CN111426846A - Kit and detection system - Google Patents

Kit and detection system Download PDF

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Publication number
CN111426846A
CN111426846A CN202010268933.4A CN202010268933A CN111426846A CN 111426846 A CN111426846 A CN 111426846A CN 202010268933 A CN202010268933 A CN 202010268933A CN 111426846 A CN111426846 A CN 111426846A
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kit
buffer solution
phosphate buffer
serum amyloid
mass ratio
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朱漩
张尤吉
刘伟
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Genrui Biotech Inc
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Genrui Biotech Inc
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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
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6893—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
    • 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
    • G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
    • G01N33/57484—Immunoassay; Biospecific binding assay; Materials therefor for cancer involving compounds serving as markers for tumor, cancer, neoplasia, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides, metabolites
    • G01N33/57488—Immunoassay; Biospecific binding assay; Materials therefor for cancer involving compounds serving as markers for tumor, cancer, neoplasia, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides, metabolites involving compounds identifable in body fluids
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/46—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans from vertebrates
    • G01N2333/47—Assays involving proteins of known structure or function as defined in the subgroups

Abstract

The embodiment of the invention relates to the technical field of chemical analysis, in particular to a kit and a detection system, wherein the kit comprises a shell, a reagent, a magnetic card and a stirrer, the reagent comprises antiserum, a buffer solution and a quality control product, the antiserum comprises a first phosphate buffer solution and latex particles coupled with goat anti-human serum amyloid A polyclonal antibody, the buffer solution comprises a second phosphate buffer solution, sodium chloride and sodium azide, the quality control product comprises a solution containing serum amyloid A, the mass ratio of the first phosphate buffer solution to the latex particles coupled with the goat anti-human serum amyloid A polyclonal antibody is (3-10): 1, the mass ratio of the second phosphate buffer solution to the sodium chloride is (1-2), the mass ratio of the second phosphate buffer solution to the sodium azide is (9-12): 1, the concentration of the amyloid serum A in the quality control product is 5-300 mg/L, the content of the serum amyloid A is detected by using the kit, the detection time is short, and the operation process is simple.

Description

Kit and detection system
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
Serum Amyloid A (SAA) is a precursor substance of tissue amyloid A, is a polymorphic protein encoded by multiple genes, and belongs to acute phase reaction protein [1] according to the expression condition, the SAA can be divided into two types, namely, constitutive SAA (C-SAA) and acute phase SAA (A-SAA). under the normal condition, the SAA in a human body is mainly derived from the C-SAA in liver cells and accounts for more than 90 percent of the total amount of the SAA. when the human body is stimulated, such as inflammation, infection, tumor and the like, the human body releases a large amount of proinflammatory factors (such as interleukin, tumor necrosis factor- α and the like) so that the A-SAA is synthesized in a large amount, becomes the SAA which is mainly in the human body at the moment, and rapidly rises by 1000 times within 5-6 hours and rapidly falls in the recovery phase of the disease.
At present, an enzyme-linked immunosorbent assay is often adopted to detect serum amyloid A. The enzyme-linked immunosorbent assay adopts horseradish peroxidase or alkaline phosphatase to mark an antibody, catalyzes a substrate to generate color change, and has the characteristics of strong specificity and long reagent stability period.
However, in the process of implementing the embodiment of the present invention, the inventors of the present invention found that: the ELISA method has low detection sensitivity and complex operation steps, and requires a standard curve at the same time during each detection, which is time-consuming and labor-consuming.
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 one aspect of the embodiment of the invention, the kit comprises a shell, a reagent, a magnetic card and a stirrer, wherein the shell is provided with an accommodating space, the reagent is accommodated in the accommodating space, the magnetic card and the stirrer are arranged in the shell, the magnetic card stores standard curve information of the kit, the reagent comprises antiserum, a buffer solution and a quality control product, the antiserum comprises a first phosphate buffer solution and latex particles coupled with goat anti-human serum amyloid A polyclonal antibody, the buffer solution comprises a second phosphate buffer solution, sodium chloride and sodium azide, the quality control product comprises a solution containing serum amyloid A, the mass ratio of the first phosphate buffer solution to the latex particles coupled with the goat anti-human serum amyloid A polyclonal antibody is (3-10): 1, the mass ratio of the second phosphate buffer solution to the sodium chloride is 1 (1-2), the mass ratio of the second phosphate buffer solution to the sodium azide is (9-12): 1, and the concentration of the amyloid A in the quality control product is 5-300 mg/L.
