Department of Laboratory Medicine, Boston Children's Hospital, Boston, Massachusetts, USA.
CIC Health, Cambridge, Massachusetts, USA.
J Clin Microbiol. 2021 Aug 18;59(9):e0112321. doi: 10.1128/JCM.01123-21.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) testing is one component of a multilayered mitigation strategy to enable safe in-person school attendance for the K-12 school population. However, costs, logistics, and uncertainty about effectiveness are potential barriers to implementation. We assessed early data from the Massachusetts K-12 public school pooled SARS-CoV2 testing program, which incorporates two novel design elements: in-school "pod pooling" for assembling pools of dry anterior nasal swabs from 5 to 10 individuals and positive pool deconvolution using the BinaxNOW antigen rapid diagnostic test (Ag RDT), to assess the operational and analytical feasibility of this approach. Over 3 months, 187,597 individual swabs were tested across 39,297 pools from 738 schools. The pool positivity rate was 0.8%; 98.2% of pools tested negative and 0.2% inconclusive, and 0.8% of pools submitted could not be tested. Of 310 positive pools, 70.6% had an N1 or N2 probe cycle threshold () value of ≤30. In reflex testing (performed on specimens newly collected from members of the positive pool), 92.5% of fully deconvoluted pools with an N1 or N2 target of ≤30 identified a positive individual using the BinaxNOW test performed 1 to 3 days later. However, of 124 positive pools with full reflex testing data available for analysis, 32 (25.8%) of BinaxNOW pool deconvolution testing attempts did not identify a positive individual, requiring additional reflex testing. With sufficient staffing support and low pool positivity rates, pooled sample collection and reflex testing were feasible for schools. These early program findings confirm that screening for K-12 students and staff is achievable at scale with a scheme that incorporates in-school pooling, primary testing by reverse transcription-PCR (RT-PCR), and Ag RDT reflex/deconvolution testing.
严重急性呼吸综合征冠状病毒 2(SARS-CoV2)检测是实现 K-12 学校人群安全面授的多层次缓解策略的一个组成部分。然而,实施的成本、后勤和对有效性的不确定性是潜在的障碍。我们评估了马萨诸塞州 K-12 公立学校汇集 SARS-CoV2 检测计划的早期数据,该计划采用了两个新的设计要素:在学校内“小团体汇集”,用于汇集来自 5 至 10 个人的干燥前鼻拭子样本,并使用 BinaxNOW 抗原快速诊断检测(Ag RDT)对阳性样本进行重新分析,以评估该方法的操作和分析可行性。在 3 个月内,对来自 738 所学校的 39,297 个样本池中的 187,597 个个体拭子进行了检测。样本池阳性率为 0.8%;98.2%的样本池检测结果为阴性和 0.2%的结果不确定,0.8%的提交样本池无法进行检测。在 310 个阳性样本池中,70.6%的 N1 或 N2 探针循环阈值(Ct)值≤30。在反射性检测(对阳性样本池中新采集的样本进行检测)中,使用 BinaxNOW 检测 1 至 3 天后,92.5%的 N1 或 N2 靶标 Ct 值≤30 的完全重新分析样本池都能识别出阳性个体。然而,在可用于分析的 124 个阳性样本池的完整反射性测试数据中,32(25.8%)个 BinaxNOW 样本池重新分析测试未能识别出阳性个体,需要进行额外的反射性测试。有了足够的人员支持和低样本池阳性率,对于学校来说,汇集样本采集和反射性测试是可行的。这些早期的项目发现证实,通过在学校内汇集、采用逆转录聚合酶链反应(RT-PCR)进行初步检测,以及 Ag RDT 反射/重新分析检测,对 K-12 学生和教职员工进行筛查是可行的。