Detection device and method for judging early pregnancy time and early pregnancy abnormity

Abstract

The invention relates to a detection device for judging early pregnancy time and early pregnancy abnormity. The detection device comprises multiple test strips and a cavity for accommodating the multiple test strips, wherein the six test strips are sequentially arranged in the cavity of the detection device and used for detecting different hCG (human chorionic gonadotropin) concentrations; an hCGcritical value detected by a first test strip is 25 mIU / ml, an hCG critical value detected by a second test strip is 100 mIU / ml, an hCG critical value detected by a third test strip is 500 mIU / ml, anhCG critical value detected by a fourth test strip is 2000 mIU / ml, an hCG critical value detected by a fifth test strip is 10000 mIU / ml, and an hCG critical value detected by a sixth test strip is 25000 mIU / ml. A product is lower in detection sensitivity, larger in detection range and longer in gestational week tracking cycle, and can detect the gestational week to the ninth week. Besides, each test strip of the product can complete detection only by one detection line, a result is more direct, the process is simpler, the product is more stable, and industrialization is easier to realize.

Description

technical field [0001] The invention relates to the technical field of immune colloidal gold detection, in particular to a detection device and method for judging early pregnancy time and early pregnancy abnormality by semi-quantitative detection of human chorionic gonadotropin colloidal gold. Background technique [0002] Human chorionic gonadotropin (hCG) is a glycoprotein hormone secreted by placental chorionic cells after implantation of fertilized eggs in women [1]. It consists of α and β dimers, where the α subunit is structurally similar to the α chains of luteinizing hormone (LH), follicle stimulating hormone (FSH), and thyroid stimulating hormone (TSH), while the β chain is specific. It can enter the blood and urine through the blood circulation. [0003] hCG has the functions of FSH and LH, which can maintain the life of the menstrual corpus luteum, thereby increasing the menstrual corpus luteum to become the pregnancy corpus luteum; secondly, it has the function ...

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Problems solved by technology

[0017] CN204359798U discloses a kind of early pregnancy detection test strip, utilizes double antibody sandwich and immunochromatography principle, utilizes α-hCG monoclonal antibody, β-hCG monoclonal antibody, f-α-hCG monoclonal antibody, f-β-hCG monoclonal antibody The cloned antibody can qualitatively detect hCG and free β-hCG at the same time to diagnose pregnancy (sensitivity 25mIU / ml), it can only determine pregnancy, but not pregnancy status

[0018] CN205749530U discloses a kind of semi-quantitative test early pregnancy colloidal gold test paper and test kit, utilize double antibody sandwich and immunochromatography principle, only use a pair of antibodies, process the α-hCG monoclonal antibody and β on 2 test strips - hCG monoclonal antibody detects different concentrations (25, 100, 300, 1000mIU / ml) of human chorionic gonadotropin, so as to estimate the number of early pregnancy weeks, but its sensitivity is too high, it can only be monitored until the 6th week of pregnancy, and cannot be measured high hormone levels

[0019] CN106932598A discloses a colloidal gold test paper and kit for semi-quantitative testing of early pregnancy, using double-antibody sandwich and immunochromatography principles, only using a pair of antibodies, and processing the α-hCG monoclonal antibody on two test strips, β -hCG monoclonal antibody and free β antibody detect different concentrations of human chorionic gonadotropin, and judge the number of weeks of pregnancy through the color development of the test line and the strength of the line color of the test line, but only the fifth gestational week can be detected;

[0020] CN106896231A discloses a colloidal gold test paper and kit for semi-quantitative testing of early pregnancy, using the double-antibody sandwich method and the principle of immune chromatography, using α-hCG monoclonal antibody and β-hCG antibody 1 processed on 5 test strips and β-hCG antibody 2 to detect different concentrations of human chorionic gonadotropin, each test strip has two detection lines, the T1 detection line is processed with β-hCG antibody 1, and the T2 detection line is processed with β-hCG antibody 2. The function of the T1 detection line is to adjust and reduce the sensitivity of the test strips, so as to achieve the sensitivity required by each test strip, and this T1 line is invisible to consumers, but without this line, the reaction cannot be completed; this process is debugged Difficulty, poor stability

[0021] CN103760368A discloses a colloidal gold quantitative detection kit for human chorionic gonadotropin, using fluorescent nanometer microspheres as a tracer probe, combined with a fluorescence detector and related software to quantitatively detect human chorionic gonadotropin in a sample, but Not suitable for patient self-examination due to the need to use a fluorescence detector and related software

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