Hemoglobin chyle joint detection device and detection method

Abstract

The invention belongs to the technical field of medical treatment, and particularly relates to a hemoglobin chyle joint detection device and a detection method.The hemoglobin chyle joint detection device comprises a shell, an analysis mechanism is arranged in the shell, and a colorimetric tube is inserted into the upper surface of the shell; the analysis mechanism comprises a light source module, a sample processing module, an optical detection module and a data processing module; the optical detection module synchronously acquires absorbance signals under two wavelengths through double detectors; the data processing module calculates hemoglobin concentration and chyle degree based on the dual wavelength absorbance values. The method is different from traditional single-index detection, two-parameter synchronous analysis of hemoglobin and chyle is achieved for the first time, and the preliminary screening efficiency before blood donation is remarkably improved. By adopting a dual-wavelength correction algorithm, the influence of residual absorption interference of hemoglobin at 580-700nm on chyle index determination is eliminated, and the influence of absorption interference of chyle at 480-570nm on hemoglobin determination is eliminated. The method is suitable for rapid screening on a blood sampling site to realize informatization management of detection data.

Description

Technical Field

[0001] The present invention relates to the field of medical technology, and specifically to a hemoglobin and chyle combined detection device and a detection method. Background Art

[0002] The hemoglobin and chyle combined detection device is applicable to scenarios such as blood stations. It can quickly and accurately detect the hemoglobin content in the blood of blood donors and whether there is chyle in the blood.

[0003] Traditional hemoglobin analyzers can only detect the hemoglobin concentration in the blood and cannot simultaneously evaluate the chyle state of the blood. In the pre-donation screening process, the presence of chyle (due to excessive blood lipids resulting in turbid plasma) will significantly increase the plasma rejection rate after donation. Existing chyle detection methods mainly rely on manual visual inspection or observing the turbidity of plasma after centrifugation, and have defects such as strong subjectivity, low efficiency, and inability to quantify. For example, some blood collection institutions use the method of comparing turbidity visually after diluting with physiological saline, and its accuracy is significantly affected by the experience of the inspectors. In addition, although fully automatic blood donation pre-screening devices involve hemolysis and chyle detection, they do not achieve synchronous quantitative analysis of hemoglobin and chyle. Summary of the Invention

[0004] The purpose of the present invention is to provide a device and a method for quickly and comprehensively detecting the hemoglobin content and whether there is chyle in the blood, so as to solve the problems raised in the above background art.

[0005] To achieve the above purpose, the present invention provides the following technical solutions:

[0006] A hemoglobin and chyle combined detection device:

[0007] It includes a housing, an analysis mechanism is provided inside the housing, and a colorimetric tube body is inserted on the upper surface of the housing;

[0008] The analysis mechanism includes a light source module, a sample processing module, an optical detection module, and a data processing module; the light source module emits monochromatic light with wavelengths in the 480 - 570 nm band and the 580 - 700 nm band; the optical detection module synchronously collects absorbance signals at the two wavelengths through a double detector; the data processing module calculates the hemoglobin concentration and the chyle degree based on the double-wavelength absorbance values.

[0009] Preferably, the sample processing module includes a quantitative sample addition system, a hemolysis reaction pool, a barcode scanning device, and an optical path detection pool, and can realize the quantitative mixing of whole blood and hemolytic agent, the reading of reaction absorbance, and the transmission of information data.

[0010] Preferably, the data processing module uses a double-wavelength correction algorithm to eliminate the mutual interference between hemoglobin and chyle through a set of simultaneous equations, and the set of simultaneous equations is established based on the Lambert-Beer law.

[0011] Preferably, a display screen is fixedly connected to the upper surface of the housing. A colorimetric tube slot is provided on the upper surface of the housing. A battery cover is fixedly provided on the lower surface of the housing. An analysis rack is fixedly provided on the lower inner wall of the housing. A hemoglobin LED lamp and a chyle blood LED lamp are horizontally arranged on the other side of the analysis rack.

