CN111948385A - Kit for prenatal screening in pregnancy - Google Patents
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- CN111948385A CN111948385A CN202010806480.6A CN202010806480A CN111948385A CN 111948385 A CN111948385 A CN 111948385A CN 202010806480 A CN202010806480 A CN 202010806480A CN 111948385 A CN111948385 A CN 111948385A
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- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
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- 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
- G01N33/54366—Apparatus specially adapted for solid-phase testing
- G01N33/54386—Analytical elements
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
- G01N21/76—Chemiluminescence; Bioluminescence
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Abstract
The invention discloses a kit for prenatal screening in pregnancy, which comprises magnetic beads coated with a screening polyclonal antibody 1, an analysis buffer solution and an enzyme working solution, wherein the screening polyclonal antibody 1 is a mixture of AFP, Total beta hCG, PAPP-A, INHA and uE3 monoclonal antibody 1, the enzyme working solution comprises an enzyme-labeled screening polyclonal antibody 2, and the screening polyclonal antibody 2 is a mixture of AFP, Total beta hCG, PAPP-A, INHA and uE3 monoclonal antibody 2. The invention coats the screening polyclonal antibody 1 on the magnetic beads, and marks the screening polyclonal antibody 2 on the enzyme to form the enzyme working solution, wherein the polyclonal antibodies in the screening polyclonal antibody 1 and the screening polyclonal antibody 2 are mixtures of AFP, Total beta hCG, PAPP-A, INHA and uE3, which can obviously improve the sensitivity of the kit.
Description
Technical Field
The invention relates to the technical field of chemiluminescence enzyme immunoassay, in particular to a kit for prenatal screening in pregnancy.
Background
Prenatal Screening (Prenatal Screening) refers to Screening and diagnosing high-risk pregnant women carrying certain congenital defect fetuses from a pregnant woman group through an economical, simple and less-traumatic detection method, so that the birth of the defect infants is reduced to the maximum extent. Prenatal screening can be performed in the early pregnancy (10-14 weeks) and the middle pregnancy (15-20 weeks), and the most main disease in the screening is Down Syndrome (DS); AFP, Total betｃA-hCG, PAPP-A, INHA and uE3 are all important serum markers for prenatal screening, and ｃA prenatal screening system is composed of in-vitro diagnostic reagents, ｃA detection instrument and screening analysis software.
Down syndrome, also known as congenital foolproof or trisomy 21 syndrome, is the most common one of congenital defects in fetuses and has the following main clinical manifestations: serious mental retardation and foolproof complexion, about 50 percent of the cases are accompanied by abnormal developments such as congenital heart disease, leukemia, microcephaly, digestive tract deformity and the like, the occurrence of the abnormal developments is accidental and random, no symptom is provided in advance, no family history exists, no clear toxic contact history exists, the incidence rate can be increased along with the increase of the age of the pregnant women, the birth rate of the pregnant women accounts for 1/800-1/700 of live-born newborns, no treatment method exists at present, and therefore the method is an important means for reducing the birth of the sick infants by finding out high-risk pregnant women through prenatal screening and carrying out prenatal diagnosis on the pregnant women.
At present, prenatal diagnosis is mainly carried out clinically by methods such as amniotic fluid puncture or chorionic villus sampling, and the prenatal diagnosis is traumatic and has a 1-2% abortion rate. Therefore, in-vitro diagnostic screening for pregnant women in advance is the main method for prenatal screening in the future, but in most cases, methods such as enzyme immunization and fluorescence immunization are adopted for prenatal screening in China, so that the operation is complicated, the sensitivity is low, and the detection rate is not high.
Disclosure of Invention
The invention aims to provide a kit for prenatal screening in a pregnancy period, and solves the problems of complex operation, poor sensitivity and low detection rate of the existing prenatal screening means in the pregnancy period.
The invention is realized by the following technical scheme:
a kit for prenatal screening in pregnancy comprises magnetic beads coated with Ganodorman 1, an analysis buffer solution and an enzyme working solution, wherein the Ganodorman 1 is a mixture of AFP, Total beta hCG, PAPP-A, INHA and uE3 monoclonal antibody 1, the enzyme working solution comprises enzyme-labeled Ganodorman 2, and the Ganodorman 2 is a mixture of AFP, Total beta hCG, PAPP-A, INHA and uE3 monoclonal antibody 2.
