[20210225]IF11774_2019冠状病毒疾病检测供应链.pdf

https:/crsreports.congress.gov February 25, 2021COVID-19 Testing Supply ChainIntroduction COVID-19 testingincluding for diagnosis, screening, and surveillanceis 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