Reagents and methods for detecting whether added sample amount is abnormal

Abstract

The present invention relates to the field of blood testing technology, and in particular to reagents and methods for detecting abnormal sample amounts. The present invention detects human albumin in a sample based on the fluorescent reaction between albumin and albumin blue. A reasonable acceptance range for emitted fluorescence is set for different sample amounts. If the acceptance range is exceeded, the sample amount added during the test is considered abnormal, indicating that the test result is invalid and requires retesting, or that the albumin concentration needs to be rechecked. Experiments have shown that the method provided by the present invention is accurate and reliable, and can effectively reduce the risk of false positives during testing.

Description

Technical Field

[0001] The present invention relates to the technical field of blood testing, and in particular to a reagent and method for detecting whether the amount of added sample is abnormal. Background Art

[0002] In in vitro diagnostics involving biochemical testing, immunoassays, and other fields involving blood or urine testing, during fully automatic, semi-automatic, and manual testing, occasional failures of the automated instrument's sample loading module or human errors may result in abnormal sample loading (lower or higher than the target sample volume), leading to the reporting of erroneous test results and clinical misdiagnosis, which may ultimately have serious consequences for patients.

[0003] In the field of biochemical testing and immunoassay, there is currently no systematic solution to abnormal sample size, and judgments mostly rely on the experience of the testing physician or clinician.

[0004] Human blood samples all contain human albumin, and its content fluctuates within a small range (for example, the content in normal human serum / plasma is usually between 35g / L and 55g / L, and the more likely range is 40g / L-50g / L). If it exceeds this range, it will show very obvious clinical indications. However, there is currently no method to use albumin as a detection marker to determine whether the sample loading amount is abnormal. Summary of the Invention

[0005] In view of this, the technical problem to be solved by the present invention is to provide a reagent and method for detecting whether the added sample amount is abnormal, and to judge whether the added sample amount is abnormal during the detection process through the fluorescent signal.

[0006] The application of albumin as a marker in the preparation of reagents for detecting whether the amount of added sample is abnormal.

[0007] The sample described in the present invention is a sample for biochemical or immunoassay testing. Specifically, it is a sample for fluorescence analysis or UV-visible spectrophotometry. In the present invention, the sample is whole blood, plasma, serum, or urine. Whether the added sample is abnormal refers to whether the amount of the sample added in the biochemical or immunoassay is higher or lower than the target sample amount.

[0008] Human albumin is present in both blood and urine samples, and its concentration fluctuates within a narrow range. For example, normal human serum / plasma concentrations typically range from 35g / L to 55g / L, with a more likely range of 40g / L to 50g / L. Exceeding this range often indicates significant symptoms and a high-risk condition. Therefore, if an abnormal albumin concentration is detected after testing, the tester should be reminded to recheck the sample's albumin concentration to eliminate any risk.

[0009] In the present invention, the use of albumin as a marker refers to detection using human serum albumin present in a sample as a marker. During the test, a substance that reacts with albumin to produce fluorescence or a color reaction is added to the reaction reagent. The amount of albumin can then be used to determine whether there is a difference between the added sample amount and the target sample amount.

[0010] In the present invention, the substance capable of reacting with albumin to produce fluorescence or a color reaction includes albumin blue, specifically albumin blue 580, albumin blue 670, or albumin blue 633. In some specific embodiments, the albumin blue used is albumin blue 580, whose Cas No. is 192140-46-8.

[0011] In the present embodiment, the present invention utilizes a reaction between human albumin raw material and albumin blue, which emits light at a wavelength of 616 nm under excitation at a wavelength of 580 nm. The intensity of the detected 616 nm light allows for quantitative determination of human albumin in blood, thereby serving as an internal reference. Therefore, if the quantitative result of adding albumin blue to the test reagent exceeds the expected albumin content in normal blood, it indicates that the sample dosage is abnormal.

[0012] In the present invention, the albumin-containing sample is whole blood, plasma, serum or urine; and the detection reagent is a biochemical detection reagent or an immunoassay reagent.

[0013] In the present invention, human serum albumin in a sample is detected based on the fluorescence reaction between albumin and albumin blue. Therefore, the detection reagent of the present invention can be used as a detection reagent for any method other than a fluorescence detection wavelength of 616 nm. In some embodiments of the present invention, the detection reagent is a detection reagent for ultraviolet-visible spectrophotometry. The target of the detection is any target suitable for detection by ultraviolet-visible spectrophotometry.

