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Placenta growth factor quality control product and preparation method thereof

A technology for placental growth factor and quality control material, applied in biological testing, material testing products, biological material analysis and other directions, can solve the problems of difficult to obtain, difficult to widely apply, expensive and other problems, and achieves convenient operation, good stability and accuracy. high sex effect

Pending Publication Date: 2021-12-24
HEBEI TEWENTE BIOTECH DEV CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The detection of placental growth factor is the main detection item in clinical auxiliary diagnosis of preeclampsia, and good indoor quality control is the prerequisite for reliable detection results. However, the provision of placental growth factor quality control products on the market mainly depends on foreign manufacturers (such as PerkinElmer), expensive, not readily available, and difficult to be widely used

Method used

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  • Placenta growth factor quality control product and preparation method thereof
  • Placenta growth factor quality control product and preparation method thereof
  • Placenta growth factor quality control product and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Use the ELISA analyzer to determine the value of the placental growth factor antigen, and the value concentration is 1.00mg / mL;

[0046] Placental growth factor quality control components are: newborn bovine serum, placental growth factor antigen, 2% casein, 2% glycerin, 2% Tween 80, 2% mannitol, 2% xylitol, 0.3% Proclin300, 0.3 %Proclin950;

[0047] The formulation steps were carried out as follows.

[0048] (1) Return the newborn bovine serum to room temperature, add it to the container, put it into the rotor, and place it on the mixer;

[0049] (2) Add casein, glycerin, Tween 80, mannitol, xylitol, Proclin300, and Proclin950 to the neonatal bovine serum returned to room temperature under stirring, and mix well to obtain a mixed solution;

[0050] (3) Determine that the quality control product preparation concentration is 32pg / mL, 100pg / mL, 1000pg / mL, take the placenta growth factor antigen and add it to the mixed solution in (2), and obtain the placenta growth fact...

Embodiment 2～12

[0054] Use the placenta growth factor antigen fixed value in embodiment 1;

[0055] Components of placental growth factor quality control product: newborn bovine serum, placental growth factor antigen, and the ratio of other components are shown in Table 1:

[0056] Table 1 Components of Placenta Growth Factor Quality Control Products of Examples 2-12 (by weight percent)

[0057]

[0058]

[0059] Preparation steps are as in Example 1.

Embodiment 13

[0069] The quality control product prepared by embodiment 1-12 and comparative example 1-4 is carried out stability measurement

[0070] 1. Storage stability of quality control products at -20°C

[0071] The lyophilized products of placental growth factor quality control products with medium concentration levels prepared in Examples 1-12 and Comparative Examples 1-3 of the present invention were stored at -20°C, and stored at 0, 1, 2, 4, and 8, respectively. , 12, 16, 24, 36, 48, and 60 weeks, take one bottle for reconstitution, and use Hebei Twente Biotechnology Development Co. Test 3 times, and calculate the relative deviation between the mean and the target value, the results are shown in Table 2.

[0072] Table 2 Stability of different quality control products

[0073]

[0074]

[0075] The experimental results in Table 2 show that the quality control products of placenta growth factor prepared in Examples 1-12 of the present invention can be stored stably for 60 w...

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Abstract

The invention provides a placenta growth factor quality control product and a preparation method thereof. The placenta growth factor quality control product comprises a placenta growth factor antigen, newborn calf serum, BSA and / or casein, glycerin and / or Tween 80, mannitol and / or xylitol and a preservative. The placenta growth factor quality control product disclosed by the invention is simple in preparation method, high in accuracy, high in precision and good in stability, can be applied to a fluorescence immunoassay platform of a POCT system, and is suitable for placenta growth factor detection kits clinically common on the platform. A quality control substance is provided for placenta growth factor kit evaluation and indoor and interventricular quality evaluation in clinical laboratories.

Description

technical field [0001] The invention belongs to the technical field of in vitro immunodiagnosis, and in particular relates to a quality control product of placenta growth factor suitable for a fluorescent immunoassay platform and a preparation method thereof. Background technique [0002] Preeclampsia (preeclampsia) is a multisystem progressive disease unique to pregnancy, characterized by new-onset hypertension and proteinuria after 20 weeks of gestation, or new-onset hypertension and end-organ dysfunction with or without with proteinuria. The condition may progress continuously and seriously affect the health of mother and child. [0003] Placental growth factor (PLGF) is a member of the vascular endothelial growth factor (VEGF) family, which is synthesized by placental syncytiotrophoblasts and umbilical vein endothelial cells. Placental growth factor has a unique regulatory effect on the function of trophoblasts and endothelial cells. On the one hand, it promotes the pr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68G01N33/58G01N33/543G01N33/531
CPCG01N33/74G01N33/6872G01N33/582G01N33/54393G01N33/531G01N2333/475Y02A50/30
Inventor 李红星何思雨景晓辉
Owner HEBEI TEWENTE BIOTECH DEV CO LTD
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