CN109470533B - Preparation method of human whole blood matrix quality control product for portable glucometer - Google Patents
Preparation method of human whole blood matrix quality control product for portable glucometer Download PDFInfo
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Abstract
The invention discloses a preparation method of a human whole blood matrix quality control product for a portable glucometer, which comprises the steps of separating whole blood cells, fixing the whole blood cells, preparing quality control products with high, medium and low blood sugar concentrations and the like. The invention can effectively detect the possible errors of the portable blood glucose meter in the detection of the blood glucose concentration of the high, the middle and the low blood glucose concentration of the medical blood glucose decision value level in time by using the quality control products of the high, the middle and the low blood glucose concentration levels. The quality control product prepared by the method is fixed with human whole blood cells, so that on one hand, the quality control product is guaranteed to be a whole blood substrate and is consistent with the type of a sample identified by a glucometer; also solves the problem that the blood sugar can generate glycolysis in the blood, and stabilizes the value of the blood sugar. The quality control product prepared by the method has good interoperability and is suitable for a plurality of portable glucometers with different brands and different models.
Description
Technical Field
The invention relates to the technical field of standard products used in clinical examination processes, in particular to a preparation method of a human whole blood matrix quality control product for a portable glucometer, and particularly relates to a method for preparing a human whole blood matrix quality control product suitable for various glucometers of different brands or models.
Background
Nowadays, the point-of-care testing (POCT) technology is gaining increasing favor of clinicians due to its advantages of rapid, simple, small sample volume, and potential improvement of the prognosis of patient treatment. As a POCT instrument with the highest frequency of use in a medical institution, the accuracy and reliability of the detection of the portable blood glucose meter play an important role in monitoring and managing the blood glucose of patients in the medical institution.
However, due to the lack of effective standard Substances (RMs) for quality control, traceability and measurement accuracy of the detection method of the portable glucometer cannot be completely guaranteed, so that effective values cannot be transmitted, detection results often differ greatly from a central laboratory, and the performance of some glucometers is in an unqualified state for a long time and is not easy to be found, thereby affecting the clinical implementation of reasonable and effective diagnosis and treatment measures.
In order to standardize the detection quality of the portable glucometer in the medical institution and improve the application value of the portable glucometer in the diagnosis and treatment of diabetes, the selection of a proper standard substance for quality control is one of the keys for exerting the clinical application value of the portable glucometer. Quality Control Materials (QCMs), one of the standard substances, are mainly used to monitor the performance of a validated test method, to detect changes over time or the occurrence of statistical runaway in the test method, and to evaluate/verify the quality of the room (eq/clinical testing, PT) or to control the quality of the room (QC). Wherein the quality evaluation/capacity verification in the laboratory means that a plurality of samples are periodically sent to the laboratory for analysis and/or identification, the result of each laboratory is compared with the results or specified values of other laboratories in the same group, and the compared results are reported to the participating laboratories. The indoor quality control means that a certain method and steps are adopted to continuously evaluate the reliability of the laboratory work, and aims to monitor the precision of the laboratory routine work and improve the consistency of the batch-to-batch sample detection in the laboratory routine work so as to determine whether the laboratory result is reliable or not and send a report or not.
Most of blood glucose calibrators or quality control products used for checking precision, stability and accuracy of blood glucose meters at present are non-human whole blood matrixes, a portable blood glucose meter mainly detects glucose in human whole blood, and a detection result obtained by using the non-human whole blood matrixes as the quality control products is different from an actual result; secondly, different blood glucose meters of different brands have different quality control products, even different blood glucose meters of the same brand and different models have different quality control products, the result of the measurement on the different brands of the instruments by using the same quality control product has difference, the target value of the measurement on the different brands of the instruments of the same brand has difference, and the detection results of the quality control products can not be intercommunicated. Moreover, the manufacturer supplies the calibration or quality control kit at a high price, and some of the imported reagents are limited by transportation conditions and supply chain. This not only increases the medical cost, but also buries the hidden danger for the management and treatment of the diabetic.
Interoperability (Commutability) is an important property of a standard substance, and refers to the degree of agreement between the numerical relationships obtained by various measurement procedures when the substance is measured by the different measurement procedures, and the numerical relationships obtained when the actual clinical samples are measured by the measurement procedures. Based on the defects, the development of the human whole blood matrix quality control product for the portable glucometer with interoperability is a substantial breakthrough for improving the blood sugar management of the diabetic, and the preparation method of the human whole blood matrix quality control product is also an urgent solution in the field.
