abbott rapid covid test false positive rate

The kits can continue to be used following the implementation of the software correction. what was the false negative rate for screening? Numerous factors can affect the outcome of a viral culture; therefore, negative culture results do not necessarily mean that no viable virus was present in those specimens, nor that the participants from whom those specimens were collected were not infectious at the time of specimen collection. To check for a positive result, look at the result window for two pink or purple lines . View data is from . These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Curative. While the chance of a false positive on a rapid test is low, it could mean the virus is less prevalent. FDA is now working with Abbott to resolve the issues. Obtained funding: Agrawal, Sennik, Stein. In total, 769 valid, paired rRT-PCR and BinaxNOW antigen test results were reported and analyzed. Digital capabilities will be the next big inflection driving growthfor GEs newly independent healthcare business. 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). First, anterior nasal swabs were used for BinaxNOW antigen testing, but NP swabs were used for real-time RT-PCR testing, which might have contributed to increased detection for the real-time RT-PCR assay (8). All participants provided written consent to participate in the screening program and to share their deidentified data with the CDL RSC, including for publication, and with public health authorities. far too serious to allow misleading or faulty tests to be distributed. The rapid antigen test is generally very accurate, and certainly worth taking if you have any reason to think you might have Covid-19. These new rapid tests were "from a different planet," Trump boasted. To register for email alerts, access free PDF, and more, Get unlimited access and a printable PDF ($40.00), 2023 American Medical Association. Fierce Biotech. The FDA issued an Emergency Use Authorization (EUA) to permit emergency use of the Alinity m Resp-4-Plex AMP test on March 4, 2021. , Kanji Among all paired testing rounds with rRT-PCR, BinaxNOW produced these results when rRT-PCR tests with Ct <37 were considered positive: PPA, 43.3% (95% CI34.6%52.4%); NPA, 100% (95% CI99.4%100.0%); PPV, 100.0% (95% CI93.5%100.0%); and NPV, 89.9% (95% CI87.5%92.0%). The initial round of rRT-PCR testing (round 0) occurred on November 1415, 2020, and identified 169 SARS-CoV-2positive staff who were subsequently isolated. 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). 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. In contrast, the 15-minute read time of the BinaxNOW antigen test kit provided results to the facility and LHD the same day as testing. Positive Predictive Value depends upon prevalence of disease in community, Role of Rapid Antigen Detection Test (RADT) for Detection of SARS Cov-2 Variants. However, some quarantined employees were permitted to return to work if they were needed to perform duties related to essential care of the horses. Testing frequency was determined by the LHD and changed as the outbreak progressed. Rapid tests more accurately provided a positive COVID-19 result when administered during the first week of symptoms. A, Kossow Validation of an At-Home Direct Antigen Rapid Test for COVID-19. These findings could inform testing protocols used to contain future outbreaks of COVID-19 in nonhealthcare workplaces. If used before the software correction, positive results should be treated as presumptive. Most staff identified as Hispanic (62.0%) (Table 1). They looked at the results of more than 900,000 rapid antigen tests conducted over 537 workplaces in Canada between January and October 2021. Prospective cohort of fluvoxamine for early treatment of coronavirus disease 19. In a clinical context, real-time RT-PCR provides the most sensitive assay to detect infection. Real-time RT-PCRpositive specimens with Ct <30 were also cultured for SARS-CoV-2 at CDPH in a Biosafety Level 3 laboratory. Abbott's rapid COVID-19 test isn't the only point-of-care test to receive FDA authorization during the pandemic, but Trump has touted it the most by far, hailing the speed at which results can be . Fourth, the BinaxNOW antigen test characteristics might be different depending on whether an individual had previously tested positive. 241(d); 5 U.S.C. I agree with the previous comment about the error in interpretation. Clinical discretion informed by COVID-19 incidence in the relevant population, as well as individual exposure history and symptoms, should be used to determine whether to quarantine persons who test negative for SARS-CoV-2 by BinaxNOW but are awaiting results of rRT-PCR testing (16). part 56; 42 U.S.C. It might also reflect a language barrier, because the question about symptoms was asked only in English by the administrative employee. But the emergence of rapid testing has helped remove some of the roadblocks for faster results. At this time, all staff were assumed to have been exposed. The kits can report false positives when wells in the assay reagent tray that contain positive samples overflow and contaminate neighboring specimens. He is positioned at the California Department of Public Health within the Occupational Health Branch and the Environmental Health