The invention integrally adopts chemiluminescence enzyme immunoassay technology (CLEIA): in the case of the double antibody sandwich method, CLEIA labels an antibody with an enzyme such as alkaline phosphatase (ALP) that participates in a certain chemiluminescent reaction, immunoreactions with a corresponding antigen in a sample to be detected to form a solid phase coated antibody-antigen to be detected-enzyme labeled antibody complex, after washing, a substrate (a luminescent agent) is added, the enzyme catalyzes and decomposes the substrate to emit light, the substrate is received by a photon reading system, a photomultiplier converts an optical signal into an electrical signal and amplifies the electrical signal, and then the electrical signal and the electrical signal are transmitted to a computer data processing system to calculate the concentration of a specific substance.
The applicant proves through tests that: the screening polyclonal antibody 1(a mixture of AFP, Total beta hCG, PAPP-A, INHA and uE3 monoclonal antibody 1) coated on the magnetic beads can obviously improve the sensitivity of the kit, and has higher detection rate compared with other screening kits.
In conclusion, the chemiluminescence enzyme immunoassay technology is used for detecting the kit, so that the kit has high sensitivity and can realize full automation; the magnetic beads are coated with the screening polyclonal antibody 1, the enzyme is marked with the screening polyclonal antibody 2 to form an enzyme working solution, and the polyclonal antibodies in the screening polyclonal antibody 1 and the screening polyclonal antibody 2 are mixtures of AFP, Total beta hCG, PAPP-A, INHA and uE3 monoclonal antibodies, so that the sensitivity of the kit can be obviously improved, and compared with other screening kits, the detection rate is higher, and the use is more convenient.
Further, the preparation method of the magnetic beads for generating the screening polyclonal antibody 1 coating comprises the following steps:
diluting the dialyzed generated sieve polyclonal antibody 1 to a set concentration, carrying out biotin labeling on the diluted generated sieve polyclonal antibody 1 to obtain a biotin antibody, and coating the biotin antibody on naked magnetic beads to obtain magnetic beads coated with the generated sieve polyclonal antibody 1.
Further, the enzyme working solution was a mixture of 0.5% BSA buffer and enzyme-labeled Sieve-producing polyclonal antibody 2.
Further, the preparation method of the enzyme-labeled sieve-producing polyclonal antibody 2 comprises the following steps:
adding D-trehalose after alkaline phosphatase activation dialysis, mixing the dialyzed product-sieve multi-antibody 2 with a cross-linking agent for activation treatment, then dialyzing, adding the activated alkaline phosphatase into the activated product-sieve multi-antibody 2 for room-temperature rolling reaction to obtain the enzyme-labeled product-sieve multi-antibody 2.
Further, the assay buffer was prepared as follows:
calf serum was diluted with purified water to a concentration of 100 mL/L.
Further, the device also comprises a calibration material and a quality control material.
Further, the preparation method of the calibrator comprises the following steps:
dissolving and diluting the produced screening antigen, and preparing a 6-concentration calibrator point by using BSA buffer solution to obtain a calibrator.
Further, the preparation method of the quality control product comprises the following steps:
dissolving and diluting the produced and screened antigen, and preparing the antigen into quality control points with 2 concentrations by using BSA buffer solution to obtain a quality control product.
Compared with the prior art, the invention has the following advantages and beneficial effects:
1. the invention coats the screening polyclonal antibody 1 on the magnetic beads, and marks the screening polyclonal antibody 2 on the enzyme to form the enzyme working solution, wherein the polyclonal antibodies in the screening polyclonal antibody 1 and the screening polyclonal antibody 2 are mixtures of AFP, Total beta hCG, PAPP-A, INHA and uE3 monoclonal antibodies, which can obviously improve the sensitivity of the kit, and compared with other screening kits, the detection rate is higher, and the use is more convenient.
