CN117169149B - Method for improving detection accuracy of HIL sample and HIL sample detection method - Google Patents
Method for improving detection accuracy of HIL sample and HIL sample detection method Download PDFInfo
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- 238000001514 detection method Methods 0.000 title claims abstract description 92
- 238000000034 method Methods 0.000 title claims abstract description 43
- 238000002835 absorbance Methods 0.000 claims abstract description 212
- 239000011159 matrix material Substances 0.000 claims abstract description 105
- BPYKTIZUTYGOLE-IFADSCNNSA-N Bilirubin Chemical compound N1C(=O)C(C)=C(C=C)\C1=C\C1=C(C)C(CCC(O)=O)=C(CC2=C(C(C)=C(\C=C/3C(=C(C=C)C(=O)N\3)C)N2)CCC(O)=O)N1 BPYKTIZUTYGOLE-IFADSCNNSA-N 0.000 claims abstract description 84
- 210000001268 chyle Anatomy 0.000 claims abstract description 57
- 230000015271 coagulation Effects 0.000 claims abstract description 38
- 238000005345 coagulation Methods 0.000 claims abstract description 38
- 230000023555 blood coagulation Effects 0.000 claims abstract description 20
- 239000000243 solution Substances 0.000 claims description 107
- 238000012360 testing method Methods 0.000 claims description 79
- 206010018910 Haemolysis Diseases 0.000 claims description 78
- 230000008588 hemolysis Effects 0.000 claims description 78
- 239000012153 distilled water Substances 0.000 claims description 57
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 57
- 206010023126 Jaundice Diseases 0.000 claims description 48
- 210000004369 blood Anatomy 0.000 claims description 36
- 239000008280 blood Substances 0.000 claims description 36
- 150000002632 lipids Chemical class 0.000 claims description 32
- 239000012490 blank solution Substances 0.000 claims description 22
- 238000006243 chemical reaction Methods 0.000 claims description 17
- 239000011550 stock solution Substances 0.000 claims description 17
- 230000001322 lipid blood level Effects 0.000 claims description 16
- 230000008569 process Effects 0.000 claims description 11
- 108010004103 Chylomicrons Proteins 0.000 claims description 4
- 102000001554 Hemoglobins Human genes 0.000 abstract description 26
- 108010054147 Hemoglobins Proteins 0.000 abstract description 26
- 238000002360 preparation method Methods 0.000 abstract description 26
- 238000004458 analytical method Methods 0.000 abstract description 10
- 230000005856 abnormality Effects 0.000 abstract description 5
- 238000005286 illumination Methods 0.000 abstract 1
- 239000000126 substance Substances 0.000 description 42
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- 230000009286 beneficial effect Effects 0.000 description 6
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- 238000005070 sampling Methods 0.000 description 6
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Abstract
The invention relates to the technical field of biology, in particular to a method for improving detection accuracy of an HIL sample and an HIL sample detection method. The invention discloses a HIL sample detection method, which is characterized in that the HIL interferent grade in a sample is calculated by acquiring the absorbance of the sample containing different concentrations of chyle, hemoglobin and bilirubin interferents under the illumination conditions of 405nm,570nm and 660 nm. In order to improve the accuracy of HIL sample detection, the invention formulates a matrix for determining the level of the HIL interferent, uses a specific interferent solution preparation mode, and adopts an interferent absorbance decoupling method, thereby effectively improving the accuracy of HIL detection. Thereby meeting the requirements of clinical institutions for further blood coagulation detection and analysis. The HIL detection is fused with the system interface of the coagulation analyzer operation software, so that a clinical institution can rapidly and conveniently detect HIL abnormality of various coagulation projects.
Description
Technical Field
The invention relates to the technical field of biology, in particular to a method for improving detection accuracy of an HIL sample and an HIL sample detection method.
Background
The coagulation test generally comprises a coagulation method, an immunoturbidimetry method, a chromogenic substrate method and the like, and interference substances in a sample to be tested influence a detection result, so that it is very important to identify HIL interference substance components and grades thereof in blood. The HIL detection comprises the detection of lipidemia (Lipemia), the detection of hemolysis (Hemolysis) and the detection of jaundice (Icterus), the absorbance data is obtained through experiments by a coagulation analyzer, and the type and the grade of the interference-containing substances in the sample to be detected are finally identified by using an HIL algorithm.
The full-automatic coagulation analyzer is an important in-vitro diagnosis and inspection device commonly used in clinical laboratories, is one of important components of in-vitro diagnosis products, is mainly imported from abroad at present and has high acquisition cost, diagnostic reagents for experiments are bundled with consumable materials in a matched manner, the price is high, and the medical cost burden of clinical patients is heavy. The domestic co-manufacturers adopt imitation import low-end instruments more, do not explore and mine the overall requirements of clinical application on a blood coagulation detection system, and do not deeply study the detection system and the requirements, so monopoly of an analyzer at home and abroad cannot be broken, and the requirements of domestic clinic and patients cannot be met better.
Most of domestic coagulation analyzers on the market at present cannot support HIL project detection or have low HIL detection accuracy. The operation software system of the blood coagulation analyzer on the market does not have the HIL detection function. When detecting samples with abnormal HIL, the method also needs to rely on other detection instruments for calculation and analysis, and cannot meet the requirements of clinical institutions for rapid and convenient diagnosis. Or the HIL detection function provided by the blood coagulation analyzer operation software system, the accuracy of the detection result of the HIL interferent is low, and the blood coagulation function of the sample is not beneficial to further analysis and examination by clinical institutions. Many manufacturers of blood coagulation analyzers supporting HIL detection calculate the level of an HIL interferent according to the absorbance principle of HIL, but the treatment of an interferent solution and a basic sample is insufficient, so that the principle and theory of HIL detection in the blood coagulation analyzer cannot be well realized. Meanwhile, the coagulation analyzer manufacturers do not fully consider the condition that the basic sample is coupled with HIL interfering substances with different concentrations, so that the calculated HIL interfering substance level has larger error. Thereby compromising the further analysis and examination of the coagulation function of the sample by the clinical institution.
Disclosure of Invention
In view of this, the present invention provides a method for improving the detection accuracy of an HIL sample and an HIL sample detection method. The invention provides a HIL sample detection method. In order to improve the accuracy of HIL sample detection, the invention formulates a matrix for determining the level of the HIL interferent, uses a specific interferent solution preparation mode, and adopts an interferent absorbance decoupling method, thereby effectively improving the accuracy of HIL detection. Thereby meeting the requirements of clinical institutions for further blood coagulation detection and analysis.
