Method for weakening effect of lipemia on transmission and scattering fusion enhanced immunoturbidimetric assay

Abstract

The present invention relates to the technical field of transmission and scattering fusion enhanced immunoturbidimetric assays. Disclosed in the present invention is a method for weakening the effect of lipemia on a transmission and scattering fusion enhanced immunoturbidimetric assay. The method specifically comprises the following steps: S1, measuring the mean value of absorbance signal values at a light measurement point in a specific section after a reaction buffer is added to each sample; S2, measuring non-lipemia turbidity values, i.e., backgrounds, of different samples which do not cause a relatively low scattering measurement, after the reaction buffer is added to each sample; and S3, comparing the value measured in step S1 with the values measured in step S2, so as to determine whether a scattering turbidimetric measurement result needs to be revised. In the method for weakening the effect of lipemia on a transmission and scattering fusion enhanced immunoturbidimetric assay, during the transmission and scattering fusion enhanced immunoturbidimetric assay, there is a strong correlation between the turbidity of fat particles of a lipemia sample and a transmission turbidity signal value after a reaction buffer is added to the sample, and the correlation is specifically quantified by means of transmission light absorbance values of the sample and R1.

Description

A method to reduce the effect of lipemia on transmissive fusion enhanced immunoturbidimetric detection Technical Field

[0001] The invention relates to the technical field of through-scattering fusion enhanced immunoturbidimetry detection, in particular to a method for reducing the influence of lipemia on through-scattering fusion enhanced immunoturbidimetry detection. Background Art

[0002] Through-scattering fusion enhanced immunoturbidimetry detection is a new methodology that emerged in 2020. It is an upgrade of the original latex immunoturbidimetry. The implementation of this methodology requires both hardware and reagent foundations.

[0003] The reagents for the trans-scatter fusion enhanced immunoturbidimetric assay typically consist of a reaction buffer (labeled R1), a sensitized latex solution labeled with the target antibody or antigen (labeled R2), calibrators of known concentrations, and quality control products. The scattering assay in the trans-scatter fusion enhanced immunoturbidimetric assay inherits all the advantages and disadvantages of traditional scattering immunoturbidimetric assays. In particular, the drawback of scattering immunoturbidimetric assays, which are strongly affected by lipemia, is also inherited by the trans-scatter fusion enhanced immunoturbidimetric assay. Since the trans-scatter fusion enhanced immunoturbidimetric assay uses scattering results in the low-concentration range, it is strongly affected by lipemia. Commercialized scattering turbidimetric assays, from the Siemens BN series in the 1980s to the Beckman IMMAGE 800 in 2006, have yet to address the effects of lipemia and can only be mitigated through methods such as sample dilution.

[0004] The reason for this is that usually automated turbidimetric detection is performed in a reaction cuvette, which results in a certain "thickness" of the solution. Scattered light detection detects the intensity of scattered light. The scattered light generated by particles (such as antigen-antibody immune complexes) in the solution close to the side of the emitting light source (front end) is blocked by other particles close to the detector side (back end) and cannot reach the scattered light detector, which will cause the scattered light signal value to decrease. Therefore, turbidimetric detection usually needs to be performed in a relatively "dilute" solution, that is, the scattered light generated by the immune complex at the front end will not be blocked or blocked as little as possible by the particles at the back end. The impact of lipemia mainly comes from the fat particles in lipemia, which makes the concentration of particles in the tested solution "thick", resulting in the scattered light signal value generated by the immunoturbidimetric reaction unable to smoothly reach the scattered light detector, resulting in a reduction in the signal value and an underestimated test result.

[0005] Traditional scattering turbidimetry can reduce the effect of "thick" particles by making them "thin" through dilution. However, if the reaction solution is too dilute, it is difficult for the antigen-antibody immune reaction to occur. In particular, when testing items with low analyte content (less than 1000ug / L concentration), it is usually necessary to increase the sample volume to improve sensitivity, and dilution is completely undesirable. At the same time, the "thickness" of lipemia in different samples is different, and the thicker it is, the more serious the effect. Automated equipment cannot perform customized testing with one dilution for each sample, and can only perform batch operations with a unified dilution. Therefore, to this day, traditional automated scattering detection still cannot solve the problem of lipemia. To this end, the present invention provides a method for reducing the effect of lipemia on through-scattering fusion enhanced immunoturbidimetric detection to solve the above problem.

