High-sensitivity antenatal screening kit of Down's Syndrome in pregnant women at second trimester as well as preparation and detection methods of kit

Abstract

The invention discloses a high-sensitivity antenatal screening kit of Down's Syndrome in pregnant women at second trimester as well as preparation and detection methods of the high-sensitivity antenatal screening kit. The kit comprises a kit body, AFP (Alpha Fetal Protein) and beta-HCG (Human Chorionic Gonadotropin) coated plates, AFP and beta-HCG standard products, AFP and beta-HCG quality control products, AFP and beta-HCG enzyme conjugates, sample diluent, light-emitting substrate liquids and concentrated scrubbing liquid. The preparation method comprises the following steps of: preparing monoclonal antibody coated plates of AFP and beta-HCG; preparing the standard products and the quality control products of AFP and beta-HCG; and preparing the enzyme conjugates of AFP and beta-HCG; and preparing the sample diluent, a light-emitting substrate liquid A, a light-emitting substrate liquid B, the concentrated scrubbing solution and the like. The high-sensitivity antenatal screening kit of the Down's Syndrome in the pregnant women at the second trimester has the advantages that the purpose of the antenatal screening of the Down's Syndrome in the pregnant women at the second trimester is realized, and the accordance rate with the clinic diagnosis reaches more than 99.7%; and the kit is high in sensitivity, strong in the specificity and accurate and reliable in result.

Description

technical field [0001] The invention relates to a prenatal screening kit, in particular to a high-sensitivity prenatal screening kit for Down syndrome in the second trimester of pregnancy and a preparation method thereof, belonging to the field of prenatal screening kits. Background technique [0002] Down's syndrome, also known as Trisomy 21 or Down's Syndrome (DS), is the most common congenital defect that causes mental retardation. Its incidence rate is about 1 / 750. Its main features are Severe mental retardation, the IQ is mostly 20-60, only 1 / 4-1 / 2 of the normal people of the same age, with symptoms such as small head, flat occiput, thick nape, small eye cleft, upward slant on the outside, deep inner canthus, etc. Its occurrence is accidental and random, and the incidence will increase with the age of pregnant women. There is currently no effective treatment for this disease. The way to prevent this kind of disease is to carry out prenatal screening and Necessary prena...

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Problems solved by technology

[0002] Down syndrome, also known as Trisomy 21 or Down's Syndrome (DS), is the most common congenital defect that causes mental retardation. Its incidence rate is about 1 / 750, and its main features are severe mental retardation, with an IQ of 20 to 60, only 1 / 4 to 1 / 2 of normal people of the same age, small head, flat occiput, and thick nape. Symptoms such as small eye cleft, lateral upward tilt, and deep inner canthus are accidental and random, and the incidence will increase with the age of pregnant women. There is currently no effective treatment for this disease to prevent the occurrence of such diseases The method adopted is to carry out prenatal screening and necessary prenatal diagnosis during pregnancy, find out as early as possible and take corresponding measures. At present, the methods of clinical prenatal diagnosis mainly use chorionic villus sampling or amniocentesis for prenatal diagnosis , these methods have played a certain role in the prenatal detection of Down syndrome fetuses and the prevention of the birth of such fetuses. However, because amniocentesis is traumatic to a certain extent, it can cause miscarriage, and it is impossible to directly treat all fetuses on a large scale. Pregnant women are tested with a confirmed method, which also requires certain technical equipment conditions, takes a long time, and costs a lot, and it is impossible to carry out extensive testing among all pregnant women.

[0003]Now, the application of monoclonal antibody technology, enzyme labeling technology and enzyme-catalyzed chemiluminescence quantitative detection technology has also appeared to detect AFP and β-HCG in serum of pregnant women. For example, the Chinese invention patent with the application number "CN200610044608.X" titled "Down Syndrome Prenatal Screening Kit in the Second Trimester", however, has the disadvantages of complicated operations, complicated preparation methods, and limited sensitivity. limit

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