Get the free daily newsletter read by industry experts. Cummings, C. Hanson, M.K. The rapid turnaround time and high PPV of BinaxNOW enabled some SARS-CoV-2positive employees to be identified and isolated faster than if rRT-PCR had been used alone. Cells were monitored for cytopathic effect. 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. Data is collected weekly and does not include downloads and attachments. Health and Human Services. Customers can self-administer the. 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. 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). The FDA is working with Abbott Molecular Inc. to resolve these issues. 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. Another false-positive problem for a SARS-CoV-2 antigen test in Japan. 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. Numerous biological (e.g., individual antibody status and specific sequence of the virus) and environmental (e.g., storage conditions and number of freeze-thaw cycles) variables can affect the sensitivity and outcome of viral culture. The authors missed the opportunity to mention how this standard practice could have prevented this supposed occurrence of false positives. Customers can self-administer the. 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. 1CDC COVID-19 Response Team; 2Arizona Department of Health Services; 3Epidemic Intelligence Service, CDC; 4Pima County Health Department, Tucson, Arizona. For details, see FDA Actions below. Licensed laboratories test validate new batches or lots prior to bringing them into service. 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. For older positive test findings, dating back as far as June, FDA is advising users to consider telling the patient their result may have been false. At the time of testing, 827 (24.2%) participants reported at least one COVID-19compatible sign or symptom, and 2,592 (75.8%) were asymptomatic. An erratumhas been published. Thank you for taking the time to confirm your preferences. AlexanderHarmon,BS; CelinaChang,BS; NolSalcedo,MS; BrenaSena,MPH; Bobby BrookeHerrera,PhD; IreneBosch,PhD; Laura E.Holberger,PhD, Joshua S.Gans,PhD; AviGoldfarb,PhD; LauraRosella,PhD. Curative is among the companies to adopt the platform. The investigation protocol was reviewed by CDC and determined to be nonresearch and was conducted consistent with applicable federal law and CDC policy.. How do I know if I have a positive or negative test? A first swab specimen was used for onsite BinaxNOW testing; a second swab specimen was placed in viral transport medium and chilled on ice packs before transport to the CDPH laboratory for rRT-PCR testing 2472 hours after collection. You will be subject to the destination website's privacy policy when you follow the link. 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). Most staff identified as Hispanic (62.0%) (Table 1). MMWR Morb Mortal Wkly Rep 2021;70:100105. Administrative, technical, or material support: Gans, Goldfarb, Agrawal, Sennik. Customize your JAMA Network experience by selecting one or more topics from the list below. 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. A false-positive result was defined as a positive screen on a rapid antigen test and a subsequent negative confirmatory PCR. 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). Atlanta, GA: US Department of Health and Human Services; 2020. On the day of testing, a facility administrative employee conducted registration and collected demographic data, including self-reported race and ethnicity. mmwrq@cdc.gov. You can review and change the way we collect information below. The data from the CDL RSC were collected to inform the operational requirements of deploying rapid antigen screens in workplaces. From January 11 to October 13, 2021, tests were conducted by employees, with some workplaces providing at-home screening and others on-site screening programs. If you have questions about this letter, contact COVID19DX@fda.hhs.gov. These persons ranged in age from 18 to 92 years (median52 years). Critical revision of the manuscript for important intellectual content: Goldfarb, Agrawal, Sennik, Stein, Rosella. Sect. Emerg Infect Dis. False positives aren't common, but they can. Workplace participation was voluntary. The first mass testing dates (round 0) only used rRT-PCR testing, so no comparison with BinaxNOW was possible. Additional rounds of testing were needed to monitor ongoing transmission and determine when the outbreak had ended. 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. part 46.102(l)(2), 21 C.F.R. The LHD decided to use BinaxNOW as a supplement to rRT-PCR to more quickly identify SARS-CoV-2positive employees for isolation. /> JAMA Netw Open 2020;3:e2016818. 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 . Results of BinaxNOW testing were available the same day, which enabled more rapid identification of infected workers for isolation than reliance on rRT-PCR alone. Please note: This report has been corrected. Department of Health and Human Services. JAMA. Message not sent. The FDA encourages users to report any adverse events or suspected adverse events experienced with the Alinity m SARS-CoV-2 AMP Kit or the Alinity m Resp-4-Plex AMP Kit. if someone tests positive for COVID-19 with a rapid test but does . The other is a PCR test, in which samples are sent away for analysis in a lab. Owing to the high transmissibility of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants, the capacity of testing systems based on the gold standard real-time reverse transcription-polymerase chain reaction (rRT-PCR) is limited. The most common include the Abbott BinaxNOW Self Test, . COVID-19: CDC guidance for expanded screening testing to reduce silent spread of SARS-CoV-2. 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. The mean Ct of culture-positive specimens (17.4) was significantly lower than culture-negative specimens (25.5) (p<0.001). T, Fukumori provided as a service to MMWR readers and do not constitute or imply Questions or messages regarding errors in formatting should be addressed to The number of rRT-PCRpositive results in each round ranged from 98 (round 1) to 0 (round 4) (Table 2). 