CN109212234B

CN109212234B - POCT (Point of Care testing) glycosylated hemoglobin analyzer and POCT glycosylated hemoglobin analysis system

Info

Publication number: CN109212234B
Application number: CN201811018418.XA
Authority: CN
Inventors: 陈宽; 陈明峰; 梅海明
Original assignee: SHENZHEN GOLDSITE DIAGNOSTICS Inc
Current assignee: SHENZHEN GOLDSITE DIAGNOSTICS Inc
Priority date: 2018-08-31
Filing date: 2018-08-31
Publication date: 2021-07-20
Anticipated expiration: 2038-08-31
Also published as: CN109212234A

Abstract

The invention discloses a POCT (Point of Care testing) glycosylated hemoglobin analyzer and a POCT glycosylated hemoglobin analysis system, wherein the POCT glycosylated hemoglobin analyzer comprises an operating platform, a positioning piece, a first driving mechanism, a piston pressing block and a detection device, wherein the operating platform is provided with an upwards extending mounting plate; the positioning piece extends in the front-back direction and is arranged on the operating platform or the mounting plate; the first driving mechanism is arranged on the mounting plate and is provided with a driving shaft extending in the front-back direction, the driving shaft is connected with a rotating piece, a driving rod extending in the front-back direction is arranged on the rotating piece, and the axis of the driving rod is not coincident with the axis of the driving shaft; the piston pressing block is positioned above the rotating piece and can be arranged on the mounting plate in a vertically moving mode; the detection device is mounted on the mounting plate in a manner of moving up and down. The POCT glycosylated hemoglobin analyzer has the advantages of simple and convenient operation and accurate test result.

Description

POCT (Point of Care testing) glycosylated hemoglobin analyzer and POCT glycosylated hemoglobin analysis system

Technical Field

The invention relates to the technical field of glycosylated hemoglobin detection, in particular to a POCT (point of care testing) glycosylated hemoglobin analyzer and a POCT glycosylated hemoglobin analysis system.

Background

Glycated hemoglobin (HbA1c) is a product of hemoglobin in red blood cells in blood combined with blood glucose. According to the 8 th report of the 2017 global diabetes map, which is newly released by the international diabetes union (IDF), 4.25 million adults in the world of 2017 are diabetic patients, which is increased by 2.41% compared with the last year. About 1.144 million diabetics exist in China, and more than 8750 million diabetics have high-risk back-up troops. It is estimated that half of the diabetics are not comprehensively under diagnostic management. The key to the treatment of diabetes is the control and stabilization of blood sugar level, and the diagnosis of diabetes is mainly judged by detecting the blood sugar level of a patient in fasting state and 2 hours after meal at present, but the diagnosis is easily influenced by diet, held medicines and the like of the patient in a spot check time period, and the true condition of the blood sugar level in the patient cannot be objectively reflected. Research shows that the average life of hemoglobin is as long as 120 days, and the generation speed of HbA1c is proportional to the blood sugar concentration level in the past 8-12 weeks, so that the blood sugar condition in the human body in the past 8-12 weeks can be more accurately reflected by the HbA1c level. And the glycosylated hemoglobin is not affected by the time of blood drawing, whether fasting, whether insulin is used, and other factors that can cause transient fluctuations in blood glucose levels. The glycosylated hemoglobin has strong detection specificity, good repeatability and high sensitivity, and is definitely specified as the internationally accepted 'gold standard' for diabetes monitoring.

However, the degree of automation of the currently used analyzer for measuring the concentration of glycated hemoglobin is generally low. In the using process, the number of manual operation steps is large, for example, the addition of a blood sample, the uniform mixing of the sample and a reaction solution, the addition of a mixed solution of the sample and the reaction solution, the addition of an eluent and the like all need to be manually operated by a user, the operation is complex, and the precision of a test result is low.

Disclosure of Invention

The invention mainly aims to provide a POCT glycosylated hemoglobin analyzer which is simple and convenient to operate and high in test result precision.

In order to achieve the above object, the present invention provides a POCT glycated hemoglobin analyzer, comprising:

the device comprises an operating platform, a lifting mechanism and a lifting mechanism, wherein the operating platform is provided with an upward extending mounting plate;

the positioning piece extends in the front-back direction and is arranged on the operating platform or the mounting plate;

the first driving mechanism is arranged on the mounting plate and is provided with a driving shaft extending in the front-back direction, the driving shaft is connected with a rotating piece, a driving rod extending in the front-back direction is arranged on the rotating piece, and the axis of the driving rod is not coincident with the axis of the driving shaft;

the piston pressing block is positioned above the rotating piece and can be arranged on the mounting plate in a vertically movable mode;

a detection device mounted on the mounting plate to be movable up and down.