Investigations Branch. The site is secure. In people with confirmed COVID-19, antigen tests correctly identified COVID-19 infection in an average of 73% of people with symptoms, compared to 55% of people without symptoms. Surasi K, Cummings KJ, Hanson C, et al. Please note: This report has been corrected. This use provided an opportunity to assess the effectiveness of the BinaxNOW rapid antigen test in detecting SARS-CoV-2 infection in a nonhealthcare workplace outbreak. CDC. Study: Abbott's Rapid Test Works on Omicron More Boxes of BinaxNow home COVID-19 tests made by Abbott are shown for sale at a store, Nov. 15, 2021, in Lakewood, Wash. (Ted S. Warren/AP) October 14, 2021, Update: The FDA took additional actions related to Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kits. Abbreviations: CI=confidence interval; COVID-19=coronavirus disease 2019; NPV=negative predictive value; PPV=positive predictive value. Author Contributions: Drs Goldfarb and Rosella had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Fierce Healthcare. This activity was reviewed by the Centers for Disease Control and Prevention (CDC) and was conducted consistent with applicable federal law and CDC policy (45 C.F.R. o Contrast that with an asymptomatic patient, in whom the likelihood of COVID-19 . Licensed laboratories test validate new batches or lots prior to bringing them into service. 2023 American Medical Association. The government says - accurately - that the "false positive rate", the chance of a test returning a positive result in a person who does not have the disease, is less than one in 1,000 . Finally, many factors might limit the ability to culture virus from a specimen, and the inability to detect culturable virus should not be interpreted to mean that a person is not infectious. The Abbott BinaxNOW rapid antigen test is cheaper and faster than real-time reverse transcription PCR (rRT-PCR) for detecting severe acute respiratory syndrome coronavirus 2. if someone tests positive for COVID-19 with a rapid test but does . Compared with real-time RT-PCR testing, the BinaxNOW antigen test had a sensitivity of 64.2% for specimens from symptomatic persons and 35.8% for specimens from asymptomatic persons, with near 100% specificity in specimens from both groups. DOI: http://dx.doi.org/10.15585/mmwr.mm7003e3external icon. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Since then, FDA has granted revisions to the EUA, most recently. All HTML versions of MMWR articles are generated from final proofs through an automated process. However, preliminary research posted to the preprint server medRxiv on July 5 confirms that certain beverages can cause false positives. Among 2,215 "all-comers" tested at a German diagnostics lab, with 338 ultimately showing positive results with PCR testing, Roche's SD Biosensor and Abbott's Panbio rapid antigen tests showed . Using real-time RT-PCR as the standard, four false-positive BinaxNOW antigen test results occurred, all among specimens from asymptomatic participants. Rapid tests are a quick and convenient way to learn about your COVID-19 status. Subscribe to MedTech Dive for top news, trends & analysis, The free newsletter covering the top industry headlines, Viz.ai Announces Agreement with Bristol Myers Squibb to Enable Earlier Detection and Managemen, AVer to Showcase Connected Health Solutions at ATA 2023 Annual Conference and Expo, Equiva Partners with Infiniti Mobile to Advance Health Equity Via Newly Unveiled Affordable Co, Vivera Welcomes Former FDA Investigator Dennis Moore as Regulatory and Compliance Advisor, By signing up to receive our newsletter, you agree to our. Workplace participation was voluntary. 3501 et seq.). 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. There were 903408 rapid antigen tests conducted for 537 workplaces, with 1322 positive results (0.15%), of which 1103 had PCR information. Virus was cultured from 96 of 274 (35.0%) specimens, including 85 (57.8%) of 147 with concordant antigen and real-time RT-PCR positive results, 11 (8.9%) of 124 with false-negative antigen test results, and none of three with false-positive antigen test results. Performing BinaxNOW tests in the recommended temperature range might have improved performance. There is a chance that any test can give you a false positive result. A positive result on an at-home COVID-19 test is usually accurate, but false negatives can occur when a person has no COVID-19 symptoms or their infection happened recently. Acquisition, analysis, or interpretation of data: Gans, Goldfarb, Agrawal, Sennik, Rosella. Cookies used to enable you to share pages and content that you find interesting on CDC.gov through third party social networking and other websites. 