In order to achieve the above object, the present invention provides the following technical solutions:
the invention provides a method for improving detection accuracy of an HIL sample, which comprises the following steps:
Step 1, detecting absorbance of an HIL interferent sample and a basic sample of a grade X based on a multi-wavelength light source to obtain an HIL interferent grade matrix;
Step 2, absorbance data of a sample to be detected is obtained based on a multi-wavelength light source, and absorbance decoupling is carried out according to the HIL interferent grade matrix in the step 1 to obtain a detection result of the sample to be detected;
The HIL interferent grade matrix comprises a lipidemia scaling matrix, a hemolysis scaling matrix and/or a jaundice scaling matrix;
The lipid blood scaling matrix comprises:
Wherein S4i, S5i and S6i represent the absorbance of the interferents, the reaction cup and the distilled water under each test wavelength of different lipid blood grades; z4i, Z5i, Z6i represent absorbance of chylomicron interferents at each of the test wavelengths for different lipid blood levels; i represents a lipid blood level selected from any integer between 0 and 10; for example, S40 is absorbance at 405nm of the interferent + cuvette + distilled water at a lipid blood level of 0;
the hemolysis scaling matrix comprises:
wherein S4j and S5j represent the absorbance of the interferents, the reaction cups and the distilled water under each test wavelength of different hemolysis grades; r4j and R5j represent the absorbance of haemoglobin pure interferents of different haemolysis grades at each test wavelength; j represents a hemolysis grade selected from any integer between 0 and 10; for example, S40 is the absorbance of interferents, reaction cup, distilled water at 405nm when the hemolysis grade is 0;
The jaundice scaling matrix comprises:
Wherein S4k represents the absorbance of the interferent, the reaction cup and the distilled water under each test wavelength; h4k represents bilirubin pure interferent absorbance at a test wavelength of 405 nm; k represents a hemolysis grade selected from any integer between 0 and 10; for example, S40 is absorbance at 405nm of interferents + reaction cup + distilled water for a jaundice grade of 0;
The HIL interferent sample of class X of step 1 comprises:
(I) A first interferent solution;
(II) a second interferent solution; or (b)
(III) a combined solution of the first interferent solution and the second interferent solution;
when X is any integer between 1 and 9, in the HIL interferent sample of class X, the volume ratio of the first interferent solution to the second interferent solution is X: (10-X);
when the X is 10, the HIL interferent sample of grade X is a first interferent solution;
When the X is 0, the HIL interferent sample of grade X is a second interferent solution;
The first interferent solution comprises an interferent stock solution and a basic sample, wherein the volume ratio of the interferent stock solution to the basic sample is 1:9, a step of performing the process;
the second interferent solution comprises an interferent blank solution and a basic sample, and the volume ratio of the interferent blank solution to the basic sample is 1:9, a step of performing the process;
the interferent stock solution comprises chyle with a concentration of 30000FTU, haemoglobin with a concentration of 5000mg/dl or bilirubin with a concentration of 250 mg/dl;
the interferent blank solution does not include concentration chyle, haemoglobin or bilirubin;
the base sample comprises distilled water.
In some embodiments of the invention, the X in the HIL interferent sample of class X comprises any integer between 0 and 10;
The class 0 HIL interferent sample comprises a second interferent solution;
the class 1 HIL interferent sample included 1 part first interferent solution and 9 parts second interferent solution;
the class 2 HIL interferent sample included 2 parts first interferent solution and 8 parts second interferent solution;
The class 3 HIL interferent sample included 3 parts first interferent solution and 7 parts second interferent solution;
The class 4 HIL interferent sample included 4 parts first interferent solution and 6 parts second interferent solution;
The class 5 HIL interferent sample comprises 5 parts first interferent solution and 5 parts second interferent solution;
The class 6 HIL interferent sample included 6 parts first interferent solution and 4 parts second interferent solution;
the class 7 HIL interferent sample included 7 parts first interferent solution and 3 parts second interferent solution;
the class 8 HIL interferent sample included 8 parts first interferent solution and 2 parts second interferent solution;
the class 9 HIL interferent sample included 9 parts first interferent solution and 1 part second interferent solution;
the class 10 HIL interferent sample comprises a first interferent solution;
The first interferent solution comprises 1 part of interferent stock solution and 9 parts of basic sample;
the second interferent solution comprises 1 part of interferent blank solution and 9 parts of basic sample;
the base sample comprises distilled water.
In some embodiments of the invention, the class X interferent solution configuration method is as follows:
In some embodiments of the invention, the X in the HIL interferent sample of class X comprises any integer between 0 and 10.
In some embodiments of the invention, the absorbance of chyle in the lipid blood scaling matrix comprises:
In some embodiments of the invention, the absorbance of hemoglobin in the hemolysis scaling matrix comprises:
in some embodiments of the invention, the absorbance of bilirubin in the jaundice scaling matrix comprises:
in some embodiments of the invention, the interferent stock solution and interferent blank solution are from an interferent assay a kit; the interference check a kit was purchased from hson america biotechnology (tin-free) limited.
In some embodiments of the invention, the multi-wavelength light source comprises one or more of a 405nm, 570nm, or 660nm wavelength light source.
In some embodiments of the invention, the absorbance decoupling comprises the steps of:
Step A, analyzing absorbance data of the sample to be tested obtained in the step 2 according to a first formula, wherein the first formula is as follows:
S6＝X6×Z6
Wherein S 6 is absorbance of the sample to be tested at a test wavelength of 660nm, X 6 is absorbance of the basic sample at a test wavelength of 660nm, and Z 6 is absorbance of lipidemia at a test wavelength of 660 nm;
Z 6 is calculated according to a first formula, and is compared with absorbance in the lipidemia scaling matrix to obtain the lipidemia grade of the sample to be detected;
And B, analyzing the absorbance data of the sample to be tested obtained in the step 2 according to a second formula, wherein the second formula is as follows:
S5＝X5×Z5×R5
wherein S 5 is the absorbance of the sample to be tested at a test wavelength of 570nm, X 5 is the absorbance of the basic sample at a test wavelength of 570nm, and Z 5,R5 is the absorbance of the lipidemia and the hemolysis at the test wavelength of 570nm respectively;
R 5 is calculated according to a second formula, and is compared with absorbance in the hemolysis scaling matrix to obtain the hemolysis grade of the sample to be detected;
and C, analyzing the absorbance data of the sample to be tested obtained in the step 2 according to a third formula, wherein the third formula is as follows:
S4＝X4×Z4×R4×H4
Wherein S 4 is absorbance of the sample to be tested at a test wavelength of 405nm, X 4 is absorbance of the basic sample at a test wavelength of 405nm, and Z 4,R4,H4 is absorbance of lipidemia, hemolysis and jaundice at a test wavelength of 405nm respectively;
And R 4 is calculated according to a third formula, and is compared with absorbance in the jaundice scaling matrix to obtain the jaundice grade of the sample to be detected.
In some embodiments of the invention, the absorbance decoupling specifically comprises the steps of:
step I, dividing the absorbance S 6 of the sample to be detected at 660nm by the absorbance X 6 of the basic sample, and obtaining the corresponding concentration level of the chyle interference substance from a lipid blood calibration matrix of the chyle to 660nm as the lipid blood level of the sample to be detected;
Step II, obtaining absorbance Z 5 of the lipid blood grade in the step I from a lipid blood calibration matrix of the chyle to 570 nm; dividing the absorbance S 5 of the sample to be detected at 570nm by the absorbance Z 5 of chyle and the absorbance X 6 of the basic sample to obtain the absorbance R 5 of hemoglobin at 570 nm; obtaining a corresponding concentration grade of the hemoglobin interferents from a hemolysis calibration matrix of the hemoglobin to 570nm as a hemolysis grade of the sample to be detected;
Step III, obtaining absorbance R 4 of the hemolysis grade in the step II from a hemolysis calibration matrix of the hemoglobin to 405 nm; obtaining absorbance Z 4 of the lipid blood grade in the step I from a lipid blood scaling matrix of chyle to 405 nm; and dividing the absorbance S 4 of the sample to be detected at 405nm by the absorbance Z 4、R4、X4 of chyle, hemoglobin and the basic sample to obtain absorbance H 4 of bilirubin at 405nm, and obtaining a corresponding bilirubin interferent concentration grade from a bilirubin-405 nm jaundice calibration matrix as the jaundice grade of the sample to be detected.
