The Need for More and Better Testing for COVID-19

Abstract

With continued community transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the US, there has been sustained focus on the role of testingtomitigateandsuppressspread.Afterthefirstcase of coronavirus disease 2019 (COVID-19) was diagnosed in the US in mid-January 2020, testing lagged behind due to challenges with test validation at the Centers for Disease Control and Prevention. In late February 2020, the US Food and Drug Administration (FDA) eased its restrictions on Emergency Use Authorization, which led to a rapid increase in the number of authorized tests. By May 2020, the private sector was performing 99% of US COVID-19 testing. By August 2020, the number of SARS-CoV-2 tests peaked and then plateaued at approximately 1 million tests per day. Multiple parallel efforts to bring diagnostic innovation to COVID-19 testing are underway and are likely to result in more tests as well as new innovative platforms. For instance, the Rapid Acceleration of Diagnostics program is a $1.5-billion US government program launched by the National Institutes of Health to support development, production scale-up, and deployment of rapid tests with a goal of 6 million tests available per day. 1

Performance of a rapid antigen test in the diagnosis of SARS‐CoV‐2 infection

“…Antigen tests have been indicated as the tests that have the potential of quickly identifying individuals that can transmit infectious viral particles. Although less sensitive than molecular tests that detect viral RNA, antigen tests perform well on individuals with high viral load in their upper respiratory tract 4,5 . Antigen test is easy to perform, it does not requires skilled personnel and give results in about 15 min.…”

Engineered CRISPR/Cas12a Enables Rapid SARS-CoV-2 Detection

“…Similar to SHERLOCK and DETECTR, a major drawback to this technology is the possibility of carryover contamination. CRISPR-based detection system provides two check points for detection: (1) an isothermal pre-amplification step such as RT-LAMP that converts SARS-CoV-2 genomic RNA into millions of dsDNA copies and (2) CRISPR reaction where crRNA:LbCas12a complex targets the amplified dsDNA. Since this detection platform is not a continuous step, contamination might occur.…”

“…With a global pandemic of over 72 million COVID-19 cases resulting in over 1.6 million deaths, there remains a crucial need for diagnostic tools that allow for quick yet accurate detection of SARS-CoV-2 without the requirement of expensive equipment and extensive training (1, 2). While vaccines are beginning to emerge from Phase III clinical trials and be granted Emergency Use Authorizations (EUAs) by the FDA (3-7), case numbers are continuing to rise as second and third waves occur in many countries across the globe, and with treatments still somewhat limited, improvements in testing are more necessary than ever to keep both case numbers and fatality numbers down in order for preventative measures to be effective down the line (8, 9).…”

Does COVID-19 Testing Create More Cases? An Empirical Evidence on the Importance of Mass Testing During a Pandemic

“…Detection and surveillance of an infectious disease is the first step in controlling a pandemic 1 . However, not much attention has been given to understand the role of testing in mitigating an infectious disease’s spread 2 .…”