In an alternative mode, the mass ratio of the first phosphate buffer to the latex particles coupled with the goat anti-human serum amyloid a polyclonal antibody is preferably 5.14: 1.
in an alternative mode, the concentration of the latex particles coupled with the goat anti-human serum amyloid A polyclonal antibody is 2 g/L.
In an alternative mode, the mass ratio of the second phosphate buffer to the sodium chloride is preferably 1: 1.54.
in an alternative mode, the mass ratio of the second phosphate buffer solution to the sodium azide is preferably 10.82: 1.
in an alternative form, the sodium chloride is present at a concentration of 15.8 g/L.
In an alternative embodiment, the sodium azide is present at a concentration of 0.95 g/L.
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 mode, the concentration of the serum amyloid A solution in the quality control product is 55 mg/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 kit provided by the embodiment of the invention has the beneficial effects that the kit is different from the existing kit, the kit comprises 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 arranged in the shell, the magnetic card stores standard curve information of the kit, the reagent comprises antiserum, a buffer solution and a quality control product, wherein the antiserum comprises a first phosphate buffer solution and latex particles coupled with goat anti-human serum amyloid A polyclonal antibody, the buffer solution comprises a second phosphate buffer solution, sodium chloride and sodium azide, the quality control product comprises a solution containing serum amyloid A, the mass ratio of the first phosphate buffer solution to the latex particles coupled with the goat anti-human serum amyloid A polyclonal antibody is (3-10): 1, the mass ratio of the second phosphate buffer solution to the sodium chloride is (1-2), the mass ratio of the second phosphate buffer solution to the sodium azide is (9-12): 1, the concentration of the serum amyloid A in the quality control product is 355-300 mg, and the reagent is not required for detecting the amyloid content of the serum in a standard curve in a simple field test process.
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 embodiment of the invention provides a kit, which is suitable for detecting the content of serum amyloid A in a blood sample. 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 blood sample to be tested, so that the blood sample and the reagent are fully mixed, and the accuracy of the test result is improved. In some embodiments, the beater 103 is a stainless steel product.
The reagent comprises: antiserum, buffer solution and quality control product.
For the antiserum, the antiserum comprises a first phosphate buffer and latex particles coupled with goat anti-human serum amyloid A polyclonal antibody, wherein the mass ratio of the first phosphate buffer to the latex particles coupled with the goat anti-human serum amyloid A polyclonal antibody is (3-10): 1, preferably, the mass ratio of the first phosphate buffer to the latex particles coupled with the goat anti-human serum amyloid A polyclonal antibody is 5.14: 1, the concentration of the first phosphate buffer is 20 mmol/L, the concentration of the latex particles coupled with the goat anti-human serum amyloid A polyclonal antibody is 2 g/L, the first phosphate buffer is composed of sodium dihydrogen phosphate and disodium hydrogen phosphate, wherein the sodium dihydrogen phosphate is strong in acidity, and when the pH value in blood is too high, alkali of redundant human serum is combined with the sodium dihydrogen phosphate to generate the disodium hydrogen phosphate, and when the pH value is too low, the redundant acid reacts with the disodium hydrogen phosphate to generate sodium dihydrogen phosphate, so that the pH value of human blood is adjusted.
For the buffer solution, the buffer solution comprises a second phosphate buffer solution, sodium chloride and sodium azide, wherein the concentration of the second phosphate buffer solution is the same as that of the first phosphate buffer solution and is 20 mmol/L, the mass ratio of the second phosphate buffer solution to the sodium chloride is 1 (1-2), preferably, the mass ratio of the second phosphate buffer solution to the sodium chloride is 1: 1.54, the mass ratio of the second phosphate buffer solution to the sodium azide is (9-12): 1, preferably, the mass ratio of the second phosphate buffer solution to the sodium azide is 10.82: 1, the sodium chloride is used for adjusting the ionic strength of the solution and avoiding causing change of the osmotic pressure of cells, the concentration of the sodium chloride is 15.8 g/L, the sodium azide is used as a preservative, and the concentration of the sodium azide is 0.95 g/L.
