Partial data from the company-funded study showed that . On the day of testing, a facility administrative employee conducted registration and collected demographic data, including self-reported race and ethnicity. Third, this investigation evaluated the BinaxNOW antigen test, and results presented here cannot be generalized to other FDA-authorized SARS-CoV-2 antigen tests. Compared to the regular laboratory-based PCR test, the Panbio COVID-19 Ag Rapid Test has a higher risk of a false negative and a false positive result. The LHD decided to use BinaxNOW as a supplement to rRT-PCR to more quickly identify SARS-CoV-2positive employees for isolation. Published Online: January 7, 2022. doi:10.1001/jama.2021.24355. Second, participants might have inadvertently reported common nonspecific symptoms as COVID-19compatible symptoms. In total, 769 valid, paired rRT-PCR and BinaxNOW antigen test results were reported and analyzed. The alert about false positives applies to both Alinity products. Throughout the pandemic, certain nonhealthcare occupational groups (e.g., meat and poultry processing workers) have experienced higher risk of contracting COVID-19; this higher risk is attributable to workplace hazards, such as lack of appropriate personal protective equipment, densely populated work areas, poorly ventilated workspaces, and prolonged close contact (9,10). In this evaluation, using real-time RT-PCR as the standard, the sensitivity of the BinaxNOW antigen test was lower among specimens from asymptomatic persons (35.8%) than among specimens from symptomatic persons (64.2%). For rRT-PCR, we isolated and purified viral nucleic acid (NA) from the swab specimens by using the KingFisher Flex Purification System and the MagMAX Viral/Pathogen Nucleic Acid Isolation Kit (ThermoFisher Scientific, https://www.thermofisher.com). Accessibility Statement, Our website uses cookies to enhance your experience. This conversion might result in character translation or format errors in the HTML version. The Alinity m Resp-4-Plex AMP Kit is only authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform moderate or high complexity tests. Cookies used to make website functionality more relevant to you. A BinaxNOW rapid COVID-19 test made by Abbott Laboratories, in Tacoma, Wash., Feb. 3, 2021. . in long-term care facilities) should also receive confirmatory testing by NAAT (1). Figure 1. Viral culture was performed on 274 of 303 residual real-time RT-PCR specimens with positive results by either test (29 were not available for culture). Among specimens positive for viral culture, sensitivity was 92.6% for symptomatic and 78.6% for asymptomatic individuals. By continuing to use our site, or clicking "Continue," you are agreeing to our, Kretschmer With the ability to identify batch issues within 24 hours, workers could return to work, problematic test batches could be discarded, and the public health authorities and manufacturer could be informed. Biotech. Kristen Garcia, Wenli Zhou, Morgan Ross, Lyndsay Wagner, Katherine Collins, Shelby Legendre, Christopher Johnson, Paradigm Laboratories, Tucson, Arizona; Spencer Graves, Pima County Health Department, Tuscon, Arizona; Anastasia Litvintseva, Dennis A. Bagarozzi, Jr., David James Petway, Jr., CDC. Performance characteristics of BinaxNOW COVID-19 antigen card for screening asymptomatic individuals in a university setting. During October 20, 2020January 15, 2021, a horse racetrack (the facility) in California, USA, experienced a COVID-19 outbreak among its 563 employees and independent contractor workers (hereafter collectively called facility staff). We performed rRT-PCR by using the ThermoFisher TaqPath COVID-19 Combo Kit, which targets 3 SARS-CoV-2 viral regions (nucleocapsid protein gene, spike protein gene, and open reading frame 1ab), and the Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument (ThermoFisher Scientific), according to the manufacturers instructions. The high specificity and rapid BinaxNOW antigen test turnaround time facilitate earlier isolation of infectious persons. Letters to Health Care Providers, Recalls, Market Withdrawals and Safety Alerts, Potential for False Positive Results with Abbott Molecular Inc. Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits - Letter to Clinical Laboratory Staff and Health Care Providers, MedWatch, the FDA Safety Information and Adverse Event Reporting program, Medical Device Reporting (MDR) regulations, FDA's user facility reporting requirements. Abbott tests earlier this year in response to a risk of false results linked to its own product. Like BINAXNow, Flowflex is a lateral flow test. Early on, it would sometimes take days to weeks to get your results. This discrepancy might have resulted from staff feeling less comfortable discussing symptoms with the administrative employee versus the racetrack physician or it could be associated with the incomplete list of COVID-19 symptoms in the administrative employees question. Persons who know their positive test result within 1530 minutes can isolate sooner, and contact tracing can be initiated sooner and be more effective than if a test result is returned days later. Among 299 real-time RT-PCR positive results, 142 (47.5%) were false-negative BinaxNOW antigen test results (63 in specimens from symptomatic persons and 79 in specimens from asymptomatic persons). the date of publication. of pages found at these sites. The PPA of BinaxNOW was 43.0% and the NPV was 89.9%. Performance and implementation evaluation of the Abbott BinaxNOW rapid antigen test in a high-throughput drive-through community testing site in Massachusetts. All rRT-PCRnegative results (n = Of 127 rRT-PCRpositive specimens, BinaxNOW detected 55, did not detect 72 (44 specimens with Ct <30, 5 specimens with Ct <20, and 6 specimens with positive viral cultures), and produced no false-positive results (Table 3). Assessment of SARS-CoV-2 screening strategies to permit the safe reopening of college campuses in the United States. If your rapid test is positive, you should assume that you have Covid. Curative is among the companies to adopt the platform. Performance of the BinaxNOW COVID-19 antigen card test relative to the SARS-CoV-2 real-time reverse transcriptase polymerase chain reaction assay among symptomatic and asymptomatic healthcare employees. remind us that it is important to ensure that tests are stored and used within the temperature range specified by the manufacturer. Cells were monitored for cytopathic effect. BinaxNOW demonstrated better concordance with positive viral culture results (88.2%) than with positive rRT-PCR results (43.3%). US CDC real-time reverse transcription PCR panel for detection of severe acute respiratory syndrome coronavirus 2. reported that several commercially available rapid antigen tests for SARS-CoV-2 suffer reduced sensitivity when stored or used at temperatures above those recommended by the manufacturer, and most relevant to the current study, they also found that two--including Abbott's Panbio--were found to suffer reduced specificity when stored and used at temperatures colder than recommended by the manufacturer (1). CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Let's say for example, the real-world false positive rate is 4% for SARS-CoV-2 RT-PCR testing. We are talking to Dr. Hanan Balkhy today, who's going to explain testing for COVID-19. Validation of an At-Home Direct Antigen Rapid Test for COVID-19. Of these, 278 false-positive results (60%) occurred in 2 workplaces 675 km apart run by different companies between September 25 and October 8, 2021. Symptoms were reported by 11 different persons at the time of testing, which accounted for 11/769 (1.4%) of collected paired specimens. 552a; 44 U.S.C. After receiving reports of false results from its own test, Curative asked FDA to revoke its EUA and struck a deal with Abbott to access the Alinity tests for COVID-19 and the set of respiratory pathogens. As disease prevalence decreases, the percent of test results that are false positives increase. The sites offered SARS-CoV-2 testing to anyone in the community who wanted testing. This document, prepared December 12, 2020, provides interim guidance on the use of the Abbott Panbio COVID-19 Antigen Rapid Test in the context of the Canadian public health system and a coordinated national response to the coronavirus disease 2019 (COVID-19) pandemic. During this period Canada reported roughly 1.7 million confirmed cases of COVID in a population of 38 million (4.5% of the population). A rapid COVID-19 test swab being processed. Rapid antigen tests, such as Abbott BinaxNOW (https://www.abbott.com) test kits, offer a less expensive and faster alternative to nucleic acid amplification tests, such as real-time reverse transcription PCR (rRT-PCR), in the diagnosis of coronavirus disease (COVID-19) (1,2). A handful of rapid antigen tests are available without a prescription, including