Fierce Pharma. CDC. Testing for COVID-19. 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. (5), we also calculated performance by using Ct <30 to define rRT-PCRpositive specimens. Accepted for Publication: December 20, 2021. I consult for the biopharma industry, although I have never consulted in the field of SARS-CoV-2 testing. Abbott first received FDA emergency use authorization for its Alinity m SARS-CoV-2 AMP test in May 2020. 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. 552a; 44 U.S.C. Our results support considering BinaxNOW-positive employees as infectious without waiting for rRT-PCR confirmation. All information these cookies collect is aggregated and therefore anonymous. The study, which was pre-published on bioRxiv and has not been peer reviewed, suggested that Abbott's test produced false negative results for almost half of the positive samples. Individuals presenting for molecular testing in two of seven lanes were offered the opportunity to also receive BinaxNOW testing. (5) that established the updated BinaxNOW card-reading technique used by the racetrack physician in this outbreak. Fierce Life Sciences Events. 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). 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. The PCR tests identified an additional 14 students who were positive for COVID-19; they were moved to isolation. 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. Another false-positive problem for a SARS-CoV-2 antigen test in Japan. Our other rapid COVID-19 test is the ID NOW system, a molecular point-of-care test the size of a toaster that's designed to deliver results in 13 minutes or less. The relevant numbers are 462 rapid screens with false-positive results, or 42% of those with reference standard PCR information. 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 . Abbott's status as a supplier to clinical laboratories means the problem will affect multiple other organizations. 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. More than 2 million tests made by the company that were . 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). This Medical News feature examines the debate about the value of frequent testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-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 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. 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. FDA is advising users to view positive results as "presumptive" and consider retesting using another product. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. 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. Accessibility Statement, Our website uses cookies to enhance your experience. 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. Approximately two-thirds of screens were trackable with a lot number. * Only those specimens that were analyzed using the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel for detection of SARS-CoV-2 and that were analyzed using viral culture are included in the graph. Consider any positive result from tests using the Alinity m SARS-CoV-2 AMP and the Alinity m Resp-4-Plex AMP Kits to be presumptive until the company can implement updated software specification files to correct the issue at each laboratory site. 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. Among 127 rRT-PCRpositive specimens, the 55 with paired BinaxNOW-positive results had a lower mean cycle threshold than the 72 with paired BinaxNOW-negative results (17.8 vs. 28.5; p<0.001). 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). I agree with the previous comment about the error in interpretation. Test + True Positive = 85 False Positive = 1 Positive Pred . The number of false-positive results was 462 (0.05% of screens and 42% of positive test results with PCR information). The rapid antigen test is generally very accurate, and certainly worth taking if you have any reason to think you might have Covid-19. to sell a version of Alinity that tests for SARS-CoV-2, two types of influenza and respiratory syncytial virus. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2020. Positive Predictive Value depends upon prevalence of disease in community, Role of Rapid Antigen Detection Test (RADT) for Detection of SARS Cov-2 Variants. All persons receiving negative test results (NAAT or antigen) should be counseled that wearing a mask, avoiding close contact with persons outside their household, and washing hands frequently remain critical to preventing the spread of COVID-19.. The results of the current evaluation differ from those of an evaluation of the BinaxNOW antigen test in a community screening setting in San Francisco (7), which found a BinaxNOW antigen test overall sensitivity of 89.0% among specimens from all 3,302 participants, regardless of the Ct value of the real-time RT-PCRpositive specimens. Before sharing sensitive information, make sure you're on a federal government site. The authors missed the opportunity to mention how this standard practice could have prevented this supposed occurrence of false positives. 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. Consider retesting positive patient specimens performed in the last two weeks with an alternate authorized test. 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. Coronavirus Disease 2019 (COVID-19): interim guidance for rapid antigen testing for SARS-CoV-2. Statistical analyses were performed using SAS (version 9.4; SAS Institute). Interpreting diagnostic tests for SARS-CoV-2. Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of 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 Abbott ID Now Rapid Molecular Test for COVID-19 is the first in-house lab testing available . O, Mathes positives observed were attributable to manufacturing issues, as suggested by the authors. 552a; 44 U.S.C. Cells were monitored for cytopathic effect. Rapid tests can help you stay safe in the Delta outbreak. Get free COVID-19 test kits through health insurance, Medicare or local health clinics. A, Kossow Performance characteristics of a rapid severe acute respiratory syndrome coronavirus 2 antigen detection assay at a public plaza testing site in San Francisco. 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. Critical revision of the manuscript for important intellectual content: Goldfarb, Agrawal, Sennik, Stein, Rosella. 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%). endorsement of these organizations or their programs by CDC or the U.S. The FDA is working with Abbott Molecular Inc. to resolve these issues. We found positive percent agreement was 43.3% (95% CI34.6%52.4%), negative percent agreement 100% (95% CI99.4%100%), positive predictive value 100% (95% CI93.5%100%), and negative predictive value 89.9% (95% CI87.5%92.0%). The Panbio COVID-19 Antigen Rapid Test is used for the qualitative . If your rapid test is positive, you should assume that you have Covid. False-positive results were matched to lot number and test manufacturer. The Altmetric Attention Score for a research output provides an indicator of the amount of attention that it has received. Viral recovery was defined as any culture in which the first passage had an N1 Ct value at least two Ct values lower than the corresponding clinical specimen. Terms of Use| A molecular test using a nasal swab is usually the best option, because it will have fewer false negative results than other diagnostic tests or samples from throat swabs or saliva. Real-time RT-PCR confirmation of BinaxNOW negative results identified 72 additional positive specimens. 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. Despite the need for research on this topic, information on the performance of BinaxNOW in the setting of nonhealthcare workplace outbreaks is lacking. A recent study of 731 people found that the Abbott BinaxNOW rapid tests performed about . for symptomatic persons or for persons with a known COVID-19 exposure) a negative antigen test result should be confirmed by NAAT. Please note: This report has been corrected. Each Abbott test cost only $5, one-20th the price of the most widely used test type. 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. Ford previously said launching the platform with the COVID-19 test "helped jumpstart demand.". Since the beginning of the pandemic, we've more than tripled the availability of ID . Performance and implementation evaluation of the Abbott BinaxNOW rapid antigen test in a high-throughput drive-through community testing site in Massachusetts. One type is a sped-up, smaller version of the PCR tests. 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).