COVID-19 Testing Task Force May 27, 2020 Christopher Ball, PhD, - PDF document

1 COVID-19 Testing Task Force May 27, 2020 Christopher Ball, PhD, Chief, Idaho Bureau of Laboratories 1

2 Overview 1. Executive summary 2. Testing capacity estimates 3. Recommendations for molecular testing 4. Weekly molecular testing projections and priority groups 5. Recommendations for serologic testing 6. Next Steps 7. Questions 2

3 Executive Summary 1. Testing for SARS-CoV2 is not a strategy that stands alone, it informs public health prevention strategies and risk mitigation efforts. 2. Well-executed risk mitigation achieves both reductions in disease transmission and a reopened economy. 3. Access to testing and investment in local testing capacity must be significantly increased to safely reopen and maintain the state economy. 4. We recommend prioritized e prioritized expansion pansion of molecular of molecular testing sting (combined with tracing and other prevention strategies) now and limited use of serologic (antibody) testing. 5. A robust approach to educating the public, businesses, industry, schools, and others must be a critical part of the enhanced public health prevention strategies required to effectively mitigate COVID-19 transmission risk. Full Executive Summary: Testing for SARS‐CoV2, the agent of COVID‐19, is not a strategy that stands alone, but it is critically important since it is directly related to other elements of a comprehensive strategy. For example, improved education will increase the identification of confirmed cases as symptomatic and knowledgeable individuals will seek testing; at the same time, the testing event can become a prime opportunity for education. Similarly, identification of cases through testing should ideally lead to tracking of other exposures; tracking of exposure creates the need for expanded testing. The Governor’s shelter‐in‐place order has slowed the COVID‐19 epidemic in Idaho and has given us time to prepare for a well‐informed reopening of the economy. Continuing the current order vs reopening the economy have often been presented as either/or scenarios: eithe r we continue and stop the spread of disease or we reopen and allow it to continue. This is faulty logic. We need to both control the spread of disease and reopen the economy. This is imperative not only from an economic perspective, but also from a public health perspective. We are already seeing patients with chronic conditions delay necessary care. Moreover, in past economic recessions or depressions, we have seen surges in suicide, substance use, 3

and worsening in chronic health conditions, likely related to the direct relationship between economic downturn and social determinants of health. With a well‐ designed and robust plan, we can achieve both a reduction in spread and a reopening of the economy. Doing so must include education, targeted testing, tracing, supported isolation, robust data intelligence, and predictive modeling. This executive summary will briefly speak to each of these elements. The remainder of the Task Force’s recommendations will be focused on the details of testing. Testing availability in Idaho has been inadequate to meet our collective needs. While healthcare providers have begun now to secure adequate testing for their own populations, the availability and access to testing must be significantly increased to support a well‐designed reopening of the state. We must understand current testing capabilities, identify gaps between current and ideal state, and prioritize the closure of those gaps in a sequential way. Once we identify the “what” in terms of testing, this work must pivot to the “how,” which should include public‐private partnerships to effectively meet the needs. Testing can be PCR‐based or serologic, and it could be applied in a targeted way or a universal way. We recommend a phased expansion of targeted PCR testing (combined with tracing) and more limited use of serologic testing. We also recommend that platforms be limited to those tests with adequately high test‐ performance characteristics. At this time, serologic approaches to testing are rapidly developing, and are best applied to populations of people. Recently released federal guidelines have encouraged the use of such tests within communities and other subpopulations in order to assess the numbers of people previously infected. Current disease knowledge and serologic test capabilities are not adequate to allow this sort of testing to inform decisions for individuals. Tracing of contacts of positive cases is a critical success factor that must be implemented with this disease, given the large percentage of people who will be asymptomatic, but still infectious. This tracing presumes that we would have the ability to recommend and incentive quarantine for at least short periods of time and during the period of greatest infectivity. While there are digital apps that can facilitate this work, Idaho’s rural nature and broadband limits will make manual contact tracing programs a foundational component of the solution. Supported isolation of positive cases will be an additional critical success factor when combined with testing. Those who are asked to quarantine must be supported with policies that will allow this to occur. These policies must protect the individual from an economic and employment perspective. Moreover, for vulnerable populations such as the homeless or housing‐insecure, additional resources will be required to support effective efforts at quarantine. We cannot effectively fight an enemy we cannot see. And we must understand the enemy on a case‐by‐case basis as well as more globally. The expansion of testing is critical to creating this visibility. But without a comprehensive and agile data and 3

