CN111398606A - Kit and detection system - Google Patents
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- CN111398606A CN111398606A CN202010243708.5A CN202010243708A CN111398606A CN 111398606 A CN111398606 A CN 111398606A CN 202010243708 A CN202010243708 A CN 202010243708A CN 111398606 A CN111398606 A CN 111398606A
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Images
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/72—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood pigments, e.g. haemoglobin, bilirubin or other porphyrins; involving occult blood
- G01N33/721—Haemoglobin
- G01N33/723—Glycosylated haemoglobin
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
- G01N33/54313—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals the carrier being characterised by its particulate form
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/577—Immunoassay; Biospecific binding assay; Materials therefor involving monoclonal antibodies binding reaction mechanisms characterised by the use of monoclonal antibodies; monoclonal antibodies per se are classified with their corresponding antigens
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/72—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood pigments, e.g. haemoglobin, bilirubin or other porphyrins; involving occult blood
- G01N33/721—Haemoglobin
- G01N33/726—Devices
Abstract
The embodiment of the invention relates to the technical field of chemical analysis, in particular to a kit and a detection system. The kit comprises: the reagent kit comprises a shell, a reagent, a magnetic card and a stirrer. The reagent comprises: the serum-free anti-inflammatory agent comprises diluent, antiserum and latex, wherein the diluent is distilled water; the antiserum comprises a first phosphate buffer solution, sodium chloride, a mouse anti-human HbA1c monoclonal antibody and a sheep anti-mouse IgG antibody, wherein the mass ratio of the first phosphate buffer solution, the sodium chloride, the mouse anti-human HbA1c monoclonal antibody to the sheep anti-mouse IgG antibody is (9000) -12000): (13000-17000): (1-2): 1; the latex comprises latex particles, a second phosphate buffer solution and an antifreeze agent, wherein the mass ratio of the latex particles to the second phosphate buffer solution is 1: (9-12), wherein the concentration of the antifreeze agent is 1% -10%. The kit is used for detecting the content of the glycosylated hemoglobin (HbA1c), the detection time is short, and the operation process is simple. The reagent contains the antifreeze agent, so the kit has wide application range.
Description
Technical Field
The embodiment of the invention relates to the technical field of chemical analysis, in particular to a kit and a detection system.
Background
Diabetes is a worldwide public health problem that seriously threatens human health. Traditional diabetes diagnosis and therapy monitoring uses fasting blood glucose, postprandial blood glucose, oral glucose tolerance tests, and the like, but the blood glucose parameter represents only the instantaneous blood glucose level at the time of blood draw.
Glycated hemoglobin (hemoglobin A1c, HbA1c) is prepared by non-enzymatic binding reaction between free aldehyde group of glucose in human blood and amino group of valine at N-terminal of β chain of hemoglobin (hemoglobin, Hb), forming unstable Schiff base (aldimine) first, then rearranging by Amadori (glucosamine), and finally forming stable ketoamine compound, wherein when the glucose concentration in blood is higher, the content of HbA1c formed in human body is also higher.
The accurate definition of total glycated hemoglobin (GHb) is a stable compound in which glucose is covalently bound to the N-terminal valine residue of hemoglobin β chain while total glycated hemoglobin (GHb) in vivo is not only one of glycated hemoglobin (HbA1c), but also HbA1a (HbA1a1, HbA1a2), HbA1b, etc. since glycated hemoglobin (HbA1c) is a major constituent of total glycated hemoglobin (GHb), accounts for 60% of total glycated hemoglobin (GHb), and is most stable after generation, the life of erythrocytes in humans is generally 120 days, the content of glycated hemoglobin (HbA1c) remains relatively unchanged before death of erythrocytes, thus the average blood glucose level before 120 days can be measured, and the fasting plasma glucose level is measured independently of the blood-drawing time, whether the patient is using insulin, etc. since hemoglobin (HbA 1) is a standard "monitor the percentage of total hemoglobin (Hb 1 c).
