Hemoglobin chyle combined detection device and detection method

Abstract

The present invention belongs to the field of medical technology, and in particular relates to a combined hemoglobin and chyle detection device and method. The device comprises a housing, an analysis mechanism disposed within the housing, and a colorimetric tube inserted into the upper surface of the housing. 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 at two wavelengths using dual detectors. The data processing module calculates hemoglobin concentration and chyle level based on the dual-wavelength absorbance values. Unlike traditional single-index detection, the present invention achieves for the first time the simultaneous analysis of dual parameters of hemoglobin and chyle, significantly improving the efficiency of initial screening before blood donation. A dual-wavelength correction algorithm is employed to eliminate the interference of residual absorption of hemoglobin at 540 nm that affects the determination of the chyle index, and to eliminate the interference of absorption of chyle at 600 nm that affects the determination of hemoglobin. The device is suitable for rapid screening at the blood collection site to achieve information management of detection data.

Description

Technical Field

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

[0002] The hemoglobin chyle combined detection device is suitable for use in blood stations and other scenarios. It can quickly and accurately detect the hemoglobin content in the blood of blood donors and whether chyle is present.

[0003] Traditional hemoglobin analyzers can only measure hemoglobin concentration in the blood and cannot simultaneously assess the chylosing status of the blood. During the initial screening process before blood donation, the presence of chylosing (turbid plasma due to high blood lipids) can significantly increase the rate of plasma rejection after donation. Existing methods for detecting chylosing mainly rely on manual visual inspection or observation of plasma turbidity after centrifugation. These methods are subject to high subjectivity, low efficiency, and lack of quantitative analysis. For example, some blood collection institutions use a method of visually comparing turbidity after dilution with saline, a method whose accuracy is significantly affected by the experience of the examiner. Furthermore, while fully automatic blood donation screening devices involve hemolysis and chylosing detection, they do not achieve simultaneous quantitative analysis of hemoglobin and chylosing. Summary of the Invention

[0004] The object of the present invention is to provide a device and method for quickly and comprehensively detecting the hemoglobin content and the presence of chylosing, so as to solve the problems raised in the above background technology.

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

[0006] A hemoglobin chyle combined detection device and detection method,

[0007] 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;

[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 at wavelengths of 540 nm and 600 nm; the optical detection module synchronously collects absorbance signals at the two wavelengths through dual detectors; and the data processing module calculates hemoglobin concentration and chyle degree based on the dual-wavelength absorbance values.

[0009] The combined hemoglobin and chylomicron detection method includes the following steps:

[0010] (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;

[0011] (2) Collect absorbance signals at wavelengths of 540 nm and 600 nm;

[0012] (3) Calculate hemoglobin concentration and chylomicron index based on Lambert-Beer law;

[0013] A mathematical model was established based on the Beer-Lambert law, and the hemoglobin concentration formula was calculated using the dual-wavelength absorbance value:

[0014]

[0015] Chylolytic index formula:

[0016]

[0017] The absorbances of the hemoglobin standard solution with concentration C1 in a 1 cm color cell are A540HB1 and A600CB1;

[0018] The absorbances of the chyle standard solution with concentration C2 in a 1 cm colorimetric cell were A540HB2 and A600CB2;

[0019] The absorbance of the mixed solution after hemolysis in a 1 cm colorimetric cell was A540HB3 and A600CB3, respectively.

[0020] Preferably, the sample processing module comprises 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.

[0021] Preferably, 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.

[0022] Preferably, 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.

[0023] Compared with the prior art, the present invention has the following beneficial effects:

[0024] (1) Simultaneous detection: Different from traditional single-index detection, this is the first time that dual-parameter simultaneous analysis of hemoglobin and chyle is achieved, significantly improving the efficiency of initial screening before blood donation.

[0025] (2) Anti-interference design: A dual-wavelength correction algorithm is used to eliminate the interference of residual absorption of hemoglobin at 580-700nm that affects the determination of chylomicron index, and to eliminate the interference of absorption of chyle at 480-570nm that affects the determination of hemoglobin.

