Newborn inherited metabolic disease screening kit

By designing a screening kit for genetic metabolic diseases in neonatal combined with dry blood spot method and fluorescence detection technology, the existing methods have solved the problems of limited detection scope, high cost and complex operation, and achieved a comprehensive, economical and simple screening effect.

CN119587018AInactive Publication Date: 2025-03-11JINAN MINGYU MEDICAL LAB CO LTD +1
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Patent Information

Application Number
CN202411792567.7
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-12-07
Publication Date
2025-03-11
Estimated Expiration
Not applicable · inactive patent

AI Technical Summary

Technical Problem

The existing screening methods for genetic metabolic diseases in neonatal have problems such as limited testing scope, high cost of equipment and consumables, complex operation, and unsuitable for popularization of primary medical institutions.

Method used

A screening kit for genetic metabolic disease in neonatal is designed, using dry blood spot method and fluorescence detection technology, combined with a reaction tube driven by a servo motor, which reduces the cost of equipment and consumables, simplifies the operating process, and is suitable for use in primary medical institutions.

Benefits of technology

It has achieved a comprehensive screening of genetic metabolic diseases in neonates, reduced the cost of equipment and consumables, simplified the operation process, and is suitable for large-scale promotion and use in primary medical institutions.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention relates to a neonatal inherited metabolic disease screening kit, and relates to the technical field of kits.The neonatal inherited metabolic disease screening kit comprises a kit body, the top of the kit body is connected with a kit cover through a hinge, the top of the kit cover is provided with a handle, a partition plate is arranged at the center of an inner cavity of the kit body, and one side of the partition plate is provided with a sampling cavity; positioning hole plates are connected to the two sides of the top of the partition plate, a first supporting plate is arranged on one side of an inner cavity of the sampling cavity, a sponge mat is connected to the top of the first supporting plate, limiting grooves are formed in the top of the sponge mat in an arrayed mode, and blood collection tubes are embedded in the tops of the multiple sets of limiting grooves. When the drawing box is opened, the blood collection tube can be jacked up to protrude out of the positioning hole plate, so that a blood collection needle and a blood collection card can be taken out, meanwhile, the blood collection tube is jacked up to be taken out quickly, more inherited metabolic diseases can be detected through the combination of a buffer solution and an enzyme reagent, and the screening comprehensiveness is improved.
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Description

Technical Field

[0001] The present application relates to the technical field of kits, and in particular to a kit for screening genetic metabolic diseases in newborns. Background Art

[0002] Neonatal screening for inherited metabolic diseases is an important means of preventing and early detecting inherited metabolic diseases. Currently, many countries and regions around the world have established neonatal screening programs to collect blood samples from newborns for early detection and treatment of inherited metabolic diseases. These screening programs usually include the detection of multiple metabolic diseases, such as phenylketonuria, congenital hypothyroidism, etc. With the development of gene sequencing technology, more and more inherited metabolic diseases can be screened through high-throughput sequencing technology, which improves the accuracy and efficiency of screening; In the prior art, the relevant technology of the neonatal genetic metabolic disease screening kit can refer to the Chinese patent with announcement number CN202994745U, which discloses a kit for neonatal genetic metabolic disease screening. The kit includes a box body, a box cover, a reagent bottle, a 96-well plate and a fixing seat. The reagent bottles are at least 5, and the fixing seat is placed at the bottom of the box body. The reagent bottles are respectively connected to the fixing seat in a detachable manner. Each reagent bottle is fixed in the box body by the fixing seat, and the 96-well plate is placed above the reagent bottle. In the process of realizing this application, the inventor found that the prior art has the following problems: At present, the main methods used for screening genetic metabolic diseases in newborns include dried blood spot method, liquid chromatography-mass spectrometry method and gene sequencing method. The dried blood spot method cannot cover all genetic metabolic diseases and is prone to missed detection. Although liquid chromatography-mass spectrometry and gene sequencing methods have a wide detection range, the cost of equipment and consumables is relatively high, which is not conducive to large-scale promotion. Liquid chromatography-mass spectrometry and gene sequencing methods require professional technicians to operate, and the data analysis is complex, which is not conducive to popularization in primary medical institutions. At the same time, existing test kits are often not convenient for ejecting test tubes for easy removal, and do not have the function of improving the mixing uniformity of reaction tubes. Summary of the invention

[0003] The purpose of this application is to provide a screening kit for neonatal genetic metabolic diseases.

[0004] In the first aspect, the present application provides a newborn genetic metabolic disease screening kit using the following technical solutions: A newborn genetic metabolic disease screening kit comprises a kit body, the top of the kit body is connected to a box cover by a hinge, the top of the box cover is provided with a handle, a partition is provided at the center of the inner cavity of the kit body, a sampling cavity is provided on one side of the partition, positioning hole plates are connected to both sides of the top of the partition, two groups of the positioning hole plates are connected to the inner wall of the kit body at one end away from the partition, mounting holes are arranged on the surface of the positioning hole plates, a No. 1 support plate is provided on one side of the inner cavity of the sampling cavity, a sponge pad is connected to the top of the No. 1 support plate, limiting grooves are arranged on the top of the sponge pad, the limiting grooves correspond to the mounting holes, blood collection tubes are embedded in the tops of multiple groups of the limiting grooves, and the blood collection tubes pass through the middle of the mounting holes, and a sliding slope is provided on the bottom end of the No. 1 support plate close to the side of the partition.

