electrode; the spacer layer has a groove opening on one side; the reaction zone space The spacer layer having a groove is defined with the substrate, the hydrophilic cover plate, and has a sample hole and a vent hole. The venting hole is located on the hydrophilic cover. The utility model provides a biological detection test strip capable of rapidly detecting an increase in blood ketone body concentration, which is not only low in cost, simple in structure, but also convenient in operation, and can rapidly detect ketoacidosis. The student The structure of the test strip is a common method for the existing related test strips. However, since the gas outlet of the cover plate is disposed directly above the reaction chamber, turbulence and bubbles are easily generated when the sample flows from the injection chamber to the reaction chamber, thereby affecting the repeatability of the detection result.

Summary of the invention

One of the objects of the present invention is to provide a liquid sample flow guiding device that has a better liquid guiding function in an atmospheric environment. Further, a liquid sample test strip comprising the liquid sample flow guiding device is provided. Further, a detecting instrument including the above liquid sample detecting strip is provided, so that reliability and repeatability in performing POCT detection are improved.

In order to solve the above first object, the technical solution adopted by the present invention is as follows:

A liquid sample guiding device comprises a cover plate and a channel plate which can be stacked under the cover plate, the cover plate is provided with a sample injection hole at one end and an air outlet at the other end; the channel plate is provided with a sample injection a cavity, a liquid flow passage, and a flow hole, wherein when the cover is stacked on the channel plate, the injection cavity is located below the injection hole and is connected through the liquid flow channel a flow hole, the flow hole of the channel plate is further connected with an extension pipe extending in a direction opposite to the injection cavity and the other side of the liquid flow pipe, when the cover plate is stacked on the channel Above the plate, the channel plate defines a venting opening communicating with the outside through the air outlet, the venting opening being located at any point of the extending duct, or the venting opening at least partially contacting the extending duct.

It should be noted that the liquid sample can flow from the injection hole to the injection chamber, and then the liquid flows to the flow hole through the liquid circulation channel. The passage plate defines a venting port communicating with the outside through the air outlet of one end of the cover plate, and the liquid in the liquid circulation passage is ventilated with the outside. The vent may be located anywhere on the extension duct, including the end of the extension duct, or the vent may be at least partially in contact with the extension duct. As a preferred embodiment, the vent is at the end of the extension channel.

Preferably, the venting opening does not overlap the flow aperture.

It should be noted that the venting port is located at any position of the above-mentioned extension pipe (rather than directly on the reaction zone), in particular, a distance between the venting port and the reaction zone (for example, 1 mm - 10 mm) can be made. The liquid fills the reaction zone more quickly, evenly and reliably.

Preferably, the gas outlet has a diameter of 0.1 mm - 5 mm.

Preferably, the ratio of the cross-sectional area of the extension duct to the cross-sectional area of the liquid flow passage is 1:1 - 1:10.

Preferably, the ratio of the length of the extension duct to the length of the liquid flow passage is 1:1 - 1:10.

Preferably, the wall of the liquid circulation channel is at least partially hydrophilic, and the hydrophilic material portion penetrates both ends of the liquid communication channel, thereby facilitating the liquid to contact the flow guiding device from the injection hole. The liquid communication channel flows to the flow aperture and then enters the reaction zone on the underlying substrate.

It should be noted that, by making the liquid circulation pipe at least partially made of a hydrophilic material, the molecule with a polar group can attract the liquid sample to flow toward the end of the liquid circulation pipe; as a preferred embodiment, At least one of the entire length of the tube wall from the head end to the end of the liquid flow conduit is a hydrophilic material, so that the liquid sample flows better from the injection chamber toward the flow hole. As a more preferred embodiment, the wall of the liquid flow conduit is entirely of a hydrophilic material, and in this embodiment the liquid flow is more effective.

Preferably, the wall of the extension duct is at least partially hydrophobic; preferably the portion of the outlet is a hydrophobic material, and the portion adjacent the orifice is a hydrophilic material, and the length of the portion of the hydrophilic material is preferably 1-2 mm. .

