PMC:7108487 / 6785-9637
Annnotations
{"target":"https://pubannotation.org/docs/sourcedb/PMC/sourceid/7108487","sourcedb":"PMC","sourceid":"7108487","source_url":"https://www.ncbi.nlm.nih.gov/pmc/7108487","text":"Building an Adaptable Infrastructure for Rapid Dissemination of Laboratory Diagnostics\nIf there has been one enduring lesson from SARS-CoV, the 2009 H1N1 influenza pandemic, MERS-CoV, Ebola, Zika, and now COVID-19, it is that the next novel or emerging viral outbreak is likely just around the corner. Therefore, a general framework to guide our response to outbreaks of global health concern is needed. This should involve the expertise and direction of government agencies (e.g., FDA/CDC), state and local public health departments, industry partners, clinical laboratories, and healthcare providers.\nDuring the early stages of an outbreak, national (i.e., CDC) and international (i.e., World Health Organization) agencies are best positioned to develop new diagnostic tests rapidly, given their 1) involvement in investigating cases; 2) role in characterizing the disease; and 3) access to clinical samples from patients with the illness. Once an assay has been developed and shown to meet established performance characteristic standards, a proposed next step would be for the national/international public health agency to partner with a contracted test manufacturer(s) to initiate the process of mass production of test reagents and submission of performance data to the FDA. As is currently the process, the FDA would then review the test performance characteristics, and if acceptable, issue an emergency use authorization. This would then allow for the test manufacturer to distribute kits to qualified laboratories, which, in the proposed model, would be expanded to include not only state and local public health laboratories, but also clinical laboratories that have participated in a thorough vetting and credentialing process. This process could involve 1) an application/registration from the clinical laboratory confirming that they have the required equipment, safety infrastructure, and personnel to complete testing; 2) a site-visit from an existing, CDC-qualified laboratory representative; and 3) successful completion of required validation studies and a blinded verification panel sent from the CDC and/or test manufacturer to the clinical laboratory. Ideally, Steps #1 and #2 would be performed outside of (i.e., prior to) an outbreak setting, and would serve as an accreditation that the clinical laboratory is qualified to be a testing site for a specified period of time (e.g., 5 years), after which re-accreditation would be required. Although this approach would likely require modifications and special considerations to account for disease-specific features (e.g., route of transmission [blood-borne versus airborne] or recommended testing approach [molecular versus serology]), it could serve as a general framework to apply during an infectious disease outbreak that has been determined to be a global health emergency.","divisions":[{"label":"Title","span":{"begin":0,"end":86}}],"tracks":[{"project":"LitCovid-PMC-OGER-BB","denotations":[{"id":"T148","span":{"begin":2619,"end":2624},"obj":"UBERON:0000178"},{"id":"T149","span":{"begin":1226,"end":1234},"obj":"CHEBI:33893;CHEBI:33893"},{"id":"T150","span":{"begin":253,"end":258},"obj":"NCBITaxon:10239"},{"id":"T151","span":{"begin":205,"end":213},"obj":"SP_7"},{"id":"T152","span":{"begin":174,"end":182},"obj":"SP_9"},{"id":"T153","span":{"begin":130,"end":138},"obj":"SP_10"}],"attributes":[{"subj":"T148","pred":"source","obj":"LitCovid-PMC-OGER-BB"},{"subj":"T149","pred":"source","obj":"LitCovid-PMC-OGER-BB"},{"subj":"T150","pred":"source","obj":"LitCovid-PMC-OGER-BB"},{"subj":"T151","pred":"source","obj":"LitCovid-PMC-OGER-BB"},{"subj":"T152","pred":"source","obj":"LitCovid-PMC-OGER-BB"},{"subj":"T153","pred":"source","obj":"LitCovid-PMC-OGER-BB"}]}],"config":{"attribute types":[{"pred":"source","value type":"selection","values":[{"id":"LitCovid-PMC-OGER-BB","color":"#ec93c3","default":true}]}]}}