[0005] By adopting the above technical scheme, the reagent box body plays a supporting role, and the hinge connection between the box cover and the reagent box body is a damping hinge, and the box cover on the side away from the hinge is connected to the reagent box body by a snap-fit, and the partition plays a partitioning role to separate the sampling chamber from the reaction chamber. The blood collection tube can be lifted up by the No. 1 support plate and the sponge pad and fixedly installed with the positioning hole plate, and the sponge pad plays a buffering role to prevent the blood collection tube from being damaged due to collision and shock when the reagent box is bumped. The blood collection tube can be used with a blood collection needle to collect blood for subsequent genetic metabolic disease screening.

[0006] A pull-out box is provided at the bottom of the No. 1 pallet, and the No. 1 pallet is in contact with the pull-out box, a blood collection needle is provided in the inner cavity of the pull-out box, a blood collection card is provided on one side of the blood collection needle, one end of the pull-out box passes through the reagent box body and is connected with a handle, a support frame is connected to the top of the pull-out box away from the handle, a sloped push plate is connected to the top of the support frame, and the top of the sloped push plate is in contact with the sliding slope.

[0007] By adopting the above technical solution, a blood collection needle and a blood collection card can be placed in the pull-out box, and the pull-out box can be pulled out to the outside of the reagent box body by pulling the handle to take out the blood collection needle and the blood collection card to perform blood collection. The blood collection needle is used to collect heel blood of newborns, the blood collection tube is used to store blood samples, and the blood collection card is used to prepare dried blood spots. The blood collection needle adopts a disposable medical stainless steel blood collection needle with a diameter of 0.5mm and a length of 10mm. The blood collection tube is made of polypropylene with a capacity of 2ml and a sealing cover. The blood collection card is made of a special filter paper material with a diameter of 3cm and a thickness of 0.5mm. It can be used through The heel blood of the newborn is collected by a blood collection needle and dripped into a blood collection tube. The blood in the blood collection tube is then dripped onto the blood collection card to prepare a dry blood spot. The movement of the pull-out box when pulled can drive the support frame and the inclined push plate to move synchronously. The movement of the inclined push plate gradually pushes the sliding inclined surface and the No. 1 support plate to move upward in a translational manner. The movement of the No. 1 support plate drives the sponge pad and the blood collection tube to move upward in a synchronous translational manner, so that the blood collection tube can be lifted up to protrude to the outside of the positioning hole plate while the pull-out box is opened, so that the blood collection needle and the blood collection card can be taken out and the blood collection tube can be lifted up to be quickly taken out.

[0008] A slide is provided on one side of the bottom of the sampling chamber, and a slider is connected to the bottom end of the pull-out box, which is embedded in the slide. Pulling the handle drives the pull-out box to translate along the axial direction of the slider, and the movement of the pull-out box drives the support frame to move synchronously, and the movement of the support frame drives the inclined push plate to translate synchronously, and the movement of the inclined push plate gradually pushes the sliding inclined surface and the No. 1 support plate to translate upward, and the movement of the No. 1 support plate drives the sponge pad and the blood collection tube to translate upward synchronously.

[0009] By adopting the above technical solution, the slider is embedded in the slideway to play a limiting role so that the pull-out box can slide along the slideway.

[0010] A reaction chamber is arranged on the side of the partition away from the sampling chamber, a No. 2 support plate is arranged at the bottom of the reaction chamber, a No. 2 sponge pad is arranged on the top of the No. 2 support plate, a mounting groove is arranged on the top of the No. 2 sponge pad, the mounting groove matches the mounting hole, and a reaction tube is embedded on the top of the mounting groove.

[0011] By adopting the above technical solution, the reaction chamber serves to place the reaction tube. The reaction tube is made of transparent polypropylene, has a capacity of 5 ml, and is equipped with a sealing cover. The reaction tube is used to hold dry blood spots and buffer solutions. The reaction tube can be lifted up by the No. 2 support plate and the No. 2 sponge pad and fixedly installed with the positioning hole plate. The No. 2 sponge pad serves as a buffer to prevent the blood collection tube from being damaged due to collision and shock when the reagent kit is bumped.

[0012] The inner walls on both sides of the reagent box body and the outer wall of the partition are provided with limiting slide grooves, the outer walls on both sides of the No. 1 and No. 2 pallets are connected to limiting movable blocks, and multiple groups of the limiting movable blocks are embedded in the corresponding limiting slide grooves.

[0013] By adopting the above-mentioned technical scheme, the limiting moving block is embedded in the corresponding limiting slide groove so that the No. 1 pallet and the No. 2 pallet can perform lifting and sliding movements in the limiting slide groove through the limiting moving block, and the limiting moving block and the limiting slide groove play a limiting role to prevent the No. 1 pallet and the No. 2 pallet 22 from tilting during the lifting process.