[0006] Summary of the Invention

[0007] (1) Technical problems solved

[0008] In view of the deficiencies of the prior art, the present invention provides a method for reducing the influence of lipemia on through-scattering fusion enhanced immunoturbidimetric detection, which solves the problems mentioned in the above background technology.

[0009] (2) Technical solution

[0010] To achieve the above objectives, the present invention is implemented through the following technical solutions: a method for reducing the influence of lipemia on through-scatter fusion enhanced immunoturbidimetric detection, specifically comprising the following steps:

[0011] S1, measuring the average absorbance signal value of the specific section photometric point after each sample is added to the reaction buffer;

[0012] S2. Determine the non-lipidemia turbidity value of different samples that does not cause a low scattering measurement after adding the reaction buffer to each sample, i.e., background;

[0013] S3. Compare the value measured in step S1 with the value measured in step S2 to determine whether the turbidimetric measurement result needs to be revised.

[0014] Preferably, the value measured in step S1 is expressed as R1a, and the value measured in step S2 is expressed as R1b.

[0015] Preferably, the judgment formula for the scattering turbidimetric measurement result in step S3 is: scattering revised value = scattering initial measurement value + scattering initial measurement value * (LN value) * correction coefficient k, wherein LN value = output value of selectivity function IF ((R1a-R1b)>0, (R1a-R1b), 0).

[0016] Preferably, the method for determining whether the initial scattering measurement value in step S3 needs to be corrected is: when R1a is greater than R1b, LN=R1a-R1b, that is, when there is a substantial lipemia turbidity value, the scattering turbidimetric measurement result is corrected; when the sample is not actually lipemia, or the particles in the lipemia are not sufficient to cause a low scattering measurement result, and only other factors cause R1a to have a non-zero value, then R1a is less than or equal to R1b, the result is output as 0, and the scattering turbidimetric measurement result is not corrected.

[0017] Preferably, the LN value range is: 0-LNH (LN upper limit).

[0018] Preferably, when the scattering revision value is within a range of ±15% of the transmission result in the transmission-scattering fusion area, the revision result is valid.

[0019] Preferably, the transmission-scattering fusion area is a section where both scattering and transmission can output results normally, that is, an overlapping area between the lower limit of the transmission technology limit value and the upper limit of the scattering technology limit value.

[0020] (3) Beneficial effects

[0021] The present invention provides a method for reducing the effect of lipemia on transmissive fusion enhanced immunoturbidimetric detection. Compared with the existing technology, it has the following advantages:

[0022] (1) The method for reducing the influence of lipemia on transmissive fusion enhanced immunoturbidimetric detection is to determine that when performing transmissive fusion enhanced immunoturbidimetric detection, the turbidity of fat particles (not triglyceride or cholesterol concentration) in the lipemia sample is strongly correlated with the transmissive turbidity signal value of the sample added to the reagent R1 (reaction buffer), and the correlation is specifically quantified through the transmissive light absorbance value of the sample and R1.

[0023] (2) The method for reducing the influence of lipemia on the transmission scattering fusion enhanced immunoturbidimetric detection is based on the principle that the aforementioned lipemia fat particles increase the "thickness" of the reaction solution, thereby hindering the scattered light from reaching the light detector. It can be inferred that the lipemia R1 transmission turbidity value (abbreviated as LN) is positively correlated with the "thickness" within a certain range, and that there is a functional relationship between LN and the underestimation of the scattering measurement results within a certain range. By studying the test results of a large number of lipemia samples, it is determined that LN is strongly correlated with the extent to which the scattering measurement results output by the transmission scattering fusion enhanced method are lower than the transmission results within a certain range; at the same time, using the functional relationship between LN and the underestimation of the scattering measurement results, a certain functional relationship (formula) is used to correct the lipemia scattering measurement results; and by introducing the correction formula into the transmission scattering integrated analyzer software system or the patient result output Lis system, the final output result can be corrected, thereby enhancing the reliability of the output result. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] FIG1 is a diagram showing the relationship between wavelength and R1b provided by a method for reducing the effect of lipemia on through-scattering fusion-enhanced immunoturbidimetric detection according to the present invention;

[0025] FIG2 is a diagram showing the relationship between wavelength and LNH provided by a method of reducing the effect of lipemia on through-scattering fusion enhanced immunoturbidimetric detection according to the present invention. DETAILED DESCRIPTION

[0026] 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.

