PCORI Biweekly COVID-19 Scan: Testing Impact Calculator, Ellume Home Test (December 24, 2020-January 8, 2021)

ECRI Horizon Scanning has selected the topics below as those with potential for impact relative to COVID-19 in the United States within the next 12 months. All views presented are preliminary and based on readily available information at the time of writing.

Because these topics are rapidly developing, we cannot guarantee the accuracy of this information after the date listed on this publication. In addition, all views expressed in the commentary section are solely those of ECRI Horizon Scanning and have not been vetted by other stakeholders. Topics are listed in alphabetical order.

Description 

The plethora of COVID-19 tests and vague guidance for pandemic mitigation can make it difficult for organizations to select an appropriate course of action, given their respective circumstances and resources. Researchers at Massachusetts General Hospital (Boston) and Massachusetts Institute of Technology (Cambridge) developed the COVID-19 ​​Testing Impact Calculator to give schools and businesses clear and customized guidance on testing and risk-reduction measures. The goal is to help organizations minimize the risk of coronavirus transmission while remaining open. The National Institutes of Health funded the research project as part of its Rapid Acceleration of Diagnostics (RADx) Tech program.

The modeling tool purportedly incorporates the latest testing and prevention strategies to visually demonstrate how public health policies can impact the spread of COVID-19 in the organization’s immediate environment. The public health policies in the calculator are mask wearing, contact tracing, limited unmasked social gatherings, and regular testing for coronavirus. The model assumes that the risk of infected people entering the organization is consistent with broader community prevalence when starting the protocol.

Users input details about their site, and the calculator provides customized surveillance testing scenarios of 4 different onsite or laboratory-based COVID-19 testing methods. The model also provides estimates of the number of people who need to be tested daily to identify and isolate potentially contagious individuals and the weekly cost for each testing method.

Commentary

The COVID-19 Testing Impact Calculator is a free and accessible modeling tool that might help schools, businesses, and other small institutions (eg, museums, houses of worship) modify their operations to reopen or remain open and minimize infection risk. Further, the calculator might help institutions preserve limited resources by avoiding unnecessary or inefficient testing or mitigation efforts.

Early feedback from ECRI internal stakeholders suggested the COVID-19 Testing Impact Calculator is a sound, data-driven approach. They thought it has moderate potential to help organizations customize their testing policies according to local conditions and resource limitations. Using the tool could potentially improve population health outcomes and reduce workloads for overburdened health care facilities. The tool might also boost local economies by allowing more people to return to work, especially the parents of children who can safely return to schools. However, stakeholders warned that poor awareness and adoption might limit the calculator’s overall impact despite its potential usefulness.  

• Categories: Systems and management
• Areas of potential impact: Population health, health care disparities, health care costs

Description

The Ellume COVID-19 Home Test (Ellume, Ltd) is the first over-the-counter coronavirus test granted an ​EUA by the FDA for use in the home setting​. It is a low-complexity and portable lateral flow immunoassay containing fluorescent nanoparticles that detect SARS-CoV-2 nucleocapsid antigens in self-collected swabs from the upper-middle part of the nasal cavity. SARS-CoV-2 is the virus that causes COVID-19.

The Ellume test is intended for use in individuals aged 2 years or older regardless of symptoms or other epidemiological reasons to suspect a COVID-19 infection. The Ellume test includes sample-processing fluid, a nasal swab, a sample-collecting dropper, and a single-use analyzer. The analyzer connects with an app on a smartphone to provide step-by-step video instructions and automatically receive test results. The app can share results with providers to enable optimal patient care and with health authorities to help monitor COVID-19 cases.

According to Ellume, the test requires a small sample volume to yield laboratory-quality results in about 20 minutes. The test will cost about $30 per kit. The EUA was based on a simulated home-use clinical study that compared the Ellume test with an EUA reverse ​transcriptase polymerase chain reaction assay in 198 mid-turbinate nasal samples​ from symptomatic and asymptomatic individuals. The Ellume test had a sensitivity of 95% and a specificity of 97%.​​  

Commentary

Over-the-counter COVID-19 testing might reduce demands on testing centers by allowing at-home self-testing during surges in cases.

Initial comments from ECRI internal stakeholders suggest that the Ellume test might provide faster and more convenient testing than going to a testing center. Home testing might improve population health by exposing fewer people seeking testing and fewer health care workers testing people with COVID-19. Use of the test could allow people testing positive to self-isolate and seek initial care via telehealth. Increased testing access might help limit super-spreader events related to travel or attending large gatherings.

Stakeholders warned that the test’s cost and assumed availability in more populated and affluent areas might increase health disparities. Needing a smartphone to receive and transmit results to providers might be a barrier for those with economic hardships or who are not technologically savvy. Further, not all people with a positive test result will self-isolate, increasing exposure risk. False negatives might encourage people to neglect wearing a mask and stop maintaining social distance. 

• Categories: Screening and diagnostics
• Areas of potential impact: Clinician and/or caregiver safety, health care delivery and process, health care costs, health care disparities, patient outcomes, population health

Horizon scanning is a systematic process that serves as an early warning system to inform decision makers about possible future opportunities and threats. Health care horizon scanning identifies technologies, innovations, and trends with potential to cause future shifts or disruptions—positive or negative—in areas such as access to care, care delivery processes, care setting, costs of care, current treatment models or paradigms, health disparities, health care infrastructure, public health, and patient health outcomes.

The PCORI Health Care Horizon Scanning System (HCHSS) conducts horizon scanning to better inform its patient-centered outcomes research investments. Initially, PCORI defined the HCHSS project scope to focus on interventions with high potential for disruption in the United States in 5 priority areas: Alzheimer’s disease and other dementias, cancer, cardiovascular diseases, mental and behavioral health conditions, and rare diseases. In addition, the system captures high-level disruptive trends across all clinical areas, which may lead PCORI to expand the project scope to include other priority areas in the future.

In early 2020, the COVID-19 pandemic created a fast-moving, widespread public health crisis. In May 2020, PCORI expanded its HCHSS to elucidate the landscape of potentially impactful applications for COVID-19. The HCHSS COVID-19 supplement scans for, identifies, monitors, and reports on emerging and available COVID-19-related treatments, diagnostics, preventive measures, management strategies, and systems changes with potential for high impact to patient outcomes—for individuals and populations—in the United States in the next 12 months.

The HCHSS COVID-19 supplement produces 3 main outputs:

• Biweekly COVID-19 Scans (eg, this document) provide ECRI Horizon Scanning with a vehicle to inform PCORI and the public in a timely manner of important topics of interest identified during ongoing scanning and topic identification or through the ECRI stakeholder survey process.
• Status Reports (quarterly) briefly list and describe all COVID-19-related topics identified, monitored, and recently archived.
• High Impact Reports (every 4 months) highlight those topics that ECRI internal stakeholders (eg, physicians, nurses, allied health professionals, public health professionals, first responders, health systems experts, clinical engineers, researchers, business and finance professionals, and information technology professionals) have identified as having potential for high impact relative to COVID-19 in the United States.