[0014] An electric heating wire is arranged around the inner wall of the reaction chamber, a semiconductor refrigerator is arranged on the outer wall of one side of the reagent box body, and the cooling end of the semiconductor refrigerator extends through the reagent box body into the reaction chamber, a temperature sensor is arranged above the inner wall of one side of the reaction chamber, and reagent tanks are embedded on both sides of the positioning hole plate close to the partition.

[0015] By adopting the above technical solution, the electric heating wire can be powered on for heating to increase the temperature inside the reaction chamber, the cooling end of the semiconductor refrigerator extends through the reagent kit body into the reaction chamber to cool the reaction chamber, the temperature sensor can monitor the temperature in the reaction chamber in real time, and the heating regulation of the electric heating wire and the cooling regulation of the semiconductor refrigerator can be coordinated to maintain a constant temperature in the reaction chamber to facilitate the reaction of the blood in the reaction tube. Buffer solution and enzyme reagent are respectively arranged in two groups of reagent tanks. The buffer solution has a pH value of 7.4 and contains phosphate buffer solution. The enzyme reagent contains a variety of specific enzymes for catalyzing the reaction of different metabolites. The dried blood spot is placed in a reaction tube, and the buffer solution and enzyme reagent are added. After mixing evenly, the mixture is placed under constant temperature conditions for reaction.

[0016] The bottom inner wall of the reaction chamber is connected to a driving shaft through a bearing, and the driving shaft is arranged at the bottom of the second support plate. The outer walls of the driving shaft are connected to eccentric wheels by keys on both sides, and adjustment seats are arranged on both sides of the bottom end of the second support plate, and the bottom end of the adjustment seat is in contact with the eccentric wheel.

[0017] By adopting the above technical scheme, the driving shaft can rotate in the reaction chamber, and the rotation of the driving shaft drives the eccentric wheel to rotate synchronously, and the rotation of the eccentric wheel drives the adjusting seat to perform reciprocating lifting motion, and the lifting of the adjusting seat drives the No. 2 pallet to perform synchronous lifting motion, and the reciprocating motion of the No. 2 pallet drives the No. 2 sponge pad and the reaction tube to perform synchronous reciprocating motion, and the dry blood spot inside the reaction tube is evenly mixed with the buffer solution and the enzyme reagent through the reciprocating lifting of the reaction tube. Through the combination of buffer solution and enzyme reagent, more genetic metabolic diseases can be detected, thereby improving the comprehensiveness of screening.

[0018] A servo motor is connected to an outer wall of one side of the test kit body, and an output end of the servo motor is connected to a driving shaft. The servo motor drives the driving shaft to rotate, and the rotation of the driving shaft drives the eccentric wheel to rotate synchronously. The rotation of the eccentric wheel drives the adjustment seat to perform reciprocating lifting motion, and the lifting of the adjustment seat drives the second pallet to perform synchronous lifting motion.

[0019] By adopting the above technical solution, the servo motor plays a driving role and can drive the reaction tube to move up and down to facilitate uniform mixing of the reaction tube. At the same time, a brake mechanism is provided in the servo motor to keep it stationary in the event of a power outage. At the same time, the servo motor can control the reaction tube to stop rotating when it is lifted up to facilitate the removal of the reaction tube.

[0020] A detection box is arranged on one side of the reagent box body, a fluorescence detector is arranged inside the detection box, a data processor is arranged on one side of the fluorescence detector, a display screen is arranged at the center of the inner wall of the box cover, ultraviolet sterilization lamps are arranged on both sides of the display screen, and the data processor is connected to the fluorescence detector, the electric heating wire, the semiconductor refrigerator and the temperature sensor through wires.

[0021] By adopting the above technical solution, the fluorescence detector adopts a high-sensitivity fluorescence detector with a detection range of 0-1000 fluorescence units. It can be detected by reacting with a fluorescent probe in a reaction tube. The fluorescent probe adopts a fluorescently labeled DNA probe designed for specific metabolites. The data processor adopts a high-performance embedded processor with data storage and processing functions. The display screen adopts a color LCD screen with a resolution of 800x600 pixels. When testing, the reaction tube can be placed in the fluorescence detector, the fluorescent probe marks the specific metabolite, and the fluorescence detector detects the fluorescence signal. Then the data processor receives the data collected by the fluorescence detector, processes and analyzes it, and the final result is displayed on the display screen. The dry blood spot method and fluorescence detection technology are used, and the equipment and consumables costs are relatively low, which is suitable for large-scale promotion. The unused test kit can be irradiated for a certain period of time by an ultraviolet sterilization lamp to perform sterilization and disinfection.