Disclosure of Invention
The invention aims to provide a preparation method of a human-derived whole blood matrix quality control product for a portable glucometer, aiming at the technical defects in the prior art, the prepared human-derived whole blood matrix quality control product can be used for portable glucometers of different brands and different models, and the detection result has the interoperability among the glucometers, and the preparation method comprises the steps of separating whole blood cells from human whole blood, fixing the whole blood cells to obtain a fixed object, preparing quality control products with three blood glucose concentrations of high, medium and low and the like.
The quality control product of the human whole blood matrix is human and is prepared from the following raw materials: human whole blood, fixative, physiological saline.
The fixing agent is selected from a solution containing formaldehyde and/or glutaraldehyde.
The fixing agent is PBS solution containing 2-8% (v/v) formaldehyde and 2-8% (v/v) glutaraldehyde; preferably, the fixing agent is a PBS solution containing 2-6% (v/v) formaldehyde and 2-6% (v/v) glutaraldehyde; a PBS solution containing 4% (v/v) formaldehyde and 4% (v/v) glutaraldehyde is preferred.
The high blood sugar concentration of the quality control product with the high, middle and low blood sugar concentrations is 12.0-16.0mmol/L, the medium blood sugar concentration is 6.0-8.0mmol/L, and the low blood sugar concentration is 2.0-3.0 mmol/L.
The human whole blood is venous blood containing red blood cells, white blood cells and platelets of a normal person of 18-50 years old.
The whole blood cell separation specifically comprises the following steps: human whole blood is centrifuged at 1500g for 10min, and the upper layer is discarded, and the lower layer is the whole blood cells.
The fixture for fixing the whole blood cells is specifically as follows: adding whole blood cells into a fixing agent, fixing for 24-48h at room temperature, wherein the volume ratio of the whole blood cells to the fixing agent is 1 (5-10);
the method also comprises the operation of purifying the fixture, which specifically comprises the following steps: centrifuging after the whole blood cells are fixed, removing the upper fixing agent, adding physiological saline into the lower fixing object for washing for 3-5 times, wherein the volume ratio of the fixing object to the physiological saline is 1 (5-10), and then filtering to obtain filtrate, namely the purified fixing object.
The quality control products for preparing the blood sugar concentrations of the high, middle and low blood sugar levels are specifically as follows: adding pre-prepared blood plasma with different blood sugar concentrations into a fixed object or a purified fixed object respectively, wherein the volume ratio of the fixed object to the blood plasma is 1 (1-2) (preferably 1:1), and obtaining a hypoglycemic concentration quality control product, a medium blood sugar concentration quality control product and a hyperglycemic concentration quality control product respectively; preferably, the plasma of different blood glucose concentrations is obtained by centrifuging venous whole blood of normal blood glucose concentration and collecting the supernatant, or collecting the supernatant and adding glucose.
The invention provides a preparation method of a human whole blood matrix quality control product suitable for portable glucometers of different brands and different models. The quality control product prepared by the method comprises the following steps:
first, three concentrations of high, medium and low medical glycemic determinant levels are involved. The blood sugar level of normal human is between 4.4 and 6.0mmol/L, and the blood sugar is too low or too high, which can cause harm to human bodies. In a medical institution, the blood sugar level of a patient is detected mainly by a portable blood glucose meter, and the therapeutic dose of insulin is adjusted. If the blood sugar result detected by the portable blood sugar meter is higher or lower, the use dosage of insulin can be directly influenced, the medical risk is increased, and the ketoacidosis caused by hypoglycemia coma or hyperglycemia of a patient can be seriously caused. The invention can effectively detect the possible errors of the portable blood glucose meter in the detection of the blood glucose concentration of the high, the middle and the low blood glucose concentration of the medical blood glucose decision value level in time by using the quality control products of the high, the middle and the low blood glucose concentration levels.
Secondly, the quality control product prepared by the method is fixed with human whole blood cells, so that on one hand, the quality control product is guaranteed to be a whole blood substrate and is consistent with the type of a specimen identified by a glucometer; also solves the problem that the blood sugar can generate glycolysis in the blood, and stabilizes the value of the blood sugar.