[0027] The embodiments of the present invention provide the following technical solutions:

[0028] 1. Formula verification:

[0029] For the ferritin FER test on a Hitachi 3500 trans-scattering analyzer, the sample volume was 8µl, the R1 was 160µl, and the R2 was 80µl (i.e., sample volume / R1 volume = 1 / 20). The lower limit of the trans-scattering technique was 30ng / ml, and the upper limit of the trans-scattering technique was 450ng / ml, indicating a trans-scattering convergence range of 30-450ng / ml. The method was validated at transmission wavelengths of 570nm, 660nm, and 800nm. After calibration using the same calibrator, the scattering-corrected results were compared with the trans-scattering results for lipemic, hemolytic, and icteric samples. For samples with a trans-scattering concentration of 0-30ng / ml, which is unreliable due to the large fluctuations in trans-scattering results, the scattering results were directly corrected and not compared with the trans-scattering results. For samples with initial trans-scattering results between 30-450ng / ml, the correction formula was applied, and the corrected results were compared with the trans-scattering results to verify the formula's reliability. For samples with trans-scattering results greater than 450ng / ml, the trans-scattering results were reported directly without correction.

[0030] Corrected formula parameters:

[0031] Scattering revised value = scattering initial measurement value + scattering initial measurement value * (LN) * correction factor k;

[0032] At 570 nm, R1b = 700, k = 0.00012; LN = IF((R1a - 700) > 0, (R1a - 700), 0);

[0033] At 660 nm, R1b = 400, k = 0.00017; LN = IF((R1a-400)>0, (R1a-400), 0);

[0034] At 800 nm, R1b=150, k=0.00025; LN=IF((R1a-150)>0, (R1a-150), 0).

[0035] Lipidemia sample 2 was used up after the 570nm test, but the 660nm and 800nm ​​tests were not completed and are not included in the statistics. As can be seen, for some samples with LN greater than 2000, the deviation correction effect of some samples was not good. Samples with LN less than 10000 were diluted 1 / 5 for retesting. Sample 45 with extremely severe lipemia was diluted 8 times for retesting. The data are as follows:

[0036] It can be seen that at a transmission wavelength of 570nm, the revised method performs well for samples in the through-scattering fusion zone and has no effect on the determination of non-lipidemia samples. After the revision, the deviation of lipemia samples is reduced to within 10% for all samples.

[0037] Lipidemia sample 2 was used up after the 570nm test, but the 660nm and 800nm ​​tests were not completed and were not included in the statistics. It can be seen that for some samples with LN greater than 1500 at 660nm, the deviation correction effect of some samples was not good. Samples with LN less than 7500 were diluted 1 / 5 for retesting. Sample 45 with extremely severe lipemia was diluted 8 times for retesting. The data are as follows:

[0038] Blood sample 2 was used up after the 570nm test, but the 660nm and 800nm ​​tests were not completed and are not included in the statistics. It can be seen that for some samples with LN greater than 800 at 800nm, the deviation correction effect of some samples was not good. Samples with LN less than 4000 were diluted 1 / 5 for retesting. Sample 45 with extremely severe lipemia was diluted 9 times for retesting. The data are as follows:

[0039] It can be seen that at a transmission wavelength of 660nm, the revised method performs well for samples in the through-scattering fusion zone and has no effect on the determination of non-lipidemia samples. After the revision, the deviation of lipemia samples is reduced to within 10% for all samples.

[0040] It can be seen that at a transmission wavelength of 800nm, the revised method performs well for samples in the through-scattering fusion zone and has no effect on the determination of non-lipidemia samples. After the revision, the deviation of lipemia samples is reduced to within 10% for all samples.

[0041] 2. Parameter k range verification:

[0042] The 570nm data is selected to show the influence of the lower limit of the k value, and the 800nm ​​data is selected to show the influence of the upper limit of the k value.

[0043] As the k value decreases, the revised value becomes smaller and the negative deviation increases; as the k value increases, the revised value becomes larger and the positive deviation increases; a suitable k value ensures that the deviation of as many samples as possible is within 15% or even 10%, and minimizes the number of samples that need to be diluted and retested.