Preferably, the piston pressing block is mounted at the bottom of the detection device.

Preferably, a detection through hole is arranged on the piston pressing block in a penetrating manner, so that the detection device can send and receive detection signals.

Preferably, the POCT glycated hemoglobin analyzer further comprises a second driving mechanism, and the second driving mechanism is connected to the detection device and is used for driving the detection device to move up and down.

Preferably, the second driving mechanism comprises a second motor, a driving wheel, a driven wheel and a transmission belt, the first motor is installed on the installation plate, the driving wheel is connected with the second motor, the driving wheel and the driven wheel are sleeved with the transmission belt, and the detection device is connected with the transmission belt.

Preferably, the bottom of the detection device is further provided with a limit stop lever extending downwards.

Preferably, the POCT glycated hemoglobin analyzer further includes a cartridge holder, which is movably installed on the operation platform in a front-and-back direction.

Preferably, the POCT glycated hemoglobin analyzer further comprises a third driving mechanism, and the third driving mechanism is connected with the reagent box bracket to drive the reagent box bracket to move back and forth.

Preferably, the operating platform is provided with a supporting plate located on one side of the reagent kit bracket, the third driving mechanism comprises a third motor, a gear and a rack meshed with the gear, the third motor is mounted on the supporting plate, the gear is connected with the third motor, and the rack extends in the front-back direction and is connected with the reagent kit bracket.

The invention also provides a POCT glycated hemoglobin analysis system, which comprises a POCT glycated hemoglobin analyzer and a kit adapted to the POCT glycated hemoglobin analyzer, wherein the POCT glycated hemoglobin analyzer comprises:

a detection device mounted on the mounting plate to be movable up and down.

According to the technical scheme, an upward extending mounting plate is arranged on an operation platform, positioning pieces extending in the front-back direction are arranged on the operation platform or the mounting plate, a first driving mechanism is arranged on the mounting plate, the first driving mechanism is provided with a driving shaft extending in the front-back direction, the driving shaft is connected with a rotating piece, a driving rod extending in the front-back direction is arranged on the rotating piece, and the axis of the driving rod is not overlapped with the axis of the driving shaft; still be equipped with piston briquetting and detection device that can reciprocate on the mounting panel, so, when adopting this analysis appearance to examine time measuring to the blood sample in the kit, the fixed body passes through the setting element to be fixed, the kit rotator then is connected with the actuating lever, thereby first actuating mechanism passes through the drive shaft and drives the rotation of rotating member, the rotation of accessible actuating lever drive kit rotator again, thereby can realize the automatic mixing of blood sample and reaction liquid, also can realize the automatic interpolation of the mixed liquid of blood sample and reaction liquid and the automatic interpolation of eluant, the operating procedure of analysis appearance has been simplified greatly, the degree of accuracy and the precision of testing result have been improved.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the structures shown in the drawings without creative efforts.

FIG. 1 is a schematic view showing the construction of a POCT glycated hemoglobin analyzer according to the present invention;

FIG. 2 is a structural view of a kit adapted to the POCT glycated hemoglobin analyzer of the present invention;

FIG. 3 is a cross-sectional view of the kit shown in FIG. 2;

FIG. 4 is a schematic diagram of the blood collection set of the kit of FIG. 2;

FIG. 5 is a detailed view of the kit and the blood collection set of FIG. 2;

FIG. 6 is a first state of use diagram of the kit shown in FIG. 2;

FIG. 7 is a second state of use diagram of the kit shown in FIG. 2;

FIG. 8 is a third state of use diagram of the kit shown in FIG. 2;

FIG. 9 is a first state diagram of the POCT glycated hemoglobin analyzer shown in FIG. 1 and the kit shown in FIG. 2;

FIG. 10 is a second state diagram of the POCT glycated hemoglobin analyzer shown in FIG. 1 and the kit shown in FIG. 2;

FIG. 11 is a third state diagram of the POCT glycated hemoglobin analyzer shown in FIG. 1 and the kit shown in FIG. 2.

The reference numbers illustrate:

the implementation, functional features and advantages of the objects of the present invention will be further explained with reference to the accompanying drawings.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

It should be noted that, if directional indications (such as up, down, left, right, front, and back … …) are involved in the embodiment of the present invention, the directional indications are only used to explain the relative positional relationship between the components, the movement situation, and the like in a specific posture (as shown in the drawing), and if the specific posture is changed, the directional indications are changed accordingly.