[0022] In summary, the present application includes at least one of the following beneficial technical effects: 1. Pull the handle to pull the pull-out box out of the reagent box body to take out the blood collection needle and the blood collection card to carry out blood collection. When the pull-out box is pulled out, it can drive the support frame and the inclined push plate to move synchronously. The inclined push plate gradually pushes the sliding inclined surface and the No. 1 support plate to move upward. The movement of the No. 1 support plate drives the sponge pad and the blood collection tube to move upward synchronously, so that the blood collection tube can be lifted up to the outside of the positioning hole plate when the pull-out box is opened, so that the blood collection needle and the blood collection card can be taken out and the blood collection tube can be lifted up to be taken out quickly. 2. The servo motor drives the driving shaft to rotate, thereby driving the eccentric wheel to rotate synchronously. The rotation of the eccentric wheel drives the adjusting seat to perform reciprocating lifting motion. The lifting of the adjusting seat drives the No. 2 pallet to perform synchronous lifting motion. The reciprocating motion of the No. 2 pallet drives the No. 2 sponge pad and the reaction tube to perform synchronous reciprocating motion. The reciprocating lifting of the reaction tube allows the dry blood spot inside to be evenly mixed with the buffer solution and the enzyme reagent. Through the combination of the buffer solution and the enzyme reagent, more genetic metabolic diseases can be detected, thereby improving the comprehensiveness of the screening.

[0023] 3. Through the combination of buffer and enzyme reagents, more genetic metabolic diseases can be detected and the comprehensiveness of screening can be improved. When conducting the test, the reaction tube can be placed in the fluorescence detector, the fluorescent probe marks the specific metabolite, the fluorescence detector detects the fluorescence signal, and then the data processor receives the data collected by the fluorescence detector for processing and analysis. The final result is displayed on the display screen. The dry blood spot method and fluorescence detection technology are used, and the cost of equipment and consumables is relatively low, which is suitable for large-scale promotion. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 It is a schematic diagram of the overall structure of Example 1 of the present application; Figure 2 is a schematic diagram of the three-dimensional structure of Example 1 of the present application; Figure 3 It is a schematic diagram of the connection structure between the limiting groove and the blood collection tube in Example 1 of the present application; Figure 4 It is a schematic diagram of the structure of the drawer box of Example 1 of the present application; Figure 5 It is a schematic diagram of the connection structure between the drawer box and the first support plate of Example 1 of the present application; Figure 6 Schematic diagram of the connection structure between the drive shaft and the eccentric wheel of Example 1 of the present application; Description of the accompanying drawings: 1. reagent box body; 2. box cover; 3. handle; 4. partition; 5. sampling chamber; 6. positioning hole plate; 7. mounting hole; 8. No. 1 support plate; 9. sponge pad; 10. limit groove; 11. blood collection tube; 12. sliding slope; 13. pull-out box; 14. blood collection needle; 15. blood collection card; 16. handle; 17. support frame; 18. inclined push plate; 19. slideway; 20. slide block; 21. reaction chamber; 22. No. 2 No. 1 pallet; 23. No. 2 sponge pad; 24. mounting slot; 25. reaction tube; 26. limit slide; 27. limit moving block; 28. electric heating wire; 29. ​​semiconductor refrigerator; 30. temperature sensor; 31. reagent tank; 32. drive shaft; 33. eccentric wheel; 34. adjustment seat; 35. servo motor; 36. detection box; 37. fluorescence detector; 38. data processor; 39. display screen; 40. ultraviolet germicidal lamp. DETAILED DESCRIPTION

[0025] The following is combined with Figure 1 - Attachment Figure 6 , further details of this application are given.

[0026] Embodiment 1: A newborn genetic metabolic disease screening kit comprises a kit body 1, the top of the kit body 1 is connected to a box cover 2 by a hinge, a handle 3 is arranged on the top of the box cover 2, a partition 4 is arranged at the center of the inner cavity of the kit body 1, a sampling cavity 5 is arranged on one side of the partition 4, positioning hole plates 6 are connected to both sides of the top of the partition 4, two groups of positioning hole plates 6 are connected to the inner wall of the kit body 1 at one end away from the partition 4, mounting holes 7 are arranged on the surface of the positioning hole plates 6, a No. 1 support plate 8 is arranged on one side of the inner cavity of the sampling cavity 5, a sponge pad 9 is connected to the top of the No. 1 support plate 8, and a limiting groove 10 is arranged on the top of the sponge pad 9, and the limiting groove 10 corresponds to the mounting hole 7, and a plurality of groups of limiting grooves 10 are embedded on the top of the blood sampling device. Tube 11, and the blood sampling tube 11 passes through the middle of the mounting hole 7, a sliding slope 12 is provided on the bottom end of the side of the No. 1 support plate 8 close to the partition 4, the reagent box body 1 plays a supporting role, and the hinge connection between the box cover 2 and the reagent box body 1 is a damping hinge, and the box cover 2 and the reagent box body 1 on the side away from the hinge are connected by a snap-fit, and the partition 4 plays a partitioning role to separate the sampling chamber 5 from the reaction chamber 21, the blood sampling tube 11 can be lifted up by the No. 1 support plate 8 and the sponge pad 9 and fixedly installed with the positioning hole plate 6, and the sponge pad 9 plays a buffering role to prevent the blood sampling tube 11 from being damaged due to collision and shock when the reagent box is bumped, and the blood sampling tube 11 cooperates with the blood collection needle 14 to collect blood for subsequent genetic metabolic disease screening.

