A dry biochemical test card, method and test card system that can identify a test item

Abstract

The application provides a dry biochemical test card, a method and a test card system capable of identifying detection items, wherein a plurality of holes with different colors are arranged in the test card, the colors in the holes are corresponded to categories of the detection items, and threshold values of the colors in the holes are stored in an ID card; when the colors in the holes are identified, the corresponding categories of the detection items can be obtained; in order to prevent the ID card corresponding to the test card from being inconsistent, the identified color information in the holes is compared with the threshold values stored in the ID card to determine consistency. The application can reduce the complexity in identifying the detection items of the test card, improve the identification efficiency, prevent inconsistency and improve effectiveness.

Description

Technical Field

[0001] This invention belongs to the medical field and relates to a dry biochemical test card, method, and test card system that can identify detection items. Background Technology

[0002] In the field of medical dry biochemical testing, using test cards to detect the tested items is a commonly used technique. For traditional single-card testing items, two main methods are currently employed to identify the test card item type: 1) Integrating a QR code storing item information onto the test card; the instrument's camera recognizes the QR code and obtains the item information, thus identifying the test card item type; 2) Each test card box is equipped with a corresponding ID (Identity Document) card, which records the type of test cards in that box. By retrieving the test card type recorded on the ID card, the test items for that test card box can be identified. However, the QR code method requires the test card to have a QR code printed on it, and the instrument to integrate a scanning device. This necessitates that the test card be large enough to accommodate both the QR code and the reagent strips required for the test. These conditions limit the portability of the instrument and increase the manufacturing cost of both the instrument and the test card. This method is currently mainly used in large-scale equipment. The ID card identification method requires storing the test card type in the ID card chip. The ID card is separate from the test card; during testing, the ID card is inserted or touched to read the test card type information. Because the ID card and test card are separate, the consistency between the ID card information and the actual test card cannot be guaranteed, leading to a high risk of operational errors. Currently, there is no portable and error-resistant dry biochemical analysis system on the market that can achieve test card item identification. Summary of the Invention

[0003] To overcome the shortcomings of existing test card items identification, such as inconvenience and high risk of operational errors, this invention discloses a dry biochemical test card, method, and test card system that can identify detection items.

[0004] This invention provides a dry biochemical test card capable of identifying detection items, comprising a card body containing at least three holes, each hole containing a color; the color inside the holes differs in at least one hole among test cards of different types.

[0005] Furthermore, the surgical holes can be arranged longitudinally or transversely.

[0006] Furthermore, the color inside the hole can include: white, light blue, light green, and light yellow.

[0007] Furthermore, the test card types include one or more of the following: liver function test card, kidney function test card, metabolic test card, glucose and lipid test card, and blood donation screening test card.

[0008] The present invention also provides a method for identifying detection items, the specific steps of which are as follows:

[0009] Step 110: Write batch information to the ID card;

[0010] Step 120: Read the information from the test card;

[0011] Step 130: Determine the detection item category of the test card based on the batch information in the ID card and the information of the test card.

[0012] Furthermore, the method for writing batch information to the ID card in step 110 is as follows:

[0013] Step 111: Obtain the color source signal value inside the hole of the test card, and set different weighting coefficients for the color source signal values ​​inside different holes according to the hole position sorting of the test card.

[0014] Step 112: Construct a weighted dual-wavelength initial color source feature sequence based on the obtained color source signal values ​​and weighting coefficients;

[0015] Step 113: Calculate the similarity coefficient between test cards for different detection items and the all-white test card, and obtain the distribution of the similarity coefficient;

[0016] Step 114: Based on the distribution of the coefficients, determine the detection item category judgment threshold and category judgment function using the maximum inter-class variance.

[0017] Furthermore, the method for reading the information of the test card in step 120 is as follows:

[0018] Read the color source signal values ​​of all holes in the test card as information for the test card.

[0019] Furthermore, step 130 determines the detection item category of the test card based on the batch information in the ID card and the information of the test card. The specific steps are as follows:

[0020] Step 131: Obtain the dual-wavelength signal value based on the information from the test card;

[0021] Step 132: Obtain the weighted signal value sequence based on the weighting coefficients;

[0022] Step 133: Calculate the correlation coefficient between the test card and the all-white test card;

[0023] Step 134: Input the judgment function to identify the category of the test card;

[0024] Step 135: Compare the correlation coefficient with the threshold in the ID card to determine whether the test card category is consistent with the recorded items in the ID card.

