Abstract

BackgroundThe 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.MethodsWe 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.FindingsFrom 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.InterpretationBy 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.FundingSkoll Foundation generously provided funding to Mobilizing Foundation and Mirimus for these studies.

Highlights

  • The number of daily tests for SARS-CoV-2 in the United States increased from approximately 400,000 in the summer of 2020, to 1 million daily tests in September, to 2 million in January 2021 [1]

  • We first determined the limit of detection (LOD) of the reverse transcriptionÀpolymerase chain reaction (RT-PCR) assay using validated whole heatinactivated SARS-CoV-2 virus spiked into known negative saliva

  • Confirmation of the preliminary LOD (313 genome copy equivalents per ml (GCE/ml)) and a level higher (625 GCE/ml) were analyzed in an additional 20 independent RNA extractions followed by RT-PCR

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Summary

Introduction

The number of daily tests for SARS-CoV-2 in the United States increased from approximately 400,000 in the summer of 2020, to 1 million daily tests in September, to 2 million in January 2021 [1]. New strategies for surveillance and screening are needed to increase the availability of testing and to reduce the overall viral burden in the community while monitoring for virus resurgence. Despite the advent of COVID À19 vaccines, continued testing is required to monitor the spread of new SARS-CoV-2 variants and for assessing the efficacy of current vaccination strategies [3]. While reverse transcriptionÀpolymerase chain reaction (RT-PCR) remains the gold standard method for detecting SARS-CoV-2, cost-effective strategies are desperately needed to permit mass testing efforts. Pooling samples substantially reduced the costs associated with PCR testing and allowed schools to rapidly assess transmission and adjust prevention protocols as necessary. Interpretation: 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

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