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AFP (Alpha-Fetoprotein) testing kit (time-resolved fluoroimmunoassay) for prenatal screening and preparation method thereof

A time-resolved fluorescence and prenatal screening technology, applied in biological tests, measuring devices, analytical materials, etc., can solve the problem of insufficient knowledge of prenatal screening, inability to carry out prenatal screening for DS congenital diseases, and unbalanced development, etc. problems, to achieve results with reliability and rigor

Active Publication Date: 2010-09-01
GUANGZHOU FENGHUA BIOENG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] my country has a vast territory, unbalanced development among regions, lagging economic technology and insufficient understanding of prenatal screening, lack of equipment, instruments, reagents and professional technicians for prenatal screening, etc., some areas are still unable to carry out DS, neurological Prenatal screening for tube defects and other congenital diseases

Method used

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  • AFP (Alpha-Fetoprotein) testing kit (time-resolved fluoroimmunoassay) for prenatal screening and preparation method thereof
  • AFP (Alpha-Fetoprotein) testing kit (time-resolved fluoroimmunoassay) for prenatal screening and preparation method thereof
  • AFP (Alpha-Fetoprotein) testing kit (time-resolved fluoroimmunoassay) for prenatal screening and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Example 1 Preparation of the prenatal screening alpha-fetoprotein assay kit (time-resolved fluorescent immunoassay) of the present invention

[0035] Second-trimester prenatal screening alpha-fetoprotein assay kit (time-resolved fluorescent immunoassay method) includes: enhancement solution: 1-5 mg / L β-naphthoyltrifluoroacetone, 15-30 mg / L tri-n-octane Phosphate-based phosphorus oxide and buffer; experimental buffer: made with 10.0ml / L~100.0ml / L calf serum and buffer; concentrated washing solution: use 1.0ml / L~10.0ml / L Tween -20 and buffer made. Monoclonal antibody-coated plate: Alpha-fetoprotein monoclonal antibody-coated plate Dilute alpha-fetoprotein monoclonal antibody into a coating solution of 1-10 μg / ml with a buffer solution containing 1-10 ppm preservative, and coat the microwell blank plate, sealed with a blocking solution containing 1.0g / L-10.0g / L of protective agent and then dried.

[0036] Standard products and quality control products: Alpha-fetoprotein ...

Embodiment 2

[0048] Embodiment 2 The using method of kit of the present invention

[0049] The specific operations of the prenatal screening alpha-fetoprotein assay kit (time-resolved fluorescent immunoassay) prepared in the above embodiment 1 are as follows:

[0050] 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.

[0051] Punch the standard, quality control or sample into the solid-phase antibody-coated plate with a hole punch of 3.0 mm in diameter, and add 100-200 μl of the above-mentioned AFP marker working solution to each well; the reaction plate is at room temperature, slowly Shake and incubate for 90-240 minutes; throw out the paper. Wash the plate 6 times with the above-mentioned working washing solution, and pat dry; add 100-200 μl enhancement solution to each well; shake slowly fo...

Embodiment 3

[0052] The analytical performance evaluation index of embodiment 3 kit of the present invention

[0053] The performance evaluation indexes of the prenatal screening alpha-fetoprotein assay kit (time-resolved fluorescent immunoassay) prepared in the above embodiment 1 are as follows:

[0054] 1. Dose response curve and linear range

[0055] 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.

[0056] Within the measurement range of the AFP kit, the linear correlation coefficient of the dose-response curve should not be lower than 0.9900.

[0057] 2. Sensitivity

[0058] Test 20 times with the zero standard, calculate the concentration mean (x) and standard deviation (s), and take x±2s as the detection limit, then the sensitivity of the AFP detection kit is not h...

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Abstract

The invention relates to an alpha-fetoprotein testing kit (time-resolved fluoroimmunoassay) applicable for 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, has high automation degree, 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 second trimester, in particular to an alpha-fetoprotein assay kit (time-resolved fluorescent immunoassay) and a preparation method for prenatal screening in the second trimester, which combines a 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 carried out in the second trimester (14-21 weeks), and the two main diseases for screening are Down syndrome (Down’s Sydrome, DS) and fetal neural tube defects (Neural Tube Defec...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68G01N33/577G01N33/532
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 GUANGZHOU FENGHUA BIOENG
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