[0025] Furthermore, the method for verifying whether the information of the test card and the information of the ID card are consistent in step 140 is as follows:

[0026] The color source signal values ​​of the two holes extracted from the information of the test card are compared with the threshold in the ID card. If they match, it means that the ID card corresponds to the matching category and the ID card corresponds to the detection item category of the test card.

[0027] This invention also provides a dry biochemical test card system capable of identifying detection items, comprising one or more of the aforementioned test cards, one or more ID cards, a spectrophotometer, a dry biochemical analyzer, and a display; the spectrophotometer writes batch information into the ID card; the dry biochemical analyzer uses the aforementioned method for identifying detection items to analyze the detection item category of the test card and determines the consistency between the detection item category of the test card and the information on the ID card; the display is used to display the test card item category when a consistency is determined.

[0028] Furthermore, the spectrophotometer writes batch information into the ID card, specifically including: the spectrophotometer acquiring the colorimetric signal values ​​of each well of the test card for different test card detection items; the spectrophotometer calculating an identification threshold based on the differences in the colorimetric signal values; and the spectrophotometer writing the threshold as batch information into the ID card.

[0029] Therefore, compared with the prior art, the present invention has the following advantages:

[0030] 1) By utilizing the color and aperture differences displayed by the color source between different items, a weighted correlation coefficient that integrates color and position information can be constructed to characterize the differences between different types of test cards. Therefore, this invention can simply and quickly realize the identification of dry biochemical test card categories, reduce the complexity of subsequent identification, and improve identification efficiency.

[0031] 2) By screening and combining color sources for multiple test strip detection items, the color difference between each test strip is ensured. The instrument can complete the identification of test items by calculating the color and well position fusion parameters. There is no need to integrate a barcode scanning device, which greatly improves the portability of the instrument and reduces the cost of the instrument.

[0032] 3) The identification information can be verified with the information stored on the ID card to prevent abnormal testing situations caused by operational errors and improve the effectiveness of detection.

[0033] In summary, this invention proposes a dry biochemical test card, method, and test card system capable of identifying test items. It uses different colored elements in the test card's apertures to identify the test items, making the test card convenient, efficient, and highly portable. Furthermore, by comparing the information within the ID card, it ensures accurate correspondence between the ID card and the test card, improving effectiveness. The method of this invention not only solves the problems existing in the prior art but also significantly improves the recognition rate. Attached Figure Description

[0034] Figure 1 The diagram shows a test card structure according to an embodiment of the present invention.

[0035] Figure 2 A flowchart illustrating a method for identifying detection items according to an embodiment of the present invention is shown.

[0036] Figure 3 This diagram illustrates a flowchart of writing batch information to an ID card according to an embodiment of the present invention.

[0037] Figure 4 The diagram illustrates a test card type identification flowchart according to an embodiment of the present invention.

[0038] Figure 5 The following diagram illustrates the similarity coefficient distribution of 100 different types of test cards and a completely white test card according to an embodiment of the present invention: a) shows the R distribution box plot of the metabolism and liver function test cards; b) shows the R distribution box plot of the kidney function and glucose and lipid test cards; c) shows the R distribution box plot of the glucose and lipid and blood donation test cards.

[0039] Figure 6 A system structure diagram for identifying detection items is shown according to an embodiment of the present invention. Detailed Implementation

[0040] The following describes embodiments of the present invention through specific examples and in conjunction with the accompanying drawings. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can also be modified and changed based on different viewpoints and applications without departing from the spirit of the present invention.

[0041] like Figure 1 As shown, the present invention provides a dry biochemical test card that can identify detection items, including a card body containing holes, the number of holes being at least three, and the holes containing colors; the colors in the holes are different in at least one hole among test cards of different types.

[0042] The surgical holes can be arranged vertically or horizontally; in addition, the holes can be numbered sequentially from left to right and from top to bottom, such as: hole 1, hole 2, hole 3, hole 4, etc.

