Emory University School of Medicine, Atlanta, Georgia.
Children's Healthcare of Atlanta, Atlanta, Georgia.
JAMA. 2022 Sep 13;328(10):935-940. doi: 10.1001/jama.2022.14877.
Despite the expansion of SARS-CoV-2 testing, available tests have not received Emergency Use Authorization for performance with self-collected anterior nares (nasal) swabs from children younger than 14 years because the effect of pediatric self-swabbing on SARS-CoV-2 test sensitivity is unknown.
To characterize the ability of school-aged children to self-collect nasal swabs for SARS-CoV-2 testing compared with collection by health care workers.
DESIGN, SETTING, AND PARTICIPANTS: Cross-sectional study of 197 symptomatic children and adolescents aged 4 to 14 years old. Individuals were recruited based on results of testing in the Children's Healthcare of Atlanta system from July to August 2021.
Children and adolescents were given instructional material consisting of a short instructional video and a handout with written and visual steps for self-swab collection. Participants first provided a self-collected nasal swab. Health care workers then collected a second specimen.
The primary outcome was SARS-CoV-2 detection and relative quantitation by cycle threshold (Ct) in self- vs health care worker-collected nasal swabs when tested with a real-time reverse transcriptase-polymerase chain reaction test with Emergency Use Authorization.
Among the study participants, 108 of 194 (55.7%) were male and the median age was 9 years (IQR, 6-11). Of the 196 participants, 87 (44.4%) tested positive for SARS-CoV-2 and 105 (53.6%) tested negative by both self- and health care worker-collected swabs. Two children tested positive by self- or health care worker-collected swab alone; 1 child had an invalid health care worker swab. Compared with health care worker-collected swabs, self-collected swabs had 97.8% (95% CI, 94.7%-100.0%) and 98.1% (95% CI, 95.6%-100.0%) positive and negative percent agreement, respectively, and SARS-CoV-2 Ct values did not differ significantly between groups (mean [SD] Ct, self-swab: 26.7 [5.4] vs health care worker swab: 26.3 [6.0]; P = .65).
After hearing and seeing simple instructional materials, children and adolescents aged 4 to 14 years self-collected nasal swabs that closely agreed on SARS-CoV-2 detection with swabs collected by health care workers.
尽管 SARS-CoV-2 检测范围不断扩大，但由于儿科自我鼻腔（鼻）拭子采集对 SARS-CoV-2 检测敏感性的影响尚不清楚，因此目前尚无可用的检测方法获得紧急使用授权，可用于检测 14 岁以下儿童。
与医护人员采集相比，评估学龄儿童自我采集鼻腔拭子进行 SARS-CoV-2 检测的能力。
设计、地点和参与者：这是一项横断面研究，纳入了 2021 年 7 月至 8 月期间亚特兰大儿童保健系统检测呈阳性的 197 名有症状的 4 至 14 岁儿童和青少年。根据参与者的检测结果，基于入组标准招募他们入组。
参与者接受了包含简短教学视频和书面及视觉步骤说明的教学材料，内容涉及自我拭子采集。参与者首先提供了自我采集的鼻腔拭子，然后医护人员采集了第二个样本。
主要结局是使用获得紧急使用授权的实时逆转录-聚合酶链反应（rRT-PCR）检测自我采集和医护人员采集的鼻腔拭子中 SARS-CoV-2 的检出情况，并通过循环阈值（Ct）进行相对定量。
在研究参与者中，194 名中有 108 名（55.7%）为男性，中位年龄为 9 岁（IQR，6-11 岁）。在 196 名参与者中，87 名（44.4%）SARS-CoV-2 检测呈阳性，105 名（53.6%）自我采集和医护人员采集的拭子均为阴性。有 2 名儿童的自我采集或医护人员采集拭子单独检测呈阳性，1 名儿童的医护人员采集拭子无效。与医护人员采集的拭子相比，自我采集的拭子在 SARS-CoV-2 阳性和阴性方面的符合率分别为 97.8%（95%CI，94.7%-100.0%）和 98.1%（95%CI，95.6%-100.0%），两组的 SARS-CoV-2 Ct 值无显著差异（平均[标准差]Ct，自我采集拭子：26.7[5.4] vs 医护人员采集拭子：26.3[6.0]；P = .65）。
在听取并观看了简单的教学材料后，4 至 14 岁的儿童和青少年自我采集了鼻腔拭子，这些拭子在 SARS-CoV-2 检测方面与医护人员采集的拭子结果非常一致。