Thirdly, experiments prove that the quality control product prepared by the method has good interoperability and is suitable for a plurality of portable glucometers with different brands and different models.
Finally, the quality control product prepared by the method has the advantages of wide raw material sources, simple preparation process and low cost, can meet the clinical requirements on the quality control of the portable glucometer, and has great market popularization and application values.
Drawings
FIG. 1 is a schematic flow chart of the production process of the present invention;
FIGS. 2-4 are graphs showing the interoperability evaluation effect of the quality control product prepared by the method of the invention on different brands of glucometers.
Detailed Description
At present, quality control products for blood sugar detection at home and abroad are mostly serum matrixes or water matrixes, and whole blood matrix quality control products suitable for portable glucometers are lacked, and the main technical difficulties of the quality control products are that the stability of cells in the whole blood matrixes is poor, the storage period is short, glucose glycolysis is easy to occur in blood sugar (the glycolysis can occur in the blood sugar value of normal human whole blood at the speed of 5-7%/h), and then the blood sugar value is reduced. Although the artificially synthesized latex particle quality control product or serum matrix quality control product is used for quality control of the portable glucometer at home and abroad, the obtained quality control product cannot be suitable for glucometers of various models and brands. Based on the reasons, the whole blood matrix quality control product is developed, so that the detection result has the intercommunity among different brands and different models of glucometers, and the whole blood matrix quality control product is applied to the quality control of portable glucometers in medical institutions, can effectively reduce the medical cost and improve the application value of the portable glucometers in blood glucose monitoring.
The invention provides a preparation method of a humanized whole blood matrix quality control product, wherein the quality control product prepared by the method is humanized and is prepared from the following raw materials: the raw materials comprise normal whole blood, a fixing agent, physiological saline and the like. Wherein the content of the first and second substances,
the normal whole blood is venous blood of 18-50 years old healthy people, and EDTK-K is used2Anticoagulation, of the same blood type, including erythrocytes, leukocytes and platelets;
the fixing agent can be selected from formaldehyde and/or glutaraldehyde, the formaldehyde has small molecular weight, strong penetrating power and mild reaction, can be used for pre-fixing of histochemical research of cells, but has poor preservation on cell matrixes, and most matrixes are lost after dehydration; and glutaraldehyde is used as a fixing agent, the reaction speed is high, but the permeation speed is lower than that of formaldehyde, and the effect of matching the glutaraldehyde with the formaldehyde is optimal. The fixative is preferably a PBS solution containing 2-8% (v/v) formaldehyde and 2-8% (v/v) glutaraldehyde (PBS buffer is obtained by dissolving 10.2g phosphate in 1L distilled water, and adjusting the pH to 7.2 with dilute hydrochloric acid), more preferably a PBS solution containing 2-6 (v/v)% formaldehyde and 2-6 (v/v)% glutaraldehyde, and most preferably a PBS solution containing 4% (v/v) formaldehyde and 4% (v/v) glutaraldehyde.
The method for preparing the human whole blood matrix quality control product provided by the invention specifically comprises the following steps:
(1) taking normal whole blood, centrifuging for 10min by adopting a low-speed centrifuge at 1500g, wherein the upper layer is plasma, the lower layer is whole blood cells, and separating the plasma and the whole blood cells for later use;
(2) adding a fixing agent into the whole blood cells obtained in the step (1), and fixing for 24-48h at room temperature; the volume ratio of the whole blood cells to the fixing agent is 1 (5-10);
(3) centrifuging at 1500g for 10min after fixation is completed, discarding upper layer of fixation solution, adding 0.9% physiological saline, washing lower layer of fixation for 3-5 times, wherein the volume ratio of fixation to physiological saline is 1 (5-10), and the washing specifically comprises: fully mixing the fixed objects and normal saline, centrifuging for 10min at 1500g, discarding the upper washing liquid, and leaving the fixed objects on the layer; then filtering the washed lower-layer fixture by using a filter screen (the aperture is 40 mu m) to remove precipitates and impurities, wherein the filtrate is the purified fixture;
