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Related Experiment Video

Updated: Dec 20, 2025

Large-Scale SARS-CoV-2 Testing Utilizing Saliva and Transposition Sample Pooling
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Clinical testing for COVID-19.

Stephanie Ward1, Andrew Lindsley1, Josh Courter2

  • 1Division of Allergy and Immunology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.

The Journal of Allergy and Clinical Immunology
|May 24, 2020
PubMed
Summary

This review details the timeline of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) diagnostic test development in the US. It compares approved tests, focusing on point-of-care and serologic assays, and discusses prioritization strategies.

Keywords:
COVID-19Centers for Disease Control and PreventionE proteinFood and Drug AdministrationM proteinN proteinRT-PCRS proteinSARS-CoV-2World Health Organizationcoronavirusguidancenucleic acid testpoint-of-careprioritizationserologic testtestviral genes

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Area of Science:

  • Virology
  • Infectious Diseases
  • Public Health

Background:

  • The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) led to rapid development of diagnostic tests.
  • Initial testing was centralized at the Centers for Disease Control and Prevention (CDC), with subsequent Emergency Use Authorization enabling broader laboratory test development.
  • The escalating pandemic highlighted critical needs for accessible and timely SARS-CoV-2 detection.

Purpose of the Study:

  • To review the timeline of diagnostic test development for SARS-CoV-2 in the United States.
  • To compare various approved nucleic acid and serologic tests based on genes detected, turnaround times, and technologies.
  • To discuss the evolution of testing guidance, prioritization strategies, and the role of point-of-care and serologic tests.

Main Methods:

  • Review of publicly available data on SARS-CoV-2 diagnostic tests approved under Emergency Use Authorization.
  • Comparative analysis of test characteristics including genes targeted, turnaround time, and platform (e.g., RT-PCR, point-of-care, serology).
  • Examination of CDC and other relevant guidance documents for testing prioritization and hospital implementation.

Main Results:

  • Multiple RT-PCR based nucleic acid tests were developed with varying specifications and turnaround times.
  • The demand for testing necessitated prioritization strategies due to supply limitations.
  • Emergence of serologic tests for surveillance and the development of point-of-care tests were key advancements.

Conclusions:

  • The rapid development and deployment of diverse SARS-CoV-2 tests were crucial during the pandemic.
  • Understanding the characteristics of different tests, including point-of-care and serologic options, is vital for effective disease management and surveillance.
  • Strategic prioritization and appropriate application of testing are essential in clinical and public health settings.