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Volume 1, Issue 1, 18 December 2020, Pages 152-157.e3
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Clinical and Translational Resource and Technology Insights
Rapid Implementation of a SARS-CoV-2 Diagnostic Quantitative Real-Time PCR Test with Emergency Use Authorization at a Large Academic Safety Net Hospital

https://doi.org/10.1016/j.medj.2020.05.001Get rights and content
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Highlights

  • Basic research laboratories can be repurposed into COVID-19 testing sites

  • Widespread testing is essential in underserved communities to contain viral spread

  • This study offers a blueprint to navigate challenges in implementing in-house testing

Context and Significance

In a setting of widespread community transmission of SARS-CoV-2 (COVID-19), it is vital to rapidly and reliably identify and isolate cases to mitigate and ultimately eradicate viral spread. National failures to launch widespread testing in the United States have necessitated academic and non-governmental institutions to fill this critical unmet need. Furthermore, it is particularly important for testing to be widely available to at-risk communities, which are greatly impacted by the current pandemic. This study describes the rapid implementation of a COVID-19 diagnostic test at a large safety net hospital that primarily treats an underserved population and aims to provide a blueprint for other institutions to navigate the logistical and regulatory challenges to provide equitable access to COVID-19 testing for all.

Summary

Background

Significant delays in the rapid development and distribution of diagnostic testing for SARS-CoV-2 (COVID-19) infection have prevented adequate public health management of the disease, impacting the timely mapping of viral spread and the conservation of personal protective equipment. Furthermore, vulnerable populations, such as those served by the Boston Medical Center (BMC), the largest safety net hospital in New England, represent a high-risk group across multiple dimensions, including a higher prevalence of pre-existing conditions and substance use disorders, lower health maintenance, unstable housing, and a propensity for rapid community spread, highlighting the urgent need for expedient and reliable in-house testing.

Methods

We developed a SARS-CoV-2 diagnostic medium-throughput qRT-PCR assay with rapid turnaround time and utilized this Clinical Laboratory Improvement Amendments (CLIA)-certified assay for testing nasopharyngeal swab samples from BMC patients, with emergency authorization from the Food and Drug Administration (FDA) and the Massachusetts Department of Public Health.

Findings

The in-house testing platform displayed robust accuracy and reliability in validation studies and reduced institutional sample turnaround time from 5–7 days to less than 24 h. Of over 1,000 unique patient samples tested, 44.1% were positive for SARS-CoV-2 infection.

Conclusions

This work provides a blueprint for academic centers and community hospitals lacking automated laboratory machinery to implement rapid in-house testing.

Funding

This study was supported by funding from the Boston University School of Medicine, the National Institutes of Health, Boston Medical Center, and the Massachusetts Consortium on Pathogen Readiness (MASS CPR).

Keywords

CAT Scale: Foundational Research

Keywords

SARS-CoV-2
COVID-19
coronavirus
pathology and laboratory medicine
clinical diagnostics
emergency use authorization

Cited by (0)

4

These authors contributed equally

5

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