(4) adding plasma with different blood sugar concentrations into the purified fixture obtained in the step (3), placing the purified fixture in a shaking table and uniformly mixing for 30min to respectively obtain a low blood sugar concentration quality control product, a medium blood sugar concentration quality control product and a high blood sugar concentration quality control product, wherein the volume ratio of the fixture to the plasma is 1 (1-2) (preferably 1: 1); the blood plasma with different blood sugar concentrations is human blood plasma, and the blood sugar measuring range of most portable blood sugar meters is 1.1-33.3mmol/L, so the quality control product is set to be low, medium and high three blood sugar levels, the blood sugar level of the quality control product is realized by the blood plasma with different blood sugar concentrations, and the preparation process of the blood plasma with different blood sugar concentrations is as follows: (1) plasma with low blood glucose concentration: selecting venous whole blood with the blood sugar concentration of about 4.0-6.0mmol/L, centrifuging for 10min at 1500g, and taking supernatant as blood plasma with low blood sugar concentration, namely the blood plasma required for preparing the quality control product with low blood sugar concentration; (2) plasma at medium blood glucose concentration: selecting venous whole blood with the blood sugar concentration of about 4.0-6.0mmol/L, centrifuging for 10min at 1500g, taking supernatant, and then adding 40 mu L of 200mmol/L glucose solution into per ml supernatant to obtain plasma with medium blood sugar concentration, namely the plasma required by the quality control product for preparing the medium blood sugar concentration; (3) plasma with high blood glucose concentration: selecting venous whole blood with blood sugar concentration of about 4.0-6.0mmol/L, centrifuging for 10min at 1500g, taking supernatant, and adding 100 μ L of 200mmol/L glucose solution into per ml supernatant to obtain blood plasma with high blood sugar concentration, namely the blood plasma required for preparing quality control product with high blood sugar concentration;
(5) and (4) subpackaging the quality control products with low, medium and high blood sugar concentration obtained in the step (4) in a small sterile test tube, and storing at 2-8 ℃ until being fully and uniformly mixed before each use.
In order to prolong the storage life of the quality control product, the purified fixture obtained in the step (3) can also be added into 0.9% of physiological saline for suspension, and the volume ratio of the fixture to the physiological saline is 1: (1-2), subpackaging in sterile small test tubes, centrifuging for 10min by adopting a low-speed centrifuge of 1500g, wherein the upper layer is normal saline, and the lower layer is a purified fixed object, and storing at 2-8 ℃. And (4) subpackaging the blood plasma with different blood sugar concentrations obtained in the step (4) in small sterile test tubes, and storing at-20 ℃ for a long time. The purified fixed object and the blood plasma with different blood sugar concentrations are separately packaged, the upper layer physiological saline of the liquid seal fixed object is discarded when the quality control product is used, the blood plasma with different blood sugar concentrations is redissolved at the temperature of 2-8 ℃, then the fixed object and the blood plasma are mixed, and the quality control product with low, medium and high blood sugar concentrations of the invention is obtained by using the conventional preparation method.
The quality control product does not need to distinguish blood types, only mixes and centrifuges normal whole blood of the same blood type in the step (1), and can be directly used without distinguishing blood types when the quality control product is used.
The invention focuses on reducing the activity of cells by fixing the cells with aldehydes, thereby inhibiting the glycolysis of the grapes in the whole blood cells and maintaining the stability of the blood sugar value. On one hand, the existence of blood cells in the quality control product prepared by the method meets the requirement that the detection of a portable glucometer needs to reach the Hematocrit (HCT) of 20-60 percent. On the other hand, except for components for fixing cells, the quality control product is not added with any other substances (such as polysaccharides such as sucrose, glucose, fructose, galactose, lactose, maltose, starch, dextrin and the like, antibiotics, sodium citrate and other preservatives), so that the consistency with a patient sample matrix is ensured, the interference of various substances such as maltose, xylose, galactose and the like to the portable glucometer in the detection process is avoided, the result is higher, and the preservative can also cause the instability of the detection result. In addition, the quality control product prepared by the method of the invention uses human blood to replace animal blood, mainly because the difference of the cell morphology of the animal blood and the human blood is large, and the difference of the Hematocrit (HCT) of the two kinds of blood is large, the accuracy of the detection result can be influenced, and the intercommunity of the quality control product between portable glucometers of different brands is poor. The quality control product prepared by the method meets the requirements that the matrix is consistent with the patient sample to the maximum extent, no interfering substance influencing the detection of the instrument is added, the stability of the blood sugar value can be maintained, and the performance that the accuracy of the detection result of the portable blood sugar instrument can be judged only by detecting the quality control product, whether systematic correction is needed or not, whether the detection result of the patient is acceptable or not can be realized.