2. The kit is used for detecting by using a chemiluminescence enzyme immunoassay technology, has high sensitivity, and can realize full automation.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail below with reference to examples, and the exemplary embodiments and descriptions thereof are only used for explaining the present invention and are not used as limitations of the present invention.
Example 1:
a kit for prenatal screening in pregnancy comprises magnetic beads (3.3mL) coated with Ganodorman 1, an analysis buffer solution (4mL), an enzyme working solution (4mL), 0.5mL multiplied by 6 calibrators and 1.2mL multiplied by 2 quality control products, wherein the Ganodorman 1 is a mixture of AFP, Total beta hCG, PAPP-A, INHA and uE3 monoclonal antibody 1, the enzyme working solution comprises enzyme-labeled Ganodorman 2, and the Ganodorman 2 is a mixture of AFP, Total beta hCG, PAPP-A, INHA and uE3 monoclonal antibody 2.
The kit of the present example was used for detection of 50 persons.
The preparation method of the magnetic beads coated with the screening polyclonal antibody 1 comprises the following steps:
A. dialyzing 0.25mg of the screening polyclonal antibody 1 by using 5LPBS dialysate, taking out the dialyzed screening polyclonal antibody 1 and diluting to 0.5 mg/mL;
B. weighing 1.0mg of BNHS, fully dissolving with 217 mu LDMSO to prepare a BNHS solution with the concentration of 10mmol/L, wherein the BNHS (N-hydroxysuccinimide Biotin ester; EZ-Link NHS-LC-Biotin, 50mg, manufacturer: Thermo Prod # 21336);
C. mixing the dialyzed sieve-producing polyclonal antibody 1 and a 3.33 mu LBNHS solution, and reacting for 30 minutes to obtain a biotinylated sieve-producing polyclonal antibody 1;
D. dialyzing the biotinylated product-sieve polyclonal antibody 1 by PBS; adding glycerol with the same volume into the dialyzed biotinylated produced-sieve polyclonal antibody 1, and preserving at the temperature of minus 20 ℃;
E. coating magnetic beads on the biotinylated product-sieve polyclonal antibody 1 according to the coating amount of 10 ug/mg; the coated beads were diluted to the set concentration with 0.1% BSA buffer.
The preparation method of the analysis buffer solution comprises the following steps:
commercial calf serum purchased was diluted with purified water to a concentration of 100 mL/L.
The preparation method of the enzyme working solution comprises the following steps:
A. activation of alkaline phosphatase (ALP):
dialyzing 2mg of enzyme, and mixing the dialyzed enzyme and a cross-linking agent for reaction for 30 minutes; dialyzing the activated enzyme by PBS (phosphate buffer solution), and adding 3% of D-trehalose for preservation after dialysis is finished;
B. alkaline phosphatase (ALP) labeling screen-producing polyclonal antibody 2:
dialyzing 1mg of the produced screening polyclonal antibody 2; mixing the dialyzed generated sieve polyclonal antibody 2 with a cross-linking agent (SMCC) and reacting for 30 minutes; dialyzing the activated screening polyclonal antibody 2; taking out the dialyzed polyclonal antibody 2, adding into the activated enzyme, and rolling reacting at room temperature for 120 min; and diluting the enzyme-labeled product sieve polyclonal antibody 2 with 0.5% BSA buffer solution according to 1/2000 to obtain the enzyme-labeled product sieve polyclonal antibody 2 working solution.
The preparation method of the calibrator and the quality control product comprises the following steps:
commercially available screening antigens were dissolved and mixed as required by the manufacturer and diluted with 1% casein buffer to 6 calibrators and two quality control spots of appropriate concentration.
The use method of the screening kit comprises the following steps:
the kit in the embodiment uses a chemiluminescence method, is provided with a full-automatic chemiluminescence immunoassay analyzer, can realize full automation of a testing process, is internally provided with measurement parameters of a production sieve item, is used for carrying out calibration on a production sieve kit, carries out quality control testing after the calibration is finished, tests a patient sample after the test is confirmed to be passed, can automatically carry out detection by the instrument according to a reaction principle of the chemiluminescence method and the built-in reaction parameters, automatically carries out fitting analysis according to a calibration curve, quickly obtains a quantitative result, and transfers the result to Down's syndrome and neural tube defect risk assessment software, thereby obtaining the occurrence probability of the birth defect of the pregnant woman.