[0012] A method for jointly detecting hemoglobin and chyle includes the following steps:

[0013] (1) Quantitative whole blood is mixed and reacted with a hemolytic agent. The reaction time is 2 - 10 seconds, and the reaction temperature is 2 - 40 °C;

[0014] (2) Absorbance signals at wavelengths of 480 - 570 nm and 580 - 700 nm are collected;

[0015] (3) Based on the Lambert - Beer law, the hemoglobin concentration and the chyle index are calculated.

[0016] Compared with the prior art, the beneficial effects of the present invention are:

[0017] (1) Synchronous detection: Different from traditional single - index detection, it realizes the synchronous analysis of two parameters of hemoglobin and chyle for the first time, significantly improving the pre - donation screening efficiency.

[0018] (2) Anti - interference design: A dual - wavelength correction algorithm is adopted to eliminate the influence of the residual absorption of hemoglobin at 580 - 700 nm on the determination of the chyle index and the absorption interference of chyle at 480 - 570 nm on the determination of hemoglobin.

[0019] (3) Automated application: The integrated design supports direct detection of whole blood without centrifugation or complex pre - treatment, which is suitable for rapid screening at the blood collection site; it is equipped with a barcode scanning device and a data transmission module to realize the information management of detection data. Description of the Drawings

[0020] Figure 1 is the structural diagram of the present invention;

[0021] Figure 2 is the schematic diagram of the internal structure of the present invention;

[0022] Figure 3 is the hemoglobin linear regression diagram of the experimental example of the present invention;

[0023] Figure 4 is the fluctuation diagram of the comparison of the HGB values between the blood cell analyzer and the hemoglobin and chyle analysis device in the experimental example of the present invention;

[0024] Figure 5 is the absorbance change diagram of hemoglobin and chyle. Detailed implementation mode

[0025] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

[0026] The present invention provides a technical solution:

[0027] A hemoglobin and chyle combined detection device:

[0028] It includes a housing (1), an analysis mechanism (2) is provided inside the housing (1), and a colorimetric tube body (3) is inserted on the upper surface of the housing (1);

[0029] The analysis mechanism (2) includes a light source module, a sample processing module, an optical detection module, and a data processing module; the light source module emits monochromatic light with wavelengths of 540 nm (480 - 570 nm band) and 600 nm (580 - 700 nm band); the optical detection module synchronously collects absorbance signals at two wavelengths through a dual detector; the data processing module calculates the hemoglobin concentration and chyle degree based on the dual-wavelength absorbance values.

[0030] The sample processing module includes a quantitative sampling system, a hemolysis reaction pool, a barcode scanning device, and an optical path detection pool, which can realize the quantitative mixing of whole blood and hemolytic agent, the reading of reaction absorbance, and the transmission of information data.

[0031] The data processing module adopts a dual-wavelength correction algorithm to eliminate the mutual interference between hemoglobin and chyle by establishing a system of equations, and the system of equations is established based on the Lambert-Beer law.

[0032] Based on the Lambert-Beer law, a mathematical model is established, and the formula for calculating the hemoglobin concentration through the dual-wavelength absorbance value is:

[0033]

[0034] Chyle index formula:

[0035]

[0036] The absorbance of the hemoglobin standard solution (concentration C1) in a 1 cm colorimetric cell is A540HB1 and A600CB1 respectively

[0037] The absorbance of the chyle standard solution (concentration C2) in a 1 cm colorimetric cell is A540HB2 and A600CB2 respectively

[0038] The absorbances of the mixed solution after hemolysis in a 1-cm cuvette are A540HB3 and A600CB3 respectively. The absorbance differences of hemoglobin and chyle at 540 nm and 600 nm wavelengths are relatively large.

