Handheld dry fluorescence immunoassay analyzer

Abstract

The utility model discloses a handheld dry fluorescence immunoassay analyzer, including first casing, the upper side of first casing is clamped with second casing, the side wall of first casing is equipped with the connecting port, the other side wall of first casing is equipped with the feed port, the inside of first casing and second casing is provided with optical detection module, the lower fixedly connected of optical detection module has the mounting panel, one side of optical detection module is provided with the key board, the one side of key board is installed with display screen, one side of display screen is provided with ID card board, the one side of ID card board is installed with battery assembly, through setting first casing, second casing and optical detection module, can carry out the fluorescence signal detection to the card strip, pushes out after detecting, and the analyzer can carry out bluetooth connection, and the card strip detection result is looked over conveniently, and the structure is compact and small, and is convenient to carry, saves time and labour.

Description

Technical Field

[0001] This utility model relates to the field of fluorescence immunoassay technology, and in particular to a handheld dry fluorescence immunoassay analyzer. Background Technology

[0002] Fluorescence immunoassay (FIMA) technology utilizes the fact that certain substances, when irradiated with a beam of light, absorb a specific wavelength of incident light and then emit light with a slightly longer wavelength than the incident light. When the incident light stops shining, the emitted light also disappears; this emitted light is called fluorescence. Dry FIMA analyzers are based on this technology. They use a light source to emit a beam of light to irradiate fluorescent substances, and then a photosensitive device receives the excited fluorescence signal. Using calibrators for traceability of dry FIMA analyzers is a recognized and reasonable traceability mechanism. However, the fluorescent substances contained in the calibrators currently used to calibrate the instruments are unstable, exhibiting fluorescence quenching, attenuation, or accumulation upon re-excitation. Furthermore, the supply of quality control materials is unstable, with long procurement cycles, making them unsuitable for purchase. Our company uses a stable fluorescence analog signal card that is stable over a long period; the coefficient of variation of the fluorescence analog signal card after repeated irradiation with emitted light is ≤1%. Fluorescence immunoassay is a technique that utilizes the fact that when certain substances are irradiated by a beam of light, they absorb a certain wavelength of incident light and then emit light with a wavelength slightly longer than the incident light. When the incident light stops irradiating, the emitted light also disappears. This emitted light is called fluorescence.

[0003] Chinese Patent CN115047179A discloses a fluorescence immunoassay analyzer, comprising a housing, a display screen outside the housing, a central processing unit inside the housing, an optical detection module, and a card displacement mechanism. The housing has card inlet and card outlet on adjacent side walls. The card displacement mechanism includes a long, narrow card holder and a drive assembly for reciprocating the card holder along its length. The card holder's length is aligned with the card inlet, and the card holder slides and adapts to the card inlet. The detection head of the optical detection module points towards the movement trajectory of the card holder. The card outlet is located on one side of the card holder's movement trajectory, and the housing contains a card-dispensing assembly for dispensing the card from the card holder to the card outlet. This application features a simple structure, ease of portability, and convenient maintenance.

[0004] However, existing handheld dry fluorescence immunoassay analyzers are inconvenient to assemble and connect during use, making it difficult for staff to perform maintenance and testing, thus reducing the efficiency of maintenance work. Therefore, we proposed a handheld dry fluorescence immunoassay analyzer to solve the above-mentioned problems. Utility Model Content

[0005] The handheld dry fluorescence immunoassay analyzer proposed in this invention aims to solve the problems mentioned in the background art.

[0006] To achieve the above objectives, the present invention adopts the following technical solution:

[0007] A handheld dry fluorescence immunoassay analyzer includes a first housing, a second housing snapped onto the top of the first housing, a connection port on one side wall of the first housing, a feed port on the other side wall of the first housing, an optical detection module disposed inside the first and second housings, a mounting plate fixedly connected to the lower end of the optical detection module, a keypad on one side of the optical detection module, a display screen mounted on one side of the keypad, an ID card plate on one side of the display screen, and a battery assembly mounted on one side of the ID card plate.

