Table 1_Exploring Chlamydia trachomatis screening in Shenzhen: a cost-effective sample pooling strategy for pre-marital and pre-pregnancy populations.xlsx

ObjectivesThis study evaluates the feasibility of a sample pooling strategy for Chlamydia trachomatis detection in pre-marital and pre-pregnancy screening in China, where pooled testing for CT remains limited despite its use in COVID-19 and HIV screening.
MethodsFrom January to May 2024, 8,142 urine samples were collected from participants in pre-marital and pre-pregnancy health checks in Nanshan District. Positive urine samples with different Ct value ranges were selected, and negative urine samples were used as diluents to simulate mixed samples. We compared the sensitivity, specificity, and other metrics between the pooling tests and individual tests. A paired t-test was used to assess the statistical significance of the mean ΔCt values.
ResultsThe 6-sample pool (1 positive:5 negative) demonstrated high sensitivity (96.7%; 95% CI: 94.1–99.3%) with a mean Ct value of 35.6 (range: 33.6–37.4). The specificity was 100% (3/3), PPV was 100% (175/175), and NPV was 33.3% (3/9). The total agreement with single testing was 96.7% (178/184; 95% CI: 94.2–99.3%). The mean ΔCt value between single and pooled tests was 2.8 (range: 2–3.2), with a statistically significant difference (p < 0.05).
ConclusionThe 6-sample pooling strategy demonstrated acceptable sensitivity (96.7%) and significantly improved screening efficiency, suggesting its potential utility for large-scale pre-marital and pre-pregnancy screening programs in appropriate settings.

研究目的：本研究旨在评估样本混检策略用于中国婚前及孕前筛查中沙眼衣原体（Chlamydia trachomatis，CT）检测的可行性；尽管混检已应用于新型冠状病毒肺炎（COVID-19）和人类免疫缺陷病毒（HIV）筛查，但国内针对CT的混检应用仍较为有限。
研究方法：本研究于2024年1月至5月期间，在南山区收集了8142份参与婚前及孕前健康检查的受试者尿液样本。筛选不同循环阈值（Cycle threshold，Ct）区间的阳性尿液样本，并以阴性尿液样本作为稀释液模拟混合样本。对比混检与单检的灵敏度、特异度等各项指标，并采用配对t检验评估平均ΔCt值的统计学显著性。
研究结果：6样本混检组（1份阳性样本：5份阴性样本）展现出较高的检测灵敏度（96.7%；95%置信区间（Confidence Interval, CI）：94.1%~99.3%），平均Ct值为35.6（范围：33.6~37.4）。该组的特异度为100%（3/3），阳性预测值（Positive Predictive Value, PPV）为100%（175/175），阴性预测值（Negative Predictive Value, NPV）为33.3%（3/9）。与单检的总符合率为96.7%（178/184；95%置信区间：94.2%~99.3%）。单检与混检的平均ΔCt值为2.8（范围：2~3.2），差异具有统计学显著性（p<0.05）。
研究结论：6样本混检策略展现出可接受的检测灵敏度（96.7%），且显著提升了筛查效率，提示该策略在适宜场景下可用于大规模婚前及孕前筛查项目。