The present invention will be described more specifically and further illustrated with reference to specific examples, which are by no means intended to limit the scope of the present invention.
Experimental example I, uniformity verification of human whole blood matrix quality control product for portable glucometer prepared by the method
Referring to the contents on the evaluation of uniformity study in CNAS-GL29 Standard, general principles and statistical methods of Standard substance/Standard sample rating, issued by the national Committee for the qualification of China, a HORIBA glucose electrode Analyzer (LP-150C) was used for the test, 10 samples (numbered 1-10) were randomly selected from quality control products of each blood glucose concentration (low, medium, and high) for uniformity evaluation, and the measurement was repeated 3 times for each sample. The sequence of the first measurement in the measurement process is: 1-3-5-7-9-2-4-6-8-10; the sequence of the second measurement is 10-9-8-7-6-5-4-3-2-1; the third measurement was performed in the order of 2-4-6-8-10-1-3-5-7-9, and the results are shown in Table 1. Statistical one-way ANOVA was used for the analysis and the results are shown in Table 2.
To check the homogeneity of the samples, i samples (i 1, 2, … … m) were taken and each sample was tested j times under repeated conditions (j 1, 2, … …, n).
Average value of test for each sample
Total average of all sample tests
Total number of tests
Sum of squares between samples
Mean square MS1＝SS1/f1
Sum of squares in sample
Mean square MS2＝SS2/f2
Degree of freedom f1＝m-1
f2＝N-m
Statistic F ═ MS1/MS2
If F < degree of freedom is (F)1，f2) And a threshold F α (F) for a given significance level α (typically α ═ 0.05)1，f2) It indicates that there is no significant difference between samples and the samples are homogeneous.
TABLE 1 measurement data of homogeneity study of quality control (unit: mmol/L)
TABLE 2 ANOVA TABLE FOR QUALITY-CONTROLLING PRODUCT UNIFORMITY RESEARCH
As can be seen from the results in tables 1 and 2, the quality control products of the human whole blood matrix for the portable glucometer prepared by the method have no significant difference in samples or between samples, which indicates that the quality control products prepared by the method are uniform and can be used as quality control products for the portable glucometer.
Experimental example II, stability verification of human whole blood matrix quality control product prepared by the method
The human whole blood matrix quality control product prepared by the method is subjected to short-term 2-8 ℃ stability evaluation according to the stability evaluation requirements in CNAS-GL29 standard issued by the China qualification national committee-standard general principle and statistical method of standard substance/standard sample definite value. 3 quality control products of each blood sugar concentration (low, medium, high) were randomly sampled, each sample was subjected to measurement 2 times, each measurement was completed within 10min, and then the remaining samples were immediately stored at 2 to 8 ℃ for 20 days by continuous measurement using HORIBA glucose electrode type analyzer (LP-150C), and differences between the results of the 2 nd, 3 rd, 5 th, 10 th, 15 th, and 20 th days of storage and the results of the 1 st day were observed. After the measurement, the results are shown in Table 3 by analyzing the results by a statistical t-test method.
The value of t is calculated as follows:
in the formula:
-first checking the mean value of the measurement data;
s1-first checking the standard deviation of the measurement data;
s2-second checking the standard deviation of the measurement data;
n1-the number of measurements of the first test measurement;
n2-the number of measurements of the second inspection measurement.
Note: in order to ensure the accuracy of the mean and standard deviation, n1 and n2 are both equal to or greater than 6.
If t < significance level α (typically α ═ 0.05) degree of freedom is critical t of n1+ n2-2α(n1+n2-2)There was no significant difference between the two averages.
TABLE 3 measurement data of quality control stability study (unit: mmol/L)
The results in table 3 show that the results of the quality control products with high, medium and low blood glucose concentrations at day 15 are still not significantly different from those at day 1 (P is greater than 0.05), which indicates that the quality control products prepared by the method of the present invention have good stability.