[0044] Scattering revised value = scattering initial measurement value + scattering initial measurement value * (LN) * correction factor k;

[0045] At 570 nm, R1b=700, k=0.00007; LN=IF((R1a-700)>0, (R1a-700), 0);

[0046] At 800 nm, R1b=150, k=0.00028; LN=IF((R1a-150)>0, (R1a-150), 0).

[0047] It can be seen that at 570nm, R1b=700, k=0.00007; when LN=IF((R1a-700)>0, (R1a-700), 0), there are two samples (lipemia sample 60 and lipemia sample 18) in the 0-LNH area with deviations exceeding negative 10%, and more samples are on the edge of negative 10%, and the revision results are not ideal.

[0048] It can be seen that at 800 nm, R1b = 150, k = 0.00028; when LN = IF((R1a-150)>0, (R1a-150), 0), although some samples with large negative deviations in the 0-LNH region have improved, the deviations of two samples (lipemia sample 59 and lipemia sample 19) exceed positive 10%, and more samples are on the edge of positive 10%, and the revised results are not ideal.

[0049] Therefore, within the commonly used latex turbidity wavelength range of 570-800nm, the optimal k value is in the range of 0.0008-0.00027, following the principle of negative correlation with wavelength.

[0050] 3. General Demonstration of Other Projects:

[0051] For the procalcitonin (PCT) project, the sample volume was 15ul, the R1 was 150ul, and the R2 was 75ul (i.e., 1 / 10 of the sample volume / R1 volume). The transmission wavelength was 700nm, the scattering angle was 20 degrees, and the reading points were 18-34. The process of establishing a formula suitable for reducing the effects of lipemia for this project was demonstrated on a Hitachi 3500 all-in-one trans-scattering instrument.

[0052] PCT project transmission and scattering fusion zone: the upper limit of the scattering technology limit value is 2000pg / ml, and the lower limit of the transmission technology limit value is 300pg / ml. The range of 300-2000pg / ml is the transmission and scattering fusion zone; the transmission result less than 300pg / ml is unreliable, the scattering result is reported, and the formula is revised, but it is not compared with the transmission result; greater than 2000pg / ml, the transmission result is reported, and the formula is not revised.

[0053] Template formula: Scattering revised value = Scattering initial measurement value + Scattering initial measurement value * (LN) * correction factor k;

[0054] First, based on the "template formula," the initial recommended R1b value of 400 and k value of 0.00017 were inserted at the 700nm transmission wavelength, which is the closest wavelength. A preliminary revised formula for the scattering output was established. This formula was then applied to the results of at least 25 selected lipemia samples (selected from the pre-sequence lipemia samples within the range of 300-2000 pg / ml) and 25 non-lipemia samples for comparison. Considering that the PCT item 300-2000 pg / ml requires inflammatory samples, 15 inflammatory samples and 10 normal samples were selected for this purpose. After these measurements, the formula was revised, and the revised deviation was compared with the initial deviation to verify the reliability of the initial R1b and k values.

[0055] As can be seen, at 700nm and a sample size / R1 ratio of 1 / 10, R1a values ​​are generally high, consistent with the positive correlation between R1a and sample size / R1 ratio. Furthermore, when the R1b and k values ​​at 660nm were incorporated, the bias was significantly improved after revision, but the negative bias remained significant. Further parameter refinement was required: based on the positive correlation between k and wavelength, the k value was increased to k = 0.00020. After testing icteric and hemolytic samples, an R1b value of 500 was estimated to be optimal.

[0056] It can be seen that samples with LN greater than 1300 have a large deviation, so they are diluted 5-fold and the measurement results after dilution are multiplied by the dilution factor.

[0057] We can see that for the PCT project, through parameter refinement and optimization, very good results were achieved by retesting with a 1 / 5 dilution at 700 nm, a 1 / 10 sample / R1 ratio, R1b = 500, k = 0.00020, and LN greater than 1300. The deviations of all samples after revision were less than 10%.

[0058] Then, more than 40 random samples were tested to ensure that at least 20 samples were within the through-scatter fusion zone (i.e., 300-2000 pg / ml). The parameters were retested with 1 / 5 dilution at 700 nm, 1 / 10 sample volume / R1 volume ratio, R1b=500, k=0.00020, and LN greater than 1300.