Currently, the glycosylated hemoglobin (HbA1C) is usually detected by ion exchange Chromatography, which is established based on the difference in charges of glycated valine at the N-terminal of the β chain of hemoglobin, and the ion exchange Chromatography mainly comprises High Performance liquid Chromatography (High-Performance L acquired Chromatography, HP L C) and a manual microcolumn method.
However, in the process of implementing the embodiment of the present invention, the inventors of the present invention found that: the high performance liquid chromatography has long detection time, has more severe environmental requirements for detection, and has expensive related instruments, reagents and consumables. The manual microcolumn method has complicated operation steps, the chromatography time and the microcolumn quality are not easy to control, operation technical errors are easy to generate, the repeatability is poor, and a plurality of interference factors exist.
Disclosure of Invention
In view of the above, embodiments of the present invention provide a kit and a detection system, which overcome or at least partially solve the above problems.
According to an aspect of an embodiment of the present invention, there is provided a kit including a case, a reagent, a magnetic card, and a stirrer; the shell is provided with an accommodating space, the reagent is accommodated in the accommodating space, the magnetic card and the stirrer are both arranged in the shell, and the magnetic card stores standard curve information of the kit; the reagent comprises: the serum-free anti-inflammatory agent comprises diluent, antiserum and latex, wherein the diluent is distilled water; the antiserum comprises a first phosphate buffer solution, sodium chloride, a mouse anti-human HbA1c monoclonal antibody and a sheep anti-mouse IgG antibody, wherein the mass ratio of the first phosphate buffer solution, the sodium chloride, the mouse anti-human HbA1c monoclonal antibody to the sheep anti-mouse IgG antibody is (9000) -12000): (13000-17000): (1-2): 1; the latex comprises latex particles, a second phosphate buffer solution and an antifreeze agent, wherein the mass ratio of the latex particles to the second phosphate buffer solution is 1: (9-12), wherein the concentration of the antifreeze agent is 1% -10%.
In an alternative mode, the mass ratio of the first phosphate buffer, sodium chloride, the mouse anti-human HbA1c monoclonal antibody and the goat anti-mouse IgG antibody is preferably 10283: 15800: 1.5: 1.
in an alternative mode, the mass ratio of the latex particles to the second phosphate buffer is preferably 1: 10.28.
in an alternative form, the cryoprotectant includes mannitol, trehalose, sucrose, and glycerol.
In an alternative form, the mannitol, trehalose, sucrose and glycerol are at concentrations of 5%, 2% and 1%, respectively.
In an alternative form, the first phosphate buffer and the second phosphate buffer are each at a concentration of 20 mmol/L.
In an alternative form, the sodium chloride is present at a concentration of 15.8 g/L.
In an alternative embodiment, the concentration of the murine anti-human HbA1c monoclonal antibody is 1.5 mg/L.
In an alternative embodiment, the concentration of the goat anti-mouse IgG antibody is 1 mg/L.
In an alternative form, the latex particles are present at a concentration of 1 g/L.
According to an aspect of the embodiments of the present invention, there is provided a detection system, including a detection apparatus and the above-mentioned kit.
The embodiment of the invention has the beneficial effects that: different from the existing kit, the kit provided by the embodiment of the invention comprises: the reagent kit comprises a shell, a reagent, a magnetic card and a stirrer. The reagent comprises: the serum-free anti-inflammatory agent comprises diluent, antiserum and latex, wherein the diluent is distilled water; the antiserum comprises a first phosphate buffer solution, sodium chloride, a mouse anti-human HbA1c monoclonal antibody and a sheep anti-mouse IgG antibody, wherein the mass ratio of the first phosphate buffer solution, the sodium chloride, the mouse anti-human HbA1c monoclonal antibody to the sheep anti-mouse IgG antibody is (9000) -12000): (13000-17000): (1-2): 1; the latex comprises latex particles, a second phosphate buffer solution and an antifreeze agent, wherein the mass ratio of the latex particles to the second phosphate buffer solution is 1: (9-12), wherein the concentration of the antifreeze agent is 1% -10%. The kit is used for detecting the content of the glycosylated hemoglobin (HbA1c), the detection time is short, and the operation process is simple. The reagent contains the antifreeze agent, so the kit has wide application range.