the Abbott BinaxNOW, the Ellume Covid-19 Home Test and the Quidel QuickVue At-Home Covid-19 Test. The research effort did not test for false negatives so we do not know if that vast majority of negatives are true or false. This cohort study examines the performance of direct antigen rapid tests compared with that of quantitative real-time polymerase chain reaction for analyzing self-collected nasal specimens for the presence of SARS-CoV-2. All information these cookies collect is aggregated and therefore anonymous. * Includes 113 persons who received testing multiple times and were included more than once in the analysis. Testing with real-time RT-PCR was performed using the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel for detection of SARS-CoV-2 (2,582 participants) or Fosun assay (837 participants). Only selected categories shown; therefore, row numbers and percentages do not sum to total or 100%. Participants were asked whether they had each individual sign or symptom from a list based on the Council of State and Territorial Epidemiologists clinical criteria for COVID-19 interim case definition, which include fever, cough, shortness of breath, fatigue, sore throat, headache, muscle aches, chills, nasal congestion, difficulty breathing, diarrhea, nausea, vomiting, abdominal pain, rigors, loss of taste, and loss of smell (https://cdn.ymaws.com/www.cste.org/resource/resmgr/ps/positionstatement2020/Interim-20-ID-02_COVID-19.pdfpdf iconexternal icon). Cells with positive cytopathic effect were tested by rRT-PCR to confirm presence of SARS-CoV-2. 45 C.F.R. JAMA. We take your privacy seriously. These cookies perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. 4 reasons your rapid COVID-19 test might show a false result. Since then, FDA has granted revisions to the EUA, most recently in August, and cleared Abbott to sell a version of Alinity that tests for SARS-CoV-2, two types of influenza and respiratory syncytial virus. National Oceanic and Atmospheric Administration, SARS-CoV-2 Spike Antibody, Dominican Republic, https://www.fda.gov/media/141570/download, https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html, https://www.cdc.gov/coronavirus/2019-ncov/community/organizations/testing-non-healthcare-workplaces.html, Effectiveness of Abbott BinaxNOW Rapid Antigen Test for Detection of SARS-CoV-2 Infections in Outbreak among Horse Racetrack Workers, California, USA, U.S. Department of Health & Human Services, Surasi K, Cummings KJ, Hanson C, Morris M, Salas M, Seftel D, et al. https://cdn.ymaws.com/www.cste.org/resource/resmgr/ps/positionstatement2020/Interim-20-ID-02_COVID-19.pdfpdf iconexternal icon. However, the results reported by Haage et al. All specimen collection and antigen testing occurred outdoors in the parking lot of the facility. Antigen tests can be an important tool in an overall community testing strategy to reduce transmission. Interpretation of results in different patient populations varies based on specimen type collected and pre-test probability of COVID-19 in the patient being tested. Dr Agrawal reported serving on the boards of Genpact and Sanctuary. Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Fierce Biotech. Corresponding Author: Joshua S. Gans, PhD, Rotman School of Management, University of Toronto, 105 St George St, Toronto, ON M5S3E6, Canada (joshua.gans@utoronto.ca). Screening results were recorded, including a deidentified record identifier, the place of employment, the test, and (optionally) the lot number. In dual-positive pairs, the median time between rRT-PCR specimen collection date and results reported date was 4 days (range 16 days). The performance of the BinaxNOW antigen test compared with real-time RT-PCR was better for those specimens with positive viral culture than for all specimens, with a sensitivity of 92.6% for specimens from symptomatic persons and 78.6% for those from asymptomatic persons. Overflow into the wells of true negative samples that are positioned near positive samples in the assay tray could produce false positive results," FDA wrote in its alert. Abbott's status as a supplier to clinical laboratories means the problem will affect multiple other organizations. part 56; 42 U.S.C. Out of 955 patients, 23 were found to be positive for COVID-19 using a lab-based test. Digital capabilities will be the next big inflection driving growthfor GEs newly independent healthcare business. Positive Predictive Value depends upon prevalence of disease in community, Role of Rapid Antigen Detection Test (RADT) for Detection of SARS Cov-2 Variants. 