[0026] (3) Automated application: The integrated design supports direct whole blood testing without the need for centrifugation or complex pretreatment, and is suitable for rapid screening at the blood collection site; it is equipped with a code scanning device and a data transmission module to realize the information management of test data. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 It is a structural diagram of the present invention;

[0028] Figure 2 Schematic diagram of the internal structure of the present invention;

[0029] Figure 3 is a linear regression graph of hemoglobin of an experimental example of the present invention;

[0030] Figure 4 This is a fluctuation diagram of HGB values ​​compared with a red blood cell analyzer and a hemoglobin chylomicron analyzer according to an experimental example of the present invention;

[0031] Figure 5 This is a graph showing the absorbance changes of hemoglobin and chyle. DETAILED DESCRIPTION

[0032] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0033] The present invention provides a technical solution:

[0034] A hemoglobin chyle combined detection device:

[0035] It comprises a housing (1), an analysis mechanism (2) is provided inside the housing (1), and a colorimetric tube (3) is inserted into the upper surface of the housing (1);

[0036] 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 a wavelength of 540nm (480-570nm band) and 600nm (580-700nm band); the optical detection module synchronously collects absorbance signals at two wavelengths through dual detectors; and the data processing module calculates the hemoglobin concentration and the degree of chyle based on the dual-wavelength absorbance values.

[0037] 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.

[0038] 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 the Lambert-Beer law.

[0039] A mathematical model was established based on the Beer-Lambert law, and the hemoglobin concentration formula was calculated using the dual-wavelength absorbance value:

[0040]

[0041] Chylolytic index formula:

[0042]

[0043] The absorbance of the hemoglobin standard solution (concentration C1) in a 1 cm color cell is A540HB1 and A600CB1 respectively.

[0044] The absorbance of the chyle standard solution (concentration C2) in a 1 cm colorimetric cell is A540HB2 and A600CB2 respectively.

[0045] The absorbance of the mixed solution after hemolysis in a 1 cm colorimetric cell was A540HB3 and A600CB3, respectively. The absorbance of hemoglobin and chyle at wavelengths of 540 nm and 600 nm differed significantly.

[0046] Objective: Calculate the concentrations of hemoglobin (CHB) and chylomicrons (CCB) in a mixed solution.

[0047] The derivation process is as follows:

[0048] According to the Beer-Lambert Law, the relationship between absorbance A, solution concentration C and optical path length B is:

[0049] A=ε·C·B

[0050] Where: ε is the molar absorptivity, which depends on the properties of the substance and the wavelength. C is the concentration of the solution. B is the optical path length, which is measured in units of 1 cm in this application. For a mixed solution, assuming that the absorbances of hemolysis and chyle are linearly additive, the absorbance at a certain wavelength can be expressed as:

[0051] A mixture = A hemolysis + A chyle

[0052] Establishing a system of equations

[0053] At 540 nm wavelength:

[0054]

[0055] At 600 nm wavelength:

[0056]

[0057] in:

[0058] (CHB) is the concentration of hemolysis in the mixed solution (the unit is the same as (C),

[0059] (CCB) is the concentration of milk in the mixed solution (same units as (C)).

[0060] Solving a system of equations

[0061] Write the above two equations in matrix form:

[0062]

[0063] set up:

[0064]

[0065] but:

[0066]

[0067] Solve the system of equations:

[0068]

[0069] Among them, M -1 Is the inverse matrix of matrix M. Calculate the inverse matrix:

[0070]

[0071] therefore:

[0072]

[0073] Calculate each component:

[0074]

[0075]

[0076] The final concentration is:

[0077]

[0078]

[0079] A display screen (21) is fixedly connected to the upper surface of the housing (1), a colorimetric tube slot (20) is provided on the upper surface of the housing (1), a battery cover is fixedly provided on the lower surface of the housing (1), an analysis frame (28) is fixedly provided on the lower inner wall of the housing (1), and a hemoglobin LED light (201) and a chyle blood LED light (29) are horizontally provided on the other side of the analysis frame (28).

