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Cdc Museum Covid 19 Timeline
Population-scale and rapid testing for SARS-CoV-2 continues to be a priority for several parts of the world. We revisit the in vitro technology platforms for COVID-19 testing and diagnostics—molecular tests and rapid antigen tests, serology or antibody tests, and tests for the management of COVID-19 patients. Within each category of tests, we review the commercialized testing platforms, their analyzing systems, specimen collection protocols, testing methodologies, supply chain logistics, and related attributes. Our discussion is essentially focused on test products that have been granted emergency use authorization by the FDA to detect and diagnose COVID-19 infections. Different strategies for scaled-up and faster screening are covered here, such as pooled testing, screening programs, and surveillance testing. The near-term challenges lie in detecting subtle infectivity profiles, mapping the transmission dynamics of new variants, lowering the cost for testing, training a large healthcare workforce, and providing test kits for the masses. Through this review, we try to understand the feasibility of universal access to COVID-19 testing and diagnostics in the near future while being cognizant of the implicit tradeoffs during the development and distribution cycles of new testing platforms.
To limit the spread of SARS-CoV-2, aggressive and scalable deployment of COVID-19 testing resources has been a priority of health and administrative officials worldwide. A COVID-19 diagnostic test is advisable for individuals experiencing COVID-19 symptoms or those exposed to persons with suspected or confirmed COVID-19 illness [1, 2]. The COVID-19 test is also advised for travel purposes, recreation, social gatherings and professional meetings, or can be enforced at the workplace by employers [3]. Patients with a confirmed COVID-19 infection develop fever and/or acute respiratory illness which may lead to death [2]. Timely test results help provide informed recommendations to the patient, thereby protecting the front-line workers and limiting the COVID-19 transmission to others in close contact [4, 5].
Early investments in new diagnostic technologies with rapid and decentralized testing have been vital in minimizing the negative health and socioeconomic impacts of SARS-CoV-2 [6, 7, 8]. In April 2020, the U.S. National Institute of Health (NIH) launched the Rapid Acceleration of Diagnostics (RADx) Initiative to ramp up development, commercialization, and implementation of COVID-19 testing technologies [9]. The goal of the RADx Initiative was to develop innovative diagnostic tests that are fast, accurate, easy-to-use, and easily accessible at home and point of care, particularly to population groups that are vulnerable and most impacted by COVID-19 [9]. On a parallel front, the Foundation for Innovative New Diagnostics (FIND), a Geneva-based not-for-profit organization, has led international partnerships for scaled-up development and delivery of COVID-19 tests through its Access to COVID-19 Tools (ACT) Accelerator [8]. Despite these commendable efforts, the pandemic continues to rattle several parts of the world, especially the low- and middle-income households where testing sites are inaccessible and test kits are cost-prohibitive or in limited supply [10]. For the long-term containment of the virus, the current goal of governments and institutions worldwide lies in the equitable distribution of COVID-19 testing resources in a sustainable manner [7, 10].
Reimbursement For At Home Covid Test
Our objective here is to review the commercialized in vitro diagnostic tests for the detection of SARS-CoV-2, primarily focusing on tests granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA). We expand upon previous review papers on COVID-19 test assays published since the start of the global pandemic [7, 10, 11, 12] by providing a comprehensive review of current testing methods available from the companies granted FDA EUA. Various attributes of COVID-19 testing platforms are tabulated and comparative studies on the evaluation and validation of available tests are discussed. We try to understand the implicit tradeoffs of cost, convenience, and quality of available COVID-19 tests based on the information gathered from websites, databases, and blogs of product companies, federal and medical agencies, and governing bodies. The outline of this paper is as follows. Section 2 provides a brief overview of in vitro diagnostic (IVD) tests for SARS-CoV-2, and the different at-home and population-scale testing strategies. Section 3 discusses the standardized regulatory and reporting guidelines for device manufacturers and testing facilities. Section 4 and Section 5 describe the molecular diagnostic tests for SARS-CoV-2 using respiratory specimens and saliva specimens, respectively. Section 6 describes the rapid antigen tests for SARS-CoV-2, including lateral flow assays with visual readout. Section 7 talks about the deployment of COVID-19 test kit vending machines and Testing-as-a-Service platforms. Section 8 deals with serology or antibody tests for SARS-CoV-2, such as assays to measure immunoglobulins or total antibodies in blood. Section 9 describes the diagnostic tests for the management of COVID-19 patients that track the biomarkers of inflammation (e.g., interleukin-6). Section 10 discusses the challenges and outlook related to lowering the testing costs, improving the performance metrics, building a robust supply chain, and better containment of new variants (such as the Delta and Lambda Variants of the Coronavirus).