[0027] A pull-out box 13 is provided at the bottom of the No. 1 support plate 8, and the No. 1 support plate 8 is abutted against the pull-out box 13. A blood collection needle 14 is provided in the inner cavity of the pull-out box 13, and a blood collection card 15 is provided on one side of the blood collection needle 14. One end of the pull-out box 13 passes through the reagent box body 1 and is connected to a handle 16. The top of the pull-out box 13 away from the handle 16 is connected to a support frame 17, and the top of the support frame 17 is connected to an inclined push plate 18, and the top of the inclined push plate 18 is abutted against the sliding inclined surface 12. The blood collection needle 14 and the blood collection card 15 can be placed through the pull-out box 13. The pull-out box 13 can be pulled out of the reagent box body 1 by pulling the handle 16 to take out the blood collection needle 14 and the blood collection card 15 to perform blood collection. The blood collection needle 14 is used to collect heel blood of newborns, the blood collection tube 11 is used to store blood samples, and the blood collection card 15 is used to prepare dry blood spots. The blood collection needle 14 adopts a disposable medical stainless steel blood collection needle with a diameter of 0.5m m, length 10mm, the blood collection tube 11 is made of polypropylene, with a capacity of 2ml and a sealing cover, and the blood collection card 15 is made of special filter paper with a diameter of 3cm and a thickness of 0.5mm. When in use, the heel blood of the newborn can be collected through the blood collection needle 14 and dripped into the blood collection tube 11, and then the blood in the blood collection tube 11 is dripped on the blood collection card 15 to prepare a dry blood spot, and the movement of the pull-out box 13 when pulled can drive the support frame 17 and the inclined push plate 18 to move synchronously, and the movement of the inclined push plate 18 gradually pushes the sliding inclined surface 12 and the No. 1 support plate 8 to move upward, and the movement of the No. 1 support plate 8 drives the sponge pad 9 and the blood collection tube 11 to move upward synchronously, so that the pull-out box 13 can be opened and the blood collection tube 11 can be lifted up to make it protrude to the outside of the positioning hole plate 6, so as to facilitate the removal of the blood collection needle 14 and the blood collection card 15 while cooperating with the blood collection tube 11 to lift it up to make it quickly removed.

[0028] A slide 19 is provided on one side of the bottom of the sampling chamber 5, and a slider 20 is connected to the bottom end of the pull-out box 13, and the slider 20 is embedded in the slide 19. Pulling the handle 16 drives the pull-out box 13 to translate along the axial direction of the slider 20, and the movement of the pull-out box 13 drives the support frame 17 to move synchronously, and the movement of the support frame 17 drives the inclined push plate 18 to translate synchronously, and the movement of the inclined push plate 18 gradually pushes the sliding inclined surface 12 and the No. 1 support plate 8 to translate upward, and the movement of the No. 1 support plate 8 drives the sponge pad 9 and the blood collection tube 11 to translate upward synchronously, and the slider 20 is embedded in the slide 19 to play a limiting role so that the pull-out box 13 can slide along the slide 19.

[0029] A reaction chamber 21 is arranged on the side of the partition 4 away from the sampling chamber 5, a No. 2 support plate 22 is arranged at the bottom of the reaction chamber 21, a No. 2 sponge pad 23 is arranged on the top of the No. 2 support plate 22, a mounting groove 24 is arranged on the top of the No. 2 sponge pad 23, and a mounting groove 24 is arranged on the top of the No. 2 sponge pad 23. The mounting groove 24 matches the mounting hole 7, and a reaction tube 25 is embedded on the top of the mounting groove 24. The reaction chamber 21 serves to place the reaction tube 25. The reaction tube 25 is made of transparent polypropylene, has a capacity of 5 ml, and is provided with a sealing cover. The reaction tube 25 is used to hold dry blood spots and buffer solutions. The reaction tube 25 can be lifted up by the No. 2 support plate 22 and the No. 2 sponge pad 23 and fixedly installed with the positioning hole plate 6, and the No. 2 sponge pad 23 serves as a buffer to prevent the blood collection tube 11 from being damaged due to collision and shock when the reagent kit is bumped.

[0030] The inner walls on both sides of the reagent box body 1 and the outer walls of the partition 4 are provided with limiting slide grooves 26, and the outer walls on both sides of the No. 1 pallet 8 and the No. 2 pallet 22 are connected to the limiting moving blocks 27, and multiple groups of limiting moving blocks 27 are embedded in the corresponding limiting slide grooves 26. The limiting moving blocks 27 are embedded in the corresponding limiting slide grooves 26 so that the No. 1 pallet 8 and the No. 2 pallet 22 can be lifted and slid in the limiting slide grooves 26 through the limiting moving blocks 27, and the limiting moving blocks 27 and the limiting slide grooves 26 play a limiting role to prevent the No. 1 pallet 8 and the No. 2 pallet 22 from tilting during the lifting process.