[0043] The test items on the test cards are all indicated by the colors within the wells. Different color combinations represent different test items. The colors within the wells can include: white, light blue, light green, and light yellow. Specific test items can include, but are not limited to, one or more of the following: liver function test cards, kidney function test cards, metabolic test cards, glucose and lipid test cards, and blood donation screening test cards. At least one well on each test card must be a different color to ensure the uniqueness of the color combination for each test item type. Test items are arranged according to their type on the test card, with similar types grouped together on one test card. For example, kidney function related tests can be grouped on one test card, and liver function test cards can be grouped on another.

[0044] In practice, multiple test cards can be used as the test items. For example, liver function, kidney function, metabolism, glucose and lipids, and blood donation screening combined tests can be used as the test items on a test card to obtain corresponding test cards for these functions. The liver function test card consists of ALT, AST, and ALB tests. These tests can be distributed according to the color information of the holes on the corresponding test card at positions 2, 3, and 4. Hole 1 is empty. The colors of holes 1-4 corresponding to the test items are white, light blue, light blue, and light yellow, respectively. The kidney function test card consists of CR, UA, and UREA tests. Similarly, these tests can be distributed according to the color information of the holes on the corresponding test card at positions 1, 2, and 4. Hole 3 is empty. The colors of holes 1-4 corresponding to the test items are light green, light blue, white, and light yellow, respectively. The metabolic test card consists of GLU, UA, and TC tests. Similarly, the color of the corresponding test item can be distributed in wells 1, 3, and 4 according to the color information of the wells on the test card. Well 2 is empty. The colors of wells 1-4 corresponding to the test items are: white, white, light blue, and white, respectively. The glucose and lipid test card consists of GLU, TG, HDL, and TC tests. Similarly, the color of the corresponding test item can be distributed in wells 1, 2, 3, and 4 according to the color information of the wells on the test card. The colors of wells 1-4 corresponding to the test items are: white, white, white, and white, respectively. The blood donation screening test card consists of ALT and HB tests. Similarly, the color of the corresponding test item can be distributed in wells 2 and 4 according to the color information of the wells on the test card. Wells 1 and 2 are empty. The colors of wells 1-4 corresponding to the test items are: white, light blue, white, and white, respectively. See Table 1 for details.

[0045] Table 1. Hole Colors of the Test Card

[0046] Kong Xu Liver function test card Kidney function test card Metabolic test card Glycolipid Test Card Blood donation screening test card 1 White pale green White White White 2 light blue light blue White White light blue 3 light blue White light blue White White 4 light yellow pale yellow White White White

[0047] Based on the color values ​​of each well on the test cards for different examination items, after reading the information of a certain test card, the colors of two wells are extracted and combined. Specifically, the colors of well 1 and well 2 are combined to obtain the following color combinations: Liver function (white, light blue), Kidney function (light green, light blue), Metabolism (white, white), Glycolipids (white, white), and Blood donation (white, light blue). This allows for a unique match to identify Kidney function. In other words, based on the color signal values ​​of well 1 and well 2, the Kidney function color threshold can be obtained first, which is used to identify the Kidney function test card. Continuing to extract and combine the colors of well 2 and well 3, the following color combinations are obtained: Liver function (light blue, light blue), Metabolism (white, light blue), Glycolipids (white, white), and Blood donation (light blue, white). Based on the extracted color signal values ​​of well 2 and well 3, the color thresholds for Liver function, Metabolism, Glycolipids, and Blood donation can be obtained, thereby identifying the Liver function test card, Metabolism test card, Glycolipids test card, and Blood donation test card.

[0048] like Figure 2 As shown, the present invention also provides a method for identifying detection items, the specific steps of which are as follows:

[0049] Step 110: Write batch information to the ID card;

[0050] Step 120: Read the information from the test card;

[0051] Specifically, the color source signal values ​​of all holes in the test card are read as information for the test card.

[0052] Step 130: Determine the detection item category of the test card based on the batch information in the ID card and the information of the test card.

[0053] like Figure 3 The flowchart shown is for step 110, writing batch information to the ID card. The specific steps are as follows:

[0054] Step 111: Obtain the color source signal value inside the hole of the test card, and set different weighting coefficients for the color source signal values ​​inside different holes according to the hole position sorting of the test card.

[0055] Step 112: Construct a weighted dual-wavelength initial color source feature sequence based on the obtained color source signal values ​​and weighting coefficients;

[0056] Step 113: Calculate the similarity coefficient between test cards for different detection items and the all-white test card, and obtain the distribution of the similarity coefficient;

[0057] Step 114: Based on the distribution of the coefficients, determine the detection item category judgment threshold and category judgment function using the maximum inter-class variance.