Drawings
One or more embodiments are illustrated by way of example in the accompanying drawings, which correspond to the figures in which like reference numerals refer to similar elements and which are not to scale unless otherwise specified.
Fig. 1 is a schematic diagram of a kit provided by an embodiment of the present invention.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is described in further detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.
The N-terminal of β chain of total glycosylated hemoglobin (GHb) provides an epitope which is easy to be identified by antibody, monoclonal antibody or polyclonal antibody can be used for specifically identifying the epitope consisting of the last 4-6 amino acids of the N-terminal of β chain of the total glycosylated hemoglobin (GHb), the content of hemoglobin (HbA1c) is determined by combining colorimetry or turbidimetry, the total glycosylated hemoglobin (GHb) is taken as a standard, the content of hemoglobin (HbA 1) is determined, the content of hemoglobin (Hb) is calculated, and the percentage of the hemoglobin (HbA1c) in the hemoglobin (Hb) is calculated.
The embodiment of the invention provides a kit which is suitable for detecting glycosylated hemoglobin (HbA1c) in blood by an immunization method. Referring to fig. 1, the kit 100 includes a housing 101, reagents (not shown), a magnetic card 102, and a stirrer 103. The housing 101 is provided with an accommodating space 104, the reagent is accommodated in the accommodating space 104, the magnetic card 102 and the stirrer 103 are both arranged in the housing 101, and the magnetic card 102 stores standard curve information of the reagent kit 100.
For the magnetic card 102, the standard curve information of the kit 100 is already stored in the magnetic card 102, and before the test using the kit 100, the standard curve information stored in the magnetic card 102 can be identified by the magnetic card sensing area after the card swiping is successful through the contact between the magnetic card 102 and the magnetic card sensing area on the detection device, so that the standard curve is not determined through repeated experiments before the test, and a large amount of detection time is saved.
For the stirrer 103, the stirrer 100 is made of stainless steel, and the stirrer 103 is arranged in the shell 101 and is used for stirring the whole blood sample to be tested, so that the whole blood sample is fully mixed with the actual whole blood sample, and the accuracy of the test result is improved.
The reagent comprises: the serum-free anti-cancer composition comprises a diluent, antiserum and latex, wherein the diluent is distilled water. The antiserum comprises a first phosphate buffer solution, sodium chloride, a mouse anti-human HbA1c monoclonal antibody and a sheep anti-mouse IgG antibody, wherein the mass ratio of the first phosphate buffer solution, the sodium chloride, the mouse anti-human HbA1c monoclonal antibody to the sheep anti-mouse IgG antibody is (9000) -12000): (13000-17000): (1-2): 1. the latex comprises latex particles, a second phosphate buffer solution and an antifreeze agent, wherein the mass ratio of the latex particles to the second phosphate buffer solution is 1: (9-12), wherein the concentration of the antifreeze agent is 1% -10%.
The diluent is distilled water for rupturing red blood cells in the whole blood sample and allowing hemoglobin (Hb) and glycated hemoglobin (HbA1c) in the red blood cells to escape.
For the above latex, the latex includes latex particles, a second phosphate buffer, and an antifreeze, and the mass ratio of the latex particles to the second phosphate buffer is preferably 1: 10.28, wherein the latex particles have the same nonspecific adsorption to hemoglobin (Hb) including glycated hemoglobin (HbA1c) in a whole blood sample and are solid-phased, the concentration of the latex particles is 1 g/L. the second phosphate buffer is composed of sodium dihydrogen phosphate and disodium hydrogen phosphate, wherein the sodium dihydrogen phosphate is highly acidic, and if the pH value in blood is too high, the excess alkali is combined with the sodium dihydrogen phosphate to form disodium hydrogen phosphate, whereas if the pH value is too low, the excess acid reacts with the disodium hydrogen phosphate to form sodium dihydrogen phosphate, thereby adjusting the pH value of human blood.A concentration of the second phosphate buffer is 20 mmol/L. the antifreeze includes mannitol, trehalose, sucrose, and glycerin, and the antifreeze stabilizes the structure of the latex particles when frozen, and stabilizes the kit 100 during transportation and storage, the mannitol, sucrose, 5%, and trehalose are 2%, 5%, and trehalose, respectively.
