Zhuang G H, Shen M W, Zeng L X, Mi B B, Chen F Y, Liu W J, Pei L L, Qi X, Li C
Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an 710061, China.
Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Mar 5;41(4):485-488. doi: 10.3760/cma.j.cn112338-20200221-00144.
The article “Potential false-positive rate among the ‘asymptomatic infected individuals’ in close contacts of COVID-19 patients” was under strong discussion after pre-published. Questions from the readers mainly focused on the article’s results and conclusions were depended on theoretical deduction, but not the field epidemiology data and further researches were needed to prove the current theory. Based on previous discussions, the article was decided to be offline by the editorial board from the pre-publish lists. As the prevention and control of COVID-19continues to advance, the active nucleic acid test screening in the close contacts of the patients has been carrying out in many parts of China. However, the false-positive rate of positive results in the screening has not been reported up to now. But to clearify the false-positive rate during screening is important in COVID-19 control and prevention. Point values and reasonable ranges of the indicators which impact the false-positive rate of positive results were estimated based on the information available to us at present. The false-positive rate of positive results in the active screening was deduced, and univariate and multivariate-probabilistic sensitivity analyses were performed to understand the robustness of the findings. When the infection rate of the close contacts and the sensitivity and specificity of reported results were taken as the point estimates, the positive predictive value of the active screening was only 19.67%, in contrast, the false-positive rate of positive results was 80.33%. The multivariate-probabilistic sensitivity analysis results supported the base-case findings, with a 75% probability for the false-positive rate of positive results over 47%. In the close contacts of COVID-19 patients, nearly half or even more of the 'asymptomatic infected individuals' reported in the active nucleic acid test screening might be false positives.
《新冠患者密切接触者中“无症状感染者”的潜在假阳性率》一文在预发表后引发了热烈讨论。读者的质疑主要集中在该文章的结果和结论依赖理论推导，而非现场流行病学数据，需要进一步研究来证实当前理论。基于此前的讨论，编辑委员会决定将该文章从预发表列表中撤下。随着新冠疫情防控工作的持续推进，我国多地已开展对患者密切接触者的主动核酸检测筛查工作。然而，目前尚未见报道筛查中阳性结果的假阳性率情况。但明确筛查过程中的假阳性率对于新冠疫情防控至关重要。基于我们目前所掌握的信息，对影响阳性结果假阳性率的指标的点值和合理范围进行了估计。推导了主动筛查中阳性结果的假阳性率，并进行了单因素和多因素概率敏感性分析，以了解研究结果的稳健性。以密切接触者的感染率以及报告结果的敏感性和特异性作为点估计时，主动筛查的阳性预测值仅为19.67%，相比之下，阳性结果的假阳性率为80.33%。多因素概率敏感性分析结果支持了基础情况的研究结果，阳性结果假阳性率超过47%的概率为75%。在新冠患者的密切接触者中，主动核酸检测筛查报告的“无症状感染者”中近半数甚至更多可能为假阳性。