It should be noted that the wall of the extension pipe is at least partially made of a hydrophobic material, which can prevent the liquid sample from flowing into the extension pipe and the liquid sample is lost; as one of the preferred embodiments, the pipe is extended from the pipe At least one of the first to the end of the tube wall is a hydrophobic material, which can better prevent the liquid sample from flowing from the liquid flow conduit to the extending conduit; as a more preferred embodiment, the tube for extending the conduit The walls are all hydrophobic and the effect of preventing liquid flow is better in this embodiment.

Preferably, the injection chamber, the liquid circulation channel, the flow hole, the extension pipe and the gas vent are all on the same straight line.

Wherein, when the injection chamber, the liquid circulation passage, the circulation hole, the extension pipe and the venting port are all on the same straight line, on the one hand, the liquid sample can flow into the circulation hole more quickly from the injection cavity, thereby improving the flow efficiency. On the other hand, the flow hole and the vent opening form a straight-through gas permeability, which can improve the gas permeable effect and improve the efficiency of the liquid flow.

Preferably, the injection chamber is located directly below the injection well.

It should be noted that when the injection chamber is directly under the injection hole, the liquid can flow from the injection hole into the injection chamber without hindrance.

Preferably, it is characterized in that the venting port has a distance of from 1 mm to 10 mm from the end of the reaction zone.

Preferably, the ratio of the area of the vent to the area of the injection hole is 1:1 - 1:100.

Preferably, the ground vent has a diameter of 0.3 mm - 5 mm.

In order to achieve the above second object, the technical solution adopted by the present invention is as follows:

A liquid sample detecting test strip comprising the above-mentioned flow guiding device, the test strip further comprising a substrate, wherein the substrate is provided with a reaction area, and when the substrate is stacked under the channel plate, the circulation The pores are located above and at least partially overlap the reaction zone.

Wherein the flow hole is for receiving a liquid sample, such that the liquid sample enters the reaction area through the flow hole, and the reaction area provides a reaction space for the liquid sample.

It should be noted that, as one of the liquid sample detecting test strips, the substrate, the channel plate and the cover plate are stacked one on another from bottom to top.

Preferably, the liquid circulation channel is a groove, and the groove may be non-emptied or hollowed out, when the groove is hollow, when the upper and lower surfaces of the channel plate are respectively stacked with the cover plate and the substrate The space defined by them forms a circulation pipe, one side wall of the pipe is the lower surface of the cover plate, and the other side wall is the upper surface of the substrate.

It should be noted that the liquid circulation passage has various implementable manners. In the present technical solution, the liquid circulation passage can be realized by a pipe formed by a space defined by the groove and the upper and lower surfaces of the channel plate when the cover plate and the substrate are respectively stacked. As one of the embodiments, the lower portion of the liquid flow passage portion on the passage plate is not hollowed out, but forms a liquid flow groove that is recessed downward, and the liquid flows into the reaction region through the groove; as another embodiment, when the liquid The circulation passage is a pipe formed by stacking a cover plate and a substrate on the upper and lower surfaces of the passage plate, and a space formed by the space defined by them, the liquid circulation passage portion of the passage plate is hollowed up and down, and the liquid circulation passage is shared by the cover plate and the substrate. Stacking and defining the resulting liquid flows into the reaction zone through the defined passage.

Preferably, the reaction zone comprises a hydrophilic material.

When the reaction zone contains a hydrophilic material, the liquid sample is drawn from the injection chamber into the reaction zone, so that the liquid sample flows more rapidly and enters the reaction zone more quickly to achieve the reaction.

Further preferably, the tube wall of the flow conduit is at least partially hydrophilic and the hydrophilic material portion extends through both ends of the liquid communication passage.

