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目的了解杭州市余杭地区孕中期妇女血清游离绒毛膜促性腺激素β亚基(Free-β-hCG)水平,并与试剂说明书[1]提供的参考值范围数据作对照,以建立本地区孕中期妇女血清Free-β-hCG参考值。方法用时间分辨荧光免疫法体外定量检测孕中期(15～20孕周)妇女血清中的Free-β-hCG水平,结合孕周时间、年龄、体重等因素,经Risks2T软件分析,计算胎儿患21三体综合征和18三体综合征的风险率。结果3355例孕中期妇女Free-β-hCG(中位值)分别为26.15 ng/mL、18.40ng/mL、14.20 ng/mL、11.40 ng/mL、10.65ng/mL、8.82ng/mL。与对照组比较差异有统计学意义(Z均=2.201,P均=0.028)。MOM值分别为1.17、0.99、0.90、0.86、0.99、0.91。各孕周之间MOM值经统计学处理,差异有统计学意义(χ2=27.163,P<0.001)。结论由于不同国家地区不同人群孕中期妇女血清Free-β-hCG水平不同,差异有统计学意义(P<0.05),故实验室在开展产前筛查唐氏综合征(21三体综合征)和爱得瓦氏综合征(18三体综合征)时,应建立本地区的参考值范围。
Objective To understand the level of serum free chorionic gonadotropin β-subunit (β-hCG) in pregnant women in Yuhang district of Hangzhou and compare them with reference data provided by reagent manual [1] Women’s serum Free-β-hCG reference value. Methods The level of Free-β-hCG in pregnant women during the second trimester (15 ~ 20 gestational weeks) was quantitatively determined by time-resolved fluorescence immunoassay in vitro. Combined with gestational age, age, body weight and other factors, Risks2T software was used to calculate the fetus 21 Trisomy syndrome and trisomy 18 risk ratio. Results The median Free-β-hCG levels in 3355 pregnant women were 26.15 ng / mL, 18.40 ng / mL, 14.20 ng / mL, 11.40 ng / mL, 10.65 ng / mL and 8.82 ng / mL, respectively. Compared with the control group, the difference was statistically significant (Z = 2.201, P = 0.028). MOM values were 1.17,0.99,0.90,0.86,0.99,0.91. The gestational age MOM values were statistically processed, the difference was statistically significant (χ2 = 27.163, P <0.001). Conclusion Because of different levels of serum Free-β-hCG in pregnant women in different populations in different countries and regions, the difference was statistically significant (P <0.05). Therefore, the laboratory is conducting prenatal screening for Down’s syndrome (trisomy 21) And Love’s Valsalva syndrome (Trisomy 18), the reference range for the region should be established.