analytics system to support the creation of a comprehensive picture, we will still be fighting in the dark. For this reason, we recommend the substantial enhancement of a comprehensive COVID‐19 disease monitoring system overseen by the state, which must be armed with both short‐term tactical and long‐term strategic forecasting capabilities. Lines of communication between frontline healthcare providers, either individual entities or as part of a system, must remain wide open, bidirectional, and must continue to inform the state’s decisions in response to the pandemic. While testing and data analysis of these results will be very useful in informing decisions, the State of Idaho Staged Approach also requires adequate healthcare system capacity for care. We recommend a continued role for a clinically led group supporting the state’s response to the pandemic, including the need for regular reporting on capacity for care. Finally, a robust approach to educating the public, businesses, industry, schools, and others must be accomplished to support the above. In fact, much of the above will also support the opportunity to provide education. In addition to more broadly applied public service announcements, the testing episode, itself, provides a potential excellent opportunity to provide education at a time when we have the attention of the person. Similarly, as businesses roll out policies to support social distancing, cleaning, or testing, the application of broader education about the disease, how it is spread, and the need for continued vigilance will be valuable. Our nation and our state can successfully achieve both control of the COVID‐19 pandemic in our area as well as a successful staged reopening of our economy. Achieving this will require an approach that is founded in good scientific and clinical data, and must include education, targeted testing, tracing, supported isolation, robust data intelligence, and predictive modeling. 3

4 Testing Modalities Mo Molecular ( cular (PCR CR & Antige gen) n) Ser Serology (Anti (Antibody) • Diagnostic (Current Infection) • Non-Diagnostic (Past Infection) • Polymerase Chain Reaction (PCR) • ELISA or Lateral Flow Immunoassay • Detects SARS-CoV-2 RNA • Detects Human Antibodies to SARS- Cov-2 • 56 methods with FDA EUA* • IgM, IgG or both • Antigen Test • 12 methods with FDA EUA* • Detects SARS-CoV Protein • Detection of antibodies does NO NOT • Cannot differentiate between SARS- infer immunity to infection CoV & SARS-Cov-2 • SARS-CoV-2 immune response is not • 1 method with FDA EUA* fully understood *Data as of 9:00am ‐ 5‐13‐20 4

5 Testing Recommendations Molecular T Molecular Tests sts Serology T Ser Test sts  Must be rapid, accurate, sensitive &  Must be accurate, sensitive & specific specific 1. Hospitalized, symptomatic for 10+ 1. Clinical evaluation of patients days, AND PCR or Antigen negative 2. Discontinuation of Isolation 2. Previously undiagnosed COVID-19 like respiratory infection after 3. Allow a diagnostic procedure December 2019 4. Begin or modify treatment • Positive result impacts care 5. Qualify for clinical trial • Negative result determines susceptibility 3. Epidemiologic & population studies 5

6 Estimated Testing Capacity – Early May • Estimated weekly testing capacity from the week of May 3-9, 2020 was ~7,500 tests per week (in-house ~5,400; send out 2100). • Estimated maximum capacity (assuming no barriers) is ~23,000 tests per week (in house ~18,000; send out ~5,000). • Point of reference: to meet the federally established goal of testing 2% of the Idaho population every month we would need to perform ~8,000 tests per week • Idaho clinical laboratory testing capacity varies regionally, and lack of local testing ability is primarily a function of access to testing materials. This situation is slowly improving. 6