Regardless of the manner in which the liquid flow conduits are formed in a stacked manner as described above, in a typical embodiment, the liquid flow passages have tubular walls that can be generally expressed in four directions (eg, two of the hollow trenches themselves). The side wall and the cover plate, the portion of the substrate and the hollow groove defined, or the portion of the non-hollowed groove itself that is defined by the three tube walls and the cover plate and the non-hollowed groove. As a preferred embodiment, at least one of the four tube walls is made of a hydrophilic material to allow the liquid to flow better from the injection chamber toward the flow hole. When all four of the tube walls are made of a hydrophilic material, The liquid flow effect is better.

In a more preferred embodiment based on the above embodiments, the extension duct of the test strip comprises a hydrophobic material or is partially made of a hydrophobic material.

Thus, the hydrophilic portion applies a pulling force to the sample liquid to pull the sample forward. As the sample passes through the flow aperture, its hydrophobic action of the extension conduit can prevent continued flow of the sample.

Preferably, the hydrophobic material is a plastic, specifically PET or ABS or PC, etc., as one of the preferred embodiments, the hydrophilic material may be hydrophilic on the surface of the hydrophobic material. Processing is accomplished, such as physical processing, chemical processing, corona treatment, or other processing methods. Preferably, the cover plate is stacked on the channel plate, the stack is movable stacked or fixedly stacked; or the substrate is stacked under the channel plate, the stack is Mobile stacked or fixed stack.

It should be noted that the stacking between the cover plate and the channel plate and between the substrate and the channel plate can be a movable stack or a fixed stack, and the stacking method is selected according to the type of test to facilitate the test. . The stack can be realized by various methods, for example, the parts can be bound together by using an object such as a buckle or a screw; or the related parts can be glued together by using a double-sided tape; or, by heating (such as ultrasonic waves) melt the surface of each part and then stick it together.

Preferably, the reaction zone is provided with an electrode; preferably, the reaction zone is also pre-loaded with a reagent; more preferably, the reagent is a dry reagent or is pretreated to a dry reagent.

It should be noted that an electrode may be disposed in the reaction region according to actual needs of the detection, so that when the liquid flows into the reaction region and is in contact with the electrode, the reaction can be performed by energization. Further, a desired reaction reagent may be preset in the reaction zone so that the reaction can be carried out when the liquid flows into the reaction zone in contact with the reaction reagent. The reagent is preferably a dry reagent or pretreated to a dry reagent to prevent the reagent from escaping during storage of the test strip.

Preferably, a spacer is further disposed between the channel plate and the substrate for defining an increased wall of the reaction region above the reaction region.

It should be noted that the wall of the reaction zone defining the increase can provide a reaction space for the reaction of the liquid to be tested and the reaction reagent to improve the reaction and the detection effect. As a preferred solution, the pad is a double-sided pad, which better realizes the fixing of the pad, prevents the misalignment of the pad, and prevents the liquid to be tested from flowing into the reaction area smoothly.

Preferably, the test strip is a blood test strip; more preferably, the prothrombin time test strip.

It should be noted that the prothrombin time test strip may be prothrombin time (PT), activated partial thromboplastin time (aPTT), and other blood parameter test strips, such as blood glucose test strips.

In order to achieve the above third object, the technical solution adopted by the present invention is as follows:

A detection instrument comprising the above test strip, further comprising a reaction signal acquisition device or a signal acquisition and analysis device for transmitting physical, chemical or electrical signals after reacting the reaction zone of the test strip to a signal acquisition device, or to Signal acquisition analysis equipment and further analysis and results display.

Preferably, the detection instrument is a prothrombin detector.

Compared with the prior art, the beneficial effects of the present invention are:

1. The air outlet passage on the cover plate and the liquid circulation passage and the extension passage on the passage plate form a venting port communicating with the outside, and the venting port is not disposed directly above the circulation hole, but is disposed at the extension pipe or at the end of the extension pipe. At the farther end, the blood sample to be tested can be more uniformly and reliably filled from the injection chamber through the liquid flow channel to the reaction area, so as to improve the repeatability and reliability of the test results.

