Abstract

Population-scale and rapid testing for SARS-CoV-2 continues to be a priority for several parts of the world. We revisit the in vitro technology platforms for COVID-19 testing and diagnostics—molecular tests and rapid antigen tests, serology or antibody tests, and tests for the management of COVID-19 patients. Within each category of tests, we review the commercialized testing platforms, their analyzing systems, specimen collection protocols, testing methodologies, supply chain logistics, and related attributes. Our discussion is essentially focused on test products that have been granted emergency use authorization by the FDA to detect and diagnose COVID-19 infections. Different strategies for scaled-up and faster screening are covered here, such as pooled testing, screening programs, and surveillance testing. The near-term challenges lie in detecting subtle infectivity profiles, mapping the transmission dynamics of new variants, lowering the cost for testing, training a large healthcare workforce, and providing test kits for the masses. Through this review, we try to understand the feasibility of universal access to COVID-19 testing and diagnostics in the near future while being cognizant of the implicit tradeoffs during the development and distribution cycles of new testing platforms.

Highlights

  • IntroductionTo limit the spread of SARS-CoV-2, aggressive and scalable deployment of COVID-19 testing resources has been a priority of health and administrative officials worldwide

  • Accepted: 28 September 2021To limit the spread of SARS-CoV-2, aggressive and scalable deployment of COVID-19 testing resources has been a priority of health and administrative officials worldwide.A COVID-19 diagnostic test is advisable for individuals experiencing COVID-19 symptoms or those exposed to persons with suspected or confirmed COVID-19 illness [1,2].The COVID-19 test is advised for travel purposes, recreation, social gatherings and professional meetings, or can be enforced at the workplace by employers [3]

  • Different agencies at global and national levels have played a critical role in accelerating the technology development, clinical validation, emergency use authorization, and deployment of in vitro diagnostic (IVD) tests against the novel coronavirus

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Summary

Introduction

To limit the spread of SARS-CoV-2, aggressive and scalable deployment of COVID-19 testing resources has been a priority of health and administrative officials worldwide. New Diagnostics (FIND), a Geneva-based not-for-profit organization, has led international partnerships for scaled-up development and delivery of COVID-19 tests through its Access to COVID-19 Tools (ACT) Accelerator [8]. Despite these commendable efforts, the pandemic continues to rattle several parts of the world, especially the low- and middle-income households where testing sites are inaccessible and test kits are cost-prohibitive or in limited supply [10].

Diagnostic Tests for SARS-CoV-2
Reporting Guidelines for Device Manufacturers and Testing Facilities
Molecular Diagnostic Tests for SARS-CoV-2 Using Respiratory Specimens
Saliva-based
Benefits for SARS-CoV-2 detection compared to respiratory respiratory
Spectrum
Rapid Antigen Tests for SARS-CoV-2
COVID-19 Vending Machines and Testing-as-a-Service Platforms
Serology or Antibody Tests for SARS-CoV-2
Findings
10. Discussion
11. Conclusions
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