[0058] like Figure 4 The diagram shows a flowchart of step 130, which involves determining the detection item category of the test card based on the batch information in the ID card and the information of the test card. The specific steps are as follows:

[0059] Step 131: Obtain the dual-wavelength signal value based on the information from the test card;

[0060] Step 132: Obtain the weighted signal value sequence based on the weighting coefficients;

[0061] Step 133: Calculate the correlation coefficient between the test card and the all-white test card;

[0062] Step 134: Input the judgment function to identify the category of the test card;

[0063] The judgment function is input based on the correlation coefficient. The parameter used in the judgment function is the correlation coefficient. Similarly, the judgment function can also be made by inputting the correlation coefficient into it, which can achieve the same effect.

[0064] Step 135: Compare the correlation coefficient with the threshold in the ID card to determine whether the test card category is consistent with the recorded items in the ID card.

[0065] The number of holes in the test card can vary. When the number of holes is 4, the specific implementation process is as follows:

[0066] Using combined test cards for liver function, kidney function, metabolism, glucose and lipid metabolism, and blood donation screening, with different color combinations of the holes on different cards, this invention obtains the chromogenic differences between these test cards. A dual-wavelength spectrophotometer / dry biochemical analyzer is used to obtain the chromogenic signal values ​​of the aforementioned test cards, constructing a dual-wavelength initial chromogenic feature sequence S0:

[0067] S0={F1,F2,F3,F4} (1)

[0068] Where F i =G i +R i G i R i Let be the signal values ​​at wavelengths 1 and 2 for the i-th aperture, respectively, where i = 1, 2, 3, 4.

[0069] Then, based on the hole positions, different weighting coefficients are set for the original color values ​​inside different holes:

[0070] C={a1,a2,a3,a4} (2)

[0071] Where a i Let be the weighting coefficients for the i-th hole, i = 1, 2, 3, 4. Based on the differences between each hole and their contribution to the calculation, after statistical analysis, C = {1, 2, 5, 10} in the patent. Then, the weighted colorimetric feature sequence Se is:

[0072] S e ={a1×F1,a2×F2,a3×F3,a4×F4} (3)

[0073] Because the color sources between the holes of different test cards differ, it can be determined that the similarity between each card and the all-white test card also varies. A discriminant function can be constructed using the similarity coefficient between each card and the all-white test card to identify the category of each test card. The similarity coefficient R between the test card and the all-white test card is defined as follows:

[0074]

[0075] Where F0 represents the dual-wavelength signal value of the white chromogen. Using a dry biochemical analyzer, the similarity coefficient R between 100 of the above test cards and the all-white test cards was obtained. The distribution of coefficient R for each card is as follows: Figure 5 As shown. According to Figure 5 The distribution of the coefficient R is determined using the maximum inter-class variance method to identify the discrimination threshold t∈T, where T={t1, t2, t3, t4, t5} and the discriminant function f.

[0076]

[0077] The discrimination threshold t can also be obtained using other threshold acquisition methods.

[0078] like Figure 6 As shown, the present invention also provides a dry biochemical test card system capable of identifying detection items, including one or more of the above-mentioned test cards, one or more ID cards, a dry biochemical analyzer, and a display; the spectrophotometer writes batch information into the ID card; the dry biochemical analyzer uses a method capable of identifying detection items to analyze the detection item category of the test card and determines the consistency between the detection item category of the test card and the information of the ID card; the display is used to display the test card item category when the determination is consistent.

[0079] The test cards are used to test sample concentration, and the ID card stores batch information such as the test card concentration conversion curve. Each type of test card has multiple test wells, with a minimum of 3 wells. The test card system can test up to 4 items simultaneously. The test card system may include one or more of the following: liver function test cards, kidney function test cards, metabolic test cards, glucose and lipid test cards, and blood donation screening test cards, including but not limited to these. In addition, the test cards within the system are independent of each other, and there are combinational differences in the chromogens of multiple wells between cards. At least one test card's well chromogen differs from the chromogen in the same well of another test card in the system.