[0059] Template formula: Scattering revised value = Scattering initial measurement value + Scattering initial measurement value * (LN) * correction factor k;

[0060] Verify and the results are as follows:

[0061] Please refer to Figures 1 and 2 for a method for reducing the effect of lipemia on transmissive fusion enhanced immunoturbidimetric detection, which specifically includes the following steps:

[0062] S1, measuring the average absorbance signal value of the specific section measuring point after each sample is added to the reaction buffer R1, i.e. R1a;

[0063] S2. Determine the non-lipidemia turbidity value (i.e., "background") of each sample after adding reaction buffer R1, which does not cause a low scattering measurement, i.e., R1b. For example, the absorbance signal value of the sample when R1 is added due to sample color, bilirubin, hemolysis, etc. This value is derived from the data summary. Among them, different parameters such as transmission wavelength and sample volume / R1 volume ratio have different influencing factors, and the specific value is different;

[0064] S3. Compare the value measured in step S1 with the value measured in step S2 to determine whether the turbidimetric measurement result needs to be revised.

[0065] In this embodiment of the present invention, the formula for determining the nephelometric measurement result in step S3 is: Scattering Revised Value = Scattering Initial Measurement Value + Scattering Initial Measurement Value * (LN Value) * Correction Factor k, where LN Value = the output value of the selectivity function IF((R1a-R1b)>0, (R1a-R1b), 0). Samples below the lower limit of the transmission technology but within the nephelometric measurement range (i.e., the section where the nephelometric results are directly output) cannot be compared with the transmission results and are therefore valid by default, and are directly revised according to this formula.

[0066] In an embodiment of the present invention, the method for determining whether the initial scattering measurement value in step S3 needs to be corrected is as follows: when R1a is greater than R1b, LN = R1a - R1b, i.e., when there is a substantial lipemia turbidity value, the nephelometric measurement result is corrected. When the sample is not actually lipemic, or the lipemic particulate matter is insufficient to cause a low scattering measurement result, and only other factors cause R1a to have a non-zero value, then R1a is less than or equal to R1b, and a result of 0 is output, and no correction is made to the nephelometric measurement result. A relatively reliable R1b value for the corresponding item can be obtained by accumulating a certain amount of data (e.g., testing a certain amount of hemolysis, icteric color samples, or turbid samples due to other reasons) using the following method. The R1b value is negatively correlated with the wavelength and positively correlated with the sample size / R1 ratio. For example, at the most common sample size / R1 ratio of 1 / 20, the recommended R1b value at a transmission wavelength of 570nm is 700; at a transmission wavelength of 660nm, the recommended R1b value is 400; and at a transmission wavelength of 800nm, the recommended R1b value is 150. When changing the wavelength or sample size / R1 amount, those skilled in the art follow the following method: at the same wavelength, the R1b value is proportional to the sample size / R1 amount ratio. For example, at 660nm, when the ratio is 1 / 20, the R1b value is 400; when the ratio is 1 / 10, the R1b value = (1 / 10) / (1 / 20)*400 = 800; the same applies to other wavelengths. When using different wavelengths, a curve graph is established with the wavelength as the X-axis and the recommended R1b value as the Y-axis. The R1b value is preliminarily selected according to the wavelength to debug the above three methods. Within the range of ±300 of the recommended R1b value, the R1b value that best suits the project is debugged. As described in the above three, at 700nm and a ratio of 1 / 10, R1b = 500 was selected for the second step of debugging, and better results were obtained.

[0067] In the embodiment of the present invention, the LN value range is: 0-LNH (LN upper limit). This value is different for different transmission wavelengths and is negatively correlated with the wavelength. At a transmission wavelength of 570nm, the LN range is preferably 0-2000; at a wavelength of 660nm, the LN range is preferably 0-1500; at a wavelength of 800nm, the LN range is preferably 0-800. When the range is greater than the upper limit of this range, the computer software will prompt an out-of-range error, reminding the operator to dilute the sample to within the range and retest. Preferably, the dilution ratio is 1 / 5 (i.e., when LN>LNH, the sample is diluted 5 times for measurement, and the reported result is the diluted measurement result multiplied by the dilution factor of 5). Only in extremely rare cases of extremely high lipemia, such as when the LN value is greater than 4000 at a wavelength of 800nm, the dilution factor needs to be increased so that the LN value after dilution is less than 800 before measurement. The calculation method is also as follows: reported result = diluted measurement result * dilution factor. The LNH value is negatively correlated with the wavelength. With wavelength as the X-axis and LNH value as the Y-axis, a curve chart is established as shown in Figure 2. For different wavelengths, select the optimal LNH value within the recommended value ±20% range based on the actual modification data. As described in the above three, for a wavelength of 700nm, select LNH=1300.