1CDC COVID-19 Response Team; 2Arizona Department of Health Services; 3Epidemic Intelligence Service, CDC; 4Pima County Health Department, Tucson, Arizona. Interim data from Abbott's 1,003-participant study shows that its test, which can deliver results in under 15 minutes, correctly identified positive COVID-19 cases 95% of the time when used . Our results indicate that BinaxNOW performs better at identifying rRT-PCRpositive specimens with lower Ct (suggestive of higher viral loads) and positive viral cultures, although these factors are not precise proxies for infectiousness. The Altmetric Attention Score for a research output provides an indicator of the amount of attention that it has received. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. A rapid COVID-19 test swab being processed. Brittany Murray/MediaNews Group/Long Beach Press-Telegram via Getty Images Rapid tests are a quick and convenient way to learn about your COVID-19 status. The study, which was pre-published on bioRxiv and has not been peer reviewed, suggested that Abbott's test produced false negative results for almost half of the positive samples. Views equals page views plus PDF downloads. False positive rapid antigen tests for SARS-CoV-2 in the real-world and their economic burden. The researchers found that rapid tests correctly identified COVID-19. All HTML versions of MMWR articles are generated from final proofs through an automated process. Rapid antigen tests (RATs) can substantially contribute to the prevention of community transmission, but their further assessment is required . Importantly, the faster time from testing to results reporting can speed isolation of infectious persons and will be particularly important in communities with high levels of transmission. Median Ct values for SARS-CoV-2 culture-positive specimens (22.1) were significantly lower than were those for culture-negative specimens (32.8) (p<0.001), indicating higher levels of viral RNA in culture-positive specimens. Thank you very much, Vismita. The first mass testing dates (round 0) only used rRT-PCR testing, so no comparison with BinaxNOW was possible. This COVID-19 test is designed to detect an active infection with or without symptoms and, according to Abbott, it can detect multiple strains, including the delta variant. Across the U.S., 7.1% of tested samples were positive in the latest CDC data. Rapid antigen tests for SARS-CoV-2 were implemented as an extra layer of protection to control transmission in workplaces throughout Canada by the Creative Destruction Lab Rapid Screening Consortium (CDL RSC). Despite a lower sensitivity to detect infection, rapid antigen tests can be an important tool for screening because of their quick turnaround time, lower costs and resource needs, high specificity, and high positive predictive value (PPV) in settings of high pretest probability. ** Based on one or more symptoms. Exposure was defined as close contact (within 6 ft for 15 min) in the 14 days before the day of testing with a person with diagnosed COVID-19. Received positive real-time RT-PCR or antigen test result. All specimens in viral transport medium were frozen at 70C within 12 hours of delivery to the laboratory. How do I know if I have a positive or negative test? A woman picks up COVID-19 rapid antigen test kits at the Watha T. Daniel-Shaw Neighborhood Library in . Webinar View data is from . Testing frequency was determined by the LHD and changed as the outbreak progressed. Acquisition, analysis, or interpretation of data: Gans, Goldfarb, Agrawal, Sennik, Rosella. Among symptomatic participants, 113 (13.7%) received a positive BinaxNOW antigen test result, and 176 (21.3%) received a positive real-time RT-PCR test result. University of California San Francisco School of Medicine, San Francisco (C. Stainken). Sect. Concept and design: Goldfarb, Agrawal, Sennik, Stein, Rosella. Among symptomatic participants, 113 (13.7%) received a positive BinaxNOW antigen test result, and 176 (21.3%) received a positive real-time RT-PCR test result. Rapid tests can help you stay safe in the Delta outbreak. Where is the Innovation in Sterilization? The kits can report false positives when wells in the assay reagent tray that contain positive samples overflow and contaminate neighboring specimens. To register for email alerts, access free PDF, and