The invention provides a HIL sample detection method, which comprises the following steps:
Step 1, detecting absorbance of an HIL interferent sample and a basic sample of a grade X based on a multi-wavelength light source to obtain an HIL interferent grade matrix;
Step 2, absorbance data of a sample to be detected is obtained based on a multi-wavelength light source, and absorbance decoupling is carried out according to the HIL interferent grade matrix in the step 1 to obtain a detection result of the sample to be detected;
The HIL interferent grade matrix comprises a lipidemia scaling matrix, a hemolysis scaling matrix and/or a jaundice scaling matrix;
The lipid blood scaling matrix comprises:
Wherein S4i, S5i and S6i represent the absorbance of the interferents, the reaction cup and the distilled water under each test wavelength of different lipid blood grades; z4i, Z5i, Z6i represent absorbance of chylomicron interferents at each of the test wavelengths for different lipid blood levels; i represents a lipid blood level selected from any integer between 0 and 10; for example, S40 is absorbance at 405nm of the interferent + cuvette + distilled water at a lipid blood level of 0;
the hemolysis scaling matrix comprises:
wherein S4j and S5j represent the absorbance of the interferents, the reaction cups and the distilled water under each test wavelength of different hemolysis grades; r4j and R5j represent the absorbance of haemoglobin pure interferents of different haemolysis grades at each test wavelength; j represents a hemolysis grade selected from any integer between 0 and 10; for example, S40 is the absorbance of interferents, reaction cup, distilled water at 405nm when the hemolysis grade is 0;
The jaundice scaling matrix comprises:
Wherein S4k represents the absorbance of the interferent, the reaction cup and the distilled water under each test wavelength; h4k represents bilirubin pure interferent absorbance at a test wavelength of 405 nm; k represents a hemolysis grade selected from any integer between 0 and 10; for example, S40 is absorbance at 405nm of interferents + reaction cup + distilled water for a jaundice grade of 0;
The HIL interferent sample of class X of step 1 comprises:
(I) A first interferent solution;
(II) a second interferent solution; or (b)
(III) a combined solution of the first interferent solution and the second interferent solution;
when X is any integer between 1 and 9, in the HIL interferent sample of class X, the volume ratio of the first interferent solution to the second interferent solution is X: (10-X);
when the X is 10, the HIL interferent sample of grade X is a first interferent solution;
When the X is 0, the HIL interferent sample of grade X is a second interferent solution;
The first interferent solution comprises an interferent stock solution and a basic sample, wherein the volume ratio of the interferent stock solution to the basic sample is 1:9, a step of performing the process;
the second interferent solution comprises an interferent blank solution and a basic sample, and the volume ratio of the interferent blank solution to the basic sample is 1:9, a step of performing the process;
the interferent stock solution comprises chyle with a concentration of 30000FTU, haemoglobin with a concentration of 5000mg/dl or bilirubin with a concentration of 250 mg/dl;
the interferent blank solution does not include concentration chyle, haemoglobin or bilirubin;
the base sample comprises distilled water.
In some embodiments of the invention, the X in the HIL interferent sample of class X comprises any integer between 0 and 10;
The class 0 HIL interferent sample comprises a second interferent solution;
the class 1 HIL interferent sample included 1 part first interferent solution and 9 parts second interferent solution;
the class 2 HIL interferent sample included 2 parts first interferent solution and 8 parts second interferent solution;
The class 3 HIL interferent sample included 3 parts first interferent solution and 7 parts second interferent solution;
The class 4 HIL interferent sample included 4 parts first interferent solution and 6 parts second interferent solution;
The class 5 HIL interferent sample comprises 5 parts first interferent solution and 5 parts second interferent solution;
The class 6 HIL interferent sample included 6 parts first interferent solution and 4 parts second interferent solution;
the class 7 HIL interferent sample included 7 parts first interferent solution and 3 parts second interferent solution;
the class 8 HIL interferent sample included 8 parts first interferent solution and 2 parts second interferent solution;
the class 9 HIL interferent sample included 9 parts first interferent solution and 1 part second interferent solution;
the class 10 HIL interferent sample comprises a first interferent solution;
The first interferent solution comprises 1 part of interferent stock solution and 9 parts of basic sample;
the second interferent solution comprises 1 part of interferent blank solution and 9 parts of basic sample;
the base sample comprises distilled water.
In some embodiments of the invention, the class X interferent solution configuration method is as follows:
In some embodiments of the invention, the X in the HIL interferent sample of class X comprises any integer between 0 and 10.
In some embodiments of the invention, the absorbance of chyle in the lipid blood scaling matrix comprises:
In some embodiments of the invention, the absorbance of hemoglobin in the hemolysis scaling matrix comprises:
in some embodiments of the invention, the absorbance of bilirubin in the jaundice scaling matrix comprises:
in some embodiments of the invention, the interferent stock solution and interferent blank solution are from an interferent assay a kit; the interference check a kit was purchased from hson america biotechnology (tin-free) limited.
In some embodiments of the invention, the multi-wavelength light source comprises one or more of a 405nm, 570nm, or 660nm wavelength light source.
In some embodiments of the invention, the absorbance decoupling comprises the steps of:
Step A, analyzing absorbance data of the sample to be tested obtained in the step 2 according to a first formula, wherein the first formula is as follows:
S6＝X6×Z6
Wherein S 6 is absorbance of the sample to be tested at a test wavelength of 660nm, X 6 is absorbance of the basic sample at a test wavelength of 660nm, and Z 6 is absorbance of lipidemia at a test wavelength of 660 nm;
Z 6 is calculated according to a first formula, and is compared with absorbance in the lipidemia scaling matrix to obtain the lipidemia grade of the sample to be detected;
And B, analyzing the absorbance data of the sample to be tested obtained in the step 2 according to a second formula, wherein the second formula is as follows:
S5＝X5×Z5×R5
wherein S 5 is the absorbance of the sample to be tested at a test wavelength of 570nm, X 5 is the absorbance of the basic sample at a test wavelength of 570nm, and Z 5,R5 is the absorbance of the lipidemia and the hemolysis at the test wavelength of 570nm respectively;
R 5 is calculated according to a second formula, and is compared with absorbance in the hemolysis scaling matrix to obtain the hemolysis grade of the sample to be detected;
and C, analyzing the absorbance data of the sample to be tested obtained in the step 2 according to a third formula, wherein the third formula is as follows:
S4＝X4×Z4×R4×H4
Wherein S 4 is absorbance of the sample to be tested at a test wavelength of 405nm, X 4 is absorbance of the basic sample at a test wavelength of 405nm, and Z 4,R4,H4 is absorbance of lipidemia, hemolysis and jaundice at a test wavelength of 405nm respectively;
And R 4 is calculated according to a third formula, and is compared with absorbance in the jaundice scaling matrix to obtain the jaundice grade of the sample to be detected.