In addition, if there is a description of "first", "second", etc. in an embodiment of the present invention, the description of "first", "second", etc. is for descriptive purposes only and is not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In addition, technical solutions between various embodiments may be combined with each other, but must be realized by a person skilled in the art, and when the technical solutions are contradictory or cannot be realized, such a combination should not be considered to exist, and is not within the protection scope of the present invention.

The invention provides a POCT glycosylated hemoglobin analysis system. The POCT glycosylated hemoglobin analysis system comprises a POCT glycosylated hemoglobin analyzer and a kit matched with the POCT glycosylated hemoglobin analyzer. The analysis system has the advantages of simple operation and accurate result.

The structure of the POCT glycated hemoglobin analyzer will be described in detail below.

Referring to fig. 1, a POCT glycated hemoglobin analyzer 200 according to the present invention includes an operation platform 210, a positioning element 220, a first driving mechanism 230, a piston pressing block (not shown), and a detecting device 240. An installation plate 211 extending upwards is arranged on the operating platform 210; the positioning member 220 extends in a front-back direction, and the positioning member 220 is mounted on the operating platform 210 or the mounting plate 211. The first driving mechanism 230 is mounted on the mounting plate 211, and has a driving shaft (not shown) extending in the forward and backward directions, the driving shaft is connected with a rotating member 232, a driving rod 233 extending in the forward and backward directions is disposed on the rotating member 232, and an axis of the driving rod 233 does not coincide with an axis of the driving shaft. The piston pressing block is located above the rotating member 232, and the piston pressing block is installed on the installation plate 211 to be movable up and down. The detecting device 240 is movably mounted on the mounting plate 211 up and down for detecting the concentration of glycated hemoglobin in the analyte in the kit 100.

The kit 100 includes a rotating body 110 and a fixed body 120 (shown in fig. 2). The positioning member 220 is used for fixing the fixing body 120 of the reagent kit 100, and the driving rod 233 is used for connecting the rotating body 110 of the reagent kit 100 to drive the rotating body 110 of the reagent kit 100 to rotate. Specifically, the rotating body 110 is provided with a limit hole 170 into which the driving rod 233 is inserted, and the fixing body 120 is provided with a fixing groove 180 into which the positioning member 220 is inserted. Here, it is understood that, in order to rotate the rotating body 110 relative to the fixed body 120, the axis of the driving rod 233 is not coincident with the axis of the driving shaft, that is, the axis of the driving rod 233 is not in line with the axis of the driving shaft. The first driving mechanism 230 includes a first motor, and the first motor is mainly used for driving the rotating frame 232 to rotate, so as to drive the rotating body 110 to rotate. In addition, the structure of the rotating member 232 may be various, for example, the rotating member 232 may be a bracket structure, a plate structure, or a rod structure, and is not limited in particular. The positioning element 220 may have various structures, for example, the positioning element 220 may be a positioning pin, etc., and is not particularly limited herein.

The piston pressing block is mainly used for pushing the pistons (the first piston 140 and the second piston 133) on the reagent kit 100 so as to realize that the liquid in the reaction liquid cavity 113 and the cleaning liquid cavity 114 of the reagent kit 100 is dripped on the filter membrane 122 (shown in fig. 3). The piston pressing block may be disposed on the detection device 240, or may be disposed independently from the detection device 240, that is, the piston pressing block is not disposed on the detection device 240. In the embodiment of the present invention, in order to make the operation more convenient, the piston pressing block may be disposed at the bottom of the detecting device 240, so that the piston pressing block may move up and down along with the up and down movement of the detecting device 240. Specifically, the piston pressing block is formed by protruding downward from the bottom of the detecting device 240, and the piston pressing block may be in a circular shape, a square shape, or another irregular shape, which is not limited herein.

The detecting device 240 includes a signal emitter for emitting a detection signal to the object to be detected, and a signal processor for receiving the detection signal reflected by the object to be detected and outputting a detection result. Specifically, a detection through hole (not shown) is formed through the piston pressing block, so that the detection device 240 can send and receive a detection signal. In addition, the detecting device 240 further includes a testing jig 242, and the piston pressing block is disposed at the bottom of the testing jig 242.

