To provide an additional layer of protection against COVID-19covid 19 and variants including Omicron, Ontario is launching a holiday testing blitz to offer voluntary rapid antigen screening to individuals free of charge at pop-up sites across the province. This initiative is part of the government’s enhanced COVID-19covid 19 testing strategy to mitigate the increased risk of transmission over the holiday season.
Throughout December to mid-January, up to two million rapid tests will be provided free of charge at pop-up sites in high-traffic locations such as malls, retail settings, holiday markets, public libraries and transit hubs. Take-home rapid tests will also be available at select LCBO stores.
People without symptoms of COVID-19covid 19 or people who have not had recent exposure to someone with COVID-19covid 19 will be able to pick up a package of free tests from a pop-up site, while supplies last, or get a free test performed on-site.
Most sites will distribute free take-home rapid antigen test kits, and some will offer testing on-site. Every person that receives a package of tests or gets a test on-site will be provided with easy-to-understand information and resources about rapid antigen screening and COVID-19covid 19 vaccination.
Rapid antigen tests for individuals
Anyone without symptoms or who has not recently been in contact with someone with COVID-19covid 19 is eligible to receive a free take-home rapid antigen test kit from a pop-up site or get a free test performed on-site as part of the government’s holiday testing blitz. You do not need an appointment to access a pop-up site. However, access to rapid antigen tests will be subject to available supply. At sites distributing tests, there is a limit of one test kit per person.
Rapid antigen tests cannot diagnose COVID-19covid 19. Anyone who receives a package of tests to take home and gets a positive result must self-isolate and book a lab-based polymerase chain reaction (PCR) test at a testing site to confirm the result. Any location that performs on-site rapid antigen screening will also offer a confirmatory PCR test for individuals who receive a positive antigen result.
If you need a COVID-19covid 19 test because you have symptoms or have been exposed to someone with a confirmed case of COVID-19covid 19, find a testing location using the testing locations tool.
Learn more about COVID-19covid 19 testing.
Rapid antigen holiday pop-up schedule
We are working with local partners, public health units and municipalities to determine specific pop-up sites based on local data and needs.
Rapid antigen tests are used as an additional screening tool only for asymptomatic individuals and not for diagnostic purposes. Do not visit these testing locations if you have symptoms of COVID-19covid 19 or have been exposed to a COVID-19covid 19 positive person.
We compared the performance of the Abbott BinaxNOW COVID-19 antigen card to that of a standard reverse transcription-PCR (RT-PCR) assay (Thermo Fisher TaqPath COVID-19 Combo kit) for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in 2,645 asymptomatic students presenting for screening at the University of Utah. SARS-CoV-2 RNA was detected in 1.7% of the study participants by RT-PCR. BinaxNOW identified 24 infections but missed 21 infections that were detected by RT-PCR. The analytical sensitivity (positive agreement) and analytical specificity (negative agreement) for the BinaxNOW were 53.3% and 100%, respectively, compared to the RT-PCR assay. The median cycle threshold (CT) value in the specimens that had concordant positive BinaxNOW antigen results was significantly lower than that of specimens that were discordant (CT of 17.6 versus 29.6; P < 0.001). In individuals with presumably high viral loads (CT of <23.0), a 95.8% positive agreement was observed between the RT-PCR assay and BinaxNOW. Due to the possibility of false-negative results, caution must be taken when utilizing rapid antigen testing for screening asymptomatic individuals.
With its high degree of transmissibility, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative pathogen for the novel 2019 coronavirus disease (COVID-19), has undoubtedly led to one of the most remarkable global public health epidemics in recent history. Timely identification and isolation of infected individuals are crucial in mitigating the rampant community spread of SARS-CoV-2.
The gold-standard method for COVID-19 diagnosis remains the detection of SARS-CoV-2 RNA in respiratory tract specimens using nucleic acid amplification techniques such as reverse transcription-PCR (RT-PCR). However, SARS-CoV-2 nucleic acid amplification tests (NAATs) are generally more expensive than alternative methodologies and may have prolonged turnaround times due to limited test supplies, reagent allocation, and fixed laboratory capacity, which have been exacerbated by extremely high demand.
Efforts to expand testing capacity have led to the development of several rapid antigen (Ag) tests designed to detect SARS-CoV-2 nucleocapsid antigen, primarily in symptomatic individuals (1). At the time of this writing, the U.S. Food and Drug Administration (FDA) has granted emergency-use authorization (EUA) to 11 SARS-CoV-2 antigen tests (2). Although these antigen tests are intended to be utilized in symptomatic individuals (within the first 5 to 7 days of symptom onset), the U.S. Department of Health and Human Services (HHS), through the Public Readiness and Emergency Preparedness Act (PREP Act), permits their use for screening asymptomatic individuals in congregate facilities, including schools (3).
However, there are limited data on the performance characteristics of rapid antigen tests in asymptomatic or presymptomatic individuals. A recent meta-analysis of published literature on rapid, point-of-care antigen tests reported an average sensitivity and specificity of 56.2% and 99.5%, respectively, compared to NAAT (1). However, these studies were not limited exclusively to asymptomatic individuals, the specimen type was primarily nasopharyngeal and/or oropharyngeal, and none of the antigen tests included have received EUA approval from the FDA.
In this study, we evaluated the diagnostic performance characteristics of the Abbott BinaxNOW COVID-19 antigen card (referred to here as BinaxNOW) in a population of college-age students who were asymptomatic at the time of testing. BinaxNOW is a rapid lateral flow immunoassay that qualitatively detects SARS-CoV-2 nucleocapsid antigen in direct nasal swab specimens. The package insert cites a positive agreement of 97.1% and a negative agreement of 98.5% compared to an EUA RT-PCR assay (4). These data were based on a clinical study involving a total of 102 patients, of whom 95 had symptoms consistent with COVID-19 and only 7 were asymptomatic. This was recently updated to a positive agreement of 84.6%, based on a larger study involving 460 symptomatic individuals. Of note, the U.S. federal government has distributed 150 million BinaxNOW antigen cards to states across the country (5). BinaxNOW also received EUA for at-home use under the supervision of a telehealth proctor (6). Therefore, characterizing the performance characteristics of BinaxNOW for off-label use in an asymptomatic population is essential given its potential widespread application for asymptomatic screening in a variety of settings.
MATERIALS AND METHODS
Study population and specimen collection.
The participants of this study were primarily college-age (undergraduate and graduate) students at the University of Utah in Salt Lake City, UT. At the time of specimen collection, the students were first queried to ensure that they were not experiencing any signs and/or symptoms of COVID-19. Specimen collection occurred at a temporary indoor testing site from 13 to 20 November 2020. Two nasal swabs were collected from each participant, according to the technique recommended by the U.S. Centers for Disease Control and Prevention (CDC) (7). The study participants were instructed to swab both nares at the level of the midturbinate for each collection. Trained nonmedical personnel observed the specimen collection process. The first swab collected from the participants was randomly assigned to be tested with either BinaxNOW or the RT-PCR assay in an effort to minimize sampling bias.