Diagnostics for SARS-CoV-2 infections

Kevadiya, Bhavesh D.; Machhi, Jatin; Herskovitz, Jonathan; Oleynikov, Maxim D.; Blomberg, Wilson R.; Bajwa, Neha; Soni, Dhruvkumar; Das, Srijanee; Hasan, Mahmudul; Patel, Milankumar; Senan, Ahmed M.; Gorantla, Santhi; McMillan, JoEllyn M; Edagwa, Benson; Eisenberg, Robert; Gurumurthy, Channabasavaiah B.; Reid, St Patrick; Punyadeera, Chamindie; Chang, Linda; Gendelman, Howard E.

doi:10.1038/s41563-020-00906-z

Cited by 666 publications

(613 citation statements)

References 105 publications

(150 reference statements)

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“…Antigen-based RDTs for SARS-CoV-2 are reported to target multiple antigens, including the SARS-CoV-2 spike or nucleocapsid protein. Recent studies support the efficacy of the nucleocapsid protein as a detection target in these types of antigen-based assays [8,20]. Reports involving SARS-related viruses demonstrate the secretion of high levels of the nucleocapsid protein relative to the other viral proteins [21].…”

Section: Discussionmentioning

confidence: 92%

Development and Clinical Evaluation of an Immunochromatography-Based Rapid Antigen Test (GenBody™ COVAG025) for COVID-19 Diagnosis

Kim

Lee

Bal

et al. 2021

Viruses

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Antigen tests for SARS-CoV-2 diagnosis are simpler and faster than their molecular counterparts. Clinical validation of such tests is a prerequisite before their field applications. We developed and clinically evaluated an immunochromatographic immunoassay, GenBody™ COVAG025, for the rapid detection of SARS-CoV-2 nucleocapsid (NP) antigen in two different clinical studies. Retrospectively, 130 residual nasopharyngeal swabs transferred in viral transport medium (VTM), pre-examined for COVID-19 through emergency use authorization (EUA)-approved real-time RT-PCR assay and tested with GenBody™ COVAG025, revealed a sensitivity and specificity of 90.00% (27/30; 95% CI: 73.47% to 97.89%) and 98.00% (98/100; 95% CI: 92.96% to 99.76%), respectively, fulfilling WHO guidelines. Subsequently, the prospective examination of 200 symptomatic and asymptomatic nasopharyngeal swabs, collected on site and tested with GenBody™ COVAG025 and EUA-approved real-time RT-PCR assay simultaneously, revealed a significantly higher sensitivity and specificity of 94.00% (94/100; 95% CI: 87.40% to 97.77%) and 100.00% (100/100; 95% CI: 96.38% to 100.00%), respectively. Clinical sensitivity and specificity were significantly high for samples with Ct values ≤ 30 as well as within 3 days of symptom onset, justifying its dependency on the viral load. Thus, it is assumed this can help with the accurate diagnosis and timely isolation and treatment of patients with COVID-19, contributing to better control of the global pandemic.

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Section: Discussionmentioning

confidence: 92%

Development and Clinical Evaluation of an Immunochromatography-Based Rapid Antigen Test (GenBody™ COVAG025) for COVID-19 Diagnosis

Kim

Lee

Bal

et al. 2021

Viruses

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“…Decentralization can improve access to testing, enable earlier and more frequent testing, and reduce exposure of health-care workers. Given these advantages, POC tests are widely considered an attractive approach to achieve a massive expansion in testing 75 , and a diverse range of POC tests have been developed that incorporate molecular, antigen-based and serological technologies 76 .…”

Section: Strategies To Scale Up Testingmentioning

confidence: 99%

Testing at scale during the COVID-19 pandemic

2021

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Assembly and publication of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) genome in January 2020 enabled the immediate development of tests to detect the new virus. This began the largest global testing programme in history, in which hundreds of millions of individuals have been tested to date. The unprecedented scale of testing has driven innovation in the strategies, technologies and concepts that govern testing in public health. This Review describes the changing role of testing during the COVID-19 pandemic, including the use of genomic surveillance to track SARS-CoV-2 transmission around the world, the use of contact tracing to contain disease outbreaks and testing for the presence of the virus circulating in the environment. Despite these efforts, widespread community transmission has become entrenched in many countries and has required the testing of populations to identify and isolate infected individuals, many of whom are asymptomatic. The diagnostic and epidemiological principles that underpin such population-scale testing are also considered, as are the high-throughput and point-of-care technologies that make testing feasible on a massive scale.

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“…Nanomaterial-based biosensors have been developed as a potential PoC approach. These alternatives to viral RNA extraction and SARS-CoV-2 sequence detection use biosensors functionalized with nucleic acid hybridization (167,168). The GenMark ePlex SARS-CoV-2 (GenMark Diagnostics, Carlsbad, CA), a PoC test based on the eSensor technology (169,170), is a "True Sample-to-Answer Solution" that targets the N gene.…”

Section: Point Of Care Molecular Diagnostic Testsmentioning

confidence: 99%

Review of Current COVID-19 Diagnostics and Opportunities for Further Development

Mardian¹,

Kosasih²,

et al. 2021

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Diagnostic testing plays a critical role in addressing the coronavirus disease 2019 (COVID-19) pandemic, caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Rapid and accurate diagnostic tests are imperative for identifying and managing infected individuals, contact tracing, epidemiologic characterization, and public health decision making. Laboratory testing may be performed based on symptomatic presentation or for screening of asymptomatic people. 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. 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. Thus, clinical presentation, contact history and contemporary phyloepidemiology must be considered when interpreting results. 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. 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. While sequencing is important to monitor on-going evolution of the SARS-CoV-2 genome, antibody assays are useful for epidemiologic purposes. The ever-expanding assortment of tests, with varying clinical utility, performance requirements, and limitations, merits comparative evaluation. We herein provide a comprehensive review of currently available COVID-19 diagnostics, exploring their pros and cons as well as appropriate indications. Strategies to further optimize safety, speed, and ease of SARS-CoV-2 testing without compromising accuracy are suggested. 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.

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Diagnostics for SARS-CoV-2 infections

Cited by 666 publications

References 105 publications

Development and Clinical Evaluation of an Immunochromatography-Based Rapid Antigen Test (GenBody™ COVAG025) for COVID-19 Diagnosis

Development and Clinical Evaluation of an Immunochromatography-Based Rapid Antigen Test (GenBody™ COVAG025) for COVID-19 Diagnosis

Testing at scale during the COVID-19 pandemic

Review of Current COVID-19 Diagnostics and Opportunities for Further Development

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