Nucleic Acid-Based Diagnostic Tests for the Detection SARS-CoV-2: An Update.

Area of Science:

• Medical Diagnostics
• Virology
• Public Health

Background:

• The COVID-19 pandemic, caused by SARS-CoV-2, has led to millions of cases and deaths globally.
• Accurate and rapid diagnostic testing is crucial for controlling the spread of SARS-CoV-2.
• The Food and Drug Administration (FDA) has issued emergency use authorizations (EUAs) for various diagnostic tests.

Purpose of the Study:

• To provide an objective overview of the latest nucleic acid-based diagnostic tests for SARS-CoV-2.
• To systematically summarize and compare amplification- and sequencing-based tests authorized by the FDA.
• To highlight the features, advantages, and disadvantages of these diagnostic tests.

Main Methods:

• Review of FDA-authorized nucleic acid-based diagnostic tests for SARS-CoV-2.
• Systematic comparison of amplification- and sequencing-based test principles, technologies, and protocols.
• Analysis of test performance characteristics, including authorized settings.

Main Results:

• Overview of various nucleic acid-based diagnostic tests for SARS-CoV-2.
• Comparison of amplification- and sequencing-based methods as alternatives to the CDC's RT-PCR panel.
• Identification of notable features, advantages, and disadvantages of authorized tests.

Conclusions:

• Nucleic acid-based tests are vital for COVID-19 diagnosis and pandemic control.
• Understanding the performance and characteristics of different tests is essential for effective implementation.
• Future perspectives and current challenges in COVID-19 diagnostics require further investigation.