[0008] Preferably, the snap-fit ​​component includes multiple sets of fixing holes, and a set of first mounting holes is provided at each of the four corners of the mounting plate. Multiple sets of first mounting rods are fixedly installed on the inner wall of the bottom end of the first housing, and the multiple sets of first mounting holes are respectively snap-fitted onto the outer side of the multiple sets of first mounting rods.

[0009] Preferably, a first auxiliary plate is connected to one side of the outer wall of each of the multiple sets of fixed rods, and a second mounting hole is provided on both sides of the button plate. A box is installed on the inner wall of the first housing, and two sets of second mounting rods are fixedly connected to the upper end of the box. The two sets of second mounting holes are respectively snapped onto the outer side of the two sets of second mounting rods.

[0010] Preferably, a groove is provided on one side of the first housing, and a set of third mounting holes are provided on both sides of the ID card plate bottom plate. Multiple sets of the third mounting rods are installed on the upper inner wall of the second housing, and the multiple sets of third mounting holes are respectively engaged and sleeved on the outer side of the multiple sets of third mounting rods.

[0011] Preferably, a first fixing opening is provided on one side of the groove, a set of fixing rods are fixedly connected to the four corners of the inner wall of the first housing, a set of fixing holes are provided at the upper ends of the multiple sets of fixing rods, a set of fixing inserts are engaged inside the multiple sets of fixing holes, and the upper ends of the multiple sets of fixing inserts are connected to the inner wall of the second housing.

[0012] Preferably, a first fixing member is installed on one side of the detachable housing, and a set of first auxiliary plates are connected to one side of the outer wall of each of the multiple sets of fixing rods, and the multiple sets of first auxiliary plates are connected to the inner wall of the first housing.

[0013] Preferably, a display panel is provided at the upper end of the second housing, and a set of second auxiliary plates are connected to one side of the outer wall of each of the multiple sets of fixed plug rods, and the multiple sets of second auxiliary plates are connected to the inner wall of the second housing.

[0014] The beneficial effects of this utility model are as follows:

[0015] This handheld dry fluorescence immunoassay analyzer, with its first and second housings and optical detection module, can detect fluorescence signals on the card strips and eject the strips after detection. The analyzer can also connect via Bluetooth for easy viewing of the test results. It has a compact structure and small size, making it easy to carry and saving time and effort. Attached Figure Description

[0016] Figure 1 This is a schematic diagram of the structure of this utility model.

[0017] Figure 2 This is a schematic diagram of the connection port in this utility model.

[0018] Figure 3 This is a schematic diagram of the internal structure of the second shell in this utility model.

[0019] Figure 4 This is a schematic diagram of the internal structure of the first shell in this utility model.

[0020] Figure 5 This is a schematic diagram of the optical detection module in this utility model.

[0021] The following are the labeling elements in the diagram: 1. First housing; 2. Second housing; 3. Connection port; 4. Feed port; 5. Optical inspection module; 6. Mounting plate; 7. Keypad; 8. Display screen; 9. ID card board; 10. Battery assembly; 11. First mounting hole; 12. First mounting rod; 13. Second mounting hole; 14. Housing; 15. Second mounting rod; 16. Third mounting hole; 17. Third mounting rod; 18. Fixing rod; 19. Fixing hole; 20. Fixing insert; 21. First auxiliary plate; 22. Second auxiliary plate. Detailed Implementation

[0022] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present utility model. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments.

[0023] Reference Figures 1-5As shown, the handheld dry fluorescence immunoassay analyzer includes a first housing 1, a second housing 2 snapped onto the top of the first housing 1, a connection port 3 on one side wall of the first housing 1, a feed port 4 on the other side wall of the first housing 1, an optical detection module 5 disposed inside the first housing 1 and the second housing 2, a mounting plate 6 fixedly connected to the lower end of the optical detection module 5, a keypad 7 disposed on one side of the optical detection module 5, a display screen 8 mounted on one side of the keypad 7, an ID card plate 9 disposed on one side of the display screen 8, and a battery assembly 10 mounted on one side of the ID card plate 9.

