Background: An increasing body of evidence has revealed that SARS-CoV-2 infection in pregnant women could increase the risk of adverse maternal and fetal outcomes. Careful monitoring of pregnancies with COVID-19 and measures to prevent neonatal infection are warranted. Therefore, rapid antibody tests have been suggested as an efficient screening tool during pregnancy.

Cases: We analysed the clinical performance during pregnancy of a rapid, lateral-flow immunochromatographic assay (ICA) for qualitative detection of SARS-CoV-2 IgG/IgM antibodies. We performed a universal screening including 169 patients during their last trimester of pregnancy. We present a series of fourteen patients with positive SARS-CoV-2 ICA rapid test result. ICA results were always confirmed by chemiluminescent microparticle immunoassays (CMIA) for quantitative detection of SARS-CoV-2 IgG and IgM+IgA antibodies as the gold standard. We observed a positive predictive value (PPV) of 50% and a false positive rate (FPR) of 50% in pregnant women, involving a significantly lower diagnostic performance than reported in non-pregnant patients.

Discussion: Our data suggest that although ICA rapid tests may be a fast and profitable screening tool for SARS-CoV-2 infection, they may have a high false positive rate and low positive predictive value in pregnant women. Therefore, Immunochromatographic assay for qualitative detection of SARS-CoV-2 IgG/IgM antibodies must be verified by other test in pregnant patients.

背景：越来越多的证据表明，孕妇的SARS-CoV-2感染可能增加母婴不良结局的风险。必须对COVID-19怀孕进行仔细的监测，并采取预防新生儿感染的措施。因此，已经提出快速抗体测试作为怀孕期间的有效筛选工具。

病例：我们分析了妊娠期快速，横向流免疫色谱分析（ICA）的临床表现，以定性检测SARS-CoV-2 IgG / IgM抗体。我们对169名患者在妊娠的最后三个月进行了全面筛查。我们提出了一系列14例SARS-CoV-2 ICA快速检测结果均为阳性的患者。ICA结果始终通过化学发光微粒免疫分析（CMIA）进行定量，以定量检测SARS-CoV-2 IgG和IgM + IgA抗体作为金标准。我们在孕妇中观察到50％的阳性预测值（PPV）和50％的假阳性率（FPR），其诊断性能明显低于未怀孕的患者。

讨论：我们的数据表明，尽管ICA快速检测可能是SARS-CoV-2感染的快速且有利可图的筛查工具，但它们在孕妇中可能具有较高的假阳性率和较低的阳性预测值。因此，用于孕妇SARS-CoV-2 IgG / IgM抗体定性检测的免疫色谱分析必须通过其他测试来验证。