The anti-serum comprises a first phosphate buffer solution, sodium chloride, a mouse anti-human HbA1c monoclonal antibody and a sheep anti-mouse IgG antibody, wherein the mass ratio of the first phosphate buffer solution, the sodium chloride, the mouse anti-human HbA1c monoclonal antibody and the sheep anti-mouse IgG antibody is preferably 10283: 15800: 1.5: 1, the concentration of the first phosphate buffer solution is 20 mmol/L, the sodium chloride is used for adjusting the ionic strength of the solution and avoiding causing change of cellular osmotic pressure, the concentration of the sodium chloride is preferably 15.8 g/L, the mouse anti-human HbA1c monoclonal antibody is used for generating agglutination by reacting with an antigen antibody of a whole blood sample, the mouse anti-human HbA c monoclonal antibody is 1.5 mg/L, the sheep anti-mouse IgG antibody is used for generating agglutination by reacting with an antigen antibody of a mouse anti-human HbA1c monoclonal antibody, and the mouse anti-human HbA1 HBA 1-364 monoclonal antibody in the whole blood sample is used for generating agglutination together with the mouse anti-human HbA 1-364 monoclonal antibody, and the mouse anti-human HbA L-HBA 1-364 monoclonal antibody in the whole blood sample.
It should be noted that, because hemoglobin (Hb) including glycated hemoglobin (HbA1c) in the whole blood sample and the latex have the same non-specific adsorption and are immobilized, when a complex of mouse anti-human HbA1c monoclonal antibody and goat anti-mouse IgG antibody is added, a complex of HbA1 c-mouse anti-human HbA1c monoclonal antibody-goat anti-mouse IgG antibody in the latex-whole blood sample is formed, and the amount of the complex generated is positively correlated with the percentage content of HbA1c in the whole blood sample, and the complex is detected by the detection device, and the content of glycated hemoglobin (HbA1c) in the whole blood sample can be obtained by comparing the standard curve data stored in the magnetic card, so that the detection time is short and the operation process is simple. The reagent contains the antifreeze agent, so the kit has wide application range.
The performance of the kit 100 for measuring the content of glycated hemoglobin (HbA1c) was evaluated using the measuring device 1, the measuring device 2, and the measuring device 3 as follows:
(1) positive reference range
Preparing a medicinal preparation for treating diseases of the subjective health, no digestive system diseases (liver cirrhosis, hepatitis, fatty liver disease, gallstone, cholecystitis, chronic diarrhea and the like), no acute and chronic infection (acute respiratory tract infection, pneumonia and tuberculosis), no kidney diseases (chronic kidney diseases, acute kidney injury and the like), no metabolic and nutritional diseases (diabetes, metabolic syndrome, dyslipidemia and the like), no rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus and the like), no thyroid diseases (hyperthyroidism, hypothyroidism), no blood system diseases (anemia, leukemia and the like), no obesity, high blood pressure, burn and muscle wound; no blood donation, blood transfusion, massive blood loss, surgery or drug administration has recently occurred, and women are not in pregnancy or lactation. The normal people have no sex difference and no requirements of age groups. Specimens 20-79 years old are selected, each 10 years old is taken as an age group, 3-4 persons in each age group are divided into 20 persons in all. Collecting blood of the normal person, and removing unqualified samples such as lipemia, hemolysis and jaundice to obtain a whole blood sample 1-20. The whole blood samples 1-20 were tested using the test device 1, test device 2 and test device 3, respectively, and the data is recorded in table 1.
In the detected data, if there is data that is likely to be outliers, the difference D between the detection result of the likely outliers and its neighboring value is divided by the data population R, and if D/R is equal to or greater than 1/3, the detected data is considered to be outliers. Less than 20 cases need to be complemented after outliers are eliminated. The 20 measured values are compared with a reference range to be verified, and if no more than 2 measured values fall outside the reference limit, the reference range can be used directly. If 3 or more than 3 measured values exceed the reference limit, 20 persons are screened again for verification, if no more than 2 measured values exceed the reference range, the method can be used, if 3 or more than 3 measured values still exceed the reference limit, the used analysis system is rechecked, whether the people group difference exists or not is considered, and whether the reference range needs to be established by self or not is considered.
