Table 1.

Curriculum and learning objectives—mission, principles, and practice

Section & topics	Learning objectives
Part I.	Getting started—the mission
Goals, objectives, and overview of uses in public health	Define POCT as testing at or near the site of care and appreciate that the definition does not depend on the instrument format or size Understand the fundamental goals and objectives of POCT for rapid and effective evidence-based decision making at points of need
Needs	Introduce situations where POCT has proven benefits for public health Describe the need for POCT in outbreaks, epidemics, and the current pandemic, as well as in disasters and complex public health crises Understand the importance of generating fast results, so that triage can be performed efficiently and immediately
Companion Tests	Why do POC monitoring of temperature, oxygen saturation, respiratory rate, and other key primary variables (e.g., d-Dimer) provide layers of protection, defense, and assessment along spatial care paths
Part II.	Fundamental principles and practice of POC testing
A. Technical
Needs assessment	Develop competency in needs assessment for POC diagnostics in public health Apply to healthcare settings limited-resource countries
Instrument formats, selection, and validation	Recognize basic formats for disposable, handheld, portable, and transportable POC technologies that perform in vitro testing Describe disposable POC tests, including smartphone modules, and their advantages, disadvantages, and marginal cost-effectiveness Have the ability to select and validate the correct instruments
Non-invasive monitoring versus in vitro diagnostic testing	Consider the operating principles of non-invasive devices, namely pulse oximetry for monitoring of oxygen saturation, and continuous hemoglobin monitoring Compare in vivo, ex vivo, and in vitro approaches and advantages
Specimen processing	Contrast whole-blood versus plasma analysis, also dry blots Outline specimen processing and suitable sample types for testing in the field, primary care, and emergency room Review special requirements associated with isolation laboratories
Quality assurance (QA), quality control (QC), and proficiency testing (PT)	Identify “waived tests” under CLIA ’88 and compare other POC tests Know the definition and importance of quality assurance, including internal quality control and external quality assessment Learn the five basic elements of the individualized quality control plan (IQCP), including environmental stress; how to customize QA, QC, and PT; and the importance of continuous quality improvement Recognize confounding factors in diagnostic testing
Environmental stresses	Overview the effects of environmental stresses on POC instruments and reagents, and how to avoid adverse consequences Study methods for modulating environmental conditions for POC reagent storage and transportation
Multiplex molecular diagnostics	Gain a basic appreciation of multiplex assays used for the detection of viruses, bacteria, and fungi, that is, pathogen detection List advantages, disadvantages, costs, and limitations Show examples of current POC disposable tests and instruments commercially available
B. Design & build
Design criteria	Read WHO and other POC device performance specifications
Commercialization	Understand custom POC test clusters, basic manufacturing requirements, commercialization processes, and timelines
Regulatory oversight	Review routine FDA 510(K) clearance and pre-market approval (PMA) Outline the FDA system of classification of diagnostic tests (i.e., CLIA-waived, moderately complex, and complex) and the criteria for home testing. Assess the ramifications for implementation, personnel, and use
FDA and WHO emergency use declarations	Study the process, legal requirements, and terms of FDA emergency use authorizations (EUAs) and WHO emergency use assessment and listings (EUALs) Locate EUA and EUAL listings and documentation of tests on the web
Accreditation options	Understand the definition of accreditation and why an organization would engage in it Discuss the main considerations and steps leading to accreditation Consider inspections options for POCT [e.g., College of American Pathologists, Joint Commission, and CMS (for waived testing)]
Part III.	Practicum
Device hands-on experience	Demonstrate CLIA ’88 waived and moderately complex POC tests Learn how to perform common POC tests, how to operate mobile POC instruments, and security features (e.g., UN & PW) Watch demonstration videos of transportable whole-blood analyzers and test clusters for critical care and support of patients in isolation
Results interpretation	Use case studies to demonstrate how to interpret basic test results
Performance evaluation	Attend a workshop illustrating POC performance evaluation, such as regression analysis, Bland-Altman plots, and locally-smoothed (LS) median absolute difference (“LS-MAD”) curves and maximum absolute difference (“LS-MaxAD”) curves
Trouble shooting	Gain experience at trouble shooting POC tests and devices See examples of error codes and how to respond to them
Establishing a POC program	Understand the steps necessary to establish a successful POC testing program