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Beta-human chorionic gonadotrophin test kit (time-resolved fluoroimmunoassay) for prenatal screening and preparation method thereof

A chorionic gonadotropin and prenatal screening technology, applied in biological testing, material inspection products, etc., can solve the problems of insufficient understanding of prenatal screening, lagging economic technology, unbalanced development, etc., and achieve reliability and rigor. sexual effect

Active Publication Date: 2010-09-01
广州市丰华生物股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009]my country has a vast territory, unbalanced development among regions, lagging economic technology and insufficient understanding of prenatal screening, lack of equipment, instruments and reagents for prenatal screening Some areas still cannot carry out prenatal screening for congenital diseases such as DS and neural tube defects

Method used

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  • Beta-human chorionic gonadotrophin test kit (time-resolved fluoroimmunoassay) for prenatal screening and preparation method thereof
  • Beta-human chorionic gonadotrophin test kit (time-resolved fluoroimmunoassay) for prenatal screening and preparation method thereof
  • Beta-human chorionic gonadotrophin test kit (time-resolved fluoroimmunoassay) for prenatal screening and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Example 1 Preparation of the prenatal screening β-human chorionic gonadotropin assay kit (time-resolved fluorescent immunoassay) of the present invention

[0036] Components of the β-human chorionic gonadotropin assay kit (time-resolved fluorescent immunoassay) for prenatal screening include:

[0037] Experiment buffer: made with 10.0ml / L~100.0ml / L calf serum and buffer;

[0038] Concentrated lotion: made with 1.0ml / L~10.0ml / L Tween-20 and buffer;

[0039] Enhancement solution: made with 1-5mg / L β-naphthoyltrifluoroacetone, 15-30mg / L tri-n-octylphosphine oxide and buffer.

[0040] Monoclonal antibody-coated plate: β-human chorionic gonadotropin monoclonal antibody-coated plate Dilute β-human chorionic gonadotropin monoclonal antibody to 1-10 μg / ml with buffer solution containing 1-10 ppm preservative The coating solution is prepared by coating a microwell blank plate, sealing it with a blocking solution containing 1.0g / L-10.0g / L protective agent, and then drying it. ...

Embodiment 2

[0054] Embodiment 2 The using method of kit of the present invention

[0055] The specific operations of the β-human chorionic gonadotropin assay kit (time-resolved fluorescent immunoassay) for the prenatal screening prepared in the above embodiment 1 are as follows:

[0056] Equilibrate the number of microwell reaction strips required by the reagent to room temperature; mix 40ml of the above-mentioned concentrated washing solution and 960ml of purified water to form a working washing solution; Marker working solution.

[0057] Punch the standard, quality control or sample into the solid-phase antibody-coated reaction plate with a hole puncher with a diameter of 3.0 mm, and add 100-200 μl of the above-mentioned β-HCG experimental buffer to each well; the reaction plate is at room temperature, Slowly shake and incubate for 1-4 hours; wash the plate 6 times with the above-mentioned working washing solution, and pat dry; add 100-200 μl of the above-mentioned β-HCG marker working...

Embodiment 3

[0058] The analytical performance evaluation index of embodiment 3 kit of the present invention

[0059] The performance evaluation indexes of the β-human chorionic gonadotropin assay kit (time-resolved fluorescent immunoassay) of the prenatal screening prepared in the above embodiment 1 are as follows:

[0060] 1. Dose response curve and linear range

[0061] Using the LOG-LOGB axis transformation mode and the SPLINE fitting algorithm, the logarithm of the content of the standard is the abscissa, and the logarithm of the fluorescence value of the corresponding reaction well is the ordinate, and the standard curve is drawn.

[0062] Within the measurement range of the β-HCG kit, the linear correlation coefficient of the dose-response curve should not be lower than 0.9900.

[0063] 2. Sensitivity

[0064] Detect 20 times with zero standard, calculate its concentration mean (x) and standard deviation (s), and take x±2s as the detection limit, then the sensitivity of the β-HCG de...

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Abstract

The invention discloses a beta-human chorionic gonadotrophin test kit (time-resolved fluoroimmunoassay) applicable for early-pregnancy and mid-pregnancy prenatal screening and a preparation method thereof. The kit comprises the following main components of an experimental buffer solution, a concentrated washing solution, an enhancement solution, a reaction plate, a standard product and a quality control product of filter paper dried blood spots and a europium marker. The method for preparing the kit according to the invention comprises the following steps of: 1. preparing the experimental buffer solution, the concentrated washing solution and the enhancement solution; 2. coating the reaction plate; 3. preparing the standard product and the quality control product; 4. preparing the europium marker; 5. separately loading; 6. sticking labels; and 7. assembling into a finished product. The invention has the characteristics that the accuracy and the sensitivity of a detected result are high, the stability is good, and a detecting method is economical, convenient and safe and has no traumatic property and the like. A filter paper dried blood spot technology is applied to prenatal screening work, which is beneficial to blood specimen collection, storage and transportation and ensures the experimental reliability.

Description

technical field [0001] The invention relates to a test kit for prenatal screening in the first trimester and the second trimester, in particular to a kit for measuring β-human chorionic gonadotropin (time-resolved fluorescent immunoassay) for the prenatal screening in the first trimester and the second trimester The preparation method combines monoclonal antibody preparation technology, solid-phase antibody coating technology, lanthanide ion labeling technology, filter paper dried blood film preparation technology and time-resolved immunofluorescence technology. Background technique [0002] Prenatal Screening refers to screening and diagnosing high-risk pregnant women with certain congenital defects from pregnant women through economical, simple and less invasive detection methods, so as to minimize the risk of birth defects. born. Prenatal screening can be performed in the first trimester (7-13 weeks) and second trimester (14-21 weeks), and the main disease for screening ...

Claims

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Application Information

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IPC IPC(8): G01N33/76
Inventor 吴道贫汪勤季涛李贵情谭玉华何海荣冯健明沈健郑元升刘胜利
Owner 广州市丰华生物股份有限公司
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