TABLE 1 Positive reference range validation data statistics Table
| Whole blood sample | Age (age) | Sex | Detection device 1 | Detection device 2 | Detection device 3 |
| Whole blood sample 1 | 23 | Woman | 5.24 | 5.334 | 5.15 |
| Whole blood sample 2 | 27 | For male | 5.40 | 5.519 | 5.50 |
| Whole blood sample 3 | 29 | For male | 5.36 | 5.436 | 5.29 |
| Whole blood sample 4 | 31 | Woman | 4.53 | 4.572 | 4.49 |
| Whole blood sample 5 | 34 | Woman | 5.61 | 5.831 | 5.58 |
| Whole blood sample 6 | 38 | For male | 5.57 | 5.704 | 5.61 |
| Whole blood sample 7 | 40 | Woman | 4.72 | 4.746 | 4.67 |
| Whole blood sample 8 | 42 | For male | 5.27 | 5.305 | 5.15 |
| Whole blood sample 9 | 45 | For male | 5.46 | 5.517 | 5.63 |
| Whole blood sample 10 | 47 | For male | 4.64 | 4.862 | 4.71 |
| Whole blood sample 11 | 51 | Woman | 5.56 | 5.459 | 5.46 |
| Whole blood sample 12 | 54 | Woman | 5.11 | 5.237 | 5.08 |
| Whole blood sample 13 | 56 | For male | 5.69 | 5.540 | 5.60 |
| Whole blood sample 14 | 59 | For male | 5.85 | 5.913 | 5.79 |
| Whole blood sample 15 | 61 | Woman | 5.93 | 5.861 | 5.88 |
| Whole blood sample 16 | 64 | Woman | 5.55 | 5.748 | 5.43 |
| Whole blood sample 17 | 66 | Woman | 5.73 | 5.945 | 5.67 |
| Whole blood sample 18 | 71 | For male | 5.89 | 5.622 | 5.74 |
| Whole blood sample 19 | 75 | For male | 6.04 | 6.004 | 6.11 |
| Whole blood sample 20 | 77 | Woman | 5.69 | 5.813 | 5.74 |
As can be seen from Table 1, the percentage of glycated hemoglobin (HbA1c) in the whole blood sample tested using the kit 100 has a positive reference range of 4.2% to 6.2%, and meets the test criteria.
(2) Sensitivity of analysis
Repeating the test 10 times with physiological saline as blank sample, and calculating the average value of the test results according to formula (1) and formula (2)
And standard deviation (S), detecting the lower limit
Should be less than 2% analytical sensitivity and the test results are reported in table 2.
In the formula:
xi-the ith test concentration value;
n-number of tests.
TABLE 2 HbA1c analysis sensitivity test results
As can be seen from Table 2, the analytical sensitivity of the kit 100 for testing glycated hemoglobin (HbA1c) is less than 2%, and the test results meet the test standards of the test margin, so that the analytical sensitivity of the kit 100 for testing glycated hemoglobin (HbA1c) meets the test requirements.
(3) Linear range
Using a high concentration (active) whole blood sample near the upper limit of the linear region, 6 dilution concentrations (x) were mixed at the dilution ratios shown in Table 3i) The kits were tested separately, 3 times for each dilution concentration, and the mean (y) of the test results was determined separatelyi). In diluted concentration (x)i) As independent variable, the mean value (y) of the detection results is usedi) Linear regression equations were solved for the dependent variables. And (3) calculating a correlation coefficient (r) of linear regression according to the formula (3), wherein the test result is in accordance with the condition that r is more than or equal to 0.990 within the range of 2-15%, and the test result is recorded in a table 4.
