Large-scale testing, in combination with contact tracing and broad public health control measures, has proven effective in containing SARS-CoV-2 in South Korea and Taiwan ( 9– 11). In response to the rapidly evolving COVID-19 pandemic, a variety of testing approaches have been employed based on local testing capacities, public health resources, and epidemiology. deaths from COVID-19 had surpassed the death toll of its citizens from World War II, the Korean War, and the Vietnam War combined ( 8). As of end-March 2021, there were more than 125 million confirmed cases and over 2.7 million deaths, reflecting a global case fatality rate of 2.19% ( 7), compared to 8,096 total cases and 774 confirmed deaths for SARS, and 2,521 total cases with 866 confirmed deaths for MERS ( 3). First reported in China, SARS-CoV-2 spread globally within months, with the Americas, South Asia, and Europe being most severely affected to-date. Transmission of SARS-CoV-2 may have been enhanced by spread from asymptomatic and mildly symptomatic individuals, as opposed to SARS-CoV and MERS where patients tended to be sicker and less mobile, thus resulting in a higher basic reproduction number (R 0) for SARS-CoV-2 ( 3– 6). COVID-19 represents the third major spill-over of a coronavirus from animals to humans during the last two decades ( 2), with greater global impact than the previous coronavirus outbreaks in 2003 (SARS-CoV) and 2012–20 (Middle East Respiratory Syndrome Coronavirus/MERS-CoV). Access to scalable diagnostic tools and continued technologic advances, including machine learning and smartphone integration, will facilitate control of the current pandemic as well as preparedness for the next one.Ĭoronavirus disease 2019 (COVID-19), caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) ( 1), has dominated the attention of clinicians, researchers, policymakers and communities worldwide. Strategies to further optimize safety, speed, and ease of SARS-CoV-2 testing without compromising accuracy are suggested. We herein provide a comprehensive review of currently available COVID-19 diagnostics, exploring their pros and cons as well as appropriate indications. The ever-expanding assortment of tests, with varying clinical utility, performance requirements, and limitations, merits comparative evaluation. While sequencing is important to monitor on-going evolution of the SARS-CoV-2 genome, antibody assays are useful for epidemiologic purposes. Alternatives to RT-PCR assay, such as other RNA detection methods and antigen tests may be appropriate for certain situations, such as resource-limited settings. Several sample-to-answer platforms, including high-throughput systems and Point of Care (PoC) assays, have been developed to increase testing capacity and decrease technical errors. Thus, clinical presentation, contact history and contemporary phyloepidemiology must be considered when interpreting results. NAAT may give false-negative results due to timing of sample collection relative to infection, improper sampling of respiratory specimens, inadequate preservation of samples, and technical limitations false-positives may occur due to technical errors, particularly contamination during the manual real-time polymerase chain reaction (RT-PCR) process. Confirmation of SARS-CoV-2 infection is typically by nucleic acid amplification tests (NAAT), which requires specialized equipment and training and may be particularly challenging in resource-limited settings. Laboratory testing may be performed based on symptomatic presentation or for screening of asymptomatic people. Rapid and accurate diagnostic tests are imperative for identifying and managing infected individuals, contact tracing, epidemiologic characterization, and public health decision making.
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