According to the technical scheme, the operating platform 210 is provided with the mounting plate 211 extending upwards, the operating platform 210 or the mounting plate 211 is provided with the positioning piece 220 extending in the front-back direction, meanwhile, the mounting plate 211 is provided with the first driving mechanism 230, the first driving mechanism 230 is provided with a driving shaft extending in the front-back direction, the driving shaft is connected with the rotating piece 232, the rotating piece 232 is provided with the driving rod 233 extending in the front-back direction, and the axis of the driving rod 233 is not coincident with the axis of the driving shaft; still be equipped with piston briquetting and detection device 240 that can reciprocate on the mounting panel 211, so, when adopting this analysis appearance 200 to detect the blood sample in the kit 100, the kit fixed body passes through setting element 220 fixedly, the kit rotator then is connected with actuating lever 233, thereby first actuating mechanism 230 drives the rotation of rotating member 232 through the drive shaft, rotating member 232 accessible actuating lever 233 drives the kit rotator rotatory again, so, can realize the automatic mixing of blood sample and reaction liquid, also can realize the automatic interpolation of the mixed liquid of blood sample and reaction liquid and the automatic interpolation of eluant, the operating procedure of analysis appearance 200 has been simplified greatly, the degree of accuracy and the precision of testing result have been improved.

The structure of the kit 100 will be described in detail below. Referring to fig. 2 to 5, the rotating body 110 has a mounting hole 111, the rotating body 110 is provided with a detection port 112, a reaction liquid cavity 113 and a cleaning liquid cavity 114 which are circumferentially arranged along the mounting hole 111, the detection port 112 is communicated with the mounting hole 111, the reaction liquid cavity 113 is communicated with the mounting hole 111 through a first flow channel 117, and the cleaning liquid cavity 114 is communicated with the mounting hole 111 through a second flow channel 118. The fixing body 120 has an open receiving groove 121, a filter membrane 122 is disposed in the receiving groove 121, the fixing body 120 is rotatably mounted in the mounting hole 111, the fixing body 120 can rotate relative to the rotating body 110, and the filter membrane 122 can be selectively made to correspond to the first flow channel 117, the second flow channel 118 and the detection port 112.

In the embodiment of the present invention, the rotating body 110 is provided in a substantially semi-cylindrical shape, but the shape of the rotating body 110 is not limited thereto, and for example, the rotating body 110 may be provided in a square shape. The mounting hole 111 is circular, and the fixing body 120 has an arc-shaped section which is in sealing contact with the inner wall of the mounting hole 111. In a preferred embodiment, the mounting hole 111 is a through hole penetrating through opposite surfaces (front and rear surfaces) of the rotating body 110. It is understood that the mounting hole 111 may be a blind hole in other embodiments. The detection port 112 communicates with the mounting hole 111, and the fixing body 120 can be partially exposed. Thus, when the rotary body 110 is rotated so that the detection port 112 faces the filter 122 of the fixed body 120, the reflectance of hemoglobin and glycated hemoglobin on the filter 122 under light irradiation at wavelengths of 625nm and 460nm, respectively, can be detected and analyzed, and the concentration of HbA1c in the blood sample can be obtained.

The reaction liquid cavity 113 and the cleaning liquid cavity 114 are distributed at intervals along the circumferential direction of the rotating body 110. There are various ways of distributing the reaction liquid chamber 113 and the cleaning liquid chamber 114, for example, the reaction liquid chamber 113 and the cleaning liquid chamber 114 may be located on one side (left or right side) of the symmetry axis of the rotating body 110, which may effectively reduce the number of operation steps. Of course, the reaction liquid chamber 113 and the cleaning liquid chamber 114 may be located on both sides of the symmetry axis of the rotating body 110, and are not particularly limited herein. Preferably, the reaction solution chamber 113 is disposed adjacent to the cleaning solution chamber 114, so as to facilitate dripping of the reaction solution and the cleaning solution onto the filter membrane 122 of the fixing body 120.

The kit 100 further includes a blood collection vessel 130. The hemostix 130 is a quantitative hemostix 130, can be independently packaged when not in use, and can be manufactured to meet the requirements of third class of medical instruments and meet the use requirements of sterilization and disinfection. After the blood sampler 130 collects the blood sample, the blood sample can be directly installed in the reaction solution cavity 113 of the kit 100, then the kit 100 with the blood sampler 130 is installed in the analyzer 200, the analyzer 200 operates on the kit 100, and the blood sample and the reaction solution are uniformly mixed; and then testing the reacted blood sample to finally obtain a measurement result. Therefore, the steps of manually preparing the test sample are reduced, so that the operation is simpler, and the test result is more accurate.

In the embodiment of the present invention, the rotating body 110 is rotated clockwise or counterclockwise by a predetermined angle alternately to uniformly mix the reaction solution in the reaction solution chamber 113 with the blood sample in the blood collection container 130, thereby improving the automation degree of the kit 100 for measuring the glycated hemoglobin concentration and reducing the number of manual steps.