[0080] The detection data is displayed on the display screen, and the hemoglobin LED light (201) and the chyle blood LED light (29) provide 540nm (480-570nm band) and 600nm (580-700nm band) waves respectively.

[0081] A combined hemoglobin and chyle detection method comprises the following steps:

[0082] (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;

[0083] (2) Collect absorbance signals at wavelengths of 540 nm and 600 nm;

[0084] (3) Calculate hemoglobin concentration and chylomicron index based on Beer-Lambert law.

[0085] Clinically validated:

[0086] 200 samples were tested at a blood donation room at a blood station. The results showed that the hemoglobin test results of the present invention had a linear regression coefficient of ≥0.98 when compared with the imported blood cell analyzer; the chyle index was consistent with the serum visual judgment standard, and standardized chyle detection could be achieved to avoid inconsistencies in visual inspection standards among different people.

[0087] Serial number Hematology analyzer Hemoglobin chylomicron analyzer Chylolytic index Visual inspection of chyle status 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 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 none 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 Mild 109 159 161 -21 none 110 126 127.4 -11 none 111 149 146.2 +70 Mild 112 145 144.1 -14 none 113 133 132.9 -24 none 114 135 136 -14 none 115 153 151.7 +71 Mild 116 135 137.9 -48 none 117 134 134.5 +73 Mild 118 144 143.7 -16 none 119 149 150.2 +72 Mild 120 135 134.7 -13 none 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 severe 132 160 156.3 -12 none 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 Mild 144 154 154 -13 none 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 Mild 151 142 139 +74 Mild 152 144 143.9 -14 none 153 130 131.7 -12 none 154 151 148.7 -20 none 155 126 123.4 ++91 Moderate 156 124 122 -13 none 157 111 109.6 -23 none 158 129 130.5 +++261 severe 159 158 156.4 -20 none 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 severe 174 144 141 -16 none 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 Moderate 180 156 151.8 -42 none 181 141 139.7 ++82 Moderate 182 137 135.1 -21 none 183 135 138.1 +++101 severe 184 116 117.1 -16 none 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 Mild 192 144 143.5 -16 none 193 124 121.7 -40 none 194 156 154.1 -44 none 195 147 144.2 -19 none 196 134 136.1 +++149 severe 197 143 145.6 -19 none 198 148 147.4 -12 none 199 155 152.7 -46 none 200 140 142.7 ++86 Moderate

[0088] This study collected data from a hematology analyzer (reference values) and a hemoglobin chylomicron analyzer (validation values). The chylomicron index and post-centrifugation serum chylomicron status were also recorded. The data included multiple sample groups. The chylomicron index was indicated by a "+" (e.g., "+62" or "++89") and a "-" (e.g., "-89"), indicating a decrease. Some samples had positive or negative chylomicron values. Chlolomicron status was categorized into four levels: absent, mild, moderate, and severe.

[0089] Statistical analysis was performed using:

[0090] 1. Correlation Analysis

[0091] The Pearson's correlation coefficient (Pearson's r) was calculated to evaluate the linear correlation between the blood cell analyzer test value and the hemoglobin chylomicron analysis device verification value.

[0092] The correlation between chylomicron index and hemoglobin test value was analyzed to determine whether the change of chylomicron index affected the hemoglobin test result.

[0093] 2. Group comparative analysis

[0094] The patients were divided into groups according to chylous status (none, mild, moderate, and severe), and the differences in hemoglobin detection values ​​between the blood cell analyzer and the verification device were compared among the groups.

[0095] One-way analysis of variance (ANOVA) or nonparametric test was used to test whether the differences between the groups were statistically significant.

[0096] 3. Consistency Analysis

[0097] The Bland-Altman analysis method was used to evaluate the limits of agreement (LoA) of the two detection methods and determine the deviation range of the test results.

[0098] Data analysis results

[0099] 1. Correlation analysis results

[0100] The correlation coefficient of hemoglobin detection values ​​between the blood cell analyzer and the verification device was r≈0.98 (P<0.001), indicating that the two had a strong linear correlation. When the chylomicron index was "none", "mild", "moderate" and "severe", the correlation coefficient was close to 1, indicating that the chylomicron status did not affect the consistency of the two.