TABLE 3 dilution ratio example table
| Serial number | 0 | 1 | 2 | 3 | 4 | 5 |
| High concentration(active) Whole blood sample | 0 portion of | 1 part of | 2 portions of | 3 portions of | 4 portions of | 5 portions of |
| Sample diluent | 5 portions of | 4 portions of | 3 portions of | 2 portions of | 1 part of | 0 portion of |
In the formula:
xi-the ith test concentration value;
yi-the estimate of the ith time;
i—1，2，3，……，n。
TABLE 4 HbA1c Linear test results%
As can be seen from Table 4, the correlation coefficient (r) of the linear regression was calculated according to the formula (3), the i-th estimated value and the average value of the reagent estimated results were each in the range of 2% to 15%, and the correlation coefficient r of the linear regression was measured to be 0.9990 or more than 0.990, so that hemoglobin (HbA1c) was detected using the kit, and the linear regression coefficient thereof satisfied the specification of the linear range.
(4) Accuracy (relative deviation is less than or equal to +/-7%)
The Certified Reference Material (CRM) or other recognized reference material (IFCC) that can be used to evaluate the conventional method was tested separately, and the test results were recorded as (X) with 3 replicates per sample concentrationi) Calculating the relative deviations (B) according to the formula (4) respectivelyi) If the results of 3 times are less than or equal to +/-7 percent, judging the product to be qualified; if the results of more than or equal to 2 times are not met, judging that the product is unqualified; if the result of 1 time does not meet the value less than or equal to +/-7 percent, continuously testing for 20 times again, and respectively calculating the relative deviation B according to the formula (4)iIf the results are less than or equal to +/-7 percent when the results are more than or equal to 19 times, judging the product to be qualified. The test results are reported in table 5.
In the formula:
Bi-relative deviation,%;
Xi-determining the concentration;
t-reference substance calibration concentration.
TABLE 5 HbA1c accuracy test results
As can be seen from Table 5, the relative deviation (B) was calculated by substituting the test results and target values in Table 5 into the formula (4)i) Are all within +/-7 percent, so the kit 100 has high accuracy and meets the test requirements.
(5) Repeatability within a batch (CV is less than or equal to 3%)
The kit 100 is used to test the high concentration (the concentration is not lower than the reference range upper limit 30 percent) in the linear range respectivelyWhole blood samples of the above, low (concentration within the reference range) and two different concentration levels, each of which was repeatedly tested 10 times, were subjected to the calculation of the mean value of the measured values according to the equations (5) and (6), respectively
And standard deviation (S), calculating Coefficient of Variation (CV) according to formula (7), wherein CV is less than or equal to 3%, and the test results are shown in Table 6.
In the formula:
CV — coefficient of variation;
xi-the ith test concentration value;
n-number of tests.
TABLE 6 HbA1c repeatability test results
As can be seen from Table 6, the kit 100 is used for testing the HbA1c batch repeatability test experiments, and the experimental results show that after the kit 100 is used for testing 10 times by using three different detection devices, the variation coefficients of the test results are all less than 3%, and the repeatability of the kit used for testing the HbA1c batch is good.