[0014] The present invention provides a method for detecting whether the amount of added sample is abnormal, comprising:

[0015] After mixing the detection reagent containing the dye, the fluorescence intensity F0 is detected;

[0016] Add the sample containing albumin, incubate, and detect the fluorescence intensity F2;

[0017] The dye is a substance that can react with albumin to produce a staining reaction;

[0018] If the F2 / F0 ratio is within the preset value range, it is judged that the added sample size is normal. If the F2 / F0 ratio is not within the preset value range, it is judged that the added sample size is abnormal.

[0019] The present invention also provides a method for detecting an albumin-containing sample, comprising:

[0020] After mixing the detection reagent containing the dye, the fluorescence intensity F0 and absorbance A0 are detected;

[0021] Add a sample containing albumin, incubate, and detect absorbance A1. After further incubation, detect fluorescence intensity F2 and absorbance A2.

[0022] The dye is a substance that can react with albumin to produce a staining reaction;

[0023] If the F2 / F0 ratio is within the preset range, the added sample amount is judged to be normal, and the concentration of the target to be tested is calculated based on the absorbance change;

[0024] If the F2 / F0 ratio is not within the preset value range, it is judged that the added sample amount is abnormal and retesting is required.

[0025] In the present invention, the preset value range is (x×downward floating index) to (x×upward floating index).

[0026] In the present invention, x is the F2 / F0 ratio measured under standard sample addition conditions. The standard sample addition conditions refer to conditions that ensure the correct sample addition amount. x is the average value measured after multiple standard sample additions.

[0027] In the present invention, the downward floating index is 80% to 99%, and the upward floating index is 101% to 120%. In embodiments, the downward floating index is 85% to 97%, and the upward floating index is 103% to 115%. In some embodiments, the downward floating index is 90% to 95%, and the upward floating index is 105% to 110%. In some specific embodiments, the downward floating index is 90%, 91%, 92%, 93%, 94%, or 95%. In some specific embodiments, the upward floating index is 105%, 106%, 107%, 108%, 109%, or 110%. In the present invention, the upward floating index and downward floating index can be adjusted according to the needs of different tests. The present invention is not limited to this. In the embodiments of the present invention, the methodological validation was performed with an x ​​value of ±5% as the acceptable error range, i.e., the upward floating index was 105% and the downward floating index was 95%.

[0028] In the present invention, the dye is a substance that can react with albumin to produce fluorescence or a color reaction. In some embodiments, the dye includes albumin blue. Specific dyes include albumin blue 580, albumin blue 670, or albumin blue 633. In some specific embodiments, the albumin blue used is albumin blue 580, whose Cas No. is 192140-46-8.

[0029] The detection reagents described in the method of the present invention include detection reagents for biochemical colorimetric detection or immunoturbidimetric detection. The number of reagents is generally two, and multiple other reagents may be included according to actual needs. For example, in addition to reagents R1 and R2, one, two, three, four, five, six, seven, eight, nine, or ten reagents may be included. The reagents include buffer solutions, metal ion solutions, salt ion solutions, suspensions of antigen- or antibody-coated microspheres, protective agent solutions, enzyme solutions, surfactant solutions, etc. required for the reaction.

[0030] Taking two reagents as an example, the detection reagents include R1 reagent and R2 reagent;

[0031] The R1 reagent includes buffer A;

[0032] The R2 reagent includes a target detection reagent, buffer B and albumin blue.

[0033] The R1 reagent of the present invention (referred to as Reagent 1 in the examples) contains a buffer solution required for the reaction of the human serum albumin concentration determination reagent and the reaction of the target detection reagent.

[0034] The R2 reagent of the present invention (referred to as Reagent 2 in the examples) contains a dye and essential reaction components of a target detection reagent.

[0035] In some specific embodiments, in the R2 reagent, the mass fraction of the albumin blue is 0.05% to 4%.

[0036] In the present invention, the buffer A and buffer B are independently selected from 4-hydroxyethylpiperazineethanesulfonic acid buffer, morpholineethanesulfonic acid buffer, phosphate buffer, pyrophosphate buffer, 3-(N-morpholino)propanesulfonic acid buffer, and 1,4-piperazinediethanesulfonic acid buffer.

[0037] In the present invention, the R1 reagent further comprises at least one of potassium salt, sodium salt, cyano compound or surfactant, or a combination of two or more thereof.

