Abstract

Role of clinical laboratories in response to the COVID-19 pandemic.

Highlights

  • Absence of adequate testing due to various factors, most significant of which being supply chain issues, is most likely contributing to community spread

  • Emergency Use Authorization (EUA) are accompanied by recommendations of the ideal test protocol, laboratories have to increase COVID-19 test output without compromising on accuracy yet with less than ideal variables

  • The pre-analytical constraints emerged as the viral transport media used for collecting nasopharyngeal (NSP) swab samples became exhausted, forcing laboratories to hold up sample collection, or revert to other collection methods

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Summary

Introduction

Absence of adequate testing due to various factors, most significant of which being supply chain issues, is most likely contributing to community spread. In response to the outbreak, several state authorities and commercial companies have developed diagnostic assays to test individuals for the SARS-CoV-2 infection. Over 40 diagnostic assays have received Emergency Use Authorization (EUA) from the Federal US FDA for COVID-19 testing.

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