CDC should work with PHLs to fulfill the mission of the LRN-B, as well as expand its capability and capacity. While the stated mission of the LRN-B includes responding to biological emergencies, the network was not activated during the COVID-19 pandemic. Additionally, the current focus has mainly been on providing assays to detect high priority pathogens that represent potential risks for bioterrorism. By working with academia to develop pathogen agnostic methods for initial detection of novel pathogens, and by involving the PHLs in subsequent method development and validation for laboratory testing, a broader capability will be achieved. The modernization initiative will also require adapting the current assays to automated extraction methods and high-throughput platforms.

By strengthening inter-network cooperation, the ability to surge testing among LRN-B laboratories in an emergency will make more efficient use of the national testing capacity that exists within the network. These efforts, in total, will make more effective use of an existing laboratory response infrastructure.

It is essential that laboratories are able to access quality test kits as quickly as possible when a new outbreak arises. Laboratories and test manufacturers should solicit a proactive FDA review and feedback (via a pEUA submission) of test designs, protocols, and accompanying validation plans prior to a health emergency. Under its existing authority, FDA can receive pEUA submissions at any time, for tests that could help address a biological emergency potentially triggering a declaration under Section 564.

Following a Section 564 emergency declaration, FDA should prioritize tests that had prior pEUA reviews. FDA should also prioritize EUA submission reviews from test developers who are willing to make test protocols publicly available, use commonly available reagents and instrument platforms, and are willing to authorize other laboratories to use these protocols. FDA should also prioritize reviews from experienced, high volume, and high throughput central lab kits developers and, at the appropriate time following a declaration, experienced, high volume POC and/or home-use test kit manufacturers.

The COVID-19 pandemic has demonstrated that point-of-care including home-use devices, can both provide major public health benefits and meet FDA quality standards. This can be accomplished by: (1) expanding access to point-of-care testing in non-medical testing sites by using the CLIA waiver process; and (2) expanding access to home-use tests by promoting their use for equitable public health benefit and providing clear guidance for the optimal test selection and use in different settings. This will allow individuals to make timely personal decisions regarding their own health and the safety of those with whom they may come into contact.

Unfortunately, much confusion remains regarding how best to use these tests to maximize their public and personal health benefit. Using information gained during the COVID-19 pandemic, best practices should be defined, using clear unambiguous language, and distributed so that it is widely accessible. This guidance should be included in training programs for health care workers using point-of-care devices at waived testing sites, and in the packaging used for the commercial sale or government distribution of home-use devices. When a new pathogen emerges, as soon as relevant information is available, the best practices information should be updated.

…including by expanding wastewater surveillance, providing easy to use analyses and maps, and sustaining and bolstering the Center for Forecasting and Analytics and the Data Modernization Initiative. Americans do not currently have regular or rapid access during outbreaks to comparable data that is visualized in a useful format. The CDC Center for Forecasting and Outbreak Analytics and the CDC Data Modernization Initiative are vital to ensure seamless and interoperable data connectivity and transfer among all laboratories and – ultimately – to ensure citizens and federal, state, local, tribal, and territorial decision-makers have the information they need to make informed and community-focused choices. These should be resourced at a level that allows for meeting the goals in this Playbook and to provide day-to-day situational awareness that is visible to the public.

The federal government should establish advanced purchase agreements for new test development or test modification, and for surge and scale testing, by buying standing capability within commercial and academic laboratories that can rapidly expand testing capacity during pandemic crises and seasonal outbreaks alike. The federal government should establish routine contracts with diagnostic manufacturers and with commercial and academic laboratories, which will be regularly available for emergencies in all regions of the United States to surge and scale testing capacity when a health emergency occurs. These contracts should guarantee funding of a minimum market size to incentivize manufacturers and laboratories to scale up processes in an emergency. This would include standing capacity to surge high throughput testing for clinical purposes from commercial and academic labs, as well as capacity to surge manufacturing of test kits for individuals.

Early testing enhances equity and provides the information needed to make informed decisions, gives clinicians and citizens the tools they need to make choices, and allows healthcare facilities to best prepare. Meeting the testing needs of different populations, especially underserved communities and indigenous and tribal communities, will require developing testing technologies and methods of data collection for use in non-medical settings. The federal government should convert initiatives like Increasing Community Access to Testing (ICATT) into permanent programs for a wide variety of public health testing. Not only will this enhance access to testing for infectious diseases and support under resourced communities, but the data will also contribute to national surveillance programs.

Test manufacturers and suppliers, commercial laboratories, and pharmacies were instrumental for surging testing to health laboratories, clinicians, hospital systems, community health clinics, tribal healthcare providers, and people at home. Early and full participation by these entities was hampered by lack of a national mechanism to coordinate these entities and, in some cases, by a lack of funding incentives for commercial entities to participate in testing. Prior to the next biological crisis, the proposed Testing Readiness Commission will be instrumental in ensuring that all relevant testing sectors are tapped to their fullest potential during an emergency.

Pre-existing emergency funding mechanisms, including the Public Health Emergency Fund, the Infectious Diseases Rapid Response Reserve Fund, the Disaster Response Fund, and the Hospital Preparedness Program, should contain sufficient emergency reserves to support widespread testing until additional emergency funding becomes available through Congress.