In the embodiment of the present invention, the fixing body 120 is provided in a substantially cylindrical shape, but the shape of the fixing body 120 is not limited thereto. The top of the fixing body 120 is provided with a mounting plane, the mounting plane is recessed downward to form the accommodating groove 121, the filter membrane 122 is mounted in the accommodating groove 121, and the liquid (waste liquid) filtered by the filter membrane 122 further drops to the bottom of the accommodating groove 121. That is, the container 121 can be used for installing the filter membrane 122, and can be used for collecting waste liquid.

In addition, the kit 100 further includes a filter membrane cover 123, the filter membrane cover 123 covers the open end of the accommodating groove 121, and the bottom of the filter membrane cover 123 abuts against the filter membrane 122. The filter membrane cover 123 is provided with a flow guide groove penetrating through the upper and lower surfaces thereof to guide the liquid onto the filter membrane 122. In this embodiment, the diversion trench is tapered from top to bottom; preferably, the guide groove is funnel-shaped.

Referring to fig. 3, the fixed body 120 is further provided with an air release opening 124, and the fixed body 120 can rotate relative to the rotating body 110, so that the air release opening 124 sequentially passes through the second flow channel 118 and the first flow channel 117. Here, the pressure relief vent 124 is used for relieving the pressure of the first flow channel 117 and the second flow channel 117, so that the liquid in the reaction liquid chamber 113 can be effectively prevented from being ejected when dripping out of the first flow channel 117, and the liquid in the cleaning liquid chamber 114 can be effectively prevented from being ejected when dripping out of the second flow channel 118, which is beneficial to quantitatively controlling the dripping liquid and the dripping rate of the liquid.

When the blood sampling device 130 is inserted into the reaction solution chamber 113, the gas in the reaction solution chamber 113 is compressed by the blood sampling device 130, and the pressure in the reaction solution chamber 113 becomes higher than the outside pressure. If the mixed liquid in the reaction liquid chamber 113 is directly dropped onto the filter membrane 122 without pressure relief through the pressure relief port 124, the mixed liquid is easily ejected, so that it is difficult to control the volume of the dropped mixed liquid and the dropping rate of the mixed liquid, and finally, the accuracy of the test result is affected to a certain extent.

Similarly, to balance the internal and external air pressures in the cleaning solution chamber 114 and prevent the liquid in the cleaning solution chamber 114 from being sprayed when it drops onto the filter membrane 122, it is also necessary to make the air release pressure port 124 pass through the second flow passage 118 to balance the internal and external air pressures in the cleaning solution chamber 114.

Referring to fig. 3, the kit 100 further includes a first piston 140, and the first piston 140 is slidably mounted in the wash solution chamber 114.

Further, a piston chamber 116 is formed at an end of the cleaning solution chamber 114 away from the second flow passage 118, and is communicated with the cleaning solution chamber 114, so that the first piston 140 can be mounted. Preferably, the inner diameter of the piston chamber 116 is larger than the inner diameter of the wash liquid chamber 114, and the first piston 140 is slidably mounted in the piston chamber 116.

In the embodiment of the present invention, the kit 100 further includes a reaction solution and a cleaning solution, the reaction solution is sealed in the reaction solution cavity 113, and the cleaning solution is sealed in the cleaning solution cavity 114. Wherein the reaction solution contains a substance which can crack red blood cells and release hemoglobin precipitates and a blue boric acid conjugate which can be combined with cis-diol groups of the glycated hemoglobin, when a blood sample is dripped into the reaction solution, the red blood cells are immediately cracked, all the hemoglobin precipitates, and the boric acid conjugate is combined with the cis-diol groups of the glycated hemoglobin. An appropriate amount of the reaction mixture is placed on the filter 122, and any precipitated hemoglobin, whether bound by the boronic acid conjugate or not, remains on the filter 122, and excess stained conjugate is washed away with a wash solution. Finally, the reflectance of blue (glycated hemoglobin) and red (total hemoglobin) under light irradiation at wavelengths of 625nm and 460nm, respectively, was analyzed by the glycated hemoglobin analyzer 200 to obtain the concentration of HbA1c in the blood sample.

Specifically, the kit 100 further comprises a first sealing film 150 and a second sealing film 160, wherein the first sealing film 150 is used for sealing the reaction solution in the reaction solution chamber 113, and the second sealing film 160 is used for sealing the cleaning solution in the cleaning solution chamber 114. The first sealing film 150 is provided with a marking line 151 for marking the insertion position of the hemostix 130. Therefore, the blood sampler 130 can be prevented from being inserted into the blood sampler by mistake to cause the loss of the blood sample, and the utilization rate of the blood sample is obviously improved.