(6) Freezing stability (Bias is less than or equal to +/-7%)
Preparing 4 parts of group A reagent (in a refrigerator at 2-8 deg.C) and group B reagent (in a refrigerator at-20 deg.C), respectively placing into corresponding temperatureIn the refrigerator, the group A and the group B are one set and 4 sets in total, and one set is measured each time, so that pollution is avoided. The test samples are clinical samples, the concentration ranges of the clinical samples are shown in the attached table 7, and the concentration ranges are respectively as follows: 2 low value samples and 4 positive samples (2 low value positive samples and 2 high value positive samples); 2 quality control products (Landau level 1, Landau level 2, batch selection). Starting a first set of sealing reagents from the 2 nd day of the beginning to perform sample deviation test, simultaneously unfreezing the other 3 parts of the group B reagents together, and putting the thawed reagents into a refrigerator at the temperature of 20 ℃ below zero for freezing storage; opening the second sleeve reagent for sample deviation test from the 4 th day of the beginning, simultaneously unfreezing the rest 2 parts of the group B reagent together, and putting the B reagent into a refrigerator at the temperature of 20 ℃ below zero for freezing storage after the B reagent is completely thawed; and measuring one set of reagents every two days, and repeating the steps in the same way, namely freezing and storing the first set of group B reagents for 1 time, repeatedly freezing and storing the second set of group B reagents for 2 times, repeatedly freezing and storing the third set of group B reagents for 3 times, and repeatedly freezing and storing the fourth set of group B reagents for 4 times. In the testing process, the detection equipment is started, preheated for 30min and preheated after the completion of the testing. Preparing for testing, placing the reagent of the group B at room temperature until the reagent is completely melted, placing the reagent and the group A into a reagent bin simultaneously, and covering an outer cover of the detection equipment; the sample was taken out of the refrigerator and left at room temperature for 15min, and equilibrated to room temperature. Testing group A reagents for 3 times, testing samples from low to high concentration, and recording the test result as (X)i) After the group A test is finished, the group B reagent test is carried out, and the group B test is carried out by the same test method as the group A. The two groups of reagents test the same sample, the average value of the test result of each sample of the group A reagents, namely (T) in the formula (4), is respectively calculated according to the formula (1), and the relative deviation (B) of each measured value of each sample is calculated according to the formula (4)i). If the results are less than or equal to +/-7 percent in all the 3 times, judging the product to be qualified; if the results of more than or equal to 2 times are not met, judging that the product is unqualified; if the result of 1 time does not meet the value less than or equal to +/-7 percent, continuously testing for 20 times again, and respectively calculating the relative deviation B according to the formula (4)iIf the results are less than or equal to +/-7 percent when the results are more than or equal to 19 times, judging the product to be qualified. The test results are shown in tables 8 and 9.
TABLE 7 clinical test sample concentration ranges
TABLE 8 HbA1c Freeze storage stability test results
TABLE 9 HbA1c Freeze stability test results
As can be seen from tables 8 and 9, the cryopreservation stability of the kit 100 is tested, and the experimental results show that the cryopreservation stability of the kit 100 meets the standard. The kit 100 can be used after repeated four cryopreservation.
In an embodiment of the invention, the kit comprises a shell, a reagent, a magnetic card and a stirrer. The reagent comprises: the serum-free anti-inflammatory agent comprises diluent, antiserum and latex, wherein the diluent is distilled water; the antiserum comprises a first phosphate buffer solution, sodium chloride, a mouse anti-human HbA1c monoclonal antibody and a sheep anti-mouse IgG antibody, wherein the mass ratio of the first phosphate buffer solution, the sodium chloride, the mouse anti-human HbA1c monoclonal antibody to the sheep anti-mouse IgG antibody is (9000) -12000): (13000-17000): (1-2): 1; the latex comprises latex particles, a second phosphate buffer solution and an antifreeze agent, wherein the mass ratio of the latex particles to the second phosphate buffer solution is 1: (9-12), wherein the concentration of the antifreeze agent is 1% -10%. The kit is used for detecting the content of the glycosylated hemoglobin (HbA1c), the detection time is short, and the operation process is simple. The reagent contains the antifreeze agent, so the kit has wide application range.
The embodiment of the invention also provides a detection system, which comprises detection equipment and the kit 100. The detection apparatus is adapted to detect the content of glycated hemoglobin (HbA1c) using the kit 100.
The detection method of the detection device for detecting the content of the glycated hemoglobin (HbA1c) by using the kit 100 is as follows:
diluting the sample, namely accurately adding the 20 mu L whole blood sample into a centrifugal tube containing the 1000 mu L diluent, tightly covering the tube cover, slightly shaking and uniformly mixing, and detecting after 2 minutes;
starting up to display a main test interface, selecting a required test item and a sample type in an item column of the main test interface of the detection equipment, and selecting whole blood as the sample type;
clicking 'batch number' in a batch number column, entering a card swiping interface, contacting the magnetic card of the corresponding item with the upper part of the magnetic card induction area of the instrument, hearing 'dropping' sound, indicating that the card swiping is successful, and automatically returning the interface to the main measuring interface. Wherein, the same reagent only needs to be punched once;
taking out the test cup under the prompt of the detection equipment, adding the stirrer into the test cup, accurately adding 300 mu l of the latex, then adding the diluted whole blood sample of 10 mu L, putting the test cup into a measurement channel, and automatically stirring the instrument once;
adding antiserum at the prompt of the detection equipment, and then accurately adding 100 mu l of the antiserum by using a pipette;
and immediately pressing a trigger key of a corresponding channel, automatically stirring by the detection equipment, and after the test is finished, displaying a measurement result and automatically printing the test result by the detection equipment.
