19 Things We Need to Conquer the COVID-19 Pandemic: Part 3

By Andrew L. Concoff, MD, FACR, CAQSM

In Part III of this series, we continue the countdown of the list of what we need to overcome the challenges of the COVID-19 Pandemic. In this installment, we turn to issues of testing and the policy that flows from testing data. Pandemic public health policy requires absolute continuity from the development and application of robust and accurate novel testing paradigms through timely, well-staffed contact tracing, to responsive public policy based upon cogent analysis of data from test results. For optimal impact, all of this must be delivered through carefully crafted messaging by leaders of uncommon skills. Even more, the appropriate level of social distancing at any given time is a delicate balance of conflicting societal needs that are in constant flux.

Risks of exponential rates of infection must be pitted against the significant emotional toll of isolating our social species and of extreme financial hardship if appropriate steps to reopen are delayed too long. The rush to provide ample diagnostic tests for COVID-19 must be measured against the harm from inaccurate results from poorly vetted test platforms. Finally, our leaders must strike a tenuous balance between truth and hope in communicating the status of the Pandemic. Elements at the heart of this challenging balancing act make up the next five things we need to solve to emerge from our current COVID-19 predicament.

10. Effective, reasoned and authentic communication of the rationale for changes to public policy to inspire adherence across communities19, 20

  • Public outreach and adoption across languages and cultures is critically important
  • Inclusive, equitable, and comprehensive approaches
  • Address the marginalized, impoverished, and homeless21
    1. Potential reservoir of viral spread
    2. Free testing and treatment in such communities are required to prevent sequential waves of infectious spread
  • Messaging that emphasizes the morality of adherent behavior may have a greater impact22
  • Clearly delineated, a priori, criteria for:
    1. Relaxation of social distancing measures
      • President Trump’s “Guidelines for Opening Up America Again” requires the following before beginning a phased reopening23
        1. Symptoms
          • Downward trajectory of influenza-like illnesses and COVID-like syndromic cases within a 14-day period
        2. Cases
          • Downward trajectory of documented cases within a 14-day period
          • Downward trajectory of positive tests as a percentage of total tests within a 14-day period
        3. Hospitals
          • Treat all patients without crisis care
          • Robust testing program in place for at-risk healthcare workers, including antibody testing
        4. Established testing and contact tracing program
        5. Adequate available surge capacity for PPE and critical medical equipment
        6. Plans to protect
          • Workers in critical industries
          • Those working and living in high-risk facilities
          • Mass transit workers and users
          • The population in case of a rebound or outbreak during efforts at relaxation
  • Return to more aggressive social distancing
    1. Identification of a priori “circuit breakers”24 indicative of increased spread
      • Gov. Andrew Cuomo of New York has set a transmission rate of 1.1, which would represent an increase from the current 0.8, as such a threshold indicator

9. Coherent, proactive and decisive leadership

  • Numerous world heads of state have failed to deliver the requisite proactive leadership16,17
  • The four attributes the public most desires of leaders during the pandemic18
    • Trust
    • Compassion
    • Stability
    • Hope
  • Establishment of a solitary “field commander”4 at each governmental level to coordinate responses

8. Moving beyond current, symptom-limited evaluation and testing paradigms to identify the prevalence and impact of COVID-19 in the US3

  • Dramatic expansion of indications for diagnostic testing are warranted
    1. Current, symptom-driven testing paradigms are inappropriate in a disease with significant asymptomatic spread and with planned relaxation social distancing
      1. Targeted surveillance of asymptomatic populations is needed as an early warning of recurrence of spread
      2. The impact of “stealth spread” has not been appreciated
        • If asymptomatic contacts of those infected are not identified by contact tracing, quarantined and tested appropriately it is impossible to recognize recurrent spread through the community in a timely fashion
  • An estimated 500,000 tests per day are needed per modeling at the Harvard Global Health Institute to safely reopen the economy9
  • An estimated 31 states are performing too few tests to identify increased transmission timely enough manner to prevent uncontrolled spread10
  • The total, raw number of tests performed is irrelevant and misleading
    • The testing rate per population is critical
    • Iceland has tested >10% of its population including symptomatic and asymptomatic citizens
    • As of 4/29/20, the United States has performed 6,026,170 COVID-19 diagnostic tests, or roughly 1.8% of the population11 (although some of those tests have been repeated on the same patients)
      1. Having tested 1.8% of our population, we rank 9th out of the top 20 most COVID-19 affected countries worldwide12
      2. Despite this limited rate of testing, the US has almost 1/3 of all confirmed cases in the world and over four times as many as the next highest country (Spain).13  
      3. The reported death rate in the US is 10th highest in the world.14
        • Different criteria for assigning cause of death vary internationally and make direct comparison difficult
    • Competing priorities may exist between a COVID-19 test’s logistics and its accuracy, a circumstance that has been exacerbated by the FDA’s approach to evaluating such tests15
      1. Los Angeles County has employed a novel, self-administered, intraoral test rather than the FDA-preferred provider intranasal test 
        • The FDA has authorized but not tested the performance of, and approved, COVID-19 tests
        • A shortage of equipment and professionals to administer the test contributed to the choice of tests
        • The sensitivity of intra-oral tests has been questioned
          1. A disclaimer is sent to patients undergoing this test indicating that a negative test may be inaccurate
          2. False negative tests may have dire consequences for:
            • Individual patients
            • Assessments of disease prevalence