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. Weekly / January 22, 2021 / 70(3);100105. The research effort did not test for false negatives so we do not know if that vast majority of negatives are true or false. Performance characteristics of BinaxNOW COVID-19 antigen card for screening asymptomatic individuals in a university setting. University of California San Francisco School of Medicine, San Francisco (C. Stainken). The prevalence of having SARS-CoV-2 real-time RT-PCR positive test results in this population was moderate (8.7% overall; 4.7% for asymptomatic participants); administering the test in a lower prevalence setting will likely result in a lower PPV. Among 11 participants with antigen-negative, real-time RT-PCRpositive specimens with positive viral culture, five were symptomatic and six asymptomatic. . Despite their reduced sensitivity to detect infection compared with real-time RT-PCR, antigen tests might be particularly useful when real-time RT-PCR tests are not readily available or have prolonged turnaround times. He was right. FDA alerts providers to false positives with two Abbott SARS-CoV-2 test kits Sep 20, 2021 - 01:46 PM The Food and Drug Administration Friday alerted clinical laboratory staff and health care providers to the potential for false positive results with two test kits made by Abbott Molecular to detect SARS-CoV-2. 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. It is incorrect to refer to all positive rapid antigen test screens in which a PCR test, taken at about the same time, was negative, as "false positive" results. Cycle threshold (Ct) values from real-time RT-PCR were compared using a Mann-Whitney U Test; 95% confidence intervals (CIs) were calculated using the exact binomial method. Abbott tests earlier this year in response to a risk of false results linked to its own product. No rRT-PCRpositive results with a Ct >29.4 were detected by BinaxNOW (Figure 1). Paired upper respiratory swabs were collected at the same timepoint from persons aged 10 years receiving testing for SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), at two Pima County Health Department community testing sites during November 317 (site A) and November 816 (site B). At both sites, a health care professional first collected a bilateral anterior nasal swab, using a swab provided in the BinaxNOW kit, immediately followed by a bilateral nasopharyngeal (NP) swab for real-time RT-PCR testing. The findings in this investigation are subject to at least five limitations. The authors assume that all RADT-positive/RTPCR-negative samples are false positives (42%). Community testing strategies focused on preventing transmission using antigen testing should consider serial testing (e.g., in kindergarten through grade 12 schools, institutions of higher education, or congregate housing settings), which might improve test sensitivity in start highlightdetectingend highlight infection (10). Of those culture-positive specimens, 45 (88.2%) were BinaxNOW-positive (Table 4; Figure 2). Comment submitted successfully, thank you for your feedback. Cells with no cytopathic effect or negative rRT-PCR results were passaged after 7 d onto fresh confluent Vero-81 and monitored for an additional 7 d before performing rRT-PCR again. T, Fukumori False-positive results mean the test results show an infection when actually there isn't one. Saving Lives, Protecting People, https://www.biorxiv.org/content/10.1101/2020.03.02.972935v1, https://cdn.ymaws.com/www.cste.org/resource/resmgr/ps/positionstatement2020/Interim-20-ID-02_COVID-19.pdf, https://www.cdc.gov/coronavirus/2019-ncov/lab/faqs.html#Interpreting-Results-of-Diagnostic-Tests, https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html, https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html, https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas, https://www.cdc.gov/coronavirus/2019-ncov/php/open-america/expanded-screening-testing.html, https://www.fda.gov/media/141570/download, https://www.fda.gov/media/137120/download, Centers for Disease Control and Prevention, U.S. Department of Health & Human Services. The PPA of BinaxNOW was 43.0% and the NPV was 89.9%. Rapid antigen tests have received Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for use in symptomatic persons (2), but data are lacking on test performance in asymptomatic persons to inform expanded screening testing to rapidly identify and isolate infected persons (3). In addition, this activity was conducted as part of a COVID-19 project determined to be nonresearch by the California Health and Human Services Agencys Committee for the Protection of Human Subjects. In the setting of a nonhealthcare workplace outbreak of COVID-19 with high attack rate (62.3%), we found that BinaxNOW was a useful adjunct to rRT-PCR testing. Abbreviation: COVID-19=coronavirus disease 2019. Of those specimens, 51 resulted in positive virus isolation. The chance that you'll have an incorrect reading, either . Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. The FDA recommends that clinical laboratory staff and health care providers: The FDA issued an Emergency Use Authorization (EUA) to permit emergency use of the Alinity m SARS-CoV-2 AMP test on May 11, 2020 and granted revisions to the EUA with the most recent revision granted in August 2021. Individuals presenting for molecular testing in two of seven lanes were offered the opportunity to also receive BinaxNOW testing. All information these cookies collect is aggregated and therefore anonymous. Both Hostin and Navarro, who are fully vaccinated against. W, Centers for Disease Control and Prevention. Abbott's status as a supplier to clinical laboratories means the problem will affect multiple other organizations. 2022;327(5):485-486. doi:10.1001/jama.2021.24355. The LHD decided to use BinaxNOW as a supplement to rRT-PCR to more quickly identify SARS-CoV-2positive employees for isolation. 