Review of analytical performance of COVID-19 detection methods

Abstract

In the recent SARS-CoV-2 pandemic, public health experts have emphasized testing, tracking infected people, and tracing their contacts as an effective strategy to reduce the spread of the virus. Several diagnostic methods are reported for detecting the coronavirus in clinical, research, and public health laboratories. Some tests detect the infection directly by detecting the viral RNA and other tests detect the infection indirectly by detecting the host antibodies. A diagnostic test during the pandemic should help make an appropriate clinical decision in a short period of time. Recently reported diagnostic methods for SARS-CoV-2 have varying throughput, batching capacity, requirement of infrastructure setting, analytical performance, and turnaround times ranging from a few minutes to several hours. These factors should be considered while selecting a reliable and rapid diagnostic method to help make an appropriate decision and prompt public health interventions. This paper reviews recent SARS-CoV-2 diagnostic methods published in journals and reports released by regulatory agencies. We compared the analytical efficiency including limit of detection, sensitivity, specificity, and throughput. In addition, we also looked into ease of use, affordability, and availability of accessories. Finally, we discuss the limitations of the methods and provide our perspectives on priorities for future test development.

Impact of SARS-CoV-2 pandemic among health care workers in a secondary teaching hospital in Spain

“…Although we have not evaluated the sensitivity and specificity of the diagnostic tools used in our study, there is evidence on the performance of the different platforms and targets. In the case of rt-PCR, sensitivity ranges of 43.6–100% and specificity of 98–100% depending on protocols and targets [ 36 ]. These data are also influenced by the sample type and quality and the time since exposition [ 37 ].…”

Evaluation of two fluorescence immunoassays for the rapid detection of SARS-CoV-2 antigen—new tool to detect infective COVID-19 patients

“…Therefore, alternative diagnostic tools allowing the rapid testing of large numbers of samples and the ability to evaluate infectivity are of high priority ( European Centre for Disease Prevention and Control (ECDC), 2020 ). Recent developments include whole-genome sequencing, CRISPR-based technologies, droplet-based digital PCR, RT-LAMP, and immunoassays for the detection of antibodies or antigen ( Giri et al, 2020 ). Rapid antigen detection tests (Ag-RDT) using immunochromatographic (ICT) or fluorescence immunoassays (FIAs) have recently become available; many of which are CE-IVD licensed and some have received FDA emergency use authorization (EUA) ( ).…”

Challenges of SERS technology as a non-nucleic acid or -antigen detection method for SARS-CoV-2 virus and its variants

“…This shows that diagnostic procedures play a vital role in mitigating rapidly spreading viruses. Generally, several analytical aspects of nucleic acid-based and serological diagnostic tests should be considered ( Giri et al, 2020 ; Ravi et al, 2020 ; Sheikhzadeh et al, 2020 ) including: accuracy, i.e., the ability of the tests to not produce false positives/negatives, reproducibility, i.e., the consistency of results after repeated tests, and specificity, i.e., the tests can correctly to identify target analyte/s.…”