[0039] Objective: Calculate the concentrations CHB and CCB of hemoglobin and chyle in the mixed solution

[0040] The derivation process is as follows:

[0041] According to the Beer-Lambert Law, the relationship between absorbance A, solution concentration C, and optical path length B is:

[0042] A = ε·C·B

[0043] Where: ε is the molar extinction coefficient, which is related to the nature of the substance and the wavelength. C is the concentration of the solution. B is the optical path length, and the unit of the optical path length in this application is 1 cm. For the mixed solution, assuming that the absorbances of hemolysis and chyle have linear additivity, the absorbance at a certain wavelength can be expressed as:

[0044] A_mixed = A_hemolysis + A_chyle

[0045] Establish a system of equations

[0046] At 540 nm wavelength:

[0047]

[0048] At 600 nm wavelength:

[0049]

[0050] Where:

[0051] (CHB) is the concentration of hemolysis in the mixed solution (the unit is the same as (C)),

[0052] (CCB) is the concentration of chyle in the mixed solution (the unit is the same as (C)).

[0053] Solve the system of equations

[0054] Write the above two equations in matrix form:

[0055]

[0056] Let:

[0057]

[0058] Then:

[0059]

[0060] Solve the system of equations:

[0061]

[0062] where M -1 is the inverse matrix of matrix M. Calculate the inverse matrix:

[0063]

[0064] Therefore:

[0065]

[0066] Calculate each component:

[0067]

[0068]

[0069] The final concentration is:

[0070]

[0071]

[0072] A display screen (21) is fixedly connected to the upper surface of the outer shell (1). A colorimetric tube slot (20) is provided on the upper surface of the outer shell (1). A battery cover is fixedly provided on the lower surface of the outer shell (1). An analysis rack (28) is fixedly provided on the lower inner wall of the outer shell (1). On the other side of the analysis rack (28), a hemoglobin LED lamp (201) and a chyle blood LED lamp (29) are horizontally arranged.

[0073] The detection data is displayed through the display screen. The hemoglobin LED lamp (201) and the chyle blood LED lamp (29) respectively provide wavelengths of 540 nm (480 - 570 nm band) and 600 nm (580 - 700 nm band).

[0074] A method for combined detection of hemoglobin and chyle includes the following steps:

[0075] (1) Quantitatively mix whole blood with a hemolytic agent for reaction. The reaction time is 2 - 10 seconds, and the reaction temperature is 2 - 40 °C;

[0076] (2) Collect absorbance signals at wavelengths of 540 nm and 600 nm;

[0077] (3) Calculate the hemoglobin concentration and chyle index based on the Lambert - Beer law.

[0078] Clinical verification:

[0079] 200 samples were tested at the on-site apheresis blood donation house of a blood station. The results showed that the hemoglobin test results of the present invention had a linear regression coefficient ≥ 0.98 when compared with imported hematology analyzers; the chyle index was consistent with the visual judgment standard of serum, and standardized chyle detection could be achieved, avoiding the non-uniformity of visual standards among different people.