For the quality control product, the quality control product comprises a solution containing serum amyloid A, the concentration of the serum amyloid A solution is 5-300 mg/L, preferably, the concentration of the serum amyloid A solution is 50-60 mg/L, the target value of the quality control product is known, and the quality control product is used for identifying whether the measurement result of the detection device is accurate.
Specifically, the goat anti-human serum amyloid a polyclonal antibody is coupled to a latex particle, and specifically binds to serum amyloid a in the blood sample to form a latex particle-antibody-serum amyloid a antigen immune complex. Since the amount of the immune complex generated is positively correlated with the serum amyloid a concentration in the blood sample, the immune complex is detected by the detection device, and the serum amyloid a content in the blood sample can be obtained by comparing the standard curve data stored in the magnetic card, so that the serum amyloid a content in the blood sample can be detected by using the kit 100.
The performance of the kit 100 for detecting the content of serum amyloid A is evaluated by using a detection device 1, a detection device 2, a detection device 3 and a detection device 4, and the method comprises the following steps:
(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 blood sample 1-20. The 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
Figure BDA0002442328430000061
Figure BDA0002442328430000071
As can be seen from table 1, the percent content of serum amyloid a in the blood sample tested by using the kit 100 has a positive reference range of 4.2% to 6.2%, and meets the test standard.
(2) Determination of a margin
Repeating the test 20 times with physiological saline as blank sample, and calculating the average value of the test results according to formula (1) and formula (2)
Figure BDA0002442328430000072
And standard deviation (S), the Detection lower limit (L lower L it of Detection,
Figure BDA0002442328430000073
should be less than the blank limit of 5 mg/L and the test results are reported in Table 2.
Figure BDA0002442328430000074
Figure BDA0002442328430000075
In the formula:
xi-the ith test concentration value;
n-number of tests.
TABLE 2 blank limit test results
Figure BDA0002442328430000081
As can be seen from Table 2, the blank limit of serum amyloid A is tested by using the kit 100, the test results are all less than 5 mg/L, and the test standards of the blank limit are met, so that the blank limit of serum amyloid A tested by using the kit 100 meets the test requirements.
(3) Linear range
Using a high concentration (active) blood sample near the upper limit of the linear region, 6 dilution concentrations (x) were mixed at the dilution ratio 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) blood sample 0 portion of 1 part of 2 portions of 3 portions of 4 portions of 5 portions of
Blood sample diluent 5 portions of 4 portions of 3 portions of 2 portions of 1 part of 0 portion of
Figure BDA0002442328430000091
In the formula:
xi-the ith test concentration value;
Figure BDA0002442328430000092
-reagent test result averages;
yi-the estimate of the ith time;
Figure BDA0002442328430000093
-average value of reagent estimates;
i—1，2，3，……，n。
table 4 serum amyloid a linear test results%
Figure BDA0002442328430000101
As can be seen from Table 4, the correlation coefficient (r) of linear regression was calculated according to the formula (3), the estimated value of the i-th time and the average value of the reagent estimation results were all in the range of 5 mg/L to 300 mg/L and the correlation coefficient r of linear regression was determined to be 0.9988 greater than 0.990, and thus, serum amyloid A was tested using the kit 100, and the linear regression coefficient thereof satisfied the specification of the linear range.
(4) Accuracy (relative deviation is less than or equal to +/-15%)
Respectively testing a Certified Reference Material (CRM) or other generally recognized (IFCC) reference material which can be used for evaluating a conventional method or human samples with three concentrations of high, medium and low, which are determined by the reference method, repeatedly detecting each concentration sample for 3 times, respectively taking the mean value of the test results, and judging the test results to be qualified if the relative deviation (B) is less than or equal to +/-15 percent according to a formula (4), wherein the test results are shown in a table 5.
Figure BDA0002442328430000102
In the formula:
m is a test mean value;
t-the value of the evidence of the reference substance (target value), or the value of the human sample at each concentration.
TABLE 5 serum amyloid A accuracy test results
Figure BDA0002442328430000111
As can be seen from Table 5, the test mean value and the target value in Table 5 are respectively substituted into the formula (4) for calculation, and the obtained relative deviation B is within +/-15%, so that the kit is high in accuracy and meets the test requirements.