2. By setting the liquid circulation channel and the extension channel, it is possible to avoid generating bubbles in the reaction zone during the process of filling the reaction zone with liquid, so as not to affect the reaction effect.

3. The liquid flow effect can be better achieved under the preferred cross-sectional area of the extended pipe, the cross-sectional area of the liquid flow path, the distance of the gas vent from the reaction zone, and the vent area.

4. By providing a pad between the channel plate and the substrate, the wall of the reaction zone is defined above the reaction zone to provide a larger reaction space for the reaction of the blood sample to be tested and the reaction reagent, thereby ensuring a good reaction effect. .

The above description is only an overview of the technical solutions of the present invention, and the above-described and other objects, features and advantages of the present invention can be more clearly understood. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, preferred embodiments will be described in detail with reference to the accompanying drawings.

DRAWINGS

1 is a schematic structural view of a prior art biological test strip;

2 is a schematic structural view of a first structure of an embodiment applied to a test strip;

3 is a schematic structural view of a second structure of an embodiment applied to a test strip;

4 is a schematic structural view showing a third structure of an embodiment applied to a test strip;

Figure 5 is a left side elevational view of the liquid flow passage of the test strip for detecting the test strip;

6 is a flow chart showing the flow guiding effect of the prior art test strip A in the experimental circulation test;

7 is a flow chart showing the flow guiding effect of the test strip B of the present invention;

In the figure, 1, cover plate; 11, injection hole; 12, air outlet; 2, channel plate; 21, injection cavity; 22, liquid circulation channel; 23, flow hole; 24, extension pipe; 31, reaction area; 32, electrode; 4, padded piece; 41, padded through hole.

detailed description

The specific embodiments, structures, features and functions of the present invention are described in detail below with reference to the accompanying drawings and preferred embodiments, in which:

Prior art embodiment

Figure 1 is a schematic view of the structure of the prior art. The bioassay strip comprises: a substrate 101 carrying an electrode, a reaction zone space provided with a reagent 104 and a hydrophilic cover 109, and a double-sided adhesive spacer 105 between the substrate 101 and the hydrophilic cover 109, A double-sided adhesive spacer 105 is formed with an open-ended groove 108, and the substrate 101 and the hydrophilic cover 109 define a corresponding reaction zone space having a sample hole 401 and a vent hole 107; the sample hole 401 Located at the opening 106 on one side of the double-sided tape, the vent 107 is located on the hydrophilic cover 109. The reaction zone space is disposed at one end of the substrate 101 so that blood samples can be taken directly from the test port 401 to the reaction zone space directly from the tester's finger or other location. The electrode includes a working electrode 102 and a reference electrode 103. The liquid to be tested enters the reaction space through the injection hole 401, reacts with the reaction reagent 104, and the electrical signal generated by the reaction is connected by the working electrode and the reference electrode through the electrode. Terminal 110 is connected to the wire output.

Embodiment 1

Fig. 2 is a schematic view showing the structure of a liquid sample detecting test strip according to a first embodiment of the present invention. The constituent elements of the liquid sample detecting strip include a cover plate 1, a channel plate 2, and a substrate 3. The injection hole 11 is disposed at the left end of the cover plate 1, and the air outlet 12 is disposed at the right end of the cover plate 1. The channel plate 2 is provided with a sample chamber 21, a groove as a liquid flow path 22, and a flow hole 23. The groove is hollowed out. When the upper and lower surfaces of the channel plate are respectively stacked with the cover plate 1 and the substrate 3, the space defined by them forms a circulation pipe, and one side wall of the pipe is the lower surface of the cover plate, and the other side The wall is the upper surface of the substrate 3. The injection chamber 21 is disposed at the left end of the channel plate 2, and when the cover plate 1 is stacked on the channel plate 2, the injection chamber 21 is located directly below the injection hole 11 in the cover plate 1.