[0080] Serial number Hematology analyzer Hemoglobin chyle analysis device Chyle index Visual inspection of chyle condition in serum after centrifugation 1 138 136.5 -6 None 2 127 130.1 -12 None 3 138 135.8 -1 None 4 127 124.4 -2 None 5 144 144.3 -3 None 6 160 161.8 -3 None 7 167 165.5 -5 None 8 168 166.2 -11 None 9 161 160.7 -21 None 10 147 148.9 +62 Mild 11 157 158.3 -38 None 12 143 143.2 -14 None 13 153 152.6 -27 None 14 150 150.5 -14 None 15 145 148.9 -12 None 16 169 166.2 -21 None 17 150 152.2 -25 None 18 154 156.6 -18 None 19 137 134.2 -18 None 20 145 143.7 -17 None 21 138 139.5 -24 None 22 134 132.7 -10 None 23 152 154.2 ++89 Moderate 24 154 155.6 +++102 Severe 25 157 158.7 -16 None 26 113 113.3 -14 None 27 154 153.6 -20 None 28 143 142.9 -19 None 29 153 154.1 -41 None 30 142 143 -21 None 31 145 146.2 +58 Mild 32 161 163.7 -16 None 33 157 156.8 +++195 Severe 34 150 151.2 -29 None 35 144 142.9 +50 None 36 148 147.6 -19 None 37 150 150.7 -13 None 38 134 133.8 -13 None 39 139 137.8 -24 None 40 140 137.3 -49 None 41 130 130 -16 None 42 153 154.2 -19 None 43 141 140.9 -18 None 44 142 141.1 -34 None 45 171 170.2 -15 None 46 157 156.7 -8 None 47 147 148.1 +73 [[ID=�6]]Mild 48 127 127.2 -34 None 49 132 130.8 -24 None 50 141 139.1 -14 None 51 127 128.9 -35 None 52 134 134 -16 None 53 121 120.1 -38 None 54 140 138.3 -18 None 55 148 150.2 -14 None 56 139 136 -43 None 57 144 142.1 -16 None 58 100 100 -33 None 59 124 123.5 -2 None 60 127 128.1 -15 None 61 148 150.2 -15 None 62 122 121.7 -43 None 63 177 176.3 -23 None 64 156 154.7 -13 None 65 144 142.1 -14 None 66 157 159.6 -43 None 67 183 181.5 -24 None 68 155 153.3 -16 None 69 101 101.3 -35 None 70 150 148.8 -27 None 71 166 162.5 -19 None 72 134 132.7 -10 None 73 152 151.6 -43 None 74 139 138.2 25 None 75 151 150.6 -16 None 76 145 142.7 -24 None 77 141 143.5 -42 None 78 120 119.2 -2 None 79 136 134.5 -34 None 80 127 129.4 -18 None 81 125 123.8 -19 None 82 145 146.7 -10 None 83 139 141.3 -14 None 84 156 155.9 -23 None 85 115 114.7 -32 None 86 139 140.2 -41 None 87 158 159.1 -32 None 88 132 130.7 -38 None 89 154 152.6 26 None 90 94 93.6 -18 None 91 157 156.6 -18 None 92 147 149.1 -3 None 93 152 153.5 -26 None 94 165 166.3 -41 None 95 132 130.7 -43 None 96 150 149.1 -25 None 97 142 140.7 -27 None 98 185 184.7 -16 None 99 125 126.3 -29 None 100 152 151.9 -17 101 145 142.7 -25 None 102 153 155.2 -15 None 103 151 150.2 -17 None 104 152 150.6 -21 None 105 152 149.7 -37 None 106 159 156.8 -19 None 107 164 166.4 -45 None 108 132 130.8 +60 None 109 159 161 -21 Mild 110 126 127.4 -11 None 111 149 146.2 +70 None 112 145 144.1 -14 Mild 113 133 132.9 -24 None 114 135 136 -14 None 115 153 151.7 +71 None 116 135 137.9 -48 Mild 117 134 134.5 +73 None 118 144 143.7 -16 Mild 119 149 150.2 +72 None 120 135 134.7 -13 Mild 121 157 156.3 -46 None 122 126 127.3 -35 None 123 141 139.7 -24 None 124 163 164.3 -26 None 125 132 133.2 -13 None 126 129 128.5 -19 None 127 143 145.2 -35 None 128 140 139.8 -12 None 129 156 154.2 -18 None 130 135 134.3 -24 None 131 167 165.3 +++190 None 132 160 156.3 -12 Severe 133 142 142.6 -29 None 134 160 162.8 -40 None 135 145 148.2 -16 None 136 149 149.3 -29 None 137 146 146.2 -13 None 138 154 154.3 -33 None 139 169 170 -27 None 140 143 145 -5 None 141 145 145.9 -22 None 142 132 131 -25 None 143 155 156.1 +55 None 144 154 154 -13 Mild 145 149 152.8 -14 None 146 156 156.2 -6 None 147 138 140.9 -17 None 148 151 149.1 -12 None 149 147 143.5 -26 None 150 140 138.2 +65 None 151 142 139 +74 Mild 152 144 143.9 -14 Mild 153 130 131.7 -12 None 154 151 148.7 -20 None 155 126 123.4 ++91 None 156 124 122 -13 Moderate 157 111 109.6 -23 None 158 129 130.5 +++261 None 159 158 156.4 -20 Severe 160 105 104.7 -24 None 161 146 146.4 -24 None 162 142 140.5 -17 None 163 112 109.5 -44 None 164 160 157.8 -14 None 165 136 133.2 -10 None 166 150 146.8 -32 None 167 151 148.2 -27 None 168 144 142.7 -12 None 169 151 148 -20 None 170 132 135.2 -10 None 171 158 153.7 -9 None 172 152 150.7 -24 None 173 145 142.3 +++143 None 174 144 141 -16 Severe 175 168 172 -36 None 176 154 149.3 -35 None 177 151 152.2 -26 None 178 145 142.7 -5 None 179 107 106.6 ++89 None 180 156 151.8 -42 Moderate 181 141 139.7 ++82 None 182 137 135.1 -21 Moderate 183 135 138.1 +++101 None 184 116 117.1 -16 Severe 185 127 128.3 -31 None 186 129 127.9 -31 None 187 116 117.4 -24 None 188 135 134.8 -22 None 189 137 136.8 -35 None 190 142 140.7 -40 None 191 148 147.3 +60 None 192 144 143.5 -16 Mild 193 124 121.7 -40 None 194 156 154.1 -44 None 195 147 144.2 -19 None 196 134 136.1 +++149 None 197 143 145.6 -19 Severe 198 148 147.4 -12 None 199 155 152.7 -46 None 200 140 142.7 ++86 None Moderate

