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Quality control method for the noninvasive screening of biochemical indicators during early pregnancy

A technology of biochemical indicators and quality control methods, applied in biological testing, material inspection products, special data processing applications, etc., can solve the problem of no quality control system for serum parameters, and achieve the effect of optimizing accuracy and improving detection rate

Inactive Publication Date: 2009-09-16
广州医学院
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Problems solved by technology

At present, most of the known screenings in China use individual serum parameters for risk assessment, and there is no relevant content about the quality control system of serum parameters

Method used

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  • Quality control method for the noninvasive screening of biochemical indicators during early pregnancy
  • Quality control method for the noninvasive screening of biochemical indicators during early pregnancy
  • Quality control method for the noninvasive screening of biochemical indicators during early pregnancy

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Embodiment Construction

[0017] 1. Determination of biochemical indicators in noninvasive screening of birth defects in the first trimester

[0018] In the non-invasive screening of birth defects in the first trimester, the maternal serum biochemical indicators are free β-hCG and PAPP-A, among which,

[0019] PAPP-A: pregnancy-associated plasma protein A, which is mainly a macromolecular glycoprotein produced by the placenta and decidua. During pregnancy, the concentration of PAPP-A in maternal blood increases with the increase of pregnancy, but at 21-3 In patients with trisomy 18 and 13, the concentration of PAPP-A in maternal blood was significantly lower, and the mean value of MoM was about 0.4.

[0020] Free β-hCG: Chorionic gonadotropin β subunit, in normal pregnancy, the level of free β-hCG in maternal blood decreases with gestational age, while in trisomy 21, the concentration of free β-hCG increases significantly, MoM The mean value is above 2.0.

[0021] The unit of measurement used in pren...

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Abstract

The invention relates to a quality control method established specially for invasive screening of biochemical indicators during early pregnancy. The method includes the steps of: determining a proper maternal serum biochemical indicator through a preposing maternal serum biochemical detection program according to a selected pregnancy period; obtaining a detection value of the maternal serum biochemical indicator input into a computer and the background parameters of a checked pregnant woman; reading the detection value of the maternal serum biochemical indicator and a corrected MoM value and plotting the values on a preset maternal serum indicator distribution model diagram of normal pregnancy cohort; forming an MoM distribution diagram and a Log10 (MoM) distribution diagram of the maternal serum biochemical indicator of a checked cohort and establishing a normal distribution model of the maternal serum biochemical indicator of the checked cohort; and taking the model as a quality control standard to conduct quality control. The method can aim at a certain range of checked cohorts to carry out the quality control on the invasive screening of the biochemical indicators during early pregnancy, optimize the accuracy of a screening evaluation system and improve the detectable rate of the screening.

Description

technical field [0001] The invention belongs to the field of medical clinical diagnosis, and relates to a quality control method specially established for non-invasive biochemical index screening in the first trimester. Background technique [0002] Prenatal screening is a simple, economical and less invasive detection method to find certain high-risk pregnant women suspected of having congenital defects and genetic diseases from among pregnant women, so as to further confirm the diagnosis. The non-invasive screening method for birth defects in the first trimester refers to the risk value of chromosomal abnormal birth defects calculated by combining the background risk of pregnant women in the first trimester, the risk of ultrasound index examination, the risk of maternal serum biochemical detection and other factors. This method involves the establishment of a large number of mathematical models and complex data calculations, and requires professional risk assessment and sc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/74G01N33/68G06F19/00
Inventor 孙筱放周大海
Owner 广州医学院
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