[0024] Furthermore, a set of first mounting holes 11 are provided at each of the four corners of the mounting plate 6. Multiple sets of first mounting rods 12 are fixedly installed on the inner wall of the bottom end of the first housing 1. The multiple sets of first mounting holes 11 are respectively snapped onto the outer side of the multiple sets of first mounting rods 12. The first mounting holes 11 and the first mounting rods 12 facilitate the installation and positioning of the mounting plate 6. A set of second mounting holes 13 are provided on both sides of the button plate 7. A housing 14 is installed on the inner wall of the first housing 1. Two sets of second mounting rods 15 are fixedly connected to the upper end of the housing 14. The two sets of second mounting holes 13 are respectively snapped onto the outer side of the two sets of second mounting rods 15. The second mounting holes 13 and the second mounting rods 13 facilitate the installation and positioning of the mounting plate 6. 15. Facilitates the installation and positioning of the keypad 7; A set of third mounting holes 16 are provided on both sides of the bottom plate of the ID card plate 9. Multiple sets of third mounting rods 17 are installed on the upper inner wall of the second housing 2. The multiple sets of third mounting holes 16 are respectively engaged with the outer sides of the multiple sets of third mounting rods 17. The third mounting holes 16 and third mounting rods 17 facilitate the installation and positioning of the ID card plate 9. A set of fixing rods 18 are fixedly connected to each of the four corners of the inner wall of the first housing 1. A set of fixing holes 19 are provided at the upper ends of the multiple sets of fixing rods 18. A set of fixing inserts 20 are engaged inside the multiple sets of fixing holes 19. The upper ends of the multiple sets of fixing inserts 20 are all connected to the inner wall of the second housing 2. A set of first auxiliary plates 21 are connected to one side of the outer wall of the multiple sets of fixing rods 18. The multiple sets of first auxiliary plates 21 are all connected to the inner wall of the first housing 1. A set of second auxiliary plates 22 are connected to one side of the outer wall of the multiple sets of fixing inserts 20. The multiple sets of second auxiliary plates 22 are all connected to the inner wall of the second housing 2. Multiple sets of fixing rods 20 are snapped into multiple sets of fixing holes 19, thereby securing the second housing 2 onto the first housing 1. This facilitates the assembly and fixation of the handheld dry fluorescence immunoassay analyzer housing, improving the ease of disassembly and maintenance. The combination of fixing rods 18, fixing holes 19, and fixing rods 20 allows the second housing 2 to be snapped into the first housing 1, making assembly and fixation of the handheld dry fluorescence immunoassay analyzer housing easier and more convenient for disassembly and maintenance. This method is quite practical.

[0025] In this embodiment, after powering on the instrument, open the Bluetooth on the mobile phone and the handheld dry fluorescence immunoassay analyzer App. On the App, click to search for Bluetooth, then click the paired instrument's Bluetooth ID to connect to the device. The software should be able to connect to the corresponding instrument via Bluetooth. When logging into the software, the software should log in successfully with the correct username and password; otherwise, it should fail to log in. After the Bluetooth connection with the instrument is complete, insert the card strip into the feed inlet 4. The optical detection module 5 detects the sample area of ​​the card strip. The compact structure and small size make it easy to carry, saving time and effort. By setting up the first housing 1, the second housing 2, and the optical detection module 5, the fluorescence signal of the card strip can be detected. After detection, the card strip is ejected. Simultaneously, the analyzer can connect via Bluetooth for easy viewing of the card strip detection results. The compact structure and small size make it easy to carry, saving time and effort.

[0026] In a specific embodiment, the product model / specification and classification are explained.