Further, the injection chamber 21 and the flow holes 23 are connected by the liquid flow path 22 so that the liquid can flow from the sample chamber 21 into the flow holes 23 through the liquid flow path 22. The flow orifice 23 extends with an extension conduit 24 of the liquid flow passage 22 relative to the distal end of the injection chamber 21. The air outlet 12 on the cover plate 1 is located directly above the end of the extension duct 24, and is located at the end of the extension duct 24 with a vent opening (not shown) defined by the passage plate 2, so that the extension duct 24 is defined by the air outlet 12 The venting port is connected to the outside.

In the present embodiment, the liquid flow path 22 is a channel for up and down hollowing, specifically, a pipe formed by the space defined by the cover plate 1 and the substrate 3 when the upper and lower surfaces of the channel plate 2 are respectively stacked.

The substrate 3 carries a reaction zone 31 and an electrode 32, and a reaction reagent (not shown) is attached to the reaction zone 31. The reaction zone 31 is located directly below the flow hole 23 of the channel plate 2.

The cover plate 1, the passage plate 2, and the substrate 3, which are provided as described above, are stacked in a movable manner from the bottom to the top to form a liquid sample test strip.

The reaction is effected in order to direct the liquid sample to flow more rapidly into the reaction zone 31. In a preferred embodiment, the reaction zone 31 comprises a hydrophilic material, or the reaction zone 31 is at least partially made of a hydrophilic material.

In a more preferred embodiment, the liquid flow passage 22 has four tube walls (such as the two side walls of the hollow trench itself and the cover plate 1, the substrate 3 and the portion defined by the hollow groove) Or at least one of the walls of the non-hollowed groove itself and the cover plate 1 and the portion of the non-hollowed groove are made of a hydrophilic material; of course, another alternative embodiment At least the liquid flow conduit at least partially comprises a hydrophilic material or is partially made of a hydrophilic material; the above effect is better when the four tube walls are all made of a hydrophilic material.

In order to prevent the liquid sample from flowing out of the gas outlet 12 from the extension pipe 24, affecting the quality of the reaction, in a preferred embodiment, the extension pipe 24 comprises a hydrophobic material, or at least partially made of a hydrophobic material; The portion near the gas outlet is a hydrophobic material, and the portion close to the flow hole is a hydrophilic material.

In use, the liquid sample to be tested is spotted in the injection hole 11, and the liquid sample flows from the injection hole 11 into the injection chamber 21. Under the action of the hydrophilic material of the cover plate 1, the liquid sample flows into the reaction area through the liquid flow channel 22. 31. In this process, since the vent opening at the end of the extension duct 24 communicates with the outside through the air outlet 12 on the cover 1, the liquid can flow forward in the liquid circulation passage 22. When the liquid sample to be tested fills the reaction zone 31, it will then flow forward into the extension duct 24 until the hydrophobic portion of the extension duct 24 is prevented from flowing by its hydrophobic action. If the viscosity of the liquid sample is large, it is possible for the liquid sample to stop flowing before reaching the hydrophobic portion of the extension pipe 24 because the hydrophilic action of the cover plate 1 is generated at this time. The tension and the flow resistance of the liquid sample are balanced. The liquid sample test strip is inserted into the test instrument to energize the electrode 32. At this time, the liquid sample and the reaction reagent are reacted in the energized electrode 32.

Embodiment 2

3 is a schematic structural view of a second embodiment of the present invention. The present embodiment is a structure in which a pad 4 is added to the above-mentioned first embodiment, which is also used for a liquid sample detecting strip. Specifically, the height of the paddle through hole 41 on the pad 4 is the same as the flow hole 23 on the channel plate 2 and the reaction region 31 on the substrate 3. The pad 4 is fixed between the channel plate 2 and the substrate 3 by means of bonding, and the flow holes 23, the pad holes 41 and the reaction area 31 are located on the same vertical plane. In a preferred embodiment, the remainder of the substrate 3 is made of a hydrophobic material except that the reaction zone 31 is made of a hydrophilic material. The pad 4 is used to restrict the reaction zone so that the reagent is spotted, and when the amount of the reagent required is large, the liquid does not overflow and is confined to the reaction zone 31 on the bottom plate 3. In addition, when the sample to be tested flows into the reaction zone 31, the pad 4 will increase the amount of the sample participating in the reaction.