552a; 44 U.S.C. After 1 h, the inoculum was removed and 200 L of minimum essential medium containing 5% fetal bovine serum and antibiotics was added to each well. Among rRT-PCRpositive specimens, those with paired BinaxNOW-positive results had a lower mean Ct (17.8) than those with paired BinaxNOW-negative results (28.5) (p < 0.001). 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. 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. October 15, 2021, Update: The FDA updated this letter to clarify that the potential for false positive results is due to the software associated with the Alinity m SARS-CoV-2 AMP Kit and Alinity. A few weeks later, cases started spiking again, as the highly infectious Delta variant spread. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Report any issues with using COVID-19 tests to the FDA. Performance was better among symptomatic persons, specimens with cycle threshold (Ct) <30 (suggestive of higher viral loads), and specimens with positive viral cultures (38). No potential conflicts of interest were disclosed. Each round was intended to test all staff who had not yet tested positive by BinaxNOW or rRT-PCR to continue identifying potentially infectious persons. Despite the need for research on this topic, information on the performance of BinaxNOW in the setting of nonhealthcare workplace outbreaks is lacking. for symptomatic persons or for persons with a known COVID-19 exposure) a negative antigen test result should be confirmed by NAAT. part 56; 42 U.S.C. Saving Lives, Protecting People, Centers for Disease Control and Prevention, Atlanta, Georgia, USA (K. Surasi), California Department of Public Health, Richmond, California, USA (K. Surasi, K.J. The PCR tests identified an additional 14 students who were positive for COVID-19; they were moved to isolation. The timing . We take your privacy seriously. Third, some missing data limit this analysis from encompassing the entire outbreak. More than 2 million tests made by the company that were . FDA used the warning to make two recommendations to users of Alinity tests. How do I know if I have a positive or negative test? The authors missed the opportunity to mention how this standard practice could have prevented this supposed occurrence of false positives. False-positive results were matched to lot number and test manufacturer. 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. 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. All information these cookies collect is aggregated and therefore anonymous. "True" and "false" refer to the accuracy of the test, while "positive" and "negative" refer to the outcome you receive, says Geoffrey Baird, M.D., Ph.D., professor and chair of the Department. The number of false-positive results was 462 (0.05% of screens and 42% of positive test results with PCR information). . Food and Drug Administration. 2021;27(11):2761-2767. https://doi.org/10.3201/eid2711.211449. 2023 American Medical Association. B, Schildgen The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. However, the results reported by Haage et al. For details, see FDA Actions below. Even a faint line next to the word "sample" on the test card is a positive result. Customize your JAMA Network experience by selecting one or more topics from the list below. Accuracy: 84.6% for detecting covid-19 infections, 98.5% for correctly identifying covid-19 negatives This is the. A 2021 study. A BinaxNOW rapid COVID-19 test made by Abbott Laboratories, in Tacoma, Wash., Feb. 3, 2021. . CEO Robert Ford picked out the rollout of the analyzer as a driver of growth in Abbott's underlying diagnostics business in July. Surasi, K., Cummings, K. J., Hanson, C., Morris, M., Salas, M., Seftel, D.Wadford, D. A. Approximately two-thirds of screens were trackable with a lot number. Thank you for taking the time to confirm your preferences. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. The Food and Drug Administration (FDA) has expanded its recall of Ellume at-home COVID-19 tests due to potential false-positive results. By continuing to use our site, or clicking "Continue," you are agreeing to our, Kretschmer Concept and design: Goldfarb, Agrawal, Sennik, Stein, Rosella. Viral culture, although more biologically relevant than real-time RT-PCR, is still an artificial system and is subject to limitations. If you have questions about this letter, contact COVID19DX@fda.hhs.gov. All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. More complete paired-testing data could have provided better insight as to the usefulness of rapid antigen testing when used for the entire duration of an outbreak. Hello, I'm Vismita Gupta-Smith and this is WHO's conversations in science. A rapid COVID-19 test swab being processed. (5), which indicates that bands are scored as positive only if they extend across the full width of the strip, irrespective of the intensity of the band. Approximately one third (31.4%) of participants identified as Hispanic or Latino, and three quarters (75.1%) identified as White. For every 100,000 people who test negative and truly don't have the infection, we would expect to . Epub December 26, 2020. Dr. Hanan Balkhy. Initial data validation was completed at the point of collection. The high specificity and rapid BinaxNOW antigen test