more, Get unlimited access and a printable PDF ($40.00), 2023 American Medical Association. Sensitivity of the BinaxNOW antigen test, compared with polymerase chain reaction testing, was lower when used to test specimens from asymptomatic (35.8%) than from symptomatic (64.2%) persons, but specificity was high. When only rRT-PCR tests with Ct <30 were considered positive, BinaxNOW produced these results: PPA, 55.6% (95% CI45.2%65.6%); NPA, 100% (95% CI99.5%100%), PPV, 100.0% (95% CI93.5%100%); and NPV, 93.8% (95% CI91.8%95.5%) (Table 3). The score is derived from an automated algorithm, and represents a weighted count of the amount of attention Altmetric picked up for a research output. There was an unexpected error. As described in Pilarowski et al. The most common include the Abbott BinaxNOW Self Test, . Viral culture, although more biologically relevant than real-time RT-PCR, is still an artificial system and is subject to limitations. Gans JS, Goldfarb A, Agrawal AK, Sennik S, Stein J, Rosella L. False-Positive Results in Rapid Antigen Tests for SARS-CoV-2. Participants were asked whether they had each sign or symptom from a list based on Council for State and Territorial Epidemiologists clinical criteria for COVID-19 that included fever, cough, shortness of breath, fatigue, sore throat, headache, muscle aches, chills, nasal congestion, difficulty breathing, diarrhea, nausea, vomiting, abdominal pain, rigors, loss of taste, and loss of smell. Among the 224 specimens undergoing viral culture that were analyzed with the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel for detection of SARS-CoV-2, median Ct values** were significantly higher for specimens with false-negative BinaxNOW antigen test results, indicating lower viral RNA levels than in those with concordant positive results (33.9 versus 22.0 in specimens from symptomatic persons [p<0.001] and 33.9 versus 22.5 in specimens from asymptomatic persons [p<0.001]) (Figure). Wadford), Golden Gate Fields, Berkeley, California, USA (D. Seftel), City of Berkeley Public Health Officer Unit, Berkeley (L. Ortiz), Kaiser Permanente San Francisco Internal Medicine Residency Program, San Francisco, California, USA (C. Stainken). FDA is asking users to consider "retesting positive patient specimens performed in the last two weeks with an alternate authorized test." Could Frequent Testing Help Squelch COVID-19? Additional Contributions: We thank Kyle Robinson, PhD, Devon Elke, HBSc, and Evgenia Gatov, MPH (all paid employees of CDL RSC, Toronto, Ontario, Canada), for assistance in collating the data. Abbott. 3501 et seq.). This study investigated the incidence of false-positive results in a large sample of rapid antigen tests used to serially screen asymptomatic workers throughout Canada. These cookies perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. More than 1.8 million Abbott ID Now tests for the novel coronavirus,. The Alinity m SARS-CoV-2 AMP Kit is only authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform moderate or high complexity tests. Accuracy: 84.6% for detecting covid-19 infections, 98.5% for correctly identifying covid-19 negatives This is the. You can review and change the way we collect information below. There is a chance that any test can give you a false positive result. [Skip to Navigation] The FDA urged clinical laboratories and healthcare providers to retest any patients who have recently received a positive result from two of Abbott's PCR COVID-19 assays after identifying a. Asymptomatic persons who receive a positive BinaxNOW antigen test result in a setting with a high risk for adverse consequences resulting from false-positive results (e.g. Food and Drug Administration. Thank you for taking the time to confirm your preferences. Sensitivity was higher for culture-positive specimens (92.6% and 78.6% for those from symptomatic and asymptomatic persons, respectively); however, some antigen test-negative specimens had culturable virus. Performance characteristics of a rapid severe acute respiratory syndrome coronavirus 2 antigen detection assay at a public plaza testing site in San Francisco. Comment submitted successfully, thank you for your feedback. Most false-positive results are thought to be due to lab contamination or other problems with how the lab has performed the test, not limitations of the test itself. In previous statements to news outlets, Abbott has said that the false positive rate of the test was only 0.02%.