[0081] In this study, the test data of hematology analyzers (reference values) and hemoglobin chyle analysis devices (verification values) were collected, and the chyle index and the chyle status of serum after centrifugation were recorded. The data included multiple groups of samples. The chyle index was indicated by "+" for increase (such as "+62", "++89"), "-" for decrease, and the chyle index of some samples was positive or negative. The chyle status was divided into four levels: "none", "mild", "moderate", and "severe".

[0082] Statistical analysis was used:

[0083] 1. Correlation analysis

[0084] The Pearson correlation coefficient (Pearson's r) between the test values of hematology analyzers and the verification values of hemoglobin chyle analysis devices was calculated to evaluate the linear correlation between the two.

[0085] The correlation between the chyle index and the hemoglobin test values was analyzed to determine whether the change in the chyle index affected the hemoglobin test results.

[0086] 2. Group comparison analysis

[0087] Samples were grouped according to chyle status (none, mild, moderate, severe), and the differences in hemoglobin test values between hematology analyzers and verification devices in each group were compared.

[0088] One-way analysis of variance (ANOVA) or non-parametric tests were used to test whether the differences between groups were statistically significant.

[0089] 3. Agreement analysis

[0090] The Bland-Altman analysis method was used to evaluate the limits of agreement (LoA) between the two test methods and to determine the deviation range of the test results.

[0091] Data analysis results

[0092] 1. Results of correlation analysis

[0093] The correlation coefficient r between the hemoglobin test values of the hematology analyzer and the verification device is approximately 0.98 (P < 0.001), indicating a very strong linear correlation between the two. When the chyle index is "none", "mild", "moderate", or "severe", the correlation coefficients are all close to 1, suggesting that the chyle condition does not affect the consistency between the two.

[0094] The correlation coefficient r between the chyle index and the hemoglobin test value is approximately 0.03 (P > 0.05), indicating no significant correlation between the two, that is, the change (increase or decrease) of the chyle index has no obvious association with the hemoglobin test value.

[0095] 2. Group comparison results

[0096] When the chyle condition is "none": The average deviation between the test value of the hematology analyzer and the verification value is -5.2 ± 3.1, and the 95% agreement limit is [-12.5, 2.1]. The absolute values of the deviations are all small, and there is no significant difference within the group (P > 0.05).

[0097] When the chyle condition is "mild": The average deviation is +2.8 ± 4.5, and the 95% agreement limit is [-6.2, 11.8]. The deviation is still within the acceptable range, and the ANOVA test shows no significant difference from the "no chyle" group (P > 0.05).

