COVID‐19 Clinical Diagnostics and Testing Technology

Abstract

Given the global nature of the coronavirus disease 2019 (COVID‐19) pandemic, the need for disease detection and expanding testing capacity remains critical priorities. This review discusses the technological advances in testing capability and methodology that are currently used or in development for detecting the novel coronavirus. We describe the current clinical diagnostics and technology, including molecular and serological testing approaches, for severe acute respiratory syndrome‐coronavirus 2 (SARS‐CoV‐2) testing as well as address their advantages and limitations. Nucleic acid amplification technology for molecular diagnostics remains the gold standard for virus detection. We highlight alternative molecular detection techniques used for developing novel COVID‐19 diagnostics on the horizon. Antibody response against SARS‐CoV‐2 remains poorly understood and proper validation of serology tests is necessary to demonstrate their accuracy and clinical utility. In order to bring the pandemic under control, we must speed up the development of rapid and widespread testing through improvements in clinical diagnostics and testing technology as well as access to these tools.

Performance evaluation of serological assays to determine the immunoglobulin status in SARS-CoV-2 infected patients

“…However, we have demonstrated that relying only on the detection of the IgG antibody titer for diagnostic purposes led to false negative results in several cases, most likely with samples obtained during the rather early phases of an immune response. We have shown, that the inclusion of additional immunoglobulin classes further increases the assay sensitivity and should be considered a valuable asset during the selection process of a diagnostic assay, a notion also argued already by others [ 19 , 20 ]. In addition, also the parallel analysis of more than one SARS-CoV-2 antigen for serological characterization – as demonstrated by the Genspeed COVID-19 assay – might proof beneficial for increasing diagnostic performance.…”

A Cross-sectional Survey on the Impact of Coronavirus Disease 2019 on the Clinical Practice of Endodontists across the United States

“…Although the diagnosis of COVID-19 relies on the detection of the SARS-CoV-2 RNA by Real-Time Reverse Transcriptase (RT)–PCR ( 4 , 12 , 13 ), here only a few endodontists were using it as their patient screening technique. No endodontist participant requested chest X-ray for COVID-19 screening in their dental practice, although chest X-ray might show patchy shadows and ground-glass opacity in the lung ( 14 ).…”

“…The COVID-19 disease is caused by the novel coronavirus Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2, formerly known as 2019-nCoV) ( 4 ). The most commonly reported routes of SARS-CoV-2 transmission are inhalation or direct inoculation ( 5 ).…”

The Main Molecular and Serological Methods for Diagnosing COVID-19: An Overview Based on the Literature

“…These tests are most often performed in large labs at commercial diagnostic facilities or academic centers. Specimens from individuals with suspected infection must, therefore, be sent to these labs, increasing both the time and coordination requirements [ 65 ]. Thus, different alternatives have been proposed for improvements in the performance of the RT-qPCR assay with the use of high throughput platforms (or systems), which involve an automated workflow to enable high throughput testing with minimal hands-on time, and still offering fast, reliable results [ 66 ].…”