Dried blood spot quality control product for neonatal screening and preparation method thereof

一种新生儿筛查、干血斑的技术,应用在测试用样品的制备、生物测试、材料检验品等方向,达到操作便捷、制备工艺简单的效果

Pending Publication Date: 2022-02-22
SHANGHAI ANPEL SCI INSTR
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The scope of quality control of the above-mentioned patents or related products can only include the traditional three major diseases, namely abnormal amino acid metabolism (including urea cycle disorders), abnormal organic acid metabolism, and abnormal fatty acid oxidation metabolism

Method used

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Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0063] S2. Preparation of blank filter paper

[0064] Place the blank filter paper in an oven at 65°C for 1.5 hours;

[0065] S3, preparation of dried blood spot quality control

[0066] Take 100 μL of the mixed standard containing 37 standard substances and add it to 900 μL of blood, mix well to make blood working solution. Use a pipette gun to pipette 50 μL of blood working solution, slowly add it to the filter paper ring, and after the blood is initially coagulated, move it to a clean room to dry naturally for 6 hours. The air-dried blood spot filter paper is the dried blood spot quality control product, which is stored in a -20°C refrigerator (to avoid organic pollution).

[0067] S4. Judgment of qualified blood spot: the blood sample completely and naturally infiltrates in the circle of the blood spot, and the diameter of the formed blood spot is 10-12mm.

[0068] The high and low concentrations of the dried blood spot quality control substances involved are shown in T...

Embodiment 1

[0073] Embodiment 1, the way of spotting blood on dried blood spot filter paper is determined

[0074] Mix blood and water at a ratio of 9:1, draw a certain amount of blood mixture with a calibrated 100 μL pipette gun, control the distance between the tip and the center of the blood spot, and slowly add blood to the Whatman 903 filter paper dry blood spot collection card (printed The diameter of the circle is 10mm), check the diffusion of blood in the filter paper, and judge whether the blood spot is qualified or not by visual inspection.

Embodiment 2

[0075] Embodiment 2, determination of spot blood volume

[0076] In Example 1, 10 μL, 25 μL, 50 μL, and 75 μL of blood samples were respectively added to the dry blood spots on filter paper, and the diffusion of different blood addition amounts was observed. From the point of view of the formation of blood spots, the blood spots formed when the spot blood volume was 50 μL just covered the diameter of the impression circle (10 mm).

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PUM

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Abstract

The invention discloses a dried blood spot quality control product for neonatal screening and a preparation method thereof. The dried blood spot quality control product comprises a filter paper carrier, the filter paper carrier is infiltrated with a blood working solution, and the blood working solution takes Chinese species blood as a matrix solution, and is formed by mixing the matrix solution and an extracting solution according to a certain proportion. The extracting solution comprises amino acid, free acyl carnitine, lysophosphatidylcholine, orotic acid and succinylacetone. The dried blood spot quality control product disclosed by the invention has good uniformity and stability, and can be used as an indoor quality control product in a neonatal screening project; and the preparation process is simple and convenient to operate.

Description

technical field [0001] The invention relates to a chemical reference substance and a preparation method thereof, in particular to a dried blood spot quality control substance for newborn screening and a preparation method thereof. Background technique [0002] Newborn disease screening refers to the screening of phenylketonuria, congenital hypothyroidism and other diseases before clinical symptoms appear through blood tests of newborns, so that the body can be effectively treated before it is damaged, and can effectively Prevent childhood disabilities. Newborn screening belongs to the tertiary prevention and is one of the main means to prevent birth defects. The sample for newborn disease screening is filter paper dry blood film. In the quality control plan of the neonatal disease screening laboratory, the use of stable and reliable quality control products is a necessary guarantee for indoor quality control work and an important basis for external quality evaluation. Accur...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N1/28G01N1/38G01N30/06G01N33/96
CPCG01N1/28G01N1/38G01N30/06G01N33/96
Inventor 陈武炼王培娟樊静静阎娜
Owner SHANGHAI ANPEL SCI INSTR
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