Referring to fig. 4, the blood collecting device 130 includes a blood collecting tube 131, a blood collecting needle 132 and a second piston 133, and the blood collecting tube 131 is detachably mounted in the blood collecting device cavity 113 b. The mode of detachably attaching the blood collection tube 131 to the blood collection chamber 113b may be various, and is not particularly limited. The lancet head 132 is made of glass and is used to take blood by directly contacting a human body. In this embodiment, an elastic sealing member 134 is provided on the outer edge of the front end of the blood collection tube 131, and the blood collection tube 131 and the inner wall of the blood collection chamber 113b are sealingly connected by the elastic sealing member 134. Specifically, the elastic sealing member 134 may be sleeved on the front end outer edge of the blood collection tube 131, or may be integrally formed on the front end outer edge of the blood collection tube 131. Preferably, the resilient seal 134 is a gasket.

When the first driving mechanism 230 drives the rotating body 110 to rotate clockwise to make the first flow channel 117 face the filter membrane 122 in the fixed body 120 (as shown in fig. 6), the piston pressing block is driven to move downwards, so that the piston pressing block pushes the piston (i.e. the second piston 133) in the reaction liquid cavity 113 to move downwards, and thus the liquid in the reaction liquid cavity 113 flows out through the first flow channel 117 and drops onto the filter membrane 122 of the fixed body 120.

When the first driving mechanism 230 drives the rotating body 110 to rotate clockwise to make the second flow channel 118 face the filter membrane 122 in the fixed body 120 (as shown in fig. 7), the piston pressing block is driven to move downwards, so that the piston pressing block pushes the piston (the first piston 140) in the cleaning solution cavity 114 to move downwards, and thus the liquid in the cleaning solution cavity 114 flows out through the second flow channel 118 and drops on the filter membrane 122 of the fixed body 120.

When the first driving mechanism 230 drives the rotating body 110 to rotate clockwise to make the detection port 112 just above the filter membrane 122 of the fixed body 120 (as shown in fig. 8 and 11), at this time, the piston pressing block is driven to move downwards, so that the piston pressing block just contacts the filter membrane cover 123, and the detection device 240 above the piston pressing block can perform a test, and a final result is obtained.

Referring to fig. 1, 9 and 10, in order to improve the automation degree of the analyzer 200 and reduce the manual operations, in this embodiment, the POCT glycated hemoglobin analyzer 200 further includes a second driving mechanism 250, and the second driving mechanism 250 is connected to the detecting device 240 for driving the detecting device 240 to move up and down. It should be noted that the second driving mechanism 250 drives the detection device 240 to move up and down, so as to drive the piston pressing block to move up and down.

The structure of the second driving mechanism 250 is many, and is not particularly limited. In a preferred embodiment, the second driving mechanism 250 includes a second motor 251, a driving wheel 252, a driven wheel 253 and a transmission belt 254, the second motor 251 is mounted on the mounting plate 211, the driving wheel 252 is connected to the second motor 251, the transmission belt 254 is sleeved on the driving wheel 252 and the driven wheel 253, and the detecting device 240 is connected to the transmission belt 254.

Further, in order to ensure that the detecting device 240 moves in the up-down direction, a first slide rail 256 extending in the up-down direction may be disposed on the mounting plate 211, and a first connecting slider 255 adapted to the first slide rail 256 may be disposed on the detecting device 240. Specifically, the first connecting slider 255 is connected to the belt 254.

In addition, the bottom of the detecting device 240 is further provided with a limit stop lever 244 extending downwards. The limiting stop lever 244 mainly functions to limit the reagent cartridge 100 and prevent the reagent cartridge 100 from moving forward and backward.

Referring to fig. 9 and 10, in the above embodiment, the POCT glycated hemoglobin analyzer 200 further includes a reagent cartridge holder 270, and the reagent cartridge holder 270 is movably installed on the operation platform 210 in a front-and-back manner.

For the convenience of automation, the POCT glycated hemoglobin analyzer 200 further includes a third driving mechanism 260, and the third driving mechanism 260 is coupled to the cartridge holder 270 to drive the cartridge holder 270 to move back and forth.

The structure of the third driving mechanism 260 may be various, and is not particularly limited. In an embodiment, the operation platform 210 is provided with a support plate 212 located at one side of the reagent cartridge holder 270, the third driving mechanism 260 includes a third motor 261, a gear 262 and a rack 263 engaged with the gear 262, the third motor 261 is mounted on the support plate 212, the gear 262 is connected with the third motor 261, and the rack 263 extends in the front-back direction and is connected with the reagent cartridge holder 270 (it is explained that the rack 263 is connected with the reagent cartridge holder 270 by a direct connection mode and an indirect connection mode, and this is only for explaining that the driving mechanism drives the reagent cartridge holder to move back and forth by the gear-rack engagement mode).