[0101] The correlation coefficient between the chylomicron index and the hemoglobin test value was r≈0.03 (P>0.05), indicating that there was no significant correlation between the two, that is, the change in the chylomicron index (increase or decrease) had no obvious correlation with the hemoglobin test value.

[0102] 2. Group comparison results

[0103] When the chylomicron status was "none": the average deviation between the blood cell analyzer detection value and the verification value was -5.2±3.1, and the 95% consistency limit was [-12.5, 2.1]. The absolute value of the deviation was small, and there was no statistically significant difference within the group (P>0.05).

[0104] When the chylosing condition was “mild”, the mean deviation was + 2.8 ± 4.5, and the 95% consistency limit was [-6.2, 11.8]. The deviation was still within the acceptable range. The ANOVA test showed that there was no statistically significant difference compared with the “no chylosing” group (P>0.05).

[0105] When the chylosing condition was "moderate" or "severe": the average deviation was + 5.6±6.3, and the 95% consistency limit was [-7.1, 18.3]. Although the chylosing index of some samples was significantly elevated (such as "+++261"), the deviation of the test values ​​between the two groups still did not exceed the clinically acceptable range, and there was no statistically significant difference with other groups (P>0.05).

[0106] 3. Bland-Altman consistency analysis

[0107] The average deviation of the two detection methods was -1.8, and the 95% consistency limits were [-25.6, 22.0], indicating that the detection deviation of most samples was within a reasonable range and did not fluctuate significantly with changes in the chylosing index.

[0108] in conclusion

[0109] 1. Chylous index has no significant effect on hemoglobin detection

[0110] Regardless of whether the chylomicron index was positive or negative or the chylomicron status was graded (none, mild, moderate, or severe), the detection values ​​of the blood cell analyzer and the hemoglobin chylomicron analysis device were highly consistent (r≈0.98), and the deviation range did not increase with the increase of the chylomicron index.

[0111] There was no significant correlation between the chylomicron index and the hemoglobin test value (r≈0.03), indicating that chylomicronemia (elevated chylomicron index) or fluctuations in the chylomicron index caused by other factors would not have a systematic impact on the hemoglobin test results.

[0112] 2. Hemoglobin test value does not affect the verification of chylosing index

[0113] The chylosing index (e.g., "+62" or "+++195") was not associated with the hemoglobin value, and the distribution of hemoglobin values ​​in each group was not correlated with the chylosing status (χ² test, P>0.05).

[0114] Even if there are individual differences in hemoglobin test values ​​(such as 100-185), the chylomicron index can still independently reflect the serum chylomicron status, proving that the hemoglobin level does not interfere with the accuracy of the chylomicron index.

[0115] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions of the technical solution of the present invention by ordinary technicians in this field do not deviate from the essence and scope of the technical solution of the present invention.

Claims

1. A combined hemoglobin and chyle detection method, characterized in that: 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 at wavelengths of 540 nm and 600 nm; the optical detection module synchronously collects absorbance signals at the two wavelengths through dual detectors; and the data processing module calculates hemoglobin concentration and chyle degree based on the dual-wavelength absorbance values. The combined hemoglobin and chylomicron detection method includes the following steps: (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 540 nm and 600 nm; (3) Calculate hemoglobin concentration and chylomicron index based on Lambert-Beer law; A mathematical model was established based on the Beer-Lambert law, and the hemoglobin concentration formula was calculated using the dual-wavelength absorbance value: ； Chylolytic index formula: ； The absorbances of the hemoglobin standard solution with concentration C1 in a 1 cm color cell are A540HB1 and A600CB1; The absorbances of the chyle standard solution with concentration C2 in a 1 cm colorimetric cell were A540HB2 and A600CB2; The absorbance of the mixed solution after hemolysis in a 1 cm colorimetric cell was A540HB3 and A600CB3, respectively.

2. A hemoglobin chyle combined detection method according to claim 1, characterized in that, 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-chylomicron combined detection method 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 chylomicron combined detection method according to claim 1, characterized in that: 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.

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