[0038] The target detection reagent of the present invention is a particle coated with an antibody against the target to be detected or a substance whose absorbance changes after reacting with the target to be detected.

[0039] When the number of reagents is 2, the method of the present invention detects the fluorescence intensity F0 and absorbance A0 after mixing R1 and R2; adds a sample containing albumin, incubates, detects the absorbance A1, and after further incubation, detects the fluorescence intensity F2 and absorbance A2.

[0040] When the number of reagents is 3, the method of the present invention detects the fluorescence intensity F0 and absorbance A0 after mixing R1 to 3; adds a sample containing albumin, incubates, and detects the absorbance A1; after further incubation, detects the fluorescence intensity F2 and absorbance A2.

[0041] When the number of reagents is 4, the method of the present invention detects the fluorescence intensity F0 and absorbance A0 after mixing R1 to 4; adds a sample containing albumin, incubates, and detects the absorbance A1; after further incubation, detects the fluorescence intensity F2 and absorbance A2.

[0042] By analogy, when adding multiple reagents, the absorbance and fluorescence intensity are tested each time after all reagents are added, and then the sample is added. After incubation, A1 is tested, and after further incubation, F2 and A2 are tested and compared with the preset value range to determine whether the sample amount is abnormal.

[0043] In the embodiments of the present invention, C-reactive protein, total bilirubin or cholinesterase are used as examples to further illustrate the solution of the present invention.

[0044] The examples of the present invention confirm that the reagent described herein can be used as a latex immunoturbidimetric assay. In addition to detecting C-reactive protein, the reagent can be applied to any other analyte detectable by latex immunoturbidimetric assay. Experiments with the C-reactive protein assay have shown that the type of buffer, salt ion selection, and concentration all have a certain impact on the results, but the parameters described in this example can achieve more accurate detection of the target substance.

[0045] In the detection of C-reactive protein:

[0046] The R1 reagent is a 4-hydroxyethylpiperazineethanesulfonic acid buffer solution containing NaCl, wherein the concentration of the 4-hydroxyethylpiperazineethanesulfonic acid buffer solution is 50 mM to 500 mM, and the concentration of NaCl is 150 mM to 500 mM.

[0047] The R2 reagent is a 4-hydroxyethylpiperazineethanesulfonic acid buffer solution containing albumin blue and C-reactive protein antibody-coated latex. The concentration of the 4-hydroxyethylpiperazineethanesulfonic acid buffer solution is 50mM to 500mM, the mass fraction of albumin blue is 0.05% to 2%, and the mass fraction of the C-reactive protein antibody-coated latex is 0.1% to 0.5%.

[0048] The examples of the present invention confirm that the reagent described herein can be used as a detection reagent for biochemical colorimetric detection methods. In addition to detecting total bilirubin or cholinesterase, the reagent can be applied to any other analyte that can be detected by a biochemical colorimetric method. In the scheme for detecting total bilirubin or cholinesterase, experiments have shown that the type of buffer, the choice of salt ions, and the concentration all have a certain impact on the results, but the parameters described in this example can achieve more accurate detection of the target.

[0049] In the detection of total bilirubin:

[0050] The R1 reagent is a morpholineethanesulfonic acid buffer containing KCl and Tween, wherein the concentration of the morpholineethanesulfonic acid buffer is 50mM to 250mM, the concentration of KCl is 150mM to 500mM, and the Tween is Tween 20, the concentration of which is 0.05% to 0.2% (w / v).

[0051] The R2 reagent is a phosphate buffer solution containing albumin blue and sodium metavanadate, wherein the concentration of the phosphate buffer solution is 50mM to 500mM, the mass fraction of albumin blue is 0.1% to 4%, and the concentration of sodium metavanadate is 1mM to 10mM.

[0052] In the detection of cholinesterase:

[0053] Reagent R1 is a pyrophosphate buffer solution containing 6-cyanoferrate, wherein the concentration of the pyrophosphate buffer solution is 50 mM to 250 mM and the concentration of the 6-cyanoferrate is 150 mM to 500 mM.

[0054] The R2 reagent is a pyrophosphate buffer solution containing albumin blue and butyrylthiocholine, wherein the concentration of the pyrophosphate buffer solution is 50mM to 500mM, the mass fraction of the albumin blue is 0.1% to 4%, and the concentration of sodium metavanadate is 5mM to 25mM.