It is understood that, in order to ensure that the reagent cartridge holder 270 moves in the front-back direction, a second slide rail 265 extending in the front-back direction may be provided on the operation platform 210, and a second connecting slider 266 adapted to the second slide rail 265 may be provided on the reagent cartridge holder 270. Specifically, the rack 263 is disposed on an upper surface of the second connecting slider 266. The rack 263 may be integrally formed on the upper surface of the second connecting slider 266, or may be detachably disposed on the upper surface of the second connecting slider 266, which is not limited herein.

In order to facilitate the installation of the reagent kit on the reagent kit tray 270, two positioning members 271 are disposed on two sides of the reagent kit tray 270, and positioning holes 190 (shown in fig. 2) adapted to the two positioning members 271 are disposed on two sides of the reagent kit 100. The structure of the positioning element 271 is not particularly limited, and in one embodiment, the positioning element 271 may be a ball plunger to facilitate the fixing and the separation of the reagent cartridge 100 and the reagent cartridge holder 270.

In addition, in order to more accurately mount the reagent cartridge to the analyzer 200 for the assay, the POCT glycated hemoglobin analyzer 200 further includes a position sensor for sensing the position of the reagent cartridge holder 270. The structure of the position sensor may be various, and is not particularly limited. In one embodiment, the position sensor includes an optical coupler 264 stop (not shown) disposed on the reagent cartridge holder 270, and an optical coupler 264 (shown in fig. 9) disposed on the support plate 212 and engaged with the optical coupler 264 stop.

The number of the optical couplers 264 is not particularly limited, for example, the number of the optical couplers 264 may be one, two, three, or the like. In a preferred embodiment, three optical couplers 264 are disposed on the supporting plate 212 and spaced from each other in the front-back direction. For convenience of description, the three optical couplers 264 distributed from front to back may be sequentially defined as a first optical coupler 264a, a second optical coupler 264b, and a third optical coupler 264 c. Referring to fig. 9, when the reagent cartridge holder 270 moves forward until the shutter of the optical coupler 264 triggers the signal of the first optical coupler 264a, the reagent cartridge holder 270 moves out of the analyzer 200, and at this time, the reagent cartridge is loaded into the analyzer 200. Then, the reagent cartridge bracket 270 moves backwards until the blocking piece of the optical coupler 264 triggers the signal of the third optical coupler 264c, at this time, the fixing groove 180 on the reagent cartridge 100 completely sleeves the positioning piece 220, and the limiting hole 170 of the reagent cartridge 100 completely sleeves the driving rod 233. Referring to fig. 10, the second driving mechanism 250 drives the detecting device 240 to move downward, so that the lower end of the limiting stop lever 244 is located at the front side of the fixed component 110 of the reagent cartridge 100, and at this time, the reagent cartridge tray 270 moves forward, and due to the limiting function of the limiting stop lever 244, the reagent cartridge 100 is separated from the reagent cartridge tray 270 and stays at the original position under the supporting function of the positioning element 220 and the driving lever 233, until the optical coupler 264 on the reagent cartridge tray 270 triggers the signal of the second optical coupler 264 b.

Referring to fig. 1 and 9, in the above embodiments of the present invention, the positioning element 220 is installed on the operating platform 210. Specifically, the operating platform 210 is provided with a support pillar extending upward, and the positioning element 220 is connected to the support pillar. Thus, on one hand, the supporting upright posts can play a role of supporting the positioning piece 220, and further play a role of supporting the reagent kit 100; on the other hand, the support posts can also serve as stops for the reagent cartridge carrier 270.

The method for using the POCT glycated hemoglobin analyzer 200 of the present invention will be described in detail below, and specifically includes the following steps:

(1) firstly, directly collecting a blood sample from a human body through a blood collector 130, and then directly inserting the blood collector 130 containing the blood sample into the reaction solution cavity 113 (blood collector cavity 113 b);

(2) the reagent kit 100 is loaded on the reagent kit bracket 270, the reagent kit bracket 270 is driven to move backwards by the third driving mechanism 260, so that the fixing groove 180 on the reagent kit 100 completely sleeves the positioning piece 220, the limiting hole 170 on the reagent kit 100 completely sleeves the driving rod 233, and finally the reagent kit bracket 270 is driven to move forwards by the third driving mechanism 260, so that the reagent kit 100 is separated from the reagent kit bracket 270;