In some embodiments of the invention, the absorbance decoupling specifically comprises the steps of:
step I, dividing the absorbance S 6 of the sample to be detected at 660nm by the absorbance X 6 of the basic sample, and obtaining the corresponding concentration level of the chyle interference substance from a lipid blood calibration matrix of the chyle to 660nm as the lipid blood level of the sample to be detected;
Step II, obtaining absorbance Z 5 of the lipid blood grade in the step I from a lipid blood calibration matrix of the chyle to 570 nm; dividing the absorbance S 5 of the sample to be detected at 570nm by the absorbance Z 5 of chyle and the absorbance X 6 of the basic sample to obtain the absorbance R 5 of hemoglobin at 570 nm; obtaining a corresponding concentration grade of the hemoglobin interferents from a hemolysis calibration matrix of the hemoglobin to 570nm as a hemolysis grade of the sample to be detected;
Step III, obtaining absorbance R 4 of the hemolysis grade in the step II from a hemolysis calibration matrix of the hemoglobin to 405 nm; obtaining absorbance Z 4 of the lipid blood grade in the step I from a lipid blood scaling matrix of chyle to 405 nm; and dividing the absorbance S 4 of the sample to be detected at 405nm by the absorbance Z 4、R4、X4 of chyle, hemoglobin and the basic sample to obtain absorbance H 4 of bilirubin at 405nm, and obtaining a corresponding bilirubin interferent concentration grade from a bilirubin-405 nm jaundice calibration matrix as the jaundice grade of the sample to be detected.
The invention also provides a coagulation analyzer operation system, which comprises an interference object detection setting interface; the coagulation analyzer operating system, when executed by a processor, is configured to implement the HIL sample detection method.
The invention also provides a coagulation analyzer, which comprises the coagulation analyzer operation system.
The beneficial effects obtained by the invention include but are not limited to:
According to the invention, through reasonably designing the HIL interferent grade matrix and configuring the experimental sample and decoupling the absorbance of the HIL interferent, the accuracy of detection of the HIL sample is improved. The method is beneficial to the clinical detection mechanism to carry out deep analysis and research on samples with abnormal HIL detection;
The blood coagulation analyzer operating system software of the invention adds the HIL detection setting interface, so that each blood coagulation project can carry out the abnormal detection of the HIL interferent grade, and the abnormal grade threshold of the HIL interferent can be set. The HIL abnormality detection can be conveniently and effectively carried out on various coagulation projects by a clinical institution.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below.
Fig. 1 shows a coagulation item HIL examination setup interface.
Detailed Description
The invention discloses a method for improving the detection accuracy of an HIL sample and the detection method of the HIL sample, and a person skilled in the art can refer to the content of the text and properly improve the implementation of process parameters. It is expressly noted that all such similar substitutions and modifications will be apparent to those skilled in the art, and are deemed to be included in the present invention. While the methods and applications of this invention have been described in terms of preferred embodiments, it will be apparent to those skilled in the relevant art that variations and modifications can be made in the methods and applications described herein, and in the practice and application of the techniques of this invention, without departing from the spirit or scope of the invention.
The UR6000 full-automatic coagulation analyzer (hereinafter referred to as analyzer) adopts an optical method principle, and acquires sample data and processes the data through a photoelectric sensing principle for detection items based on a coagulation method, a chromogenic background method and an immunoturbidimetry to obtain detection results of the detection items. The device mainly comprises a sample adding system, a testing system, an operation software system, an auxiliary system and the like. The sample adding system can realize sample adding of samples and reagents, the testing system realizes testing and data acquisition of the samples, the operation software system and the auxiliary system realize a man-machine interaction operation interface and comprise functions of samples, reagents, calibration, quality control, reporting and system setting, and analysis of blood coagulation detection projects and output of test results are realized.
In recent years, the domestic coagulation detection industry rapidly develops, and domestic coagulation analyzers are also gradually put into wide use. The blood coagulation analyzer has higher and higher integration degree, and gradually fuses more blood coagulation detection projects and detection algorithms. Aiming at the problem of low HIL detection accuracy of the coagulation analyzer, the invention provides an HIL sample detection method which is adaptive to a UR6000 full-automatic coagulation analyzer, designs a matrix for determining the level of an HIL interferent, and determines specific absorbance information of the HIL interferent level matrix by using a regression mode. And (3) reasonably configuring and mixing the basic sample and the HIL interference substance solution, and decoupling the absorbance of the basic sample and the HIL interference substances with different concentrations, so that the detection of the HIL sample has higher accuracy. In addition to human blood plasma, distilled water, D1 coagulation quality control level 1 was used as a base sample to be added to the HIL interferent solution for comparative experiments. The influence of HIL interferents on absorbance change is examined from various aspects, and the influence of insufficient human blood plasma and other impurities on experiments is eliminated. The invention fully considers the coupling condition of the sample and HIL interference substances with different concentrations, improves the accuracy of HIL detection, and is favorable for the clinical detection mechanism to deeply analyze and study the sample with abnormal HIL detection.
The detection principle of the invention is as follows:
When light reaches the detector from the transmitting end through the sample to be detected, only light intensity information of corresponding wavelength can be finally obtained; the intensity I finally obtained may be affected by factors such as the intensity of the incident light I 0, the cuvette B, the plasma X, the detector sensitivity L, the blood fat (chyle) Z, the haemolysis (haemoglobin) R, and the jaundice (bilirubin) H.
Note that:
(a) Square cup: the absence of lens focusing effects does not affect the received light intensity;
(b) The sensitivity of the detector to light with different wavelengths is different;
According to lambert's law, the output light intensity I and the influencing factor can establish the following relationship: i=i 0 ×b×x×l×z×r×h.
Constructing a basic model:
in the system, the plasma X and the interferent Z/R/H belong to a sample to be detected and cannot be eliminated in advance; other parameters can be eliminated in advance by the following method:
firstly, measuring the light intensity of the empty reaction cup: i B＝I0 XB X L;
And measuring the light intensity of the added sample: i=i 0 ×b×x×l×z×r×h;
It can be deduced that absorbance s=i/I B＝(I0×B×X×L×Z×R×H)/(I0 ×b×l) =x×z×r×h.
The above formula is the basic model to be measured.