[0055] The present invention also provides a method for detecting abnormal loading of an albumin-containing sample, comprising:

[0056] Mixing the R1 reagent and the R2 reagent in the detection reagent of the present invention, and detecting the fluorescence intensity F0;

[0057] Add the sample containing albumin, incubate for 3 min to 5.5 min, and then detect the fluorescence intensity F2;

[0058] If the F2 / F0 ratio measured under standard sample addition conditions is x, the F2 / F0 ratio measured under test conditions is x×(80% to 120%), which is considered normal. If the F2 / F0 ratio measured under test conditions is less than 80% x or greater than 120% x, which is considered abnormal.

[0059] In the present invention, the standard addition conditions refer to the conditions for ensuring that the addition amount is correct. The x value is the average value measured after multiple standard additions.

[0060] The present invention also provides a method for detecting an albumin-containing sample, comprising:

[0061] Mixing the R1 reagent and the R2 reagent in the detection reagent of the present invention, and detecting the fluorescence intensity F0 and the absorbance A0;

[0062] Add the sample containing albumin and incubate for 5 to 30 seconds before measuring the absorbance A1;

[0063] Continue incubation for 3 to 5 minutes, and detect the fluorescence intensity F2 and absorbance A2;

[0064] The F2 / F0 ratio measured under standard sample addition conditions is x:

[0065] Under the test conditions, the F2 / F0 ratio measured is x×(80% to 120%), which is considered normal. The concentration of the target to be tested is calculated based on the absorbance change;

[0066] If the F2 / F0 ratio measured under the test conditions is less than 80%x or greater than 120%x, it is considered abnormal and requires retesting.

[0067] In the present invention, the albumin-containing sample is whole blood, plasma, serum or urine; the targets to be detected are total bilirubin, C-reactive protein, cholinesterase, β2-microglobulin, cystatin C, and serum amyloid A.

[0068] In the present invention, human serum samples are taken as an example, and the amount of sample added in the test is 3 to 20 μL.

[0069] The standard sample volume is 3 μL. A measured F2 / F0 ratio of 4.16 to 6.24 is considered normal sample addition. A measured F2 / F0 ratio of <4.16 or a measured F2 / F0 ratio of >6.24 is considered abnormal sample addition.

[0070] The standard sample volume is 10 μL. A measured F2 / F0 ratio of 14.11 to 21.05 is considered normal sample addition. A measured F2 / F0 ratio of <14.11 or a measured F2 / F0 ratio of >21.05 is considered abnormal sample addition.

[0071] The standard sample volume is 5 μL. A measured F2 / F0 ratio of 7.08 to 10.55 is considered normal sample addition. A measured F2 / F0 ratio of <7.08 or a measured F2 / F0 ratio of >10.55 is considered abnormal sample addition.

[0072] Albumin is used as a marker in the preparation of a reagent for detecting abnormal sample amounts. Human albumin in the sample is detected based on the fluorescence reaction between albumin and albumin blue. A reasonable acceptance range for emitted fluorescence is set for different sample amounts. If the acceptance range is exceeded, the sample amount is considered abnormal during the test, indicating that the test result is invalid and requires retesting or rechecking the albumin concentration. Experiments have shown that the method provided by this invention is accurate and reliable, effectively reducing the risk of false positives during detection. DETAILED DESCRIPTION

[0073] The present invention provides reagents and methods for detecting whether the amount of added sample is abnormal. Those skilled in the art can refer to the content of this article and appropriately improve the process parameters to achieve it. It is particularly important to point out that all similar replacements and modifications are obvious to those skilled in the art and are considered to be included in the present invention. The methods and applications of the present invention have been described through preferred embodiments, and relevant personnel can obviously modify or appropriately change and combine the methods and applications herein without departing from the content, spirit and scope of the present invention to implement and apply the technology of the present invention.

[0074] The test materials used in the present invention are all common commercial products and can be purchased in the market.

[0075] The present invention will be further described below in conjunction with the embodiments:

[0076] Example 1

[0077] ① Target item to be tested: C-reactive protein;

[0078] ② Experimental materials: The samples to be tested are fresh human serum samples;

[0079] ③Reagent 1: 4-Hydroxyethylpiperazineethanesulfonic acid buffer 50mM~500mM; NaCl 150mM~500mM;

[0080] ④Reagent 2: 4-hydroxyethylpiperazineethanesulfonic acid buffer 50mM~500mM; albumin blue 0.05%~2%; C-reactive protein antibody coated latex 0.1%~0.5%;

[0081] ⑤Albumin concentration determination reagent threshold: 3.94~6.56;

