Table 3.

Curriculum and learning objectives—public health preparedness, emergency management, and the COVID-19 crisis

Section & topics	Learning objectives
Part I.	Preparedness for outbreaks, epidemics, and isolation
A. Test metrics
Dynamic evidence-based medicine	Compare sensitivity, specificity, and predictive values of POC tests Point out that false negatives, FN(t), are a function of time, and therefore, sensitivity and the ability to rule out disease are dynamic characteristics when testing patients with evolving infections Explain why 95% confidence intervals for diagnostics introduce peaks and valleys of uncertainty that vary with prevalence for infectious targets
B. Past perspective
Ebola virus and other highly infectious diseases	Document how the 2014-16 Ebola virus disease epidemic and cases entering the U.S. proved unequivocally the need for POCT Overview how POCT could have curtailed the 2014-16 epidemic Compare how rapid response limited the recent 2017+ outbreaks Survey POC technologies available for Ebola virus disease and other high-risk pathogens
B. COVID-19 pandemic	Special section
Metrics of testing	Compare and contrast molecular diagnostics, antigen assays, and antibody tests used to diagnose COVID-19, plot temporal trends, detect stealth infections, and judge immunity, including detection of variants (e.g., Delta) Identify how sensitivity and specificity impact PPV, NPV, PV GM2, FP/TP, FN/TN, false omission rates, and other test metrics in settings of low, moderate, and high prevalence Observe that patients with false negative results can spread SARS-CoV-2 unknowingly, and false positives can place people at danger when quarantined with who have COVID-19 Show how uncertainty, in terms of 95% confidence intervals, impact test results
FDA Emergency Use Authorizations (EUAs)	Outline FDA procedures and criteria for obtaining EUAs for COVID-19 tests, visit the FDA EUA website (https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas), and inspect authorization documents
Management of EUA tests	Consult Clinical and Laboratory Standards Institute white paper EP43-Edl, “Implementing a Laboratory Test Under Emergency Conditions,” for method establishment, guidance on method implementation, and general management of EUA tests, including their potential retirement
Safe spacing & contagion	Learn mobile POC strategies, such as drive-up/drive-through testing, kiosks at points of need, elderly access, home self-testing, and other safe approaches Describe the role of POCT in contact tracing, its effectiveness or lack thereof, and the economics of pursuing superspreaders, reinfections, and herd immunity
Maximize the effectiveness of rapid antigen tests (RAgTs) and empower without intimidating	Predictive value performance patterns suggest Tier 2 — positive percent agreement (sensitivity) of 95% and negative percent agreement specificity) of 97.5% — should become the minimum performance threshold for RAgTs. See reference 14 for details of tiers, performance patterns, and other details of RAgT clinical use. Consider the current community prevalence and its impact on test results, especially in the high range of prevalence. Self- and home test using a RAgT kit as soon as signs or symptoms arise and within the first 3 to 5 days for optimal detection of SARS-CoV-2. When self- and home testing, repeat the test at 36 hours and follow the protocol specified by the manufacturer. Repeat testing will improve the performance of low and sub-tier tests. Establish performance metrics (e.g., PPA, NPA, CI, and LOD) in diverse large multicenter populations with a full range of SARS-CoV-2 viral loads. Explicitly characterize the reference method (e.g., Ct brackets). Harmonize preanalytical and assay methods. Do not compare to an inferior test. Test free of charge everywhere, anytime. Test at home, when traveling, or any place in the world, and use the results to avoid and manage risk, not to punish. When a person is not vaccinated, test weekly with a PCR assay or twice per week using a dual test RAgT kit if in the workplace, university, or similar environments. Avoid stigmatizing positive test results by requiring unnecessary prolonged quarantine or shameful detention. Do not use test results to intimidate. Instead, optimize human resources. End quarantine when test results turn negative. Allow work and other activities to resume with minimal personal and economic loss. Create a positive and reassuring social milieu, a point of care culture of self-motivated frequent testing, so that empowered individuals can stop variant outbreaks and avoid spread to highly vulnerable people. Expect COVID-19 to become endemic worldwide. Adapt by vaccinating, testing, and empowering. Diagnostic testing allows us to calibrate and manage our own personal risk.
C. Workshops	Highly infectious diseases
Personal protective equipment (PPE)	Don PPE and practice performing POC tests, then doff the PPE and show that work was performed without personal exposure
Isolation laboratory and quarantine	Be able to read floor plans, design an isolation laboratory, equip it with POCT, and route specimen workflow Understand specifications for biosafety cabinets and limits to performing molecular diagnostics and POC tests within them Identify special aspects of personnel training and protection
Spatial care pathsTM	Demonstrate sentinel case discovery, 911 intent, and fastest rescue routes in healthcare SWNs Place POCT to optimize efficiency and effectiveness
IQCP, its five key components, and plan design	Practice designing individualized quality control plans (IQCP) Remember the five components of the testing process: specimen, test system, reagent, environment, and testing personnel Sketch out an IQCP for POCT in an isolation laboratory associated with a hospital and in an alternate care facility
Global pandemic preparedness	Write a summary of POC strategies used in different countries to mitigate the COVID-19 pandemic and avoid saturation of hospital resources, such as ICU beds Describe how POCT pivots community resources to optimize public health planning in the Unites States, then compare limited-resource settings Define the specific roles of molecular diagnostics, antigen assays, and antibody tests, and which are available in portable or hand-held formats for testing onsite Consider the economic tradeoffs of lockdowns, testing, and vaccination
Part II.	Disasters, emergencies, complex crises, and rapid response
Disaster caches and complex crises	List the test clusters in DMAT POCT caches, the three US sites of storage, personnel training, and regional deployment, including Alaska and Hawaii Recognize necessary steps in opening and using the compact and larger laboratory caches, test clusters, and their different purposes Review the basics of specimen collection and sample preparation, including for infectious diseases, under challenging field conditions Recognize the analytical limitations of POCT under disaster and complex crisis conditions
Performance standards	Establish QC criteria necessary to complete before using POC devices from caches in the field during emergencies and disasters Develop backup procedures in case of QA failures Know National Disaster Medical System routines for maintaining high levels of performance when using POCT from caches in the field
Telehealth	Gain familiarity with field connectivity and telecommunications
Alternate care facilities	Integrate DMAT resources with community alternate care facilities
Bioterrorism	Be aware of major threats, methods of detection, containment