[0027] Model: JW-800, JW-800A

[0028] The software version naming convention for this product consists of: Major Version Number. Minor Version Number. Revision Number. Revision Sequence Number. Major Version Number: Indicates significant changes or architectural shifts in the software, occurring when most features and functionalities of the entire product change. It is represented numerically, e.g., upgrading from v1.xxx to v2.xxx. Minor Version Number: Indicates new features added or known issues fixed based on the major version number, including network security updates. It is represented numerically, e.g., upgrading from vx.0.xx to vx.1.xx. Revision Number: Indicates updates such as bug fixes or performance optimizations. It is represented numerically, e.g., upgrading from vx.x.1.x to vx.x.2.x. Revision Sequence Number: Indicates the first build generated during the software release process, e.g., upgrading from vx.xx2 to vx.xx3.

[0029] performance:

[0030] Repeatability

[0031] One of the following methods can be selected:

[0032] (a) Using analog signal cards: Three analog signal cards for testing the fluorescence intensity ratio (T / C) of the detection line / control line: high, medium, and low. Intra-batch measurement repeatability, CV≤3%.

[0033] (b) Use the matching reagents: test samples at high, medium and low concentration levels within the linear range; intra-batch measurement repeatability, CV ≤ 10%.

[0034] stability

[0035] One of the following methods can be selected:

[0036] (a) Using analog signal cards: Three analog signal cards with high, medium and low fluorescence intensity ratio (T / C) of test line / quality control line. The relative deviation of the measurement results at 4h and 8h after the machine is turned on and in a stable state from the measurement results at the beginning of the stable working state should not exceed ±5%.

[0037] (b) Use the matching reagents: test samples at three concentration levels (high, medium and low) within the linear range; the relative bias of the test results at 4h and 8h after the instrument is turned on and in a stable working state with the test results in a stable working state shall not exceed ±10%.

[0038] linear

[0039] One of the following methods can be selected:

[0040] (a) Using an analog signal card: The linear correlation coefficient (r) is ≥0.99 within a range where the fluorescence intensity ratio (T / C) of the detection line / control line is not less than 3 orders of magnitude.

[0041] (b) Use of matching reagents: within the linear range claimed by the manufacturer, the linear correlation coefficient (r) ≥ 0.99.

[0042] Accuracy

[0043] One of the following methods can be selected:

[0044] Relative deviation: For tests using certified reference materials, the relative deviation Δn should not exceed ±10%.

[0045] When testing with an analog signal card, the detection deviation Δn should not exceed ±8%.

[0046] Safety requirements shall comply with the applicable clauses in GB4793.1-2007 and YY0648-2008.

[0047] Electromagnetic compatibility requirements shall comply with the applicable clauses in GB / T18268.1-2010 and GB / T18268.26-2010.

[0048] Cybersecurity

[0049] Data interface: Bluetooth.

[0050] User access control: Accessing the software requires a username and password.

[0051] Test methods

[0052] Work environment

[0053] 1) Mains power input: 220V~50Hz

[0054] 2) Operating voltage and current: 5V 2A; Rated power: 10VA

[0055] 3) Ambient temperature: 10℃~30℃;

[0056] 4) Relative humidity: ≤70%;

[0057] 5) Atmospheric pressure: 86 kPa~106 kPa;

[0058] 6) The instrument should be placed on a stable workbench with good grounding, and should not be exposed to direct sunlight or strong electromagnetic interference.

[0059] Repeatability

[0060] Randomly select any batch of analog signal cards, select three levels (high, medium, and low) for testing, repeat the test 10 times, record the concentration values, and calculate the coefficient of variation (CV, %) according to formula (1). It should meet the above requirements.

[0061] Taking C-reactive protein as an example, randomly select a batch of CRP test cards and select three concentrations (high, medium, and low) for testing. For example, select calibrators with concentrations of (0.4-0.6) mg / L, (9-11) mg / L, and (90-110) mg / L (calibrators traceable to national reference materials), repeat the test 10 times, and calculate the coefficient of variation (CV, %) according to formula (1). It should meet the above requirements.