Embodiment 3

Fig. 4 is a schematic view showing the structure of a third embodiment of the present invention, which is also a structure for a liquid sample detecting test strip. The difference from the second embodiment is that the air outlet 12 on the cover plate 1 is not directly above the end of the extension duct 24, but is located directly above the midpoint of the extension duct 24, and at this time, the air outlet 12 and the passage plate 2 are defined. The venting opening (not shown) is located at the midpoint of the extension duct 24 such that the extension duct 24 communicates with the outside through the vent opening defined by the air outlet 12. During use of this embodiment, the vent opening at the midpoint of the extension duct 24 communicates with the outside through the air outlet 12 on the cover plate 1.

By setting in this manner, the blood sample to be tested can be more uniformly and reliably filled from the injection chamber 21 through the liquid flow channel to the reaction region 31, so as to better improve the repeatability and reliability of the test result, and at the same time avoid liquid filling. During the reaction zone 31, bubbles are generated in the reaction zone 31 to better influence the reaction effect.

Embodiment 4

As in Embodiment 1, the groove as the liquid flow path 22 is not hollowed out below. Figure 5 shows a left side view of the channel plate 2 containing non-hollowed grooves. By the arrangement of the non-hollowed grooves, when the liquid flows in the liquid circulation passage 22, it can smoothly flow into the reaction region 31 on the basis of the bottom of the groove.

Embodiment 5

Circulation experiment test

In order to verify the advantages of the structure of the present invention, the liquid flow after spotting of the blood sample, and the probability of occurrence of liquid bubbles or underfill in the device were tested by the following experiments.

testing method:

The test strip A existing in the prior art is compared with the test strip B of the present invention (the specific structure is set as in the second embodiment), wherein the structure difference between the test strip A and the test strip B is mainly in the detection The vent of the test strip A is disposed on the flow hole, and the vent of the test strip B is disposed at one point of the extended pipe, and the remaining structures are equally disposed to form a quantitative experiment.

During the experiment, 10 μl of blood samples were placed into the injection chambers of the test strip A and the test strip B, respectively, and the blood samples flowed into the reaction zone through the flow holes through the liquid flow channels of the test strips.

Test Results:

6 and FIG. 7 show the difference between the flow guiding effect of the test strip A and the test strip B in the experiment. In the experiment, as shown in FIG. 6, the process of detecting the blood sample in the test strip A in filling the reaction chamber is shown in FIG. In the middle, eddy currents or turbulence can be clearly seen, and there is also a phenomenon of filling dissatisfaction. In contrast, as shown in FIG. 7, the blood sample in the test strip B can fill the reaction chamber very uniformly, smoothly, and reliably.

In addition, after repeated experiments, it is shown that the test strip B can ensure that the blood sample is 100% evenly and smoothly filled in the reaction chamber during the diversion process, and the test strip A will appear bubble or not full, and the incidence rate may be Up to 5% or more.

Moreover, when the test strip of the present invention is used for testing, the time required for the blood sample to be filled from the spotting to the reaction zone is shorter, and the reaction zone can be filled in 4-5 s, which further improves the signal quality.

Through the above flow test test, it can be proved that the liquid sample test strip provided by the invention can make the blood sample to be tested more uniformly and reliably fill the reaction area from the injection cavity through the liquid flow channel, so as to improve the repeatability and reliability of the test result. Sex, while avoiding the generation of bubbles in the reaction zone during the filling of the reaction zone with liquid, to achieve the technical purpose of not affecting the reaction effect.

The above embodiments are merely preferred embodiments of the present invention and are not intended to limit the protection of the present invention. Scope, any insubstantial variations and substitutions made by those skilled in the art based on the present invention are within the scope of the invention as claimed.

