Diagnostic Testing for the Novel Coronavirus

Abstract

Controversies over diagnostic testing have dominated US headlines about severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the novel coronavirus responsible for coronavirus disease 2019 . Technical challenges with the first test developed by the Centers for Disease Control and Prevention (CDC) left the nation with minimal diagnostic capacity during the first few weeks of the epidemic. The CDC also initially limited access to testing to a narrow group of individuals with known exposure. The delayed discovery of a case of COVID-19 in California, followed quickly by evidence of community transmission in multiple states, revealed the shortcomings of this strategy. In the early stages, COVID-19 has spread beyond the nation's ability to detect it.On February 29, the US Food and Drug Administration (FDA) moved to expand testing capacity by eliminating a requirement that advanced laboratories obtain prior FDA authorization before using their own, laboratory-developed tests. 1 Then, on March 3, Vice President Pence announced the removal of all federal limits on testing, stating that "subject to doctors' orders, any American can be tested." These steps left many with questions about what had happened with testing and what should happen next.

Potential preanalytical and analytical vulnerabilities in the laboratory diagnosis of coronavirus disease 2019 (COVID-19)

“…Clear instructions on how the specimens, especially nasopharyngeal and oropharyngeal swabs, shall be collected, managed and stored before testing shall then be provided to the healthcare personnel [45]. The assay procedures must be thoughtfully followed, including standard confirmatory testing and test report guidelines, and quality assurance carried out to validate each analytical session [46]. External quality assessment (EQA) schemes shall be established as soon as possible for purposes of monitoring analytical quality and harmonizing the assays.…”

“…Despite the urge to provide high throughput and short turnaround time for diagnosing SARS-CoV-2 infection, extensive validation of RT-PCR assay is compellingly needed to enable the adoption of the most appropriate public health measures on individual and population bases. Finally, further refinement of molecular target(s) would also be needed, in order to identify regions of viral genome that may enable to reach the highest possible diagnostic accuracy [46,47].…”

Preliminary Results of Initial Testing for Coronavirus (COVID-19) in the Emergency Department

“…4 The early stages of the response to COVID-19 in the US was hampered by multiple challenges and issues, particularly availability of diagnostic testing for the novel coronavirus. 5 As a result, testing has been limited with specific criteria recommended by the CDC including severity of disease, such as requiring hospitalization, recent travel, or risk factors for significant morbidity and mortality. 6 In response, a number of innovative approaches have been piloted to assess patients for the disease.…”

Innovation and Knowledge Sharing Can Transform COVID‐19 Infection Prevention Response

“…In the United States, which now has the highest number of COVID-19 cases worldwide, there were technical difficulties with the first diagnostic test developed by the Centers for Disease Control and Prevention (CDC) and subsequent delays in scaling up access to COVID-19 diagnostic testing. 2 The strategy of initially reserving testing only for those who were critically ill meant that by the time patients with COVID-19 were being diagnosed, widespread community spread had occurred because of the lack of detection of individuals with less severe or asymptomatic infections.…”