[0031] An electric heating wire 28 is arranged around the inner wall of the reaction chamber 21, a semiconductor refrigerator 29 is arranged on the outer wall of one side of the reagent box body 1, and the cooling end of the semiconductor refrigerator 29 extends through the reagent box body 1 into the reaction chamber 21, a temperature sensor 30 is arranged above the inner wall of one side of the reaction chamber 21, and reagent tanks 31 are embedded on both sides of the positioning hole plate 6 close to the partition 4. The electric heating wire 28 can be electrically heated to heat the inside of the reaction chamber 21, and the cooling end of the semiconductor refrigerator 29 extends through the reagent box body 1 into the reaction chamber 21 to cool the reaction chamber 21. The model of the temperature sensor 30 is It is DS18B20+, and the temperature sensor 30 can monitor the temperature in the reaction chamber 21 in real time. The temperature increase regulation of the electric heating wire 28 and the temperature decrease regulation of the semiconductor refrigerator 29 can make the reaction chamber 21 maintain a constant temperature so as to facilitate the reaction of the blood in the reaction tube 25. The two groups of reagent tanks 31 are respectively provided with a buffer solution and an enzyme reagent. The pH value of the buffer solution is 7.4, and it contains a phosphate buffer solution. The enzyme reagent contains a variety of specific enzymes for catalyzing the reaction of different metabolites. The dried blood spot is placed in the reaction tube 25, and the buffer solution and enzyme reagent are added. After mixing evenly, the mixture is placed under constant temperature conditions for reaction.

[0032] The bottom inner wall of the reaction chamber 21 is connected to a driving shaft 32 through a bearing. The driving shaft 32 is arranged at the bottom of the No. 2 support plate 22. Eccentric wheels 33 are connected by keys on both sides of the outer wall of the driving shaft 32. Adjustment seats 34 are arranged on both sides of the bottom end of the No. 2 support plate 22. The bottom ends of the adjustment seats 34 abut against the eccentric wheels 33. The driving shaft 32 can rotate in the reaction chamber 21. The rotation of the driving shaft 32 drives the eccentric wheel 33 to rotate synchronously. The rotation of the eccentric wheel 33 drives the adjustment seat 34 to perform reciprocating lifting motion. The lifting of the adjustment seat 34 drives the No. 2 support plate 22 to perform synchronous lifting motion. The reciprocating motion of the No. 2 support plate 22 drives the No. 2 sponge pad 23 and the reaction tube 25 to perform synchronous reciprocating motion. The reciprocating lifting of the reaction tube 25 allows the dry blood spots inside the reaction tube 25 to be evenly mixed with the buffer solution and the enzyme reagent. Through the combination of the buffer solution and the enzyme reagent, more genetic metabolic diseases can be detected, thereby improving the comprehensiveness of the screening.

[0033] A servo motor 35 is connected to the outer wall of one side of the reagent kit body 1, and the output end of the servo motor 35 is connected to the driving shaft 32. The servo motor 35 drives the driving shaft 32 to rotate, and the rotation of the driving shaft 32 drives the eccentric wheel 33 to rotate synchronously. The rotation of the eccentric wheel 33 drives the adjusting seat 34 to perform reciprocating lifting motion, and the lifting of the adjusting seat 34 drives the second support plate 22 to perform synchronous lifting motion. The servo motor 35 plays a driving role and can drive the reaction tube 25 to perform reciprocating lifting so that the reaction tube 25 can be mixed evenly. At the same time, a brake mechanism is provided in the servo motor 35, which can keep it stationary when the power is off. At the same time, the servo motor 35 can control the reaction tube 25 to stop rotating when it is lifted up to facilitate the removal of the reaction tube 25.

[0034] A detection box 36 is arranged on one side of the reagent box body 1, a fluorescence detector 37 is arranged inside the detection box 36, a data processor 38 is arranged on one side of the fluorescence detector 37, a display screen 39 is arranged at the center of the inner wall of the box cover 2, ultraviolet sterilization lamps 40 are arranged on both sides of the display screen 39, the data processor 38 is connected to the fluorescence detector 37, the electric heating wire 28, the semiconductor refrigerator 29 and the temperature sensor 30 through wires, the fluorescence detector 37 adopts a high-sensitivity fluorescence detector with a detection range of 0-1000 fluorescence units, which can be detected by a fluorescent probe reacting with the reaction tube 25, and the fluorescent probe adopts a fluorescently labeled DNA probe designed for specific metabolites. The data processor 38 adopts a high-performance embedded processor with data storage and processing functions. The display screen 39 adopts a color LCD screen with a resolution of 800x600 pixels. When performing detection, the reaction tube 25 can be placed in the fluorescence detector 37, and the fluorescent probe can be used to mark specific metabolites. The fluorescence detector 37 detects the fluorescence signal. Then the data processor 38 receives the data collected by the fluorescence detector 37, processes and analyzes it, and the final result is displayed on the display screen 39. The dry blood spot method and fluorescence detection technology are used, and the equipment and consumables costs are relatively low, which is suitable for large-scale promotion. The ultraviolet sterilization lamp 40 can be used to irradiate the test kit for a certain period of time when it is not in use to perform sterilization and disinfection.

