PCORI Biweekly COVID-19 Scan: BinaxNOW COVID-19 Ag Card, Saliva-based Nucleic Acid Assays (September 3-16, 2020)
The Briefing provides an at-a-glance view of some important developments in the information universe surrounding COVID-19. The views presented here are solely those of ECRI Horizon Scanning and have not been vetted by other stakeholders.
The World Health Organization (WHO) recently reported a record rise in new cases globally, and concerns exist across the United States regarding possible coronavirus risks created with the reopening of schools, complications due to the approaching flu season, and the possibility of coronavirus reinfection.
Some scientists propose that natural herd immunity to the novel 2019 coronavirus could take up to 3 epidemic cycles and cost from a half-million to 2 million US lives. However, researchers have been gathering insights into a possible “path to immunity” and how vaccines might help us follow that path.
Continued developments in COVID-19 diagnostics might help control the spread of the virus and help infected patients get timely care. The newest tests collect samples in a more patient-friendly way than previous tests (see Saliva-based Nucleic Acid Assays in Topics to Watch) and return results more rapidly (see BinaxNOW COVID-19 Ag Card in Topics to Watch). They can be given regardless of the patient's location (eg, hospital, doctor’s office, or even at home). The next wave of tests aimed at the Food and Drug Administration (FDA) Emergency Use Authorization (EUA) includes a variety of breathalyzer tests that purport to be highly specific to the electrical signature of either the virus itself or markers of the virus.
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.
BinaxNOW COVID-19 Ag Card Point-of-Care Test to Diagnose COVID-19
At a Glance
- BinaxNOW COVID-19 Ag Card (BinaxNOW) is a simple point-of care test that uses nasal swabs and works like a home pregnancy test. It can be read in about 15 minutes to help health care practitioners rapidly start treating and isolating infected people.
- BinaxNOW had a sensitivity of 97.1% and a specificity of 98.5% compared with an EUA RT-PCR assay.
- In August 2020, the FDA granted an EUA to BinaxNOW.
- The manufacturer claims that each test costs $5 and results can be sent to a mobile device app (NAVICA), which might be used as a temporary digital health pass.
BinaxNOW COVID-19 Ag Card (BinaxNOW) is a point-of care test developed by Abbott Diagnostics Scarborough. The test uses a lateral flow antigen immunoassay platform to help health care practitioners rapidly begin treatment and isolation for patients with COVID-19.
BinaxNOW works and reads like a home pregnancy test. It consists of a single-use card, containing color-labeled antibodies that detect the nucleocapsid protein of coronavirus, which is detectable during the first 7 days of symptom onset. A patient’s nasal swab is inserted into a small test card along with an extraction reagent that exposes the viral proteins for testing. Results can be sent to a mobile device app (NAVICA), which might be used as a temporary digital health pass renewable after each test.
In a study that served as the basis of the EUA, BinaxNOW’s performance was evaluated in 102 nasal samples that were compared with an EUA RT-PCR assay. BinaxNOW had a sensitivity of 97.1% and a specificity of 98.5%.
The manufacturer claims that each $5 BinaxNOW card yields results in about 15 minutes. In August 2020, the FDA granted BinaxNOW an EUA. United States government agencies plan to strategically deploy 150 million tests to high needs areas.
The BinaxNow assay is a point-of-care test that does not require specialized equipment or training. It allows patient testing and triaging of infected and uninfected people soon after arriving at a health center. The $5 cost of BinaxNOW is substantially less than tests performed in central laboratories.
ECRI internal stakeholders thought that the test’s high sensitivity and specificity were promising. BinaxNOW might be suited for triaging people in urgent care, continuing care communities, universities, and business settings compared with unproven screening strategies, such as questionnaires and temperature measurements.
Stakeholders remain skeptical of the test’s purported accuracy due to the limited data available. If the test does not detect very low levels of viral proteins in samples, it might increase the risk of false-negative test results. This could lead to COVID-19 spread by infected people who relax their social distancing after a negative test result. Stakeholders were also concerned that unapproved use outside of its authorized indication, such as broad screening of people without symptoms, might waste tests and create supply shortages.
- Area of Potential Impact: Patient outcomes, population health, health care delivery and process, health care disparities, health care costs
- Category: Screening and diagnostics
Saliva-based Nucleic Acid Assays to Diagnose COVID-19
At a Glance
- Saliva-based nucleic acid assay sampling can be performed at home or health centers to detect coronavirus nucleic acids in a patient-collected saliva sample, a less invasive and less costly method than standard nasopharyngeal swab sample collection.
- A rapid systematic review of published reports found that saliva-based nucleic acid tests were comparable to nasopharyngeal swab-based testing.
- The FDA granted an EUA to 3 tests, CRL Rapid Response, SalivaDirect, and TaqPath SARS-CoV-2, for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The EUAs for CRL Rapid Response and TaqPath SARS-CoV-2 allow patients to collect samples at home.
Saliva-based nucleic acid assays, such as CRL Rapid Response (Clinical Reference Laboratory, Inc), SalivaDirect (Yale School of Public Health), and TaqPath SARS-CoV-2 (Rutgers Clinical Genomics Laboratory), are used to diagnose COVID-19 by detecting SARS-CoV-2 nucleic acids from a patient's saliva sample.
Compared with traditional sampling using nasopharyngeal swabs, saliva sampling is less invasive, less costly, and can be performed at home or at a health center without the supervision of a health care worker. Some saliva-based assays have been validated to use minimally processed saliva samples, obviating the need for a nucleic acid extraction step, which might save time and testing supplies.
A rapid systematic review showed that saliva-based nucleic acid testing yields similar outcomes to nasopharyngeal swab–based nucleic acid testing. The FDA has granted an EUA to CRL Rapid Response, SalivaDirect, and TaqPath SARS-CoV-2 for use in laboratories certified under CLIA. The EUAs for CRL Rapid Response and TaqPath SARS-CoV-2 allow samples to be collected by patients at home.
Similar to nasopharyngeal tests, saliva-based tests might also help triage patients. Further, saliva samples can be collected at home without the supervision of a health care worker, which might reduce the risk of transmitting the coronavirus to medical staff and other patients while easing the burden at centers with limited testing supplies and personal protective equipment.
Early responses from ECRI internal stakeholders indicated adopting saliva-based tests might improve patient willingness to undergo testing, thus increasing testing rates, including infected patients who are not yet showing symptoms.
Stakeholders thought that the context of numerous authorized tests, public test fatigue, and bad COVID-19 publicity might hamper the adoption of saliva-based assays. They also raised concerns that data comparing the accuracy of saliva-based assays with nasopharyngeal assays are limited, of low quality, and not peer reviewed. Saliva-based tests might increase the spread of coronavirus if the tests cannot detect viral nucleic acids at all stages of infection.
- Area of Potential Impact: Clinician and/or caregiver safety, health care delivery and process, health care costs, health care disparities, patient outcomes, population health
- 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.
Commentary in this COVID-19 Scan reflects preliminary views of ECRI Horizon Scanning and internal ECRI stakeholders.
The information contained in this document has not been vetted by other stakeholders.
We welcome your comments on this Scan. Send them by email to [email protected].
Posted: September 23, 2020
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