Deducing:
the three wavelengths 405nm/570nm/660nm are affected by the interferents as follows:
a) 660 nm-absorption by lipidemia
B) 570 nm-absorption by blood fat/hemoglobin
C) 405 nm-absorption of both lipemia/hemoglobin/bilirubin
The absorption spectrum of the interfering substance is shown in fig. 1. Therefore, the following relationship can be established by using the light intensities collected by the three wavelengths respectively through the basic model:
At 660nm wavelength, the influence of jaundice H and hemolysis R on absorbance is negligible, so the absorbance is S 6＝X6×Z6;
at 570nm, the influence of jaundice H on absorbance is negligible, so the absorbance is S 5＝X5×Z5×R5;
At 405nm, the absorbance is affected by the lipidemia Z, hemolysis R and jaundice H, so the absorbance is S 4＝X4×Z4×R4×H4;
Based on the above conclusion, we can derive the following formula:
S6＝X6×Z6
S5＝X5×Z5×R5
S4＝X4×Z4×R4×H4
Wherein S 4,S5,S6 is absorbance of the sample containing the interfering substance at test wavelengths of 405nm, 570nm and 660nm, X represents absorbance of the basic sample, Z, R and H represent absorbance of lipidemia, hemolysis and jaundice respectively. From the above formula, it can be seen that the blood lipid Z depends on the absorbance of the blood plasma X, the hemolysis R depends on the blood plasma X and the blood lipid Z, and the jaundice H depends on the blood plasma X, the blood lipid Z and the hemolysis R; firstly, the lipidemia Z is solved, and the hemolysis R and the jaundice H can be obtained through recursion.
HIL sample identification:
1. The absorbance of a sample with known single interferent grade is detected by a multi-wavelength light source, and a calibration matrix of each interferent grade of HIL is obtained.
1.1 Lipid blood scaling matrix
1) S4, S5, S6 represent the absorbance (interferents+cuvettes+distilled water) at each test wavelength.
2) Z4, Z5, Z6 represent the pure interferent absorbance at each wavelength tested (interferent main component: chyle).
3) I represents a lipid blood level.
4) Sample preparation method
A. and (3) dissolving an interfering substance: according to the instruction, the dissolution of the interfering substance is performed.
B. Basic sample: distilled water (without interfering substance)
C. calibration matrix sample preparation method (reference: interference check A kit description)
Preparing a high-concentration sample of an interfering substance: (chyle: distilled water=1:9).
| Grade of interferents | 10 |
| Chyle (mu l) | 200 |
| Distilled water (mul) | 1800 |
| Total amount of high concentration sample of interferents (μl) | 2000 |
Preparing a low-concentration sample of an interfering substance: (chyle (blank liquid): distilled water=1:9).
| Grade of interferents | 0 |
| Chyle (blank liquid) (mul) | 200 |
| Distilled water (mul) | 1800 |
| Total amount of interferent low concentration sample (μl) | 2000 |
Experimental samples: the high-concentration sample and the low-concentration sample of the interfering substance are prepared into experimental samples with 11 concentration gradients of equal volume according to the following table, and note that the sampling volume in the preparation process must be accurate.
1.2 Hemolysis scaling matrix
1) S4, S5 represents the absorbance (interferent + cuvette + distilled water) at each test wavelength.
2) R4, R5 represent the pure interferent absorbance at each test wavelength (interferent main component: haemoglobin haemolysis).
3) J represents the hemolysis grade.
4) Sample preparation method
A. and (3) dissolving an interfering substance: according to the instruction, the dissolution of the interfering substance is performed.
B. Basic sample: distilled water (without interfering substance)
C. calibration matrix sample preparation method (reference: interference check A kit description)
Preparing a high-concentration sample of an interfering substance: (formulation ratio: haemoglobin: distilled water=1:9).
| Grade of interferents | 10 |
| Haemoglobin haemolyticus | 200 |
| Distilled water (mul) | 1800 |
| Total amount of high concentration sample of interferents (μl) | 2000 |
Low concentration of interferents samples were prepared (preparation ratio: haemoglobin (blank solution): distilled water=1:9).
| Grade of interferents | 0 |
| Haemoglobin (blank liquid) | 200 |
| Distilled water (mul) | 1800 |
| Total amount of interferent low concentration sample (μl) | 2000 |
Experimental samples: the high-concentration sample and the low-concentration sample of the interfering substance are prepared into experimental samples with 11 concentration gradients of equal volume according to the following table, and note that the sampling volume in the preparation process must be accurate.
1.3 Jaundice scaling matrix
1) S4 represents the absorbance (interferent + cuvette + distilled water) at each test wavelength.
2) H4 represents the absorbance of pure interferents at the 405nm test wavelength (interferents main component: bilirubin).
3) K represents the hemolysis grade.
4) Sample preparation method
A. and (3) dissolving an interfering substance: according to the instruction, the dissolution of the interfering substance is performed.
B. Basic sample: distilled water (without interfering substance)
C. calibration matrix sample preparation method (reference: interference check A kit description)
Preparing a high-concentration sample of an interfering substance: (formulation ratio: bilirubin: distilled water=1:9).
| Grade of interferents | 10 |
| Bilirubin | 200 |
| Distilled water (mul) | 1800 |
| Total amount of high concentration sample of interferents (μl) | 2000 |
Preparing a low-concentration sample of an interfering substance: (preparation ratio: bilirubin blank solution: distilled water=1:9).
| Grade of interferents | 0 |
| Bilirubin (blank liquid) | 200 |
| Distilled water (mul) | 1800 |
| Total amount of interferent low concentration sample (μl) | 2000 |
Experimental samples: the high-concentration sample and the low-concentration sample of the interfering substance are prepared into experimental samples with 11 concentration gradients of equal volume according to the following table, and note that the sampling volume in the preparation process must be accurate.
2. The absorbance of the sample to be tested is obtained at a multi-wavelength light source, and the data are as follows:
| 405nm | 570nm | 660nm |
| S4 | S5 | S6 |
3. and (5) decoupling the absorbance to obtain the grades of the interferents of the sample to be tested. The decoupling process is as follows:
1) Lipid blood level decoupling: and judging that the absorbance of the sample S6 to be detected in the section S6X-S6x+1 where the absorbance of the lipidemia scaling matrix is at 660nm, wherein the lipidemia grade of the sample to be detected is X because the S6 is closer to the S6X (in the near principle). The absorbance of the sample to be measured at 570nm wavelength of the pure lipidemia interference substance is set to be Z5 x, and the absorbance of the sample to be measured at 405nm wavelength of the pure lipidemia interference substance is set to be Z4 x.
2) Hemolysis grade decoupling: the effect of the lipid blood interferents was excluded, i.e. s=s5/Z5 x. S is closer to S5J (on the principle of approximation) in a section S5J-S5j+1 where the hemolysis calibration matrix is located at 570nm absorbance, and the lipid blood level of the sample to be detected is J. And setting the absorbance of the pure hemolysis interference object of the sample to be detected at 405nm wavelength as R4j.
3) Jaundice grade analysis: the influence of the lipidemia and hemolysis interferents, namely S=S4/Z4 x/R4j, is eliminated. S is closer to S4K (on the principle of approximation) in the interval S4K-S4K+1 where the absorbance of the jaundice calibration matrix at 405nm is located, and the lipid blood level of the sample to be detected is K.
4) In summary, the sample interferent grades to be tested are as follows:
| Chyle grade | Grade of hemolysis | Jaundice grade |
| X | J | K |
The invention also provides a coagulation analyzer operation system, which comprises an interference object detection setting interface; the coagulation analyzer operating system, when executed by the processor, is configured to implement the HIL sample detection function.
The invention also provides a coagulation analyzer comprising a coagulation analyzer operating system.