[0068] Among them, the coefficient k is a specific functional relationship value between LN and the low amplitude of the scattering measurement value. The value is different for different projects and different parameters such as transmission wavelength and other influencing factors. According to the above method, a relatively reliable k value for the corresponding project can be obtained through certain data accumulation and debugging. Preferably, in the wavelength range of 570-800nm ​​commonly used for latex turbidimetry, the k value is usually between 0.00008-0.00028; the k value is positively correlated with the wavelength. Preferably, the k value of the transmission wavelength of 570nm is 0.00012±0.00003; the k value of the transmission wavelength of 660nm is 0.00017±0.00003; the k value of the 800nm ​​wavelength is recommended to be 0.00025±0.00003.

[0069] In the embodiment of the present invention, when the scattering revision value is within a range of ±15% of the transmission result in the transmission-scattering fusion area, the revision result is valid.

[0070] In the embodiment of the present invention, the transmission-scattering fusion area is a section where both scattering and transmission can output results normally, that is, an overlapping area between the lower limit of the transmission technology limit value and the upper limit of the scattering technology limit value.

[0071] Meanwhile, the contents not described in detail in this specification belong to the prior art known to those skilled in the art.

[0072] It should be noted that, in this document, relational terms such as first and second, etc., are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the terms "comprises," "comprising," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that includes a list of elements includes not only those elements but also other elements not explicitly listed, or elements inherent to such process, method, article, or apparatus.

[0073] While embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions, and variations may be made to these embodiments without departing from the principles and spirit of the invention, and that the scope of the invention is defined by the appended claims and their equivalents.

Claims

1. A method for reducing the effect of lipemia on through-scatter fusion enhanced immunoturbidimetric detection, characterized in that: The specific steps include: S1, determining the average value of the absorbance signal value at the photometric point in a specific section after each sample is added with the reaction buffer; S2, measuring the non-lipidemia turbidity values ​​of different samples that do not cause a low scattering measurement after adding the reaction buffer to each sample, i.e., background; S3. Compare the value measured in step S1 with the value measured in step S2 to determine whether the nephelometry measurement result needs to be revised.

2. The method for reducing the effect of lipemia on through-scatter fusion enhanced immunoturbidimetric detection according to claim 1, characterized in that: The value measured in step S1 is expressed as R1a, and the value measured in step S2 is expressed as R1b.

3. The method for reducing the effect of lipemia on through-scatter fusion enhanced immunoturbidimetric detection according to claim 1, characterized in that: The determination formula of the scattering turbidimetric measurement result in step S3 is: scattering revised value = scattering initial measurement value + scattering initial measurement value * (LN value) * correction coefficient k, wherein LN value = output value of selectivity function IF ((R1a-R1b)>0, (R1a-R1b), 0).

4. The method for reducing the effect of lipemia on through-scatter fusion enhanced immunoturbidimetric detection according to claim 3, characterized in that: The method for determining whether the initial scattering measurement value in step S3 needs to be corrected is as follows: when R1a is greater than R1b, LN=R1a-R1b, that is, when there is a substantial lipemia turbidity value, the scattering turbidimetric measurement result is corrected; when the sample is not actually lipemia, or the particles in lipemia are not sufficient to cause the scattering measurement result to be low, and only other factors cause R1a to have a non-zero value, then R1a is less than or equal to R1b, and the output result is 0, and the scattering turbidimetric measurement result is not corrected at this time.

5. The method for reducing the effect of lipemia on through-scatter fusion enhanced immunoturbidimetric detection according to claim 3, characterized in that: The LN value range is: 0-LNH (LN upper limit).

6. The method for reducing the effect of lipemia on through-scatter fusion enhanced immunoturbidimetric detection according to claim 3, characterized in that: When the scattering revision value is within the range of ±15% of the transmission result in the transmission-scattering fusion area, the revision result is valid.

7. The method for reducing the effect of lipemia on through-scatter fusion enhanced immunoturbidimetric detection according to claim 6, characterized in that: The transmission-scattering fusion area is a section where both scattering and transmission can output results normally, that is, the cross-overlapping area between the lower limit of the transmission technology limit value and the upper limit of the scattering technology limit value.

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