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目的:评估我国早孕期血清学筛查质量控制（简称质控）水平。方法:收集参与国家卫生健康委员会临床检验中心2022年早孕期血清学筛查室间质评计划的576家实验室上报的数据。血清学筛查指标包括游离人绒毛膜促性腺激素β亚基（human chorionic gonadotropin β subunit，β-hCG）、总β-hCG和妊娠相关血浆蛋白A（pregnancy-associated plasma protein A，PAPP-A）。分析这些指标的变异系数、偏倚、质控规则和检验方法等信息。使用六西格玛管理体系评估实验室质量水平和质控规则合理性。使用Wilcoxon检验评估月份和检验方法对西格玛水平的影响。结果:（1）共119家实验室检测总β-hCG，457家实验室检测游离β-hCG，565家实验室检测PAPP-A。仅检测1个指标的实验室有17家，检测2个指标的实验室有553家，检测3个指标的实验室有6家。（2）5月和9月同一指标的西格玛水平差异无统计学意义。游离β-hCG达到6σ的比例最高［71.9%（567/788）］；总β-hCG虽然达到6σ比例最低［53.4%（103/193）］，但小于3σ的比例也最低［3.1%（6/193）］。（3）早孕期血清学产前筛查主要涉及5种试剂，主要使用化学发光法和时间分辨荧光法（游离β-hCG只使用化学发光法）。使用时间分辨荧光法实验室总体西格玛水平高于使用化学发光法的实验室［总β-hCG和PAPP-A分别为9.56（7.01~13.22）与5.84（4.36~9.12），以及9.04（6.40~12.62）与5.71（4.22~8.15）， W值分别为53 114.00和75 752.00， P值均<0.001］。质控规则符合Westgard西格玛规则所占比例为16.1%（31/193）～19.6%（166/846）。其中，质控规则过松的实验室所占比例为24.8%（210/846）～32.1%（62/193），质控规则过严者所占比例为51.8%（100/193）～55.6%（470/846）。 结论:我国产前筛查实验室的质控水平总体表现良好，但在质控规则设置上仍需改进。

Objective:To evaluate the quality level of early pregnancy serum screening in China.Methods:Information on the coefficient of variation, bias, quality control (QC) rules, and testing methods from 576 laboratories participating in the 2022 early pregnancy serum screening inter-laboratory proficiency testing program by the National Health Commission Clinical Laboratory Center was collected. Serological screening indicators included free human chorionic gonadotropin β subunit (β-hCG), total β-hCG, and pregnancy-associated plasma protein A (PAPP-A). Six Sigma (σ) management was used to assess the quality level of the laboratories and the rationality of QC rules. Wilcoxon test was used to evaluate whether different testing time and methods affected the Sigma level.Results:A total of 119 laboratories tested total β-hCG, 457 laboratories tested free β-hCG, and 565 laboratories tested PAPP-A. Seventeen laboratories tested only one marker, 553 laboratories tested two markers, and six laboratories tested three markers. There was no statistically significant difference in sigma levels for the same analyte tested in May and September. The proportion of free β-hCG reaching 6σ was the highest at 71.9% (567/788); although total β-hCG had the lowest proportion reaching 6σ at 53.4% (103/193), it also had the lowest proportion below 3σ at 3.1% (6/193). Early pregnancy serum prenatal screening mainly involved five reagents and primarily used chemiluminescence and time-resolved fluorescence methods (free β-hCG was only tested using chemiluminescence). Laboratories using time-resolved fluorescence had overall higher sigma levels [total β-hCG: 9.56 (7.01-13.22) vs. 5.84 (4.36-9.12), W=53 114.00; PAPP-A: 9.04 (6.40-12.62) vs. 5.71 (4.22-8.15), W=75 752.00; both P<0.001] compared to those using chemiluminescence. The proportion of QC rules conforming to Westgard sigma rules ranged from 16.1% (31/193) to 19.6% (166/846). Among them, the proportion of laboratories with overly lenient QC rules was 24.8% (210/846) to 32.1% (62/193), and the proportion with overly strict QC rules was 51.8% (100/193) to 55.6% (470/846). Conclusion:The overall QC level of prenatal screening laboratories in China is fine, but there is still room for improvement in the setting of QC rules.