[0062]

[0063] Where: CV—coefficient of variation;

[0064] SD—the standard deviation of 10 measurements;

[0065] M—The average of 10 measurements.

[0066] stability

[0067] (a) Randomly select a batch of analog signal cards. After the detector is turned on and in a stable working state, select any three signal cards (high, medium, and low) for testing. Repeat the test three times and calculate the average value of the test results. After 4 hours and 8 hours, repeat the test three times and calculate the average value of the test results. Use the first test result as the benchmark value and calculate the relative bias (a, %) according to formula (2). It should meet the above requirements.

[0068] (b) Taking C-reactive protein as an example, randomly select a batch of CRP test cards. After the detector is turned on and in a stable working state, select any three concentrations (high, medium, and low) for testing. For example, select calibrators with concentrations of (0.40~0.60) mg / L, (9.0~11.0) mg / L, and (90.0~110.0) mg / L. Repeat the test three times for each, calculate the average value of the test results, and repeat the test three times after 4 hours and 8 hours respectively. Calculate the average value of the test results. Use the first test result as the baseline value and calculate the relative bias (a, %) according to formula (2). It should meet the above requirements.

[0069]

[0070] In the formula: --------The mean values ​​measured at 4h and 8h;

[0071] ---------The mean of the initial measurements;

[0072] linear

[0073] (a) Test at least 5 control strips, with the fluorescence intensity ratio (T / C) of the test line / control line evenly distributed across at least 3 orders of magnitude. Each control strip is tested 3 times, and the arithmetic mean (Yi) of the measurement results is calculated. Using the fluorescence intensity ratio (Xi) of the test line / control line as the independent variable and the arithmetic mean (Yi) of the measurement results as the dependent variable, calculate the linear regression equation. Calculate the correlation coefficient (r) of the linear regression according to formula (5), which should meet the above requirements.

[0074] (b) Taking C-reactive protein as an example, randomly select a batch of CRP test cards and test at least 5 concentrations of samples. For example, select calibrators with concentrations of (0.4–0.6) mg / L, (4.0–6.0) mg / L, (9.0–11.0) mg / L, (45.0–55.0) mg / L, and (90.0–110.0) mg / L. Repeat the test 3 times for each reference sample and calculate the average value (Yi) for each sample. Use the nominal concentration value (Xi) as the independent variable and the mean value of the test results (Yi) as the dependent variable to obtain the linear regression equation y = a + bx and the correlation coefficient r. The results should meet the above requirements.

[0075]

[0076] In the formula:

[0077] b—the slope of the regression line;

[0078] |a|—The absolute value of the intercept of the regression line;

[0079] r—regression coefficient;

[0080] X i — Calibration value (or nominal concentration value);

[0081] Y i — Mean of three repeated measurements of each reference sample;

[0082] i — 1, 2, 3, …, n;

[0083] n — Number of determination samples

[0084] Accuracy

[0085] Using the supporting reagents, test the certified reference material, record the test value as (Xi), and calculate the relative deviation (Bi) according to formula (6) respectively. If the three measurement results all meet the above requirements, it is judged as qualified. If more than or equal to two measurement results do not meet the requirements, it is judged as unqualified. If one measurement result does not meet the requirements, 20 consecutive tests should be carried out again, and the relative deviation should be calculated according to formula (6). If more than or equal to 19 measurement results meet the above requirements, it is judged as qualified.

[0086] B i =(X i -T) / T×100%…………(6)

[0087] Where:

[0088] X i — Each measured value;

[0089] T — Labeled value of the certified reference material;

[0090] Randomly select a batch of analog signal cards, arbitrarily select three high, medium and low ones for on-machine detection, test three times respectively, calculate the average value of the measurement results (ni) respectively, and record the calibration value as (n0). Then the deviation Δn = (n0 - ni) / n0 * 100%, which should meet the above requirements.