Experimental example III, intercommunity verification of human whole blood matrix quality control product for portable glucometer prepared by the method
Collecting 33 clinical samples with blood sugar concentrations in three concentration ranges of high, medium and low, respectively, detecting the samples and quality control products with three blood sugar concentrations to be verified by glucometers with different brands and different models and a central laboratory large biochemical analyzer (HITACHI 7600), performing linear regression on two groups of data, drawing 95% confidence intervals of detection methods of the glucometers for the central laboratory, judging whether the measured values of the quality control products fall in the 95% confidence intervals or not, and showing that the interoperability is good or not in the 95% confidence intervals, and showing that the interoperability is poor, wherein the results are shown in figures 2-4 (in the figure: ● represents clinical samples, ■ represents three blood sugar concentration quality control products, and … … … represents 95% confidence intervals).
The present experimental example relates to a 15 model portable blood glucose meter, which is, respectively, ACCU-CHEK Performa Roche, ACCU-CHEK Active Roche, Bayer CONTOUR TS, Bayer CONTOUR PLUS, Bayer1455, YapeFreStyle Optium, Akeak ARKRAY GT-1820, Akeak ARKRAY GT-1970, Tylox MEDISAFEFIT, HORIBA LP-150C, Qiangsheng StatStrip, Qiangsheng ONETOUCH UltraVue, Rightest GM300, Wanfu EC-102 and Botangping type II.
The results in FIGS. 2-4 show that the quality control products prepared by the method of the present invention have good interoperability in 9 portable glucometers such as Rockwell ACCU-CHEK Performance, Rockwell ACCU-CHEK Active, Bayer CONTOUR TS, Bayer CONTOUR PLUS, YapeFreStyle Optium, Akyco ARKRAY GT-1820, Tylox MEDISAFE FIT, HORIBA LP-150C, and Stat strip, and the three quality control product measurement values of blood sugar concentration all fall in 95% confidence interval. Compared with the prior art that the quality control product can only be suitable for a certain type of portable glucometer of a certain brand, the quality control product prepared by the method is a breakthrough.
Experimental example four, indoor quality control application
The quality control products with high, medium and low blood sugar concentration are applied to indoor quality control, two quality control products with blood sugar concentration matched with 2 portable glucometers are selected as comparison, and the detection is continuously carried out for 5 days and repeated for 4 times every day. Portable blood glucose meter 1: HORIBA glucose electrode analyzer (LP-150C), quality control products are QC1, QC2 respectively; the portable glucometer 2 comprises ROCHE, ACCU-CHEK Performa and quality control products of QC3 and QC 4. Calculating the mean value and Standard Deviation (SD) and Coefficient of Variation (CV) of the detection results, and issuing general technical conditions [ S/OL ] of a blood glucose monitoring system for self-test of an in vitro diagnosis and inspection system of the national standard with the State food and drug administration of the people' S republic of China, wherein SD is less than 0.42mmol/L when the blood glucose concentration is less than 5.5 mmol/L; when the blood sugar concentration is more than or equal to 5.5mmol/L, the CV is less than 7.5 percent.
TABLE 4 quality control in quality control Chamber
| Quality control product | Mean value (mmol/L) | SD | CV(％) |
| High blood sugar concentration | 14.48 | 0.09 | 0.63 |
| Middle blood sugar concentration | 7.56 | 0.05 | 0.66 |
| Low blood sugar concentration | 2.48 | 0.04 | 1.65 |
| QC1 | 2.55 | 0.09 | 3.71 |
| QC2 | 26.69 | 0.30 | 1.12 |
| QC3 | 2.56 | 0.07 | 2.69 |
| QC4 | 17.1 | 0.22 | 1.29 |
Table 4 shows that the SD value of the low blood sugar concentration quality control product prepared by the method is 0.04 and less than 0.42mmol/L, the CV values of the medium blood sugar concentration quality control product and the high blood sugar concentration quality control product are 0.66 percent and 0.63 percent respectively and are less than 7.5 percent respectively, which shows that the three blood sugar concentration quality control products all accord with the national standard, the result is similar to the commercial quality control product, and the method can be applied to the daily indoor quality control of the portable blood sugar meter.
The quality control product can be divided into a fixed value quality control product and a non-fixed value quality control product. The mean value and standard deviation of the non-constant quality control products are obtained by performing at least 20 bottles of tests in different days or performing at least 4 repeated tests every day in at least 5 days by adopting a laboratory conventional method. The quality control product prepared by the method is used as an indeterminate value quality control product because the quality control product is suitable for detecting the blood sugar of the whole blood matrix, has traceability and can be used for quality control product assignment instruments which are not very popular in clinical medical institutions at present.