In some embodiments, the detection apparatus is a fully automatic detection apparatus which detects the content of glycated hemoglobin (HbA1c) using the kit 100 by a detection method comprising:
starting up to display a main test interface, and selecting a project to be tested and a sample type in a project bar;
clicking 'batch number' in a batch number column, entering a card swiping interface, contacting the magnetic card of the corresponding item with the upper part of the magnetic card induction area of the instrument, successfully swiping the card, automatically returning the interface to a main measurement interface, and swiping the same batch of reagent only once; and putting the whole blood sample under a sampling needle, and automatically sucking the sample by the full-automatic detection equipment and automatically finishing the measurement process. After the test is completed, the instrument displays the measurement result and automatically prints the test result.
Finally, it should be noted that: the above examples are only intended to illustrate the technical solution of the present invention, but not to limit it; within the idea of the invention, also technical features in the above embodiments or in different embodiments may be combined, steps may be implemented in any order, and there are many other variations of the different aspects of the invention as described above, which are not provided in detail for the sake of brevity; although the present invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; and the modifications or the substitutions do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present invention.
Claims (11)
1. The kit is characterized by comprising a shell, a reagent, a magnetic card and a stirrer;
the shell is provided with an accommodating space, the reagent is accommodated in the accommodating space, the magnetic card and the stirrer are both arranged in the shell, and the magnetic card stores standard curve information of the kit;
the reagent comprises: the serum-free anti-inflammatory agent comprises diluent, antiserum and latex, wherein the diluent is distilled water; the antiserum comprises a first phosphate buffer solution, sodium chloride, a mouse anti-human HbA1c monoclonal antibody and a sheep anti-mouse IgG antibody, wherein the mass ratio of the first phosphate buffer solution, the sodium chloride, the mouse anti-human HbA1c monoclonal antibody to the sheep anti-mouse IgG antibody is (9000) -12000): (13000-17000): (1-2): 1; the latex comprises latex particles, a second phosphate buffer solution and an antifreeze agent, wherein the mass ratio of the latex particles to the second phosphate buffer solution is 1: (9-12), wherein the concentration of the antifreeze agent is 1% -10%.
2. The kit according to claim 1, wherein the mass ratio of the first phosphate buffer, sodium chloride, the murine anti-human HbA1c monoclonal antibody and the goat anti-mouse IgG antibody is preferably 10283: 15800: 1.5: 1.
3. the kit according to claim 1, wherein the mass ratio of the latex particles to the second phosphate buffer is preferably 1: 10.28.
4. the kit of claim 1, wherein the cryoprotectant comprises mannitol, trehalose, sucrose, and glycerol.
5. The kit of claim 4, wherein the concentrations of mannitol, trehalose, sucrose and glycerol are 5%, 2% and 1%, respectively.
6. The kit of claim 1, wherein the first phosphate buffer and the second phosphate buffer are each at a concentration of 20 mmol/L.
7. The kit of claim 1, wherein the concentration of sodium chloride is 15.8 g/L.
8. The kit of claim 1, wherein said murine anti-human HbA1c monoclonal antibody is present at a concentration of 1.5 mg/L.
9. The kit of claim 1, wherein the concentration of the goat anti-mouse IgG antibody is 1 mg/L.
10. The kit of claim 1, wherein the concentration of the latex particles is 1 g/L.
11. A test system comprising a test device and a kit according to any one of claims 1 to 10.
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| CN114689874A (en) * | 2022-06-01 | 2022-07-01 | 深圳市帝迈生物技术有限公司 | D-dimer reagents for liquid stabilization and freeze-thaw resistance |
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Application publication date: 20200710 |