7. Development of a comprehensive and massive new testing infrastructure to distribute, perform, and respond to the various COVID-19 test types

  • Widespread distribution of:
    1. Rapid, ubiquitous diagnostic testing for all symptomatic patients3,4
    2. Targeted screening of representative, asymptomatic communities3
    3. “Return-to-work” lab kits including either
      • Rapid, on-site diagnostic tests5
        1. Identify infection (including asymptomatic infection)
        2. Repeated, even daily, testing may be needed and/or
      • Serologic tests6,7
        1. For use as part of the return to work/end of isolation programs
        2. Certificates of immunity document safety to return to work
          • For this approach to be viable, the following are required:
            1. Validation of serologic test performance (see below)
            2. Further temporal understanding of immunity after infection (if any present) (see below)
    4. Biomarkers tests of impending decompensation8
      • Distribution, at scale, to hospitals for monitoring in-patients and emergency department patients
        • Repurposed existing tests (e.g., serumIL-6 level if predictive) preferred over novel tests given ease of scaling
  • New infrastructure for widespread population screening
    • Markedly expanded, drive-through testing centers (to limit spread to testing center workers)6
    • Requires rapid, large-scale development of a COVID Corps of trained health care workers4 to perform testing and to perform contract tracing
      1. New source of employment at a time of need
      2. Necessary new workforce to combat the pandemic
        • Appropriate PPE required for test-site workers

6. Validation of current, and development of next-generation, laboratory tests16

  • Tests in three classes are needed:
    • Diagnostic
      • Novel attributes:
        1. Rapidity, on-site
      • Self-test, at home (in the manner of home pregnancy tests)
      • Scalable (see below)
      • Accurate
    • Identification of prognostic biomarkers indicative of greater disease severity and/or of impending decompensation (ARDS, risk of intubation)
      • Body fluid-based
      • Imaging
    • Serologic indicators of immunity from resolved infection
      • Used to
        1. Allow informed and accurate return to work decisions
        2. Reflect the degree of spread within a local community
      • Leading candidate:  Specific anti-spike (S) protein IgG antibodies
  • Comprehensive validation of each version (brand) of each type of test is required before wide application
    • Government regulation must provide oversight over tests for this purpose to appropriately validate the performance of all tests used for this purpose
    • Over 70 companies producing and offering these tests without adequate validation as of 4/14/2020
    • Rapid diagnostic tests
      1. Internal validation:
        • Clinimetrics of each test must be established prior to use to prevent:
          1. False positives: Inappropriately exclude well patients for those without COVID-19 infection
          2. False negatives: Inappropriately allow access to the workplace for those with COVID-19 infection
    • Serologic tests indicative of Immunity
      1. External validation:
        • Neutralizing antibodies appear to be generated long before viral shedding has ceased.1 Therefore, the test cannot be administered immediately after a known, recent infection; the delay from symptoms to testing must correlate with the understanding of the temporal relationship between the generation of neutralizing antibodies and the end of viral shedding
        • Higher neutralizing S-protein antibodies have been seen in the elderly, raising concern about overly aggressive immune responses related to such antibodies2
      2. Internal validation:
        • Clinimetrics of each test must be established prior to use to prevent:
          1. False positives: Inappropriately allow access to patients from the workplace by suggesting infection and immune response has occurred, that neutralizing antibodies have been generated when they have not
          2. False negatives: Inappropriately exclude the individual from access by suggesting infection and immune response have not occurred, the neutralizing antibodies are not present when it, in fact, they are

To be continued in part 4 – #5 to #1

Stay safe, stay healthy, stay United. 