To verify the technical effect of the kit described in this example, the following experiments were performed:
experiment one: five monoclonal antibody kits are respectively prepared by AFP, Total betｃA hCG, PAPP-A, INHA and uE3 monoclonal antibodies, and six kit sensitivity comparisons are carried out by adopting ｃA mixed polyclonal antibody preparation screening polyclonal antibody kit.
Experimental materials: BNHS, 0.2mol/L PBS buffer, 0.1% BSA buffer, 0.5% BSA buffer, calf serum, 1% casein buffer, glycerol, DMSO, five monoclonal antibodies related to production and screening 1(AFP, Total β hCG, PAPP-A, INHA, uE3), five monoclonal antibodies related to production and screening 2(AFP, Total β hCG, PAPP-A, INHA, uE3), five antigens (AFP, Total β hCG, PAPP-A, INHA, uE3), production and screening polyclonal antibody 1, production and screening polyclonal antibody 2, production and screening antigen, naked magnetic beads, alkaline phosphatase (ALP), substrate solution, cleaning solution, and full-automatic chemiluminescence immunoassay analyzer.
Respectively coating five different monoclonal antibodies 1 and the screening polyclonal antibody 1 into magnetic bead working solution, marking five different monoclonal antibodies 2 and the screening polyclonal antibody 2 into enzyme working solution by adopting the method of the embodiment one, and combining the enzyme working solution and the prepared analysis buffer solution into 6 kits; the five antigens and the produced screening antigen are respectively prepared into a calibrator.
The 6 kits were used to perform calibrator tests on full-automatic chemiluminescence apparatus, and the sensitivity of the kits was compared, and the results are shown in tables 1 and 2:
TABLE 1
TABLE 2
And (4) experimental conclusion: as can be seen by comparing tables 1 and 2, the sensitivity of the screening polyclonal antibody kit is obviously improved compared with that of the rest five monoclonal antibody kits.
Experiment two: on the basis of the first experiment, detection rate comparison research objects of six kits are further carried out: pregnant women who are in clinical fixed-point hospitals for prenatal examination; adopting the principle of informed consent and signature, and carrying out antenatal screening on Down syndrome on 2000 pregnant women with single pregnancy; the age is 20-45 years, wherein more than 32 years 498 people account for 49.8% of the screened pregnant women, and the early pregnancy period and the middle pregnancy period of the pregnant women are respectively detected.
The research method comprises the following steps: (1) the method comprises the steps of strictly recording information of pregnant women coming for hospital detection, including the age, the gestational period and the body mass of the pregnant women during blood taking, obtaining venous blood centrifugal separation of the pregnant women to obtain serum, respectively testing the same human serum by using the 6 kits, respectively inputting six different test results into risk statistical software, calculating the probability of risk occurrence of Down syndrome through quantitative concentration measurement results and combining the age, the gestational period and the body mass of the pregnant women during blood taking, and performing data statistical analysis.
(2) Further checking the pregnant women with high risk, selecting proper means (ultrasonic diagnosis/amniocentesis) to carry out prenatal diagnosis under the condition that the pregnant women know the conditions, and finally carrying out confirmed diagnosis; if the diagnosis is determined to be abnormal, performing labor induction operation under the condition of informed consent to timely terminate pregnancy, and performing appearance and pathological anatomy examination after labor induction; if the high-risk pregnant woman does not want to further diagnose, the pregnant woman can make a strict follow-up diagnosis after delivery, and the suspected DS infant patient can be subjected to chromosome examination after birth.
The results of the experiment are shown in table 3:
in the above test results of 2000 cases of pregnant women with single pregnancy, 25 patients who were finally diagnosed were obtained, and by comparing the information of the clinically detected pregnant women with the information of the finally diagnosed patients, statistics of the number of false positives and the number of detected persons were performed in table 3 (detection rate and false positive rate statistics), and the detection rate and false positive rate were calculated.