[0082] ⑥ Testing Process: The reagent / sample needle transfers 150μl of Reagent 1 into the reaction chamber. Then, the reagent / sample needle transfers 150μl of Reagent 2 into the same reaction chamber and mixes thoroughly. The fluorescent light source is activated to read the fluorescence intensity F0, while the UV light source is activated to read A0. The reagent / sample needle transfers 3μl of the serum sample to be tested into the aforementioned reaction cup / chamber and mixes thoroughly. Incubate for 5-30 seconds, and the UV light source is activated to read A1. Incubate for another 3-5 minutes, and the fluorescent light source is activated to read the fluorescence intensity F2, while the UV light source is activated to read A2. The fluorescence intensity of the sample to be tested is calculated using the formula F2 / F0. The measured fluorescence intensity is compared to the threshold value of the albumin concentration determination reagent. An intensity above 4.55 indicates an abnormally high sample size, while an intensity below 2.45 indicates an abnormally low sample size. The C-reactive protein signal is calculated using the formula ΔAB = A2 - A1, and substituted into the built-in calibration curve to obtain the C-reactive protein concentration of the sample.

[0083] Example 1 measurement results:

[0084]

[0085] The accuracy of the test was also verified:

[0086]

[0087] Note: The reference value of the reference product is the value assigned by the standard method (the method of albumin blue is not introduced in this protocol).

[0088] The results show that this method can accurately determine whether the sample addition amount is too high or too low during the C-reactive protein detection process, and at the same time, it does not interfere with the accuracy of the test results.

[0089] Example 2

[0090] ① Target item to be tested: total bilirubin;

[0091] ② Experimental materials: The samples to be tested are fresh human serum samples;

[0092] ③Reagent 1: Morpholineethanesulfonic acid buffer 50mM~250mM; KCl 150mM~500mM; Tween 20 0.05%~0.2% (w / v);

[0093] ④Reagent 2: phosphate buffer 50mM~500mM; albumin blue 0.1%~4%; sodium metavanadate 1mM~10mM;

[0094] ⑤Albumin concentration determination reagent threshold: 13.22~21.93

[0095] ⑥ Testing Procedure: The reagent / sample needle transfers 240 μl of Reagent 1 into the reaction chamber. Then, the reagent / sample needle transfers 60 μl of Reagent 2 into the same reaction chamber and mixes thoroughly. The fluorescent light source is activated to read the fluorescence intensity Fo, while the UV light source is activated to read A0. The reagent / sample needle transfers 10 μl of the serum sample to be tested into the aforementioned reaction cup / chamber and mixes thoroughly. Incubate for 5-30 seconds, and the UV light source is activated to read A1. Continue incubation for 3-5 minutes, then activate the fluorescent light source to read the fluorescence intensity F2, while the UV light source is activated to read A2. Calculate the fluorescence intensity of the sample to be tested using the formula F2 / F0. Compare the measured fluorescence intensity to the threshold value of the albumin concentration determination reagent. An intensity above 4.55 indicates an abnormally high sample size, while an intensity below 2.45 indicates an abnormally low sample size. Calculate the total bilirubin detection signal using the formula ΔAC = A2 - A0. Substitute this into the built-in calibration curve to obtain the total bilirubin concentration of the sample.

[0096] Example 2 measurement results:

[0097]

[0098] The accuracy of the test was also verified:

[0099]

[0100] Note: The reference value of the reference product is the value assigned by the standard method (the method of albumin blue is not introduced in this protocol).

[0101] The results showed that this method can accurately determine whether the sample addition amount is too high or too low during the total bilirubin detection process, and at the same time, it does not interfere with the accuracy of the test results.

[0102] Example 3

[0103] ①Target item to be tested: cholinesterase;

[0104] ② Experimental materials: The samples to be tested are fresh human serum samples;

[0105] ③Reagent 1: pyrophosphate buffer 50mM~250mM; 6-cyanoferrate 0.5mM~5mM;

[0106] ④Reagent 2: pyrophosphate buffer 50mM~500mM; albumin blue 0.1%~4%; butyrylthiocholine 5mM~25mM;

[0107] ⑤Albumin concentration determination reagent threshold: 6.21~11.40;