REFERENCES:

1.  To K K-W, Tsang O T-Y, et al.  Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study.  Lancet, 2020; https://doi.org/10.1016/ S1473-3099(20)30196-1

2.  Wu F, Wang A, et al.  Neutralizing antibody responses to SARS-CoV-2 in a COVID-19 recovered

2 patient cohort and their implications.  MedRxiv, 2020; doi: https://doi.org/10.1101/2020.03.30.20047365

3. Carrol AE.  We need 1 million tests a week.  The Atlantic, 3/31/2020.  https://www.theatlantic.com/ideas/archive/2020/03/we-need-1-million-tests-week/609154/

4.  Fineberg HV.  Ten weeks to crush the curve.  NEJM, 2020; DOI: 10.1056/NEJMe2007263 

5.  Abbott Laboratories.  Press Release.  Detect COVID-19 in as little as 5 minutes.  https://www.abbott.com/corpnewsroom/product-and-innovation/detect-covid-19-in-as-little-as-5-minutes.html

6.  Irfan U.  How Covid-19 immunity testing can help people get back to work.  Vox, 4/2/2020. https://www.vox.com/2020/3/30/21186822/immunity-to-covid-19-test-coronavirus-rt-pcr-antibody

7.  Horowitz J.  In Italy, going back to work may depend on having the right antibodies.  New York Times, 4/4/2020. https://www.nytimes.com/2020/04/04/world/europe/italy-coronavirus-antibodies.html

8.   Pesheva E.  Ending the pandemic. Scienmag, 2020; https://scienmag.com/ending-the-pandemic/

9.  Lee E & Ma V.  At Least 500,000 Tests Needed Per Day to Reopen Economy, Harvard Researchers Say.  The Harvard Crimson, 4/22/2020.  https://www.thecrimson.com/article/2020/4/22/harvard-coronavirus-hghi-daily-tests/

10.  Begley S.  Many states are far short of Covid-19 testing levels needed for safe reopening, new analysis shows.  STAT, 4/27/2020.  https://www.statnews.com/2020/04/27/coronavirus-many-states-short-of-testing-levels-needed-for-safe-reopening/

11.  COVID-19 Map. Johns Hopkins Coronavirus Resource Center, https://coronavirus.jhu.edu/map.html

12.  Elflein J.  Rate of coronavirus (COVID-19) tests performed in the most impacted countries worldwide as of April 29, 2020 (per million population); Statista, 4/29/2020.  https://www.statista.com/statistics/1104645/covid19-testing-rate-select-countries-worldwide/

13.  Elflein J. Number of coronavirus (COVID-19) cases worldwide as of April 29, 2020, by country.  Statista, 4/29/2020.  https://www.statista.com/statistics/1043366/novel-coronavirus-2019ncov-cases-worldwide-by-country/

14.  Elflein J.  Number of novel coronavirus (COVID-19) deaths worldwide as of April 29, 2020, by country.  Statista, 4/29/2020.   https://www.statista.com/statistics/1093256/novel-coronavirus-2019ncov-deaths-worldwide-by-country/

15.  Lau M & Petersen M.  L.A. is using a streamlined coronavirus test.  But it has potential risks and rewards.  Los Angeles Times, 4/28/2020.  https://www.latimes.com/california/story/2020-04-28/coronavirus-new-mouth-test-los-angeles

16.  Karnitschnig M.  The incompetence pandemic.  The first victim of coronavirus? Leadership. Politico, 3/16/2020.  https://www.politico.com/news/2020/03/16/coronavirus-pandemic-leadership-131540.

17.  Burgo J.  Why leaders are struggling worldwide with the COVID-19 crisis.  Psychology Today, 3/21/2020.  https://www.psychologytoday.com/us/blog/shame/202003/why-leaders-are-struggling-worldwide-the-covid-19-crisis

18.  Harter J. COVID-19: what employees need from leaders right now. Workplace, 3/23/2020.  https://www.gallup.com/workplace/297497/covid-employees-need-leaders-right.aspx

19.  Berger ZD, Evans NG, et al.  Covid-19: control measures must be equitable and inclusive.  BMJ, 2020; doi: 10.1136/bmj.m1141

20. Gonsalves GS, Kapczynski A, et al. Achieving a fair and effective COVID-19 response:  an open letter to vice-president Mike Pence and other federal, state, and local leaders from public health and legal experts in the United States.  3/2/2020; DOI:  10.31234/osf.io/9yqs8

21.  Centers for Disease Control.  Responding to coronavirus disease 2019 (COVID-19) among people experiencing unsheltered homelessness:  interim guidance;  https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/unsheltered-homelessness.html; accessed 4/6/2020

22.  Everett JAC, Colombatto C, et al.  The effectiveness of moral messages on public health behavioral intentions during the COVID-19 pandemic.  PsyArXiv, 2020; DOI: 10.31234/osf.io/9yqs8

23.  President Trump’s proposed guidelines for relaxing social distancing guidance.  The Washington Post, 4/16/2020. https://www.washingtonpost.com/context/president-trump-s-proposed-guidelines-for-relaxing-social-distancing-guidance/b7768600-7906-408c-89a3-06fd5a47aa26/

24.  Passy C.  New York Will Have Coronavirus ‘Circuit Breaker’ in Place as Economies Reopen.  Wall Street Journal, 4/8/2020.  https://www.wsj.com/articles/new-york-will-have-coronavirus-circuit-breaker-in-place-as-economies-reopen-11588106124

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