Claims

A liquid sample guiding device comprises a cover plate and a channel plate which can be stacked under the cover plate, the cover plate is provided with a sample injection hole at one end and an air outlet at the other end; the channel plate is provided with a sample injection a cavity, a liquid flow passage, and a flow hole, wherein when the cover is stacked on the channel plate, the injection cavity is located below the injection hole and is connected through the liquid flow channel The flow hole is characterized in that the flow hole of the channel plate is further connected with an extension pipe extending in a direction relative to the other side of the injection cavity and the liquid circulation pipe, when the cover plate When stacked on the channel plate, the channel plate defines a venting port communicating with the outside through the air outlet, the venting port is located at any point of the extending pipe, or the venting port is at least partially Extend the pipe contact.
The flow guiding device according to claim 1, wherein the injection chamber, the liquid circulation passage, the flow hole, the extension duct, and the gas vent are all on the same straight line.
A flow guiding device according to any of the preceding claims, wherein the wall of the liquid flow channel is at least partially hydrophilic and the hydrophilic material portion extends through both ends of the liquid communication channel.
A flow guiding device according to any of the preceding claims, wherein the wall of the extension duct is at least partially hydrophobic; preferably the portion of the outlet is a hydrophobic material and the portion adjacent the orifice is a hydrophilic material; Preferably, the hydrophilic material portion has a length of 1-2 mm.
A flow guiding device according to any of the preceding claims, wherein the gas outlet has a pore diameter of from 0.1 mm to 5 mm; preferably, the cross-sectional area of the extension duct and the cross-sectional area of the liquid flow passage The ratio is 1:1–1:10.
A flow guiding device according to any of the preceding claims, wherein the ratio of the length of the extension duct to the length of the liquid flow passage is 1:1 - 1:10.
A flow guiding device according to any of the preceding claims, wherein the injection chamber is located directly below the injection opening.
A flow guiding device according to any of the preceding claims, wherein the distance of the gas vent from the end is from 1 mm to 10 mm; preferably, the area of the gas vent and the area of the injection hole It is 1:1–1:100.
A liquid sample detecting test strip characterized by comprising the flow guiding device according to any of the preceding claims, wherein the test strip further comprises a substrate, and the substrate is provided with a reaction region, wherein the substrate is stacked on the substrate The flow aperture is located above and at least partially overlaps the reaction zone when the channel plate is below the channel plate.
A test strip according to claim 9, wherein said liquid flow path is a groove; preferably, said groove is non-hollowed or hollowed out when said groove is hollowed out and aisle When the upper and lower surfaces of the plate are respectively stacked with the cover plate and the substrate, the space defined by them forms a flow conduit; preferably, the reaction region contains a hydrophilic material; further preferably, the pipe wall of the flow conduit is at least Part of the hydrophilic material, and the hydrophilic material portion penetrates both ends of the liquid communication channel.
A test strip according to any of the preceding claims, wherein said cover plate is stacked on said channel plate, said substrate being stacked under said channel plate.
A test strip according to any of the preceding claims, wherein an electrode is provided in the reaction zone; preferably, the reaction zone is also pre-loaded with a reagent; more preferably, the reagent is dry The reagent is either pretreated to a dry reagent.
The test strip according to any of the preceding claims, wherein a spacer for defining an elevated reaction zone wall above the reaction zone is further disposed between the channel plate and the substrate. .
The test strip according to any of the preceding claims, wherein the test strip is a blood test strip; preferably, the blood test strip is a prothrombin time test strip.
A detecting instrument comprising the detecting strip according to any one of the preceding claims and 9-14, characterized in that it further comprises a reaction signal collecting device or a signal collecting and analyzing device for said said test strip The physical/chemical signals after the reaction zone reaction are conducted to a signal acquisition device, or to the signal acquisition and analysis device for further analysis and display of results; preferably, the detection device is a prothrombin time detector.