The FDA has granted Emergency Use Authorization (EUA) to several in vitro diagnostic tests for SARS-CoV-2 [6]. These IVD tests are grouped into three categories − diagnostic tests (i.e., molecular tests and ‘rapid’ antigen tests), serology or antibody tests, and tests for the management of COVID-19 patients depending on their suitability to detect the disease parameters from the onset of symptoms (Figure 1) [10, 11, 13]. The first type of IVD tests are diagnostic tests that detect parts of the SARS-CoV-2 virus for the diagnosis of active COVID-19 infection (i.e., where there is active shedding of the virus). The samples for diagnostic tests are collected using a nasal or throat swab, or from saliva by spitting into a tube. Sometimes, secretions from the lower respiratory tract, such as sputum and bronchoalveolar lavage fluid, are also used for confirmatory tests [7]. The second type of IVD tests are serology or antibody tests that measure the presence of antibodies to SARS-CoV-2 from serum, plasma or whole blood from finger stick or veins. The detected antibodies are indicative of previous exposure to the virus or immune status of the individual. The third type of IVD tests evaluate the severe inflammatory response in patients with confirmed COVID-19 infection, typically by measuring the levels of interleukin-6 (IL-6) in serum, plasma or whole blood [11].
The FDA and Centers for Disease Control and Prevention (CDC) have taken several steps to speed up scientific discovery towards commercialization and reduce the burden of test validation for new test developers [6]. For instance, the FDA allows any new developer to leverage the data from previous EUA-authorized assays by submitting a right of reference from the sponsor. By doing so, new developers can leverage the CDC’s in silico and cross reactivity tests, rather than repeating the tests on their assays. As an example, the CDC has granted the right of reference for its CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel and Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay to any entity seeking an FDA EUA for a COVID-19 diagnostic device or developing a multi-analyte respiratory panel including SARS-CoV-2 [6].
Diagnosing Covid 19: The Disease And Tools For Detection
The FDA’s In Vitro Diagnostics EUAs website provides a list of companies whose COVID-19 test kits have received Emergency Use Authorization (EUA) [6]. At the time of this publication, there were roughly 243 entries for authorized SARS-CoV-2 molecular diagnostic tests, 79 entries for authorized SARS-CoV-2 serology or antibody tests, and 3 entries for authorized in vitro diagnostic tests for the management of COVID-19 patients. In this review, we primarily focus on these COVID-19 test kits granted FDA EUA. On a cautionary note, IVD tests are not suitable for COVID-19 patients showing emergency warning signs, such as “breathing difficulty, persistent pain or pressure in the chest, inability to wake up or stay awake, new confusion, and bluish lips or face” [3].
Within the United States, IVD tests are offered at local health centers and select pharmacies such as Walgreens, CVS Health, Rite Aid, Walmart, Health Mart, eTrueNorth, and Topco. The U.S. Families First Coronavirus Response Act ensures that COVID-19 tests are freely available to anyone. Some at-home IVD tests produce results within a few minutes, while others
The FDA’s In Vitro Diagnostics EUAs website provides a list of companies whose COVID-19 test kits have received Emergency Use Authorization (EUA) [6]. At the time of this publication, there were roughly 243 entries for authorized SARS-CoV-2 molecular diagnostic tests, 79 entries for authorized SARS-CoV-2 serology or antibody tests, and 3 entries for authorized in vitro diagnostic tests for the management of COVID-19 patients. In this review, we primarily focus on these COVID-19 test kits granted FDA EUA. On a cautionary note, IVD tests are not suitable for COVID-19 patients showing emergency warning signs, such as “breathing difficulty, persistent pain or pressure in the chest, inability to wake up or stay awake, new confusion, and bluish lips or face” [3].
Within the United States, IVD tests are offered at local health centers and select pharmacies such as Walgreens, CVS Health, Rite Aid, Walmart, Health Mart, eTrueNorth, and Topco. The U.S. Families First Coronavirus Response Act ensures that COVID-19 tests are freely available to anyone. Some at-home IVD tests produce results within a few minutes, while others
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