Mendoza Rachelle P, Bi Chongfeng, Cheng Hui-Ting, Gabutan Elmer, Pagaspas Guillerre Jan, Khan Nadia, Hoxie Helen, Hanna Stephen, Holmes Kelly, Gao Nicholas, Lewis Raychel, Wang Huaien, Neumann Daniel, Chan Angela, Takizawa Meril, Lowe James, Chen Xiao, Kelly Brianna, Asif Aneeza, Barnes Keena, Khan Nusrat, May Brandon, Chowdhury Tasnim, Pollonini Gabriella, Gouda Nourelhoda, Guy Chante, Gordon Candice, Ayoluwa Nana, Colon Elvin, Miller-Medzon Noah, Jones Shanique, Hossain Rauful, Dodson Arabia, Weng Meimei, McGaskey Miranda, Vasileva Ana, Lincoln Andrew E, Sikka Robby, Wyllie Anne L, Berke Ethan M, Libien Jenny, Pincus Matthew, Premsrirut Prem K
Mirimus Inc, 760 Parkside Ave. Suite 206, Brooklyn, NY 11226, USA.
Department of Pathology, SUNY Downstate Health Sciences University, 450 Clarkson Ave., Brooklyn, NY 11226, USA.
EClinicalMedicine. 2021 Aug;38:101028. doi: 10.1016/j.eclinm.2021.101028. Epub 2021 Jul 17.
The negative impact of continued school closures during the height of the COVID-19 pandemic warrants the establishment of cost-effective strategies for surveillance and screening to safely reopen and monitor for potential in-school transmission. Here, we present a novel approach to increase the availability of repetitive and routine COVID-19 testing that may ultimately reduce the overall viral burden in the community.
We implemented a testing program using the SalivaClear࣪ pooled surveillance method that included students, faculty and staff from K-12 schools (student age range 5-18 years) and universities (student age range >18 years) across the country (Mirimus Clinical Labs, Brooklyn, NY). The data analysis was performed using descriptive statistics, kappa agreement, and outlier detection analysis.
From August 27, 2020 until January 13, 2021, 253,406 saliva specimens were self-collected from students, faculty and staff from 93 K-12 schools and 18 universities. Pool sizes of up to 24 samples were tested over a 20-week period. Pooled testing did not significantly alter the sensitivity of the molecular assay in terms of both qualitative (100% detection rate on both pooled and individual samples) and quantitative (comparable cycle threshold (Ct) values between pooled and individual samples) measures. The detection of SARS-CoV-2 in saliva was comparable to the nasopharyngeal swab. Pooling samples substantially reduced the costs associated with PCR testing and allowed schools to rapidly assess transmission and adjust prevention protocols as necessary. In one instance, in-school transmission of the virus was determined within the main office and led to review and revision of heating, ventilating and air-conditioning systems.
By establishing low-cost, weekly testing of students and faculty, pooled saliva analysis for the presence of SARS-CoV-2 enabled schools to determine whether transmission had occurred, make data-driven decisions, and adjust safety protocols. We provide strong evidence that pooled testing may be a fundamental component to the reopening of schools by minimizing the risk of in-school transmission among students and faculty.
Skoll Foundation generously provided funding to Mobilizing Foundation and Mirimus for these studies.
在新冠疫情高峰期持续关闭学校所带来的负面影响，使得有必要制定具有成本效益的监测和筛查策略，以安全地重新开放学校并监测校内潜在传播情况。在此，我们提出一种新方法，以提高重复和常规新冠病毒检测的可及性，这最终可能降低社区中的总体病毒负担。
我们实施了一项使用SalivaClear™混合监测方法的检测计划，该计划涵盖了全国范围内从幼儿园到12年级的学校（学生年龄范围为5至18岁）以及大学（学生年龄范围大于18岁）的学生、教职员工（纽约布鲁克林的Mirimus临床实验室）。数据分析采用描述性统计、kappa一致性分析和异常值检测分析。
从2020年8月27日至2021年1月13日，从93所幼儿园到12年级的学校和18所大学的学生、教职员工中自行采集了253,406份唾液样本。在20周的时间里，对多达24个样本的混合样本进行了检测。从定性（混合样本和单个样本的检测率均为100%）和定量（混合样本和单个样本之间的循环阈值（Ct）值可比）测量来看，混合检测并未显著改变分子检测的灵敏度。唾液中新冠病毒的检测结果与鼻咽拭子相当。混合样本大大降低了与聚合酶链反应（PCR）检测相关的成本，并使学校能够迅速评估传播情况，并在必要时调整预防方案。有一次，在学校主办公室确定了病毒的校内传播，并促使对供暖、通风和空调系统进行审查和修订。
通过建立低成本的每周对学生和教职员工进行检测，对唾液进行混合分析以检测新冠病毒，使学校能够确定是否发生了传播，做出基于数据的决策，并调整安全方案。我们提供了有力证据，表明混合检测可能是学校重新开放的一个基本组成部分，通过最大限度地降低学生和教职员工在校内传播的风险。
斯科尔基金会慷慨地为动员基金会和Mirimus提供资金用于这些研究。
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