PCORI Biweekly COVID-19 Scan: Isolation Bags for Safe CT Imaging, Population-wide Antibody Testing (June 25-July 8, 2020)

Treatments and vaccines play a central role in reducing impacts of COVID-19; however, infection control and prevention also remain key strategies for mitigating negative COVID-19–related outcomes. With hospitals facing increased patient loads and exposure risks, novel infection control methods are emerging (see Topics to Watch).

As people continue to be exposed to coronavirus in the United States, antibody testing provides a way to measure the extent of the spread of the virus in the population (see Topics to Watch). Antibody testing is also being considered as a way to measure acquired immunity that could form the basis for “immunity passports”; however, concerns exist regarding this concept. Data released in Spain and Switzerland show low seroprevalence (ie, levels of a pathogen in blood samples taken from a population) even in hotspots, and a study in China suggests that acquired antibodies might fade in 2 to 3 months. The possibility of immunity to coronavirus remains an open question. These findings echo concerns about the prudent use of antibody tests.

Description

CT scans can be used in alternative diagnostics or to guide management of COVID-19 complications. However, protecting patients and staff requires lengthy cleaning procedures between patients to adequately decontaminate imaging equipment and exam rooms. An international team led by NIH researchers has developed a simple, inexpensive bag intended to safely isolate patients during CT scans.

The disposable isolation bag features breathing valves and is made from readily available​​, translucent (ie, almost clear) ​​plastic material commonly used to protect patients and imaging and surgical equipment in other health care settings. The bag covers the head and chest and is secured at the waist with a disposable elastic or Velcro belt. Patients wear a hat with a visor to keep the bag off the face.

Researchers estimate that use of the isolation bag might allow about 14 times more patients per day to undergo CT on a single CT scanner in a hospital emergency department using this cost-effective and easily implementable method​.

Commentary

Isolation bags might reduce coronavirus exposure risk to imaging staff, increase the number of patients with suspected COVID-19 who can undergo CT scans, and reduce time required for treatment decisions.

Early feedback from ECRI internal stakeholders suggested that isolation bags might help reduce operational overhead if they increase patient throughput and limit down time needed to disinfect CT scanners between patients. Stakeholders also thought that isolation bags might enable hospitals to avoid the designation of COVID-19–only “dirty” CT machines, which do not eliminate cross-contamination issues or exposure to healthcare workers. Further, stakeholders anticipated that if material costs were low enough, use of isolation bags might become standard in imaging procedures in nonpandemic situations to extend additional protection to health care personnel.

• Area of Potential Impact: Population health, clinician and/or caregiver safety, health care delivery and process, health care costs
• Category: Devices

Description

The COVID-19 pandemic has caused substantial public health and economic crises. Testing for coronavirus seroprevalence can measure the spread of the virus. ​The presence of coronavirus-specific antibodies in a person’s blood could indicate exposure to the virus, regardless of the presence or absence of symptoms. Therefore, widespread testing could elucidate the extent of coronavirus spread. CDC plans to study blood samples from 325 000 donors in 25 US cities over 18 months. A nonprofit blood service provider, Vitalant (Scottsdale, Arizona), will partner with CDC and NIH to collect samples for this study.

In addition, NIH has launched an antibody study ​of 15 000 participants with no known coronavirus infection or exposure. The institute is collecting blood samples from employee volunteers at its Bethesda, Maryland, campus​ and using at-home blood collection kits developed by Neoteryx (Torrance, California) to obtain samples from other volunteers.

Commentary

Widespread, large-scale antibody testing might inform and guide public health policies based on prevalence rates. Early feedback from ECRI internal stakeholders suggests that antibody testing might reduce stress and anxiety related to the uncertainty surrounding COVID-19. However, concerns exist about whether antibodies can protect someone against reinfection, and whether antibodies can protect a person from a new form of the virus.

Stakeholders also expressed concerns regarding legal, privacy, and security issues; potential issues related to discriminatory employment or workplace policies and practices; and potential to provide a false sense of safety, which might encourage unsafe behaviors.

• Area of Potential Impact: Patient outcomes, population health, clinician and/or caregiver safety, health care delivery and process, health care disparities, health care costs
• Category: Screening and diagnostics

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.