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用于学校中SARS-CoV-2监测的聚合酶链反应(RT-qPCR)检测——一项整群随机试验。

Pooled RT-qPCR testing for SARS-CoV-2 surveillance in schools - a cluster randomised trial.

作者信息

Joachim Alexander, Dewald Felix, Suárez Isabelle, Zemlin Michael, Lang Isabelle, Stutz Regine, Marthaler Anna, Bosse Hans Martin, Lübke Nadine, Münch Juliane, Bernard Marie-Annett, Jeltsch Kathrin, Tönshoff Burkhard, Weidner Niklas, Kräusslich Hans-Georg, Birzele Lena, Hübner Johannes, Schmied Patricia, Meyer-Bühn Melanie, Horemheb-Rubio Gibran, Cornely Oliver A, Haverkamp Heinz, Wiesmüller Gerhard, Fätkenheuer Gerd, Hero Barbara, Kaiser Rolf, Dötsch Jörg, Rybniker Jan

机构信息

Department of Pediatrics, University Hospital Cologne, University of Cologne, Cologne, Germany.

Institute of Virology, University Hospital Cologne, University of Cologne, Cologne, Germany.

出版信息

EClinicalMedicine. 2021 Sep;39:101082. doi: 10.1016/j.eclinm.2021.101082. Epub 2021 Aug 25.

Abstract

BACKGROUND

The extent to which children and adolescents contribute to SARS-CoV-2 transmission remains not fully understood. Novel high-capacity testing methods may provide real-time epidemiological data in educational settings helping to establish a rational approach to prevent and minimize SARS-CoV-2 transmission. We investigated whether pooling of samples for SARS-CoV-2 detection by RT-qPCR is a sensitive and feasible high-capacity diagnostic strategy for surveillance of SARS-CoV-2 infections in schools.

METHODS

In this study, students and school staff of 14 educational facilities in Germany were tested sequentially between November 9 and December 23, 2020, two or three times per week for at least three consecutive weeks. Participants were randomized for evaluation of two different age adjusted swab sampling methods (oropharyngeal swabs or buccal swabs compared to saliva swabs using a 'lolli method'). Swabs were collected and pooled for SARS-CoV-2 RT-qPCR. Individuals of positive pooled tests were retested by RT-qPCR the same or the following day. Positive individuals were quarantined while the SARS-CoV-2 negative individuals remained in class with continued pooled RT-qPCR surveillance. The study is registered with the German Clinical Trials register (registration number: DRKS00023911).

FINDINGS

5,537 individuals were eligible and 3970 participants were enroled and included in the analysis. In students, a total of 21,978 swabs were taken and combined in 2218 pooled RT-qPCR tests. We detected 41 positive pooled tests (1·8%) leading to 36 SARS-CoV-2 cases among students which could be identified by individual re-testing. The cumulative 3-week incidence for primary schools was 564/100,000 (6/1064, additionally 1 infection detected in week 4) and 1249/100,000 (29/2322) for secondary schools. In secondary schools, there was no difference in the number of SARS-CoV-2 positive students identified from pooled oropharyngeal swabs compared to those identified from pooled saliva samples (lolli method) (14 vs. 15 cases; 1·3% vs. 1·3%; OR 1.1; 95%-CI 0·5-2·5). A single secondary school accounted for 17 of 36 cases (47%) indicating a high burden of asymptomatic prevalent SARS-CoV-2 cases in the respective school and community.

INTERPRETATION

In educational settings, SARS-CoV-2 screening by RT-qPCR-based pooled testing with easily obtainable saliva samples is a feasible method to detect incident cases and observe transmission dynamics.

FUNDING

Federal Ministry of education and research (BMBF; Project B-FAST in "NaFoUniMedCovid19"; registration number: 01KX2021).

摘要

背景

儿童和青少年对严重急性呼吸综合征冠状病毒2(SARS-CoV-2)传播的影响程度仍未完全明确。新型高容量检测方法可能会在教育环境中提供实时流行病学数据,有助于制定合理的方法来预防和减少SARS-CoV-2传播。我们调查了通过逆转录定量聚合酶链反应(RT-qPCR)对样本进行合并检测以检测SARS-CoV-2是否是一种用于监测学校SARS-CoV-2感染的敏感且可行的高容量诊断策略。

方法

在本研究中,2020年11月9日至12月23日期间,德国14所教育机构的学生和学校工作人员每周接受两到三次检测,连续至少三周。参与者被随机分组,以评估两种不同的年龄调整拭子采样方法(口咽拭子或颊拭子与使用“棒棒糖法”的唾液拭子相比)。采集拭子并合并用于SARS-CoV-2 RT-qPCR检测。合并检测呈阳性的个体在同一天或第二天通过RT-qPCR重新检测。阳性个体被隔离,而SARS-CoV-2阴性个体留在班级继续接受合并RT-qPCR监测。该研究已在德国临床试验注册中心注册(注册号:DRKS00023911)。

结果

5537人符合条件,3970名参与者被纳入分析。在学生中,共采集了21978份拭子,并合并进行了2218次合并RT-qPCR检测。我们检测到41次合并检测呈阳性(1.8%),通过个体重新检测在学生中确定了36例SARS-CoV-2病例。小学的累计3周发病率为564/100000(6/1064,第4周额外检测到1例感染),中学为1249/100000(29/2322)。在中学,与从合并唾液样本(棒棒糖法)中确定的SARS-CoV-2阳性学生数量相比,从合并口咽拭子中确定的数量没有差异(14例对15例;1.3%对1.3%;比值比1.1;95%置信区间0.5-2.5)。一所中学占36例中的17例(47%),表明该校及社区中无症状SARS-CoV-2流行病例负担较高。

解读

在教育环境中,通过基于RT-qPCR的合并检测并使用易于获取的唾液样本进行SARS-CoV-2筛查是检测新发病例和观察传播动态的可行方法。

资助

联邦教育与研究部(BMBF;“NaFoUniMedCovid19”项目中的B-FAST项目;注册号:01KX2021)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/22a6/8397903/7a948cd6944a/gr1.jpg

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