241(d); 5 U.S.C. 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. You can review and change the way we collect information below. 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). CDC twenty four seven. The findings in this investigation are subject to at least five limitations. actually correct (positive) but the PCR a false negative. The kits can report false positives when wells in the assay reagent tray that contain positive samples overflow and contaminate neighboring specimens. Coronavirus Disease outbreak Global news World News. Self-reported race and ethnicity produced cell sizes that are too small to report, so only Hispanic ethnicity is presented in this study. 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. 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. 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. Instead of taking hours . 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. A few weeks later, cases started spiking again, as the highly infectious Delta variant spread. B, Schildgen But you have to use them correctly. 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. It's also molecular-based, so it's looking for genetic material from the virus in the mucus and infected cells in the sample from the patient. 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. Y, 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. Pilarowski G, Marquez C, Rubio L, et al. 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). Among specimens with positive viral culture, the sensitivity of the BinaxNOW antigen test compared with real-time RT-PCR in specimens from symptomatic participants was 92.6% (95% CI=83.7%97.6%) and in those from asymptomatic participants was 78.6% (95% CI=59.1%91.7%). https://cdn.ymaws.com/www.cste.org/resource/resmgr/ps/positionstatement2020/Interim-20-ID-02_COVID-19.pdfpdf iconexternal icon. The authors assume that all RADT-positive/RTPCR-negative samples are false positives (42%). No staff were permitted to return to onsite residence until the outbreak had ended. 3501 et seq.). 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. Each Abbott test cost only $5, one-20th the price of the most widely used test type. Fierce Life Sciences Events. 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. perhaps the more concerning limitation, given that they are used to "clear" persons for return to work, school, or clinical practice. Concordance of BinaxNOW rapid antigen test results with positive rRT-PCR results over 6 testing rounds among staff at a horse racetrack, California, USA, NovemberDecember 2020. View data is from . We performed statistical analyses using R version 4.0.1 (R Foundation for Statistical Computing, https://www.r-project.org). Consider retesting positive patient specimens performed in the last two weeks with an alternate authorized test. | noon ET, Dexcoms Jake Leach discusses preparations for G7 launch next year, Friday Q&A: For GE HealthCare, the future is digital, CEO Arduini says, Medicare to expand CGM coverage to more Type 2 diabetes patients, Medtronic says renal denervation consensus could open up multibillion-dollar market, Boston Scientific to lay off 120 people at ex-Preventice site, continuing run of medtech cuts, FDA Class I recalls hit 15-year high in 2022, 8 Strategies to Reduce Costs and Extend Runway in Life Sciences, How a New Blood Test is Helping Health Systems and Doctors Detect Cancer Early, 5 Factors Holding Back Healthcare Practices From Adopting RPM, Mountains of Cath Lab Waste Could Be Recycled, Study Estimates. The exact binomial method was used to calculate 95% CIs. 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. For participants who were within 7 days of symptom onset, the BinaxNOW antigen test sensitivity was 71.1% (95% CI = 63.0%78.4%), specificity was 100% (95% CI = 99.3%100%), PPV was 100% (95% CI = 96.4%100%), and NPV was 92.7% (95% CI = 90.2%94.7%). The alert about false positives applies to both Alinity products. 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. Both Hostin and Navarro, who are fully vaccinated against. Testing frequency was determined by the LHD and changed as the outbreak progressed. Test + True Positive = 85 False Positive = 1 Positive Pred . Curative. In response, the LHD ordered that all nonessential work activities (e.g., horse racing) be stopped until mass testing of all staff demonstrated no further transmission. et al. 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). far too serious to allow misleading or faulty tests to be distributed. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Federal health officials are alerting doctors to a potential accuracy problem with a rapid test for COVID-19 used at thousands of hospitals, clinics and testing sites across the U.S., including the Dr. Surasi is an Epidemic Intelligence Service Officer with the Center for Surveillance, Epidemiology, and Laboratory Services, Centers for Disease Control and Prevention. 552a; 44 U.S.C. * 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). Abbott first received FDA emergency use authorization for its Alinity m SARS-CoV-2 AMP test in May 2020. 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). Despite the limitations of interpreting culture-negative specimens, a positive viral culture is strong evidence for the presence of infectious virus. doi:10.1001/jama.2021.24355. False positives A false positive means that your results show a positive test even though you don't actually have a COVID-19 infection. part 56; 42 U.S.C. 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. Since then, FDA has granted revisions to the EUA, most recently. Tests were most accurate when used in the first week after symptoms began (an average of 82% of confirmed cases had positive antigen tests). Across the U.S., 7.1% of tested samples were positive in the latest CDC data. False-positive results mean the test results show an infection when actually there isn't one. 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). 