turnaround time facilitate earlier isolation of infectious persons. False-Positive Results in Rapid Antigen Tests for SARS-CoV-2 | Clinical Pharmacy and Pharmacology | JAMA | JAMA Network This study examines the incidence of false-positive results in a sample of rapid antigen tests used to serially screen asymptomatic workers throughout Canada. If a test result was positive, the patient was immediately referred for a confirmatory polymerase chain reaction (PCR) test to be completed within 24 hours. Coronavirus Disease outbreak Global news World News. Performance characteristics of a rapid severe acute respiratory syndrome coronavirus 2 antigen detection assay at a public plaza testing site in San Francisco. A, Grne Ford previously said launching the platform with the COVID-19 test "helped jumpstart demand.". The BinaxNOW rapid antigen test received Emergency Use Authorization by the Food and Drug Administration for testing specimens from symptomatic persons; performance among asymptomatic persons is not well characterized. Before a Senate committee last week, Francis Collins, director of the National Institutes of Health, testified the rapid Abbott test had a 15 percent false-negative rate, an apparent reference to . Rapid antigen tests (RATs) can substantially contribute to the prevention of community transmission, but their further assessment is required . But you have to use them correctly. actually correct (positive) but the PCR a false negative. BinaxNOW showed NPA and PPV of 100%. "The false positive results may be related to current mixing parameters of the PCR reaction mixture that may result in potential overflow that could carry over into neighboring wells in the assay reagent tray. The median time between rRT-PCR specimen collection date and results reported date for these BinaxNOW false-negative specimens was 5 days (range 17 days). This indicates a failure in either quality control or product design (less likely as all false-positive results were attributed to a single batch of product). False positive rapid antigen tests for SARS-CoV-2 in the real-world and their economic burden. Abbott first received FDA emergency use authorization for its Alinity m SARS-CoV-2 AMP test in May 2020. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. The risk of false-negative or false-positive test results depends on the type and sensitivity of the COVID-19 diagnostic test, thoroughness of the sample collection, and accuracy of the lab analysis. Prices. Limitations of the study include the convenience sample of workplaces and that reporting of PCR confirmatory results and identification of lot number was not compulsory. When the pretest probability for receiving positive test results for SARS-CoV-2 is elevated (e.g., in symptomatic persons or in persons with a known COVID-19 exposure), a negative antigen test result should be confirmed by NAAT (1). Both can reliably determine whether you . Overflow into the wells of true negative samples that are positioned near positive samples in the assay tray could produce false positive results. Rapid antigen tests can be an important tool for screening because of their quick turnaround time, lower requirement for resources, high specificity, and high PPV in settings of high pretest probability (e.g., providing testing to symptomatic persons, to persons with a known COVID-19 exposure, or where community transmission is high). Some antigen-negative, real-time RT-PCRpositive specimens possibly could represent noninfectious viral particles, but some might also represent infectious virus not detected by the antigen test. Paltiel AD, Zheng A, Walensky RP. BinaxNOW demonstrated better concordance with positive viral culture results (88.2%) than with positive rRT-PCR results (43.3%). Preliminary results of the rapid assessment conducted by UKs NHS and Foundation for Innovative New Diagnostics (FIND) suggest that the accuracy of RADTs has. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. The false positive results may be related to current mixing parameters of the PCR reaction mixture that may result in potential overflow that could carry over into neighboring wells in the assay reagent tray. 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. 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. Out of 955 patients, 23 were found to be positive for COVID-19 using a lab-based test. Drafting of the manuscript: Gans, Goldfarb. Because estimates suggest that over 50% of transmission occurs from persons who are presymptomatic or asymptomatic (9), expanded screening testing, potentially in serial fashion for reducing transmission in specific venues (e.g., institutions of higher education, schools, and congregate housing settings), is essential to interrupting transmission (3). Third, this investigation evaluated the BinaxNOW antigen test, and results presented here cannot be generalized to other FDA-authorized SARS-CoV-2 antigen tests. URL addresses listed in MMWR were current as of Accepted for Publication: December 20, 2021. The purpose of this analysis is to compare BinaxNOW with rRT-PCR in paired specimens from persons during a COVID-19 outbreak among horse racetrack workers. Rethinking Covid-19 test sensitivitya strategy for containment. This low false-positive rate is consistent with results from Pilarowski et al.