(3) the first driving mechanism 230 drives the rotating member 232 and the driving rod 233 to rotate, so that the rotating body 110 alternately rotates clockwise or counterclockwise around the fixed body 120 by a preset angle, so that the reaction solution in the reaction solution cavity 113 is uniformly mixed with the blood sample in the blood collector 130;

(4) after uniform mixing, the first driving mechanism 230 drives the rotating body 110 to rotate counterclockwise, so that the second flow channel 118 and the first flow channel 117 sequentially pass through the air pressure release port 124, and the internal and external air pressures of the cleaning liquid cavity 114 and the reaction liquid cavity 113 are kept balanced;

(5) then the first driving mechanism 230 drives the rotating body 110 to rotate clockwise until the first flow channel 117 faces the filter membrane 122 in the fixed body 120 (as shown in fig. 6), at this time, the second driving mechanism 250 drives the detecting device 240 to move downward, so that the piston pressing block pushes the piston in the reaction liquid cavity 113 to move downward, and thus the liquid in the reaction liquid cavity 113 flows out through the first flow channel 117 and drops on the filter membrane 122 of the fixed body 120; the piston press block is moved upwards and is separated from the reagent kit 100;

(6) after waiting for a period of time (e.g., 10 to 30 seconds), the first driving mechanism 230 drives the rotating body 110 to rotate clockwise to make the second flow channel 118 face the filter membrane 122 in the fixed body 120 (as shown in fig. 7), at this time, the second driving mechanism 250 drives the detecting device 240 to move downward again, so that the piston pressing block moves downward again, and pushes the piston in the cleaning solution cavity 114 to move downward, so that the liquid in the cleaning solution cavity 114 flows out through the second flow channel 118 and drops on the filter membrane 122 of the fixed body 120; the piston press block is moved upwards and is separated from the reagent kit 100;

(7) after waiting for a period of time (e.g., 10 to 30 seconds), the first driving mechanism 230 drives the rotating body 110 to rotate clockwise to make the detection port 112 just above the filter membrane 122 of the fixed body 120 (as shown in fig. 8), at this time, the second driving mechanism 250 drives the detection device 240 to move downward again, so that when the piston pressing block just contacts the filter membrane cover 123, the detection device 240 above the piston pressing block can perform a test, and obtain a final result.

In the step (1), the blood sample may be collected by the blood collecting instrument 130, and the kit 100 with the blood collecting instrument 130 may be loaded into the glycated hemoglobin analyzer 200 for measurement. This makes it possible to omit step (3), thereby further simplifying the operation steps.

The above description is only a preferred embodiment of the present invention, and is not intended to limit the scope of the present invention, and all modifications and equivalents of the present invention, which are made by the contents of the present specification and the accompanying drawings, or directly/indirectly applied to other related technical fields, are included in the scope of the present invention.

Claims

1. A POCT glycated hemoglobin analyzer, comprising:

a detection device mounted on the mounting plate to be movable up and down.

2. The POCT glycated hemoglobin analyzer of claim 1, wherein the piston press block is attached to a bottom of the measuring device.

3. The POCT glycated hemoglobin analyzer of claim 2, wherein the piston press block has a measurement through hole formed therethrough for the measurement device to transmit and receive measurement signals.

4. The POCT glycated hemoglobin analyzer of claim 2, further comprising a second driving mechanism coupled to the measuring device for driving the measuring device to move up and down.

5. The POCT glycated hemoglobin analyzer of claim 4, wherein the second driving mechanism comprises a second motor, a driving wheel, a driven wheel, and a transmission belt, the second motor is mounted on the mounting plate, the driving wheel is connected to the second motor, the transmission belt is sleeved on the driving wheel and the driven wheel, and the detection device is connected to the transmission belt.

6. The POCT glycated hemoglobin analyzer of claim 1, wherein a stopper rod extending downward is further provided at the bottom of the measuring device.

7. The POCT glycated hemoglobin analyzer of claim 1, further comprising a cartridge holder, wherein the cartridge holder is movably mounted on the operation platform in a front-and-back direction.

8. The POCT glycated hemoglobin analyzer of claim 7, further comprising a third drive mechanism coupled to the cartridge holder to drive the cartridge holder forward and backward.

9. The POCT glycated hemoglobin analyzer of claim 8, wherein a support plate is provided on the operation platform on a side of the cartridge holder, the third driving mechanism includes a third motor, a gear, and a rack engaged with the gear, the third motor is mounted on the support plate, the gear is connected to the third motor, and the rack extends in a front-rear direction and is connected to the cartridge holder.

10. A POCT glycated hemoglobin analysis system comprising the POCT glycated hemoglobin analyzer of any one of claims 1 to 9, and a kit adapted to the POCT glycated hemoglobin analyzer.