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. 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). Results are available within 15 minutes. 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). 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). (2021). The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. 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. Figure 1. This report suggests that a product from one of the most respected manufacturers of diagnostic tests was the source of so many false-positive results. [Skip to Navigation] https://www.cdc.gov/coronavirus/2019-ncov/lab/faqs.html#Interpreting-Results-of-Diagnostic-Tests. 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) But the MSU study showed something else that is troubling false positive. A rapid COVID-19 test swab being processed. 2021;27(11):2761-2767. https://doi.org/10.3201/eid2711.211449. . The number of staff tested in each round, which varied because of attrition and exclusion of SARS-CoV-2positive staff from further testing, ranged from 333 persons (round 1) to 57 persons (round 4). Clin Infect Dis 2020. Statistical analyses were performed using SAS (version 9.4; SAS Institute). (Bloomberg) Abbott Laboratories said an ongoing study showed that its ID NOW Covid-19 test had a high rate of accuracy, as the company attempts to counter a claim by outside doctors that the test may return too many false negatives. Real-time RT-PCRpositive specimens with Ct <30 were also cultured for SARS-CoV-2 at CDPH in a Biosafety Level 3 laboratory. We thank Lisa B. Hernandez, James Allard, Beimnet Taye, the California Department of Public Health Viral and Rickettsial Disease Laboratory staff, and the racetrack staff described in this report. Rethinking Covid-19 test sensitivitya strategy for containment. 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. Therefore it should come as no surprise that there was a high proportion of false positive tests. Acquisition, analysis, or interpretation of data: Gans, Goldfarb, Agrawal, Sennik, Rosella. Performance characteristics of a rapid severe acute respiratory syndrome coronavirus 2 antigen detection assay at a public plaza testing site in San Francisco. There were only 0.15% positive results in this sample. Abbreviation: COVID-19=coronavirus disease 2019. These reports have focused on community testing sites and outbreaks in healthcare facilities. Effectiveness of Abbott BinaxNOW Rapid Antigen Test for Detection of SARS-CoV-2 Infections in Outbreak among Horse Racetrack Workers, California, USA. 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. 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. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. All specimens in viral transport medium were frozen at 70C within 12 hours of delivery to the laboratory. Among specimens positive for viral culture, sensitivity was 92.6% for symptomatic and 78.6% for asymptomatic individuals. o Contrast that with an asymptomatic patient, in whom the likelihood of COVID-19 . As disease prevalence decreases, the percent of test results that are false positives increase. This Medical News feature examines the debate about the value of frequent testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Our comparison supports immediate isolation for BinaxNOW-positive persons and confirmatory testing for negative persons. Viral replication in these specimens was defined as a decrease in Ct over the culture period. A questionnaire capturing demographic information and current and past14-day symptoms was administered to all participants. 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 research effort did not test for false negatives so we do not know if that vast majority of negatives are true or false. Paired upper respiratory swabs were collected from 3,419 persons, including 1,458 (42.6%) from site A and 1,961 (57.4%) from site B (Table 1). University of California San Francisco School of Medicine, San Francisco (C. Stainken). 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. Cookies used to make website functionality more relevant to you. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. Rapid antigen tests, such as the Abbott BinaxNOW COVID-19 Ag Card (BinaxNOW), offer results more rapidly (approximately 1530 minutes) and at a lower cost than do highly sensitive nucleic acid amplification tests (NAATs) (1). In a study published in the Journal of Clinical Virology, Haage et al. I agree with the previous comment about the error in interpretation. to sell a version of Alinity that tests for SARS-CoV-2, two types of influenza and respiratory syncytial virus. For example, a test with 98% specificity would have a PPV of just over 80% in a population with. Effectiveness of Abbott BinaxNOW Rapid Antigen Test for Detection of SARS-CoV-2 Infections in Outbreak among Horse Racetrack Workers, California, USA. . Concerns have been raised whether rapid antigen tests for SARS-CoV-2 can result in false-positive test results1,2 and undermine pandemic management for COVID-19. DOI: http://dx.doi.org/10.15585/mmwr.mm7003e3external icon. 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). * Specimens were used to perform a limiting-dilution inoculation of Vero CCL-81 cells, and cultures showing evidence of cytopathic effect were tested by real-time RT-PCR for the presence of SARS-CoV-2 RNA. If you have reason to doubt the result, you can take a second test. 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. Performance was better among symptomatic persons, specimens with cycle threshold (Ct) <30 (suggestive of higher viral loads), and specimens with positive viral cultures (38). Gans and colleagues found 1322 positive results in 903,408 rapid antigen tests conducted in 537 workplaces; with 1103 of the positive rapid tests followed by PCR testing.462 of the 1103 (42%) were determined to be false positive, with 278 of these (60%) at 2 workplaces, from the same lot-batch of Abbott's Panbio COVID-19 Ag Rapid Test Device. There are two types of rapid COVID-19 tests that detect the coronavirus.