[0035] The implementation principle of the embodiment of the present application is as follows: first, the box cover 2 is opened, and the partition 4 acts as a partition to separate the sampling chamber 5 from the reaction chamber 21. The blood collection tube 11 can be lifted up by the No. 1 support plate 8 and the sponge pad 9 and fixedly installed with the positioning hole plate 6, and the sponge pad 9 acts as a buffer to prevent the blood collection tube 11 from being damaged due to collision and shock when the reagent box is bumped. The blood collection tube 11 can be used with the blood collection needle 14 to collect blood for subsequent genetic metabolic disease screening. When blood is collected, the handle 16 is first pulled to pull the pull-out box 13 out of the reagent box body 1 to take out the blood collection needle 14 and the blood collection card 15 to perform blood collection work, and the pull-out box 13 can drive the support frame 17 and the inclined push plate 18 to move synchronously when being pulled, and the inclined push plate 18 moves and gradually pushes The movable sliding inclined plane 12 and the No. 1 support plate 8 perform upward translational movement, and the No. 1 support plate 8 moves to drive the sponge pad 9 and the blood collection tube 11 to perform synchronous upward translational movement, so that the blood collection tube 11 can be lifted up to make it protrude to the outside of the positioning hole plate 6 while opening the pull-out box 13, so that the blood collection needle 14 and the blood collection card 15 can be taken out and the blood collection tube 11 can be lifted up to make it quickly taken out, the blood collection needle 14 is used to collect the heel blood of the newborn, and the blood is dripped into the blood collection tube 11, and the blood in the blood collection tube 11 is dripped onto the blood collection card 15 to prepare a dry blood spot, and the dry blood spot is placed in the reaction tube 25, and a buffer solution and an enzyme reagent are added, and the drive shaft 32 is driven by the servo motor 35 to rotate, thereby driving the eccentric wheel 33 to rotate synchronously, and the eccentric wheel 33 rotates to push the adjustment seat The adjustment seat 34 performs reciprocating lifting motion, and the lifting of the adjustment seat 34 drives the No. 2 support plate 22 to perform synchronous lifting motion. The reciprocating motion of the No. 2 support plate 22 drives the No. 2 sponge pad 23 and the reaction tube 25 to perform synchronous reciprocating motion. The reaction tube 25 is lifted and lowered to make the dry blood spots, buffer solution and enzyme reagent inside the reaction tube 25 evenly mixed. After the mixture is evenly mixed, the servo motor 35 stops rotating, and the reaction tube 25 is stationary in the reaction chamber 21. The temperature in the reaction chamber 21 is detected by the temperature sensor 30, and the signal is transmitted to the data processor 38. The data processor 38 controls the temperature increase regulation of the electric heating wire 28 and the temperature decrease regulation of the semiconductor refrigerator 29, so that the reaction chamber 21 can maintain a constant temperature for the reaction in the reaction tube 25. The reaction is carried out under the constant temperature condition for 10 minutes. , put the reaction tube 25 into the fluorescence detector 37, start the detection program, receive the data collected by the fluorescence detector 37 through the data processor 38, process and analyze it, and finally display the result on the display screen 39. According to the displayed result, it is judged whether the newborn has a genetic metabolic disease to ensure the accuracy of the test result. At the same time, it should be noted that the blood collection needle 14 and the blood collection tube 11 must be used once to avoid cross infection. The reaction tube 25 and the fluorescence detector 37 must be kept clean to avoid contamination. The aseptic operation specifications should be strictly followed during the operation. The blood collection needle 14 can select blood collection needles of different diameters and lengths according to different needs. The blood collection tube 11 can select blood collection tubes of different specifications according to different capacity requirements. The fluorescent probe can select different fluorescent labeled probes according to different metabolites.The use of dry blood spot method and fluorescence detection technology has relatively low equipment and consumables costs, which is suitable for large-scale promotion. At the same time, the sampling and detection process is simple, does not require complex equipment and technicians, and is suitable for use in primary medical institutions and home environments.

[0036] The embodiments of this specific implementation are all preferred embodiments of the present application, and are not intended to limit the protection scope of the present application. The same components are represented by the same figure marks. Therefore, any equivalent changes made based on the structure, shape, and principle of the present application should be included in the protection scope of the present application.

Claims

1. A neonatal genetic metabolic disease screening kit, comprising a kit body (1), characterized in that: The top of the reagent box body (1) is connected to a box cover (2) via a hinge, and a handle (3) is provided on the top of the box cover (2). A partition (4) is provided at the center of the inner cavity of the reagent box body (1), and a sampling cavity (5) is provided on one side of the partition (4). Positioning holes (6) are connected to both sides of the top of the partition (4). The ends of the two groups of positioning holes (6) away from the partition (4) are connected to the inner wall of the reagent box body (1), and the surfaces of the positioning holes (6) are arranged with mounting holes (7). ), a first support plate (8) is provided on one side of the inner cavity of the sampling cavity (5), a sponge pad (9) is connected to the top of the first support plate (8), limiting grooves (10) are arranged on the top of the sponge pad (9), the limiting grooves (10) correspond to the mounting holes (7), a plurality of groups of the limiting grooves (10) are embedded with blood sampling tubes (11) on the top, and the blood sampling tubes (11) pass through the middle of the mounting holes (7), and a sliding inclined surface (12) is provided on the bottom end of the first support plate (8) on the side close to the partition (4).