(5) Repeatability within a batch (CV is less than or equal to 8%)
The kit 100 is used to test a medically determined level of a normal concentration control substance and an abnormal concentration control substance, respectively, each of which is repeated 10 times, and the average value of the measured values is calculated according to the formula (5) and the formula (6), respectively
Figure BDA0002442328430000121
And standard deviation (S), calculating Coefficient of Variation (CV) according to formula (7), wherein CV is less than or equal to 8%, and the test results are shown in Table 6.
Figure BDA0002442328430000122
Figure BDA0002442328430000123
Figure BDA0002442328430000124
In the formula:
CV — coefficient of variation;
xi-the ith test concentration value;
n-number of tests.
TABLE 6 serum amyloid A reproducibility test results
Figure BDA0002442328430000125
Figure BDA0002442328430000131
As can be seen from table 6, the experimental results of the batch repetitive quality control test experiments for testing serum amyloid a by using the kit 100 show that after the quality control product in the same kit 100 is tested for 10 times by using four different detection devices, the variation coefficients of the test results are all less than 8%, and the repeatability of testing serum amyloid a in the same batch of kit 100 is good.
(6) Difference between batches (R is less than or equal to 10%)
The same control substance was tested with 3 different lot numbers of the kit 100 (kit 1, kit 2 and kit 3), each lot number was tested 3 times, and the mean of 3 replicate determinations for each lot number was calculated according to equation (5)
Figure BDA0002442328430000132
Calculate the mean of all measurements according to equation (8)
Figure BDA0002442328430000133
And calculating the relative range (R) of the three batch number reagents according to the formula (9), wherein the obtained result is less than or equal to 10 percent, and the test results are shown in a table 7.
Figure BDA0002442328430000134
Figure BDA0002442328430000135
In the formula:
Figure BDA0002442328430000136
—
Figure BDA0002442328430000137
maximum value of (1);
Figure BDA0002442328430000138
—
Figure BDA0002442328430000139
minimum value of (1);
Figure BDA00024423284300001310
-overall mean value.
TABLE 7 results of inter-batch Difference in serum amyloid A test
Figure BDA0002442328430000141
As can be seen from table 7, the detection device 1, the detection device 2, the detection device 3, and the detection device 4 respectively test the control substance with the same concentration through the 3 different lot numbers of the kit 100, and the test results show that the relative range (R) measured by the three lot number kits is respectively 4.17%, 4.11%, 4.81%, and 4.60%, and the test results are all less than 10%, which indicates that the lot-to-lot difference of the kit 100 is relatively small and meets the test requirements.
(7) Specificity (Bias is less than or equal to +/-10%)
The experimental method refers to interference evaluation documents of C L SI EP07-A2 clinical chemical examination to make and evaluate the conventional anti-interference capability of the kit to be detected.
Taking a quality control product or a calibrator with known concentration as a sample, subpackaging the sample into 6 centrifugal tubes, wherein the label is No. 0-5, repeatedly testing the No. 0 sample for 5 times, obtaining a measurement result mean value (TV) according to a formula (5) as a sample index value, adding about 30mg/d L bilirubin into the No. 1 sample, adding 750mg/d L hemoglobin into the No. 2 sample, adding 400mg/d L triglyceride into the No. 3 sample, adding 30mg/d L ascorbic acid into the No. 4 sample, adding 10mg/d L rheumatoid factor into the No. 5 sample for measurement, repeatedly measuring for 3 times, obtaining the measurement result mean value after adding an interference substance according to the formula (5)
Figure BDA0002442328430000151
According to the calculation result of the formula (4), the result meets the requirement that after the interference substances are added, the relative deviation between the test result and the target value of the reference substance or the calibrator meets the requirement of less than or equal to +/-10 percent.
TABLE 8 serum amyloid A specificity test results
Figure BDA0002442328430000152
Figure BDA0002442328430000161
As can be seen from table 8, different interference factors are added to the quality control materials with known concentrations in the kit 100 for testing, and the results show that the relative deviations between the obtained test results and the reference materials are within ± 10%, and the kit 100 has good specificity and meets the test requirements.