The beneficial effects obtained by the invention are as follows:
the invention calculates the absorbance values under HIL interferents of different grades through a large amount of experimental data. In blood coagulation HIL detection, determining the HIL interferent grade of the sample finally by comparing the HIL interferent absorbance information of the sample with an HIL interferent grade matrix;
According to the invention, through reasonably designing the HIL interferent grade matrix and configuring the experimental sample and decoupling the absorbance of the HIL interferent, the accuracy of detection of the HIL sample is improved. The method is beneficial to the clinical detection mechanism to carry out deep analysis and research on samples with abnormal HIL detection;
The blood coagulation analyzer operating system software of the invention adds the HIL detection setting interface, so that each blood coagulation project can carry out the abnormal detection of the HIL interferent grade, and the abnormal grade threshold of the HIL interferent can be set. The HIL abnormality detection can be conveniently and effectively carried out on various coagulation projects by a clinical institution.
The stock solution of the interferents and the blank solution of the interferents are from an interference check A kit (Hissen Meikang Biotechnology (tin-free) Co., ltd.).
If not specified, the method for improving the detection accuracy of the HIL sample and the raw materials and reagents used in the method for detecting the HIL sample provided by the invention can be purchased from the market.
The invention is further illustrated by the following examples:
example 1 preparation of three interferents at different gradients
1. Preparation of lipidemia calibration matrix sample
A. and (3) dissolving an interfering substance:
TABLE 1 dissolution of interferents (chyle)
B. Basic sample: distilled water (without interfering substance)
C. calibration matrix sample preparation method (reference: interference check A kit description)
High concentration sample of interferents (first interferent solution) formulation: (formulation ratio: chyle: distilled water=1:9).
TABLE 2 preparation of high concentration samples of interferents (chyle)
| Grade of interferents | 10 |
| Chyle (mu l) | 200 |
| Distilled water (mul) | 1800 |
| Total amount of high concentration sample of interferents (μl) | 2000 |
Low concentration sample of interferents (second interferent solution) formulation: (formulation ratio: chyle (blank solution): distilled water=1:9).
TABLE 3 Low concentration sample formulation of interferents (chyle)
| Grade of interferents | 0 |
| Chyle (blank liquid) (mul) | 200 |
| Distilled water (mul) | 1800 |
| Total amount of interferent low concentration sample (μl) | 2000 |
Experimental samples: the high-concentration sample and the low-concentration sample of the interfering substance are prepared into experimental samples with 11 concentration gradients of equal volume according to the following table, and note that the sampling volume in the preparation process must be accurate.
TABLE 4 preparation of solutions of different gradient interferents (chyle)
| Grade of interferents | 0 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 |
| Concentration of interferents (FTU) | 0 | 300 | 600 | 900 | 1200 | 1500 | 1800 | 2100 | 2400 | 2700 | 3000 |
| High concentration sample of interferent (μl) | 0 | 25 | 50 | 75 | 100 | 125 | 150 | 175 | 200 | 225 | 250 |
| Low concentration sample of interferents (μl) | 250 | 225 | 200 | 175 | 150 | 125 | 100 | 75 | 50 | 25 | 0 |
| Total amount of interferents (μl) | 250 | 250 | 250 | 250 | 250 | 250 | 250 | 250 | 250 | 250 | 250 |
2 Hemolysis scaling matrix sample preparation
A. and (3) dissolving an interfering substance: according to the instruction, the dissolution of the interfering substance is performed.
TABLE 5 dissolution of interferents (haemoglobin)
B. Basic sample: distilled water (without interfering substance)
C. calibration matrix sample preparation method (reference: interference check A kit description)
High concentration sample of interferents (first interferent solution) formulation: (formulation ratio: haemoglobin: distilled water=1:9).
TABLE 6 preparation of high concentration samples of interferents (haemoglobin)
| Grade of interferents | 10 |
| Haemoglobin haemolyticus | 200 |
| Distilled water (mul) | 1800 |
| Total amount of high concentration sample of interferents (μl) | 2000 |
Low concentration sample of interferents (second interferent solution) formulation: (preparation ratio: haemoglobin (blank solution): distilled water=1:9).
TABLE 7 Low concentration sample preparation of interferents (haemoglobin)
| Grade of interferents | 0 |
| Haemoglobin (blank liquid) | 200 |
| Distilled water (mul) | 1800 |
| Total amount of interferent low concentration sample (μl) | 2000 |
Experimental samples: the high-concentration sample and the low-concentration sample of the interfering substance are prepared into experimental samples with 11 concentration gradients of equal volume according to the following table, and note that the sampling volume in the preparation process must be accurate.
TABLE 8 preparation of solutions of different gradient interferents (haemoglobin)
3 Jaundice calibration matrix sample preparation
A. and (3) dissolving an interfering substance: according to the instruction, the dissolution of the interfering substance is performed.
TABLE 9 dissolution of interferents (bilirubin)
B. Basic sample: distilled water (without interfering substance)
C. calibration matrix sample preparation method (reference: interference check A kit description)
High concentration sample of interferents (first interferent solution) formulation: (formulation ratio: bilirubin: distilled water=1:9).
TABLE 10 preparation of high concentration samples of interferents (bilirubin)
| Grade of interferents | 10 |
| Bilirubin | 200 |
| Distilled water (mul) | 1800 |
| Total amount of high concentration sample of interferents (μl) | 2000 |
Low concentration sample of interferents (second interferent solution) formulation: (preparation ratio: bilirubin blank solution: distilled water=1:9).
TABLE 11 preparation of Low concentration samples of interferents (bilirubin)
Experimental samples: the high-concentration sample and the low-concentration sample of the interfering substance are prepared into experimental samples with 11 concentration gradients of equal volume according to the following table, and note that the sampling volume in the preparation process must be accurate.
TABLE 12 preparation of solutions of different gradient interferents (bilirubin)
Example 2 different classes of interferent absorbance matrices
The absorbance of three interferents with different gradients and different wavelengths in the embodiment 1 is obtained through a full-automatic coagulation analyzer, so that the absorbance matrixes of the interferents with different grades are obtained.
TABLE 13 lipid blood scaling matrix
TABLE 14 hemolysis scaling matrix
Table 15 jaundice calibration matrix
Example 3HIL detection
The absorbance (table 17) of the sample to be tested with different wavelengths is obtained by the full-automatic coagulation analyzer, and the preparation method of the sample to be tested is shown in table 16.
Table 16 sample preparation to be tested (method for preparing pure interferents of each grade is consistent with method for preparing calibration matrix)
TABLE 17 absorbance of samples to be measured at different wavelengths
The specific decoupling steps are as follows:
① From the lipid blood calibration matrix of example 2 chyle versus 660nm, the corresponding chyle interferent concentration level can be found by dividing the absorbance S 6 of the sample at 660nm by the absorbance X 6 of the base sample. If the absorbance is between the two grades, a closer chyle interferent grade I is selected.
② Absorbance Z 5 at chyle interferent grade I was obtained from the chyle versus 570nm lipid blood scale matrix.
③ From the absorbance S 5 of the sample at 570nm, absorbance Z 5 of chyle was subtracted to obtain absorbance R 5＝S5/X5/Z5 of hemoglobin at 570 nm. From the haemolysis calibration matrix of haemoglobin versus 570nm, the corresponding haemoglobin interferent concentration levels can be found. If the absorbance is between the two classes, a closer hemoglobin interferent class II is selected.