[0080] The spectrophotometer writes batch information into the ID card, specifically including: the spectrophotometer acquiring the chromatic amplification signal values ​​of each well of the test card for different test card detection items; the spectrophotometer calculating an identification threshold based on the differences in the chromatic amplification signal values; and the spectrophotometer writing the threshold as batch information into the ID card. This enables test card category identification without storing QR code information, which helps reduce the cost of detection equipment, reduce the internal structure of detection equipment, and improve instrument portability.

[0081] Using MATLAB 2019a and a spectrophotometer, the proposed method was employed to extract signals from the test cards within the system, plot 2D spatial scatter points, and obtain thresholds. Signal values ​​from 50 test cards each for blood lipids and blood glucose, liver function, kidney function, metabolism, and blood donation screening were collected. The method achieved a 100% recognition rate for each test card. It is evident that the weighted correlation between the test cards and the all-white test cards within the system is calculated based on the color of the test cards and the location of the colored holes. The optimal classification threshold is obtained based on the maximum inter-class variance of the weighted correlation distribution of the test cards within the system. This method fuses color and location information into a single feature value, resulting in a simple implementation and high accuracy.

[0082] The above content is only for illustrating the technical concept of the present invention and should not be construed as limiting the scope of protection of the present invention. Any modifications made to the technical solution based on the technical concept proposed in this invention shall fall within the scope of protection of the claims of this invention.

Claims

1. A method for identifying detection items using a dry biochemical test card, characterized in that, This includes the use of dry biochemical test cards, wherein the dry biochemical test card includes a card body; The card body contains holes, with at least three holes, and each hole has a color; the color inside the hole is different in at least one hole among test cards of different test card types; The method includes: Step 110: Write batch information to the ID card; Step 120: Read the information from the test card; Step 130: Determine the detection item category of the test card based on the batch information in the ID card and the information of the test card; The method for writing batch information to the ID card in step 110 is as follows: Step 111: Obtain the color source signal value inside the hole of the test card, and set different weighting coefficients for the color source signal values ​​inside different holes according to the hole position sorting of the test card. Step 112: Construct a weighted dual-wavelength initial color source feature sequence based on the obtained color source signal values ​​and weighting coefficients; Step 113: Calculate the similarity coefficient between test cards for different detection items and the all-white test card, and obtain the distribution of the similarity coefficient; Step 114: Based on the distribution of the coefficients, determine the detection item category judgment threshold and category judgment function using the maximum inter-class variance. Step 115: Write the category judgment threshold as batch information into the ID card; The method for reading the information of the test card in step 120 is as follows: Read the color source signal values ​​of all holes in the test card as the information of the test card; Step 130 determines the detection item category of the test card based on the batch information in the ID card and the information of the test card. The specific method is as follows: Step 131: Obtain the dual-wavelength signal value based on the information from the test card; Step 132: Obtain the weighted signal value sequence based on the weighting coefficients; Step 133: Calculate the correlation coefficient between the test card and the all-white test card; Step 134: Input the judgment function to identify the category of the test card; Step 135: Compare the correlation coefficient with the threshold in the ID card to determine whether the test card category is consistent with the recorded items in the ID card.

2. The method for identifying detection items using the dry biochemical test card as described in claim 1, characterized in that: The surgical holes can be arranged longitudinally or transversely.

3. The method for identifying detection items using a dry biochemical test card as described in claim 1 or 2, characterized in that: The colors inside the holes include: white, light blue, light green, and light yellow.

4. The method for identifying detection items using a dry biochemical test card as described in claim 1 or 2, characterized in that: The test card types include one or more of the following: liver function test card, kidney function test card, metabolism test card, glucose and lipid test card, and blood donation screening test card.

5. A dry biochemical test card system capable of identifying detection items, characterized in that, The device includes one or more test cards, one or more ID cards, a spectrophotometer, a dry biochemical analyzer, and a display. The spectrophotometer writes batch information into the ID card. The dry biochemical analyzer uses any one of the methods in claims 1-4 to analyze the test card's detection item category and determine the consistency between the test card's detection item category and the information on the ID card. The display is used to display the test card's item category when a consistency is determined.

6. The dry biochemical test card system capable of identifying detection items as described in claim 5, characterized in that: The spectrophotometer writes batch information into the ID card, specifically including: The spectrophotometer acquires the colorimetric signal values ​​of each well of the test card for different test card detection items; The spectrophotometer calculates the identification threshold based on the differences in the color source signal values; The spectrophotometer writes the threshold as batch information into the ID card.

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