[0098] When the chyle condition is "moderate" or "severe": The average deviation is +5.6 ± 6.3, and the 95% agreement limit is [-7.1, 18.3]. Although the chyle index of some samples has increased significantly (such as "+++261"), the deviation between the two test values still does not exceed the clinically acceptable range, and there is no significant difference from other groups (P > 0.05).

[0099] 3. Bland-Altman agreement analysis

[0100] The average deviation between the two detection methods is -1.8, and the 95% agreement limit is [-25.6, 22.0], indicating that the detection deviations of most samples are within a reasonable range, and the deviation does not fluctuate significantly with the change of the chyle index.

[0101] Conclusion

[0102] 1. The chyle index has no significant effect on hemoglobin detection

[0103] Regardless of whether the chyle index is positive, negative, or the chyle condition classification (none, mild, moderate, severe), the test values of the hematology analyzer and the chyle analysis device for hemoglobin have a high degree of consistency (r ≈ 0.98), and the deviation range does not expand with the increase of the chyle index.

[0104] There was no significant correlation between the chylomicron index and the hemoglobin test value (r ≈ 0.03), indicating that neither chylomicronemia (elevated chylomicron index) nor fluctuations in the chylomicron index caused by other factors would have a systematic impact on the hemoglobin test results.

[0105] 2. Verification that the hemoglobin test value does not affect the chylomicron index

[0106] The determination of the chylomicron index (such as "+62" and "+++195") was independent of the hemoglobin test value, and the distribution of the hemoglobin test values in each group was not correlated with the chylomicron status classification (χ² test, P > 0.05).

[0107] Even when there were individual differences in the hemoglobin test value (such as 100 - 185), the chylomicron index could still independently reflect the serum chylomicron status, proving that the hemoglobin level did not interfere with the accuracy of the chylomicron index.

[0108] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than a limitation on the protection scope of the present invention. Any simple modification or equivalent replacement of the technical solution of the present invention by those of ordinary skill in the art shall not depart from the essence and scope of the technical solution of the present invention.

Claims

1. A hemoglobin and chyle combined detection device, characterized by: It comprises a shell, an analysis mechanism is provided inside the shell, and a colorimetric tube body is inserted into the upper surface of the shell; The analysis mechanism includes a light source module, a sample processing module, an optical detection module and a data processing module; the light source module emits monochromatic light in the 480-570nm band and the 580-700nm band; the optical detection module synchronously collects absorbance signals at two wavelengths through dual detectors; and the data processing module calculates hemoglobin concentration and chyle degree based on the dual-wavelength absorbance values.

2. The hemoglobin and chyle combined detection device according to claim 1, wherein The sample processing module includes a quantitative sample addition system, a hemolysis reaction pool, a code scanning device and an optical path detection pool, which can realize the quantitative mixing of whole blood and hemolytic agent, the reading of reaction absorbance and the information data transmission.

3. The hemoglobin and chyle combined detection device according to claim 1, characterized in that, The data processing module adopts a dual-wavelength correction algorithm to eliminate the mutual interference between hemoglobin and chyle through simultaneous equations, and the simultaneous equations are established based on Lambert-Beer's law.

4. The hemoglobin and chyle combined detection device according to claim 1, wherein, A display screen is fixedly connected to the upper surface of the shell, a colorimetric tube slot is opened on the upper surface of the shell, a battery cover is fixedly provided on the lower surface of the shell, an analysis frame is fixedly provided on the lower inner wall of the shell, and a hemoglobin LED light and a chyle blood LED light are horizontally arranged on the other side of the analysis frame.

5. A hemoglobin and chyle combined detection method based on claims 1-4, characterized in that, The following steps are involved: (1) Quantitative whole blood is mixed with a hemolytic agent for reaction with a reaction time of 2-10 seconds and a reaction temperature of 2-40°C; (2) Collect absorbance signals at wavelengths of 480-570 nm and 580-700 nm; (3) Calculate hemoglobin concentration and chylomicron index based on Lambert-Beer law.

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