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1 [1] (February 25, 2021)

handle is hein.crs/govecjv0001 and id is 1 raw text is: COVID-19 Testing Supply Chain 0 February 25, 2021 Introduction COVID-19 testing-including for diagnosis, screening, and surveillance-is a critical component of responding to the COVID-19 pandemic, and its implementation has posed numerous challenges. Issues have included those related to Food and Drug Administration (FDA) regulation of tests, reimbursement and coverage for testing, equitable access to testing, and infrastructure and supply chain stressors, among others. In particular, the diagnostic testing supply chain has shown evidence of significant and ongoing stress since early in the pandemic, and problems persist with ascertainment, production, and distribution of almost all testing supply chain components. COVID-19 tests include molecular (e.g., polymerase chain reaction, PCR), antigen, and serology tests. Molecular and antigen tests are used for diagnosis, screening, and surveillance, while serology tests are currently used only for surveillance. Tests may be available in different settings based on their Emergency Use Authorization (EUA). Specifically, they may require a central laboratory for processing; may be available at the point-of-care in a Clinical Laboratory Improvement Amendments (CLIA)- regulated environment; or may be nonlaboratory tests, able to be carried out in any setting, including the home. Tests with EUA may be commercially manufactured test kits, which include all required test reagents in a single unit, or a laboratory-developed test (LDT), which are tests developed by and carried out in specific clinical laboratories. Although commercial test kits and the platforms to run them may be in short supply, LDTs rely on numerous reagents and components, most of which have been variably in shortage. Private efforts, spearheaded by the American Society for Microbiology (ASM) and the Association for Supply Chain Management (ASCM), nationally monitor and publicly report on inventory and supply shortages experienced by clinical laboratories. Recent data from these efforts indicate that clinical laboratories are operating at 40% of their capacity, that key supply shortages continue (e.g., test kits, consumables), and that supplies for non-COVID-19 testing are being affected. The Biden Administration's National Strategy for the COVID-19 Response and Pandemic Preparedness notes that in an end-to-end manner the federal government will identify, inventory, and monitor the need, availability, and manufacturing capacity of critical supplies, including for testing and Personal Protective Equipment (PPE). Testing Supply Chain To date, testing supply chain issues have largely arisen with molecular tests and specifically real-time RT (reverse transcriptase)-PCR tests that are carried out in central laboratories. These tests are highly complex, require specialized equipment and trained personnel, and involve numerous steps. Steps include sample collection, storage, and transport; sample preparation, including extraction of nucleic acid; and sample analysis and processing. These steps are described in further detail below. Point-of-care and nonlaboratory tests are generally less complex. While they require fewer steps, they sometimes rely on specialized equipment for processing, but are often able to be read visually. These tests are simpler to manufacture and have a less intricate supply chain; however, this type of test was authorized for clinical use by the FDA later in the pandemic, and so supply chain issues have manifested more recently. Shortages have included foam swabs, nitrocellulose paper, and machinery needed to manufacture the tests. In order to support the manufacturing and procurement of medical countermeasures to COVID-19, the Trump Administration developed Operation Warp Speed (OWS), an interagency effort involving the Department of Defense (DOD), the Department of Health and Human Services (HHS), and public-private partnerships between these agencies and the biomedical industry. Under the Biden Administration, OWS is being modified and renamed. Acting through OWS, DOD, and HHS invested to increase the manufacturing of COVID-19 diagnostics and procured diagnostics and ancillary supplies (e.g., pipette tips) for use in responding domestically to the pandemic. For example, DOD recently awarded $231.8 million to Ellume to increase production of its at-home over-the-counter test and procure 8.5 million tests. Sample Collection Individually wrapped, sterile, single-use swabs are the preferred tool to collect upper respiratory samples. Some tests may allow patients to swab themselves, while others require a health care professional to perform the sampling. Swabs used specifically for testing are FDA-regulated products constructed with a flexible stem and a bud made of synthetic materials that do not contaminate or interact with the patient sample. These are not substitutable with other cotton swabs or buds. Reports of swab shortages have been ongoing throughout the pandemic, representing a limiting factor in achieving adequate levels of testing nationwide. Sample Storage and Transport Swab samples must be placed in a preserving chemical solution while in transport to a lab for analysis. Point-of- care and nonlaboratory tests, in which evaluation of the sample is conducted almost immediately after it is taken, do not require sterile transport. The most common preserving transport solution is Viral Transport Medium (VTM), which ittps://crsreports~congress~gov

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