[0091] Safety test

[0092] Test according to the methods specified in GB4793.1 - 2007 and YY0648 - 2008, and the results should meet the above requirements.

[0093] Electromagnetic compatibility test

[0094] Test according to the methods specified in GB / T18268.1 - 2010 and GB / T18268.26 - 2010, and the results should meet the above requirements.

[0095] Network security

[0096] Turn on the instrument, turn on Bluetooth on your phone and the JW-800 handheld dry fluorescence immunoassay analyzer app, click to search for Bluetooth on the app, click the paired instrument's Bluetooth number to connect to the device, and the software should be able to connect to the corresponding instrument via Bluetooth.

[0097] When logging into the software, the software should be able to log in normally if the correct username and password are entered; the software should be unable to log in if the incorrect username and password are entered.

[0098] The above description is only a preferred embodiment of the present utility model, but the protection scope of the present utility model is not limited thereto. Any equivalent substitutions or changes made by those skilled in the art within the technical scope disclosed in the present utility model, based on the technical solution and the inventive concept of the present utility model, should be included within the protection scope of the present utility model.

Claims

1. A hand-held dry fluorescence immunoassay analyzer characterized in that, The device includes a first housing (1), a second housing (2) is snapped onto the top of the first housing (1), a connection port (3) is provided on one side wall of the first housing (1), a feed port (4) is provided on the other side wall of the first housing (1), an optical detection module (5) is provided inside the first housing (1) and the second housing (2), an mounting plate (6) is fixedly connected to the lower end of the optical detection module (5), a keypad (7) is provided on one side of the optical detection module (5), a display screen (8) is installed on one side of the keypad (7), an ID card plate (9) is provided on one side of the display screen (8), and a battery assembly (10) is installed on one side of the ID card plate (9).

2. The hand-held dry fluorescence immunoassay analyzer according to claim 1, characterized in that, The mounting plate (6) has a set of first mounting holes (11) at each of its four corners. Multiple sets of first mounting rods (12) are fixedly installed on the inner wall of the bottom end of the first housing (1). The multiple sets of first mounting holes (11) are respectively snapped onto the outer side of the multiple sets of first mounting rods (12).

3. The hand-held dry fluorescence immunoassay analyzer according to claim 2, wherein, The keypad (7) has a set of second mounting holes (13) on both sides. A housing (14) is installed on the inner wall of the first housing (1). Two sets of second mounting rods (15) are fixedly connected to the upper end of the housing (14). The two sets of second mounting holes (13) are respectively snapped onto the outside of the two sets of second mounting rods (15).

4. The hand-held dry fluorescence immunoassay analyzer according to claim 1, wherein, The ID card plate (9) has a set of third mounting holes (16) on both sides of its bottom plate. The upper inner wall of the second housing (2) is equipped with multiple sets of third mounting rods (17). The multiple sets of third mounting holes (16) are respectively snapped onto the outside of the multiple sets of third mounting rods (17).

5. The hand-held dry fluorescence immunoassay analyzer according to claim 4, wherein, A set of fixing rods (18) is fixedly connected to each of the four corners of the inner wall of the first housing (1). A set of fixing holes (19) are opened at the upper end of each of the fixing rods (18). A set of fixing inserts (20) are snapped into the interior of each of the fixing holes (19). The upper ends of each of the fixing inserts (20) are connected to the inner wall of the second housing (2).

6. The hand-held dry fluorescence immunoassay analyzer according to claim 5, wherein, Each of the multiple sets of fixing rods (18) has a set of first auxiliary plates (21) connected to one side of its outer wall, and the multiple sets of first auxiliary plates (21) are connected to the inner wall of the first housing (1).

7. The hand-held dry fluorescent immunoassay analyzer of claim 5, wherein, Each of the multiple sets of fixed inserts (20) has a set of second auxiliary plates (22) connected to one side of its outer wall, and the multiple sets of second auxiliary plates (22) are connected to the inner wall of the second housing (2).

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