In the embodiment of the invention, the kit comprises a shell, a reagent, a magnetic card and a stirrer, wherein the shell is provided with an accommodating space, the reagent is accommodated in the accommodating space, the magnetic card and the stirrer are arranged on the shell, the magnetic card stores standard curve information of the kit, the reagent comprises antiserum, a buffer solution and a quality control product, wherein the antiserum comprises a first phosphate buffer solution and latex particles coupled with goat anti-human serum amyloid A polyclonal antibody, the buffer solution comprises a second phosphate buffer solution, sodium chloride and sodium azide, the quality control product comprises a solution containing serum amyloid A, the mass ratio of the first phosphate buffer solution to the latex particles coupled with the goat anti-human serum amyloid A polyclonal antibody is (3-10): 1, the mass ratio of the second phosphate buffer solution to the sodium chloride is (1-2), the mass ratio of the second phosphate buffer solution to the sodium azide is (9-12): 1, the concentration of the amyloid A in the quality control product is 5-300 mg/L, the serum content of the amyloid A is detected by using the kit, the standard curve is not required by simple field test, and the operation process is not required.
The embodiment of the invention also provides a detection system, which comprises detection equipment and the kit 100. The detection device is suitable for detecting the serum amyloid A content by using the kit 100.
The detection method for detecting the content of the serum amyloid A by using the kit 100 by the detection equipment comprises the following steps:
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' on a batch number column, entering a card swiping interface, contacting the magnetic card with a magnetic card sensing area of the detection equipment, and hearing 'dropping' to indicate that the card swiping is successful, wherein the card swiping is only needed once for the same batch of the kit;
taking out the test cup under the prompt of the detection equipment, adding the stirrer into the test cup, accurately adding 400 mu l of the buffer solution, then adding 2 mu L of the blood sample, placing the test cup into a measurement channel, and automatically stirring by an instrument once;
the instrument interface prompts "please put the measuring cup";
taking out the test cup, adding a stirrer into the test cup, and accurately adding 400 mu l of buffer solution; then 2. mu.l of sample was added; placing the test cup into a measurement channel, and automatically stirring once by an instrument;
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 device is a fully automatic detection device, and the detection method for detecting the serum amyloid a content by using the kit 100 is as follows:
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, and contacting a magnetic card of a corresponding item with the upper part of the magnetic card induction area of the full-automatic detection equipment, wherein the same batch of the kit only needs to be swiped once; and placing the blood sample to a reagent position, 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.
When the detection device uses the kit 100 to perform serum amyloid A, a reagent used for testing does not need to be configured on site and a standard curve test does not need to be performed, so that the test time is saved, the detection efficiency is improved, and the test steps are simplified.
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 (10)

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 antiserum, buffer solution and a quality control product, wherein the antiserum comprises a first phosphate buffer solution and latex particles coupled with goat anti-human serum amyloid A polyclonal antibody, the buffer solution comprises a second phosphate buffer solution, sodium chloride and sodium azide, the quality control product comprises a solution containing serum amyloid A, the mass ratio of the first phosphate buffer solution to the latex particles coupled with the goat anti-human serum amyloid A polyclonal antibody is (3-10): 1, the mass ratio of the second phosphate buffer solution to the sodium chloride is 1: (1-2), the mass ratio of the second phosphate buffer solution to the sodium azide is (9-12): 1, and the concentration of the serum amyloid A in the quality control product is 5-300 mg/L.
2. The kit according to claim 1, wherein the mass ratio of the first phosphate buffer to the latex particles conjugated with goat anti-human serum amyloid A polyclonal antibody is preferably 5.14: 1.
3. the kit according to claim 1, wherein the concentration of the latex particles conjugated to goat anti-human serum amyloid A polyclonal antibody is 2 g/L.
4. The kit according to claim 1, wherein the mass ratio of the second phosphate buffer to the sodium chloride is preferably 1: 1.54.
5. the kit according to claim 1, wherein the mass ratio of the second phosphate buffer solution to the sodium azide is preferably 10.82: 1.
6. the kit of claim 4, wherein the concentration of sodium chloride is 15.8 g/L.
7. The kit of claim 1, wherein the concentration of sodium azide is 0.95 g/L.
8. The kit of claim 1, wherein the first phosphate buffer and the second phosphate buffer are each at a concentration of 20 mmol/L.
9. The kit of claim 1, wherein the concentration of serum amyloid A solution in the quality control product is 50-60 mg/L.
10. A test system comprising a test device and a kit according to any one of claims 1 to 9.
CN202010268933.4A 2020-04-08 2020-04-08 Kit and detection system Pending CN111426846A (en)

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Application publication date: 20200717