[0108] ⑥ Testing Procedure: The reagent / sample needle transfers 240 μl of Reagent 1 into the reaction chamber. Then, the reagent / sample needle transfers 60 μl of Reagent 2 into the same reaction chamber and mixes thoroughly. The fluorescent light source is activated to read the fluorescence intensity Fo, while the UV light source is activated to read A0. The reagent / sample needle transfers 5 μl of the serum sample to be tested into the aforementioned reaction cup / chamber and mixes thoroughly. Incubate for 5-30 seconds, and the UV light source is activated to read A1. Incubate for another 3-5 minutes, and the fluorescent light source is activated to read the fluorescence intensity F2, while the UV light source is activated to read A2. The fluorescence intensity of the sample to be tested is calculated using the formula F2 / F0. The measured fluorescence intensity is compared to the threshold value of the albumin concentration determination reagent. An intensity above 11.4 indicates an abnormally high sample size, while an intensity below 6.2 indicates an abnormally low sample size. The cholinesterase detection signal is calculated using the formula ΔA / min = (A2 - A1) / T. This signal is substituted into the built-in calibration curve to determine the cholinesterase content of the sample.

[0109] Example 3 measurement results:

[0110]

[0111] The accuracy of the test was also verified:

[0112]

[0113] Note: The reference value of the reference product is the value assigned by the standard method (the method of albumin blue is not introduced in this protocol).

[0114] The results showed that this method can accurately determine whether the sample addition amount is too high or too low during the cholinesterase detection process, and at the same time, it does not interfere with the accuracy of the test results.

[0115] As can be seen from the above results, the method of the present invention has demonstrated the expected effects in a variety of different types of projects. It can accurately identify when the sample amount is obviously abnormally high or low, effectively reducing the risk of false positives during detection.

[0116] The above are only preferred embodiments of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. Use albumin as a marker in the preparation of reagents for detecting whether the amount of added sample is abnormal.

2. The use according to claim 1, characterized in that The sample is whole blood, plasma, serum or urine, and whether the added sample is abnormal refers to whether the amount of the added sample is higher or lower than the target sample amount in the biochemical test or immunoassay.

3. A method for detecting whether the amount of added sample is abnormal, characterized in that: include: After mixing the detection reagent containing the dye, the fluorescence intensity F0 is detected; Add the sample containing albumin, incubate, and detect the fluorescence intensity F2; The dye is a substance that can react with albumin to produce a staining reaction; If the F2 / F0 ratio is within the preset value range, it is judged that the added sample size is normal. If the F2 / F0 ratio is not within the preset value range, it is judged that the added sample size is abnormal.

4. A method for detecting albumin-containing samples, characterized in that: include: After mixing the detection reagent containing the dye, the fluorescence intensity F0 and absorbance A0 are detected; Add a sample containing albumin, incubate, and detect absorbance A1. After further incubation, detect fluorescence intensity F2 and absorbance A2. The dye is a substance that can react with albumin to produce a staining reaction; If the F2 / F0 ratio is within the preset range, the added sample amount is judged to be normal, and the concentration of the target to be tested is calculated based on the absorbance change; If the F2 / F0 ratio is not within the preset value range, it is judged that the added sample amount is abnormal and retesting is required.

5. The method according to claim 3 or 4, characterized in that The preset value range is (x×downward floating index)~(x×upward floating index); The x is the F2 / F0 ratio measured under standard sample addition conditions; The downward floating index is 80% to 99%, and the upward floating index is 101% to 120%.

6. The method according to claim 3 or 4, characterized in that The dye is albumin blue.

7. The method according to any one of claims 3 or 4, characterized in that The detection reagents include R1 reagent and R2 reagent; The R1 reagent includes buffer A; The R2 reagent includes a target detection reagent, buffer B and albumin blue; The mass fraction of albumin blue in the R2 reagent is 0.05% to 4%.

8. The method according to claim 7, characterized in that The buffer A and buffer B are independently selected from 4-hydroxyethylpiperazineethanesulfonic acid buffer, morpholineethanesulfonic acid buffer, phosphate buffer, pyrophosphate buffer, 3-(N-morpholino)propanesulfonic acid buffer, 1,4-piperazinediethanesulfonic acid buffer; The target detection reagent is a particle coated with an antibody against the target or a substance whose absorbance changes after reacting with the target.

9. The method according to claim 7, characterized in that The R1 reagent further comprises at least one of potassium salt, sodium salt, cyano compound or surfactant.

10. The method according to claim 4, characterized in that The albumin-containing sample is whole blood, plasma, serum or urine; the target to be detected is total bilirubin, C-reactive protein, cholinesterase, β2-microglobulin, cystatin C or serum amyloid protein A.

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