Abstract
The recent outbreak of the Coronavirus disease 2019 (COVID-19) has quickly spread worldwide since its discovery in Wuhan city, China in December 2019. A comprehensive strategy, including surveillance, diagnostics, research, clinical treatment, and development of vaccines, is urgently needed to win the battle against COVID-19. The past three unprecedented outbreaks of emerging human coronavirus infections at the beginning of the 21st century have highlighted the importance of readily available, accurate, and rapid diagnostic technologies to contain emerging and re-emerging pandemics. Real-time reverse transcriptase-polymerase chain reaction (rRT-PCR) based assays performed on respiratory specimens remain the gold standard for COVID-19 diagnostics. However, point-of-care technologies and serologic immunoassays are rapidly emerging with high sensitivity and specificity as well. Even though excellent techniques are available for the diagnosis of symptomatic patients with COVID-19 in well-equipped laboratories; critical gaps still remain in screening asymptomatic people who are in the incubation phase of the virus, as well as in the accurate determination of live viral shedding during convalescence to inform decisions for ending isolation. This review article aims to discuss the currently available laboratory methods and surveillance technologies available for the detection of COVID-19, their performance characteristics and highlight the gaps in current diagnostic capacity, and finally, propose potential solutions. We also summarize the specifications of the majority of the available commercial kits (PCR, EIA, and POC) for laboratory diagnosis of COVID-19.
Highlights
Infectious diseases impose a major health threat globally, leading to 15 million deaths annually [1].Infectious diseases remain the third leading cause of death in the US [2]
Transforming the molecular diagnostic testing for SARS-CoV-2 from laboratory settings to point of care (POC) is potentially important to increase the quantity of testing that can be conducted [39,42], potentially reducing the time to obtain an actionable result, and supporting earlier identification of positive cases
Another challenge of using manual enzyme-linked immunosorbent assays (ELISA) for SARS-CoV-2 detection is that IgM antibodies are notoriously non-specific, and given the time it takes for the development of specific IgG antibodies, serology testing will not likely play an active role in the detection of early cases (Figure 1) except for diagnosis/confirming late cases or to determine the immunity of healthcare personnel as the outbreak progresses [60]
Summary
Infectious diseases impose a major health threat globally, leading to 15 million deaths annually [1]. Traditional diseases which appeared to be “on their way out” (such as malaria and tuberculosis) are resurging [2] and, most importantly, the latest coronavirus disease pandemic (COVID-19) This novel virus (SARS-CoV-2) recently emerged in Wuhan-China, causing a new public health crisis threatening the world. The introduction of rapid molecular diagnostic techniques and rapid serological assays in the reference diagnostic laboratories would enable the rapid identification, isolation, and treatment of COVID-19 positive cases. This demonstrates, once more, that laboratory medicine is integral to most care pathways [7] and will perhaps remain so for many years to come. We will summarize the associated vulnerabilities and gaps in the performance of the current diagnostic technologies that are likely to have serious consequences against the global efforts to contain the outbreak
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