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目的:探讨相同实验室不同检测系统间血清学产前筛查AFP测定结果的可比性。方法:随机抽取55例孕15~20周妇女血清标本,然后再分成两份,用两种不同的检测系统进行检测,比较两种不同检测系统血清学产前筛查测定结果的差异及唐氏综合征和神经管缺陷高风险的检出情况。结果:55例血清标本经两种不同检测系统检测:AFP水平分别为(43.40±20.80)U/ml(37.78~49.02 U/ml)和(42.23±21.51)U/ml(36.42~48.04 U/ml);AFP中位数的倍数(AFPM)分别为(1.07±0.47)(0.94~1.20)和(1.04±0.48)(0.90~1.17);经配对t检验,两种不同检测系统结果差异有统计学意义(P=0.008,P=0.009);两种不同检测系统结果的相关系数>0.975。两种不同检测系统分别检测55例血清标本,PE系统检出唐氏综合征高风险1例、神经管缺陷高风险2例;DPC系统检出唐氏综合征高风险2例、神经管缺陷高风险2例,经McNemar卡方检验,两方法差异无统计学意义(P=1.000)。结论:IMMULITE 1000化学发光仪及配套筛查分析软件用于产前筛查实验时,筛查结果符合临床要求,但与PerkinElmer公司的Auto DELFIA 1235型全自动仪器相比还存在一定的差距,需要在操作过程中严格按照实验室标准操作文件来进行。
OBJECTIVE: To investigate the comparability of AFP results of serological prenatal screening among different testing systems in the same laboratory. Methods: Serum samples of 55 pregnant women aged 15-20 weeks were randomly selected and then divided into two parts. Two different detection systems were used to detect serum samples. The difference of serological prenatal screening results between two different detection systems was compared with that of Down’s Syndrome and high risk of neural tube defects detected. Results: The serum samples of 55 cases were detected by two different detection systems: AFP levels were (43.40 ± 20.80) U / ml (37.78-49.02 U / ml) and (42.23 ± 21.51) U / ml ); AFPM (AFPM) were (1.07 ± 0.47) (0.94-1.20) and (1.04 ± 0.48) (0.90-1.17), respectively. The paired t-test showed that there were statistically significant differences between the two detection systems Significance (P = 0.008, P = 0.009). The correlation coefficient of the two different detection systems was> 0.975. Two different detection systems were detected in 55 cases of serum samples, PE system detection of Down’s syndrome high risk in 1 case, 2 cases of high risk of neural tube defects; DPC system detected Down’s syndrome in 2 cases of high risk of neural tube defects There were 2 cases of risk. There was no significant difference between the two methods by McNemar’s Chi-square test (P = 1.000). CONCLUSIONS: The IMMULITE 1000 chemiluminescence analyzer and its accompanying screening analysis software were used in prenatal screening tests to meet clinical requirements, but there was still a gap compared to PerkinElmer’s Auto DELFIA 1235 fully automatic instrument, which required In the operation of the process in strict accordance with the standard laboratory documents.