The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and decorations can be made without departing from the principle of the present invention, and these modifications and decorations should also be regarded as the content of the present invention.
Claims (14)
1. A preparation method of a human whole blood matrix quality control product for a portable glucometer is characterized by comprising the following steps: separating whole blood cells from normal human whole blood, fixing the whole blood cells by using a fixing agent to obtain a fixed object, and preparing quality control products of high, medium and low blood glucose concentrations; the fixing agent is PBS solution containing 2-8% (v/v) formaldehyde and 2-8% (v/v) glutaraldehyde;
the quality control products for preparing the blood sugar concentrations of the high, middle and low blood sugar levels are specifically as follows: adding pre-prepared blood plasma with different blood sugar concentrations into a fixed object respectively, and mixing to obtain a low blood sugar concentration quality control product, a medium blood sugar concentration quality control product and a high blood sugar concentration quality control product respectively; the blood sugar concentration of the low blood sugar concentration quality control product is 2.0-3.0mmol/L, the blood sugar concentration of the medium blood sugar concentration quality control product is 6.0-8.0mmol/L, and the blood sugar concentration of the high blood sugar concentration quality control product is 12.0-16.0 mmol/L.
2. The preparation method of claim 1, wherein the human whole blood matrix quality control material is human and is prepared from the following raw materials: human whole blood, fixative, physiological saline.
3. The method according to claim 1, wherein the fixative is a PBS solution containing 2-6% (v/v) formaldehyde and 2-6% (v/v) glutaraldehyde.
4. The method of claim 1, wherein the fixative is a PBS solution containing 4% (v/v) formaldehyde and 4% (v/v) glutaraldehyde.
5. The method according to any one of claims 1 to 4, wherein the human whole blood is venous blood containing red blood cells, white blood cells and platelets of a normal human aged 18 to 50 years.
6. The method according to any one of claims 1 to 4, wherein the isolated whole blood cells are specifically: human whole blood is centrifuged at 1500g for 10min, and the upper layer is discarded, and the lower layer is the whole blood cells.
7. The method for preparing according to claim 5, wherein the separated whole blood cells are specifically: human whole blood is centrifuged at 1500g for 10min, and the upper layer is discarded, and the lower layer is the whole blood cells.
8. The method for preparing according to any one of claims 1 to 4, wherein the fixed whole blood cell obtaining immobilizate is specifically: the whole blood cells are added into the fixative and fixed for 24-48h at room temperature, and the volume ratio of the whole blood cells to the fixative is 1 (5-10).
9. The method for preparing according to claim 5, wherein the fixed whole blood cell obtaining immobilizate is specifically: the whole blood cells are added into the fixative and fixed for 24-48h at room temperature, and the volume ratio of the whole blood cells to the fixative is 1 (5-10).
10. The method for preparing as claimed in claim 6, wherein the fixed whole blood cell obtaining immobilizate is specifically: the whole blood cells are added into the fixative and fixed for 24-48h at room temperature, and the volume ratio of the whole blood cells to the fixative is 1 (5-10).
11. The method for preparing as claimed in claim 7, wherein the fixed whole blood cell obtaining immobilizate is specifically: the whole blood cells are added into the fixative and fixed for 24-48h at room temperature, and the volume ratio of the whole blood cells to the fixative is 1 (5-10).
12. The method according to claim 8, further comprising an operation of purifying the fixture, in particular: centrifuging after the whole blood cells are fixed, removing the upper fixing agent, adding physiological saline into the lower fixing object for washing for 3-5 times, wherein the volume ratio of the fixing object to the physiological saline is 1 (5-10), and then filtering to obtain filtrate, namely the purified fixing object.
13. The preparation method according to claim 12, wherein the quality control substances for preparing the high, medium and low blood glucose concentrations are specifically: respectively adding pre-prepared blood plasma with different blood sugar concentrations into a fixed object or a purified fixed object for mixing, wherein the volume ratio of the fixed object to the blood plasma is 1 (1-2), and respectively obtaining a hypoglycemic concentration quality control product, a medium blood sugar concentration quality control product and a hyperglycemic concentration quality control product; the blood plasma with different blood sugar concentration is obtained by centrifuging venous whole blood with normal blood sugar concentration and taking supernatant, or adding glucose after taking supernatant.
14. The method of claim 13, wherein the volume ratio of the immobilizate to the plasma is 1: 1.
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