TABLE 3
Detection rate: the abnormal fetus with the screening disease confirmed by the screening before delivery diagnosis accounts for the proportion of the born baby with the birth defect of the screened disease at the final delivery;
false positive rate: the proportion of pregnant women who are high-risk pregnant women in the screening but found no abnormality in the prenatal diagnosis, among the entire population participating in the screening.
And (4) experimental conclusion: in the sample screening of the above 2000 cases, the detection rates and the false positive rates of the six kits are obtained, wherein the detection rates of three monoclonal antibody kits of PAPP-A, AFP and Total betｃA-hCG are relatively close and are in the range of 36-48%; the detection rates of the two monoclonal antibody kits of the uE3 and the INHA are both very low, and are only 4%; the detection rate of the screening multi-resistance kit is obviously improved and can reach about 92%, and the false positive rate is also obviously reduced by only 3%.
For pregnant women who want to diagnose down syndrome at an early stage, the screening by using the birth-screening polyclonal antibody kit in combination with the age, the gestational period, the body mass and the like of the mother is an ideal screening method at present; the kit has no damage to the fetus, has little pain to the pregnant woman, is simple and convenient, is suitable for group screening, can effectively reduce the birth rate of children suffering from Down syndrome, achieves the purpose of eugenics, and is worth popularizing and applying.
The above-mentioned embodiments are intended to illustrate the objects, technical solutions and advantages of the present invention in further detail, and it should be understood that the above-mentioned embodiments are merely exemplary embodiments of the present invention, and are not intended to limit the scope of the present invention, and any modifications, equivalent substitutions, improvements and the like made within the spirit and principle of the present invention should be included in the scope of the present invention.
Claims (8)
1. The kit for prenatal screening in the pregnancy period is characterized by comprising magnetic beads coated with Ganodorman 1, an analysis buffer solution and an enzyme working solution, wherein the Ganodorman 1 is a mixture of AFP, Total beta hCG, PAPP-A, INHA and uE3 monoclonal antibody 1, the enzyme working solution comprises enzyme-labeled Ganodorman 2, and the Ganodorman 2 is a mixture of AFP, Total beta hCG, PAPP-A, INHA and uE3 monoclonal antibody 2.
2. The kit for prenatal screening during pregnancy according to claim 1, wherein the preparation method of the screening polyclonal 1 coated magnetic beads comprises the following steps:
diluting the dialyzed generated sieve polyclonal antibody 1 to a set concentration, carrying out biotin labeling on the diluted generated sieve polyclonal antibody 1 to obtain a biotin antibody, and coating the biotin antibody on naked magnetic beads to obtain polyclonal antibody coated magnetic beads.
3. The kit of claim 1, wherein the enzyme working fluid is a mixture of 0.5% BSA buffer and enzyme-labeled Sieve-producing polyclonal 2.
4. The kit for prenatal screening during pregnancy according to claim 1 or 3, wherein the enzyme-labeled screening polyclonal 2 is prepared by the following method:
adding D-trehalose after alkaline phosphatase activation dialysis, mixing the dialyzed product-sieve multi-antibody 2 with a cross-linking agent for activation treatment, then dialyzing, adding the activated alkaline phosphatase into the activated product-sieve multi-antibody 2 for room-temperature rolling reaction to obtain the enzyme-labeled product-sieve multi-antibody 2.
5. The kit of claim 1, wherein the assay buffer is prepared by the following method:
calf serum was diluted with purified water to a concentration of 100 mL/L.
6. The kit of claim 1, further comprising a calibrator and a quality control.
7. The kit for prenatal screening during pregnancy according to claim 6, wherein the calibrator is prepared by:
dissolving and diluting the produced screening antigen, and preparing a 6-concentration calibrator point by using BSA buffer solution to obtain a calibrator.
8. The kit for prenatal screening during pregnancy according to claim 6, wherein the quality control is prepared by the following steps:
dissolving and diluting the produced and screened antigen, and preparing the antigen into quality control points with 2 concentrations by using BSA buffer solution to obtain a quality control product.
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