④ Absorbance R 4 at hemoglobin interferent grade II was obtained from a haemolysis calibration matrix of hemoglobin versus 405 nm. Absorbance Z 4 at chyle interferent grade I was obtained from the chyle versus 405nm lipid blood scale matrix.
⑤ The absorbance H 4＝S4/X4/Z4/R4 of bilirubin at 405nm was obtained by subtracting the absorbance Z 4、R4 of chyle and hemoglobin from the absorbance S 4 of the sample at 405 nm. From the bilirubin versus 405nm jaundice calibration matrix, the corresponding bilirubin interferent concentration levels can be found. If the absorbance is between the two levels, a closer bilirubin interferent level III is selected. The concentration levels I, II and III of the interferents are the results of HIL detection.
The invention compares the interference object grade automatically resolved by the full-automatic coagulation analyzer with the actual interference object grade, and the details are shown in table 18:
TABLE 18 ratio of interferent grade to actual interferent grade automatically resolved by fully automatic coagulation Analyzer
The interferent grade (actual) represents the actual value of the interferent grade, and can be accurately determined when the interferent solution is configured; interferent grade (analytical) interferent grade obtained by testing and calculating; the actual grade of most chyle, hemoglobin, bilirubin is the same as or relatively close to the grade of the interferent calculated by the HIL experiment. The interference solution with different interference levels is randomly extracted, and the regression verification experiment is repeated for a plurality of times, so that the obtained HIL interference error result is the same, and the HIL detection has higher accuracy.
From examples 2 and 3, the following can be concluded:
TABLE 19 conclusion
When the absorbance of the hemolyzed sample and the jaundice sample exceeds 20, the test system cannot identify the interference level.
Example 4HIL detection System
The HIL detection is fused into the detection of items such as seven items of blood coagulation, and the HIL detection setting can be carried out on blood coagulation examination items at a system setting interface of an operation software system, and the HIL detection is shown in fig. 1 in detail. Blood lipid tests, hemolysis tests, jaundice tests, test grades (range 0-10) of HIL tests and analysis result display method parameters can be set in the blood coagulation project. When the HIL interferent level of the coagulation item is greater than the system-set examination level (threshold), an abnormality is displayed in the coagulation report. The design is beneficial to the clinical institution to rapidly and conveniently detect HIL abnormality of various coagulation projects.
The inspection grade is calculated as follows:
The sample to be tested can be detected by a coagulation analyzer to obtain the absorbance of the sample to be tested and the basic sample under the test wavelengths of 405nm, 570nm and 660 nm:
① From the lipid blood calibration matrix of example 2 chyle to 660nm, the corresponding chyle interferent concentration level can be found by dividing the absorbance S6 of the sample at 660nm by the absorbance X6 of the base sample. If the absorbance is between the two grades, a closer chyle interferent grade I is selected.
② Absorbance Z5 at chyle interferent grade I was obtained from the chyle versus 570nm lipidemia scaling matrix.
③ From the absorbance S5 of the sample at 570nm, absorbance Z5 of chyle was subtracted to obtain absorbance r5=s5/X5/Z5 of hemoglobin at 570 nm. From the haemolysis calibration matrix of haemoglobin versus 570nm, the corresponding haemoglobin interferent concentration levels can be found. If the absorbance is between the two classes, a closer hemoglobin interferent class II is selected.
④ Absorbance R4 at hemoglobin interferent grade II was obtained from a haemolysis calibration matrix of hemoglobin versus 405 nm. Absorbance Z4 at chyle interferent grade I was obtained from a chyle to 405nm lipid blood scale matrix.
⑤ From the absorbance S4 of the sample at 405nm, the absorbance Z4 and R4 of chyle and hemoglobin were subtracted to obtain the absorbance h4=s4/X4/Z4/R4 of bilirubin at 405 nm. From the bilirubin versus 405nm jaundice calibration matrix, the corresponding bilirubin interferent concentration levels can be found. If the absorbance is between the two levels, a closer bilirubin interferent level III is selected. The concentration grades I, II and III of the interferents are the detection results of HIL, namely the detection grades of blood fat detection, hemolysis detection and jaundice detection.
The foregoing is merely a preferred embodiment of the present invention and it should be noted that modifications and adaptations to those skilled in the art may be made without departing from the principles of the present invention, which are intended to be comprehended within the scope of the present invention.
Claims (8)
1. A method of detecting a HIL sample comprising the steps of:
Step 1, detecting absorbance of an HIL interferent sample and a basic sample of a grade X based on a multi-wavelength light source to obtain an HIL interferent grade matrix;
Step 2, absorbance data of a sample to be detected is obtained based on a multi-wavelength light source, and absorbance decoupling is carried out according to the HIL interferent grade matrix in the step 1 to obtain a detection result of the sample to be detected;
The HIL interferent grade matrix comprises a lipidemia scaling matrix, a hemolysis scaling matrix and/or a jaundice scaling matrix;
The lipid blood scaling matrix comprises:
Wherein S4i, S5i and S6i represent the absorbance of the interferents, the reaction cup and the distilled water under each test wavelength of different lipid blood grades; z4i, Z5i, Z6i represent absorbance of chylomicron interferents at each of the test wavelengths for different lipid blood levels; i represents a lipid blood level selected from any integer between 0 and 10;
the hemolysis scaling matrix comprises:
Wherein S4j and S5j represent the absorbance of the interferents, the reaction cups and the distilled water under each test wavelength of different hemolysis grades; r4j and R5j represent the absorbance of haemoglobin pure interferents of different haemolysis grades at each test wavelength; j represents a hemolysis grade selected from any integer between 0 and 10;
The jaundice scaling matrix comprises:
Wherein S4k represents the absorbance of the interferent, the reaction cup and the distilled water under each test wavelength; h4k represents bilirubin pure interferent absorbance at a test wavelength of 405 nm; k represents a hemolysis grade selected from any integer between 0 and 10;
The HIL interferent sample of class X of step 1 comprises:
(I) A first interferent solution; or (b)
(II) a second interferent solution; or (b)
(III) a combined solution of the first interferent solution and the second interferent solution;
when X is any integer between 1 and 9, in the HIL interferent sample of class X, the volume ratio of the first interferent solution to the second interferent solution is X: (10-X);
when the X is 10, the HIL interferent sample of grade X is a first interferent solution;
When the X is 0, the HIL interferent sample of grade X is a second interferent solution;
The first interferent solution comprises an interferent stock solution and a basic sample, wherein the volume ratio of the interferent stock solution to the basic sample is 1:9, a step of performing the process;
the second interferent solution comprises an interferent blank solution and a basic sample, and the volume ratio of the interferent blank solution to the basic sample is 1:9, a step of performing the process;
the interferent stock solution comprises chyle with a concentration of 30000FTU, haemoglobin with a concentration of 5000mg/dl or bilirubin with a concentration of 250 mg/dl;
The interferent blank solution does not include concentration chyle, haemoglobin or bilirubin;
the base sample comprises distilled water.
2. The method of claim 1, wherein the multi-wavelength light source comprises one or more of a 405nm, 570nm, or 660nm wavelength light source.