2. A neonatal genetic metabolic disease screening kit according to claim 1, characterized in that: A pull-out box (13) is provided at the bottom of the No. 1 support plate (8), and the No. 1 support plate (8) is in contact with the pull-out box (13). A blood collection needle (14) is provided in the inner cavity of the pull-out box (13), and a blood collection card (15) is provided on one side of the blood collection needle (14). One end of the pull-out box (13) passes through the reagent box body (1) and is connected to a handle (16). A support frame (17) is connected to the top of the pull-out box (13) away from the handle (16). A sloped push plate (18) is connected to the top of the support frame (17), and the top of the sloped push plate (18) is in contact with the sliding slope (12).

3. A newborn genetic metabolic disease screening kit according to claim 2, characterized in that: A slideway (19) is provided on one side of the bottom of the sampling chamber (5); a slider (20) is connected to the bottom end of the pull-out box (13); the slider (20) is embedded in the slideway (19); the handle (16) is pulled to drive the pull-out box (13) to perform translational movement along the axial direction of the slider (20); the movement of the pull-out box (13) drives the support frame (17) to perform synchronous movement; the movement of the support frame (17) drives the inclined surface push plate (18) to perform synchronous translation; the movement of the inclined surface push plate (18) gradually pushes the sliding inclined surface (12) and the first support plate (8) to perform upward translational movement; the movement of the first support plate (8) drives the sponge pad (9) and the blood collection tube (11) to perform synchronous upward translational movement.

4. A neonatal genetic metabolic disease screening kit according to claim 1, characterized in that: A reaction chamber (21) is arranged on a side of the partition (4) away from the sampling chamber (5); a second support plate (22) is arranged at the bottom of the reaction chamber (21); a second sponge pad (23) is arranged on the top of the second support plate (22); a mounting groove (24) is arranged at the top of the second sponge pad (23); the mounting groove (24) matches the mounting hole (7); and a reaction tube (25) is embedded in the top of the mounting groove (24).

5. A neonatal genetic metabolic disease screening kit according to claim 4, characterized in that: The inner walls on both sides of the reagent box body (1) and the outer wall of the partition (4) are both provided with limit sliding grooves (26), and the outer walls on both sides of the No. 1 support plate (8) and the No. 2 support plate (22) are both connected to limit moving blocks (27), and a plurality of groups of the limit moving blocks (27) are embedded in the limit sliding grooves (26) at corresponding positions.

6. A neonatal genetic metabolic disease screening kit according to claim 4, characterized in that: An electric heating wire (28) is arranged around the inner wall of the reaction chamber (21), a semiconductor refrigerator (29) is arranged on the outer wall of one side of the reagent box body (1), and the cooling end of the semiconductor refrigerator (29) passes through the reagent box body (1) and extends into the reaction chamber (21), a temperature sensor (30) is arranged above the inner wall of one side of the reaction chamber (21), and reagent tanks (31) are embedded on both sides of the positioning hole plate (6) close to the partition (4).

7. A neonatal genetic metabolic disease screening kit according to claim 6, characterized in that: The bottom inner wall of the reaction chamber (21) is connected to a driving shaft (32) via a bearing, the driving shaft (32) is arranged at the bottom of the second support plate (22), and eccentric wheels (33) are connected by keys on both sides of the outer wall of the driving shaft (32), and adjustment seats (34) are arranged on both sides of the bottom end of the second support plate (22), and the bottom end of the adjustment seat (34) is in contact with the eccentric wheel (33).

8. A neonatal genetic metabolic disease screening kit according to claim 7, characterized in that: A servo motor (35) is connected to an outer wall of one side of the reagent box body (1); an output end of the servo motor (35) is connected to a driving shaft (32); the servo motor (35) drives the driving shaft (32) to rotate; the driving shaft (32) rotates to drive the eccentric wheel (33) to rotate synchronously; the eccentric wheel (33) rotates to drive the adjustment seat (34) to perform reciprocating lifting motion; the lifting of the adjustment seat (34) drives the second support plate (22) to perform synchronous lifting motion.

9. A neonatal genetic metabolic disease screening kit according to claim 6, characterized in that: A detection box (36) is arranged on one side of the reagent box body (1), a fluorescence detector (37) is arranged inside the detection box (36), a data processor (38) is arranged on one side of the fluorescence detector (37), a display screen (39) is arranged at the center of the inner wall of the box cover (2), ultraviolet sterilization lamps (40) are arranged on both sides of the display screen (39), and the data processor (38) is connected to the fluorescence detector (37), the electric heating wire (28), the semiconductor refrigerator (29) and the temperature sensor (30) through electric wires.

Citation Information

Patent Citations

  • Reagent kit for screening neonate inherited metabolic diseases

    CN202994745U