3. The method of claim 1 or 2, wherein the absorbance decoupling comprises the steps of:
Step A, analyzing absorbance data of the sample to be tested obtained in the step 2 according to a first formula, wherein the first formula is as follows:
S6＝X6×Z6
Wherein S 6 is absorbance of the sample to be tested at a test wavelength of 660nm, X 6 is absorbance of the basic sample at a test wavelength of 660nm, and Z 6 is absorbance of lipidemia at a test wavelength of 660 nm;
Z 6 is calculated according to a first formula, and is compared with absorbance in the lipidemia scaling matrix to obtain the lipidemia grade of the sample to be detected;
And B, analyzing the absorbance data of the sample to be tested obtained in the step 2 according to a second formula, wherein the second formula is as follows:
S5＝X5×Z5×R5
wherein S 5 is the absorbance of the sample to be tested at a test wavelength of 570nm, X 5 is the absorbance of the basic sample at a test wavelength of 570nm, and Z 5,R5 is the absorbance of the lipidemia and the hemolysis at the test wavelength of 570nm respectively;
R 5 is calculated according to a second formula, and is compared with absorbance in the hemolysis scaling matrix to obtain the hemolysis grade of the sample to be detected;
and C, analyzing the absorbance data of the sample to be tested obtained in the step 2 according to a third formula, wherein the third formula is as follows:
S4＝X4×Z4×R4×H4
Wherein S 4 is absorbance of the sample to be tested at a test wavelength of 405nm, X 4 is absorbance of the basic sample at a test wavelength of 405nm, and Z 4,R4,H4 is absorbance of lipidemia, hemolysis and jaundice at a test wavelength of 405nm respectively;
And R 4 is calculated according to a third formula, and is compared with absorbance in the jaundice scaling matrix to obtain the jaundice grade of the sample to be detected.
The HIL sample detection method is characterized by comprising the following steps:
Step 1, detecting absorbance of an HIL interferent sample and a basic sample of a grade X based on a multi-wavelength light source to obtain an HIL interferent grade matrix;
Step 2, absorbance data of a sample to be detected is obtained based on a multi-wavelength light source, and absorbance decoupling is carried out according to the HIL interferent grade matrix in the step 1 to obtain a detection result of the sample to be detected;
The HIL interferent grade matrix comprises a lipidemia scaling matrix, a hemolysis scaling matrix and/or a jaundice scaling matrix;
The lipid blood scaling matrix comprises:
Wherein S4i, S5i and S6i represent the absorbance of the interferents, the reaction cup and the distilled water under each test wavelength of different lipid blood grades; z4i, Z5i, Z6i represent absorbance of chylomicron interferents at each of the test wavelengths for different lipid blood levels; i represents a lipid blood level selected from any integer between 0 and 10;
the hemolysis scaling matrix comprises:
Wherein S4j and S5j represent the absorbance of the interferents, the reaction cups and the distilled water under each test wavelength of different hemolysis grades; r4j and R5j represent the absorbance of haemoglobin pure interferents of different haemolysis grades at each test wavelength; j represents a hemolysis grade selected from any integer between 0 and 10;
The jaundice scaling matrix comprises:
Wherein S4k represents the absorbance of the interferent, the reaction cup and the distilled water under each test wavelength; h4k represents bilirubin pure interferent absorbance at a test wavelength of 405 nm; k represents a hemolysis grade selected from any integer between 0 and 10;
The HIL interferent sample of class X of step 1 comprises:
(I) A first interferent solution; or (b)
(II) a second interferent solution; or (b)
(III) a combined solution of the first interferent solution and the second interferent solution;
when X is any integer between 1 and 9, in the HIL interferent sample of class X, the volume ratio of the first interferent solution to the second interferent solution is X: (10-X);
when the X is 10, the HIL interferent sample of grade X is a first interferent solution;
When the X is 0, the HIL interferent sample of grade X is a second interferent solution;
The first interferent solution comprises an interferent stock solution and a basic sample, wherein the volume ratio of the interferent stock solution to the basic sample is 1:9, a step of performing the process;
the second interferent solution comprises an interferent blank solution and a basic sample, and the volume ratio of the interferent blank solution to the basic sample is 1:9, a step of performing the process;
the interferent stock solution comprises chyle with a concentration of 30000FTU, haemoglobin with a concentration of 5000mg/dl or bilirubin with a concentration of 250 mg/dl;
the interferent blank solution does not include concentration chyle, haemoglobin or bilirubin;
the base sample comprises distilled water.
5. The HIL sample detection method of claim 4, wherein the multi-wavelength light source comprises one or more of 405nm, 570nm, or 660nm wavelength light sources.
6. The HIL sample detection method of claim 4 or 5, wherein the absorbance decoupling comprises the steps of:
Step A, analyzing absorbance data of the sample to be tested obtained in the step 2 according to a first formula, wherein the first formula is as follows:
S6＝X6×Z6
Wherein S 6 is absorbance of the sample to be tested at a test wavelength of 660nm, X 6 is absorbance of the basic sample at a test wavelength of 660nm, and Z 6 is absorbance of lipidemia at a test wavelength of 660 nm;
Z 6 is calculated according to a first formula, and is compared with absorbance in the lipidemia scaling matrix to obtain the lipidemia grade of the sample to be detected;
And B, analyzing the absorbance data of the sample to be tested obtained in the step 2 according to a second formula, wherein the second formula is as follows:
S5＝X5×Z5×R5
wherein S 5 is the absorbance of the sample to be tested at a test wavelength of 570nm, X 5 is the absorbance of the basic sample at a test wavelength of 570nm, and Z 5,R5 is the absorbance of the lipidemia and the hemolysis at the test wavelength of 570nm respectively;
R 5 is calculated according to a second formula, and is compared with absorbance in the hemolysis scaling matrix to obtain the hemolysis grade of the sample to be detected;
and C, analyzing the absorbance data of the sample to be tested obtained in the step 2 according to a third formula, wherein the third formula is as follows:
S4＝X4×Z4×R4×H4
Wherein S 4 is absorbance of the sample to be tested at a test wavelength of 405nm, X 4 is absorbance of the basic sample at a test wavelength of 405nm, and Z 4,R4,H4 is absorbance of lipidemia, hemolysis and jaundice at a test wavelength of 405nm respectively;
And R 4 is calculated according to a third formula, and is compared with absorbance in the jaundice scaling matrix to obtain the jaundice grade of the sample to be detected.
7. The blood coagulation analyzer operating system is characterized by comprising an interference object detection setting interface; the coagulation analyzer operating system, when executed by a processor, is configured to implement the HIL sample detection method of any one of claims 4 to 6.
8. A coagulation analyzer comprising the coagulation analyzer operating system of claim 7.
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| CN116399836A (en) * | 2022-11-23 | 2023-07-07 | 上海交通大学 | Cross-talk fluorescence spectrum decomposition method based on alternating gradient descent algorithm |
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| WO2021232006A1 (en) * | 2020-05-15 | 2021-11-18 | Baebies, Inc. | Digital microfluidics analytical techniques |
| CN116399836A (en) * | 2022-11-23 | 2023-07-07 | 上海交通大学 | Cross-talk fluorescence spectrum decomposition method based on alternating gradient descent algorithm |
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