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. 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. 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. With serial BinaxNOW testing, some of the persons with discordant paired results could have tested positive with subsequent BinaxNOW testing. 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%). Conflict of Interest Disclosures: All authors are members of the Steering Committee of the Creative Destruction Lab Rapid Screening Consortium (CDL RSC; a nonprofit organization in Canada). The exact binomial method was used to calculate 95% CIs. 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). An erratumhas been published. Original Publication Date: September 01, 2021, Table of Contents Volume 27, Number 11November 2021. Field performance and public health response using the BinaxNOW TM Rapid SARS-CoV-2 antigen detection assay during community-based testing. https://cdn.ymaws.com/www.cste.org/resource/resmgr/ps/positionstatement2020/Interim-20-ID-02_COVID-19.pdfpdf iconexternal icon. I consult for the biopharma industry, although I have never consulted in the field of SARS-CoV-2 testing. The Panbio COVID-19 Antigen Rapid Test is used for the qualitative . (5), we also calculated performance by using Ct <30 to define rRT-PCRpositive specimens. Since the beginning of the pandemic, we've more than tripled the availability of ID . 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 vitro diagnostics EUAs. The outbreak was discovered by the contact tracing efforts of the local health department (LHD), the City of Berkeley Public Health Officer Unit. 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). JN, Proctor 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. These results inform the discussion of whether rapid antigen tests will result in too many false-positives that could overwhelm PCR testing capacity in other settings.1,2 Also, the results demonstrate the importance of having a comprehensive data system to quickly identify potential issues. Performance and implementation evaluation of the Abbott BinaxNOW rapid antigen test in a high-throughput drive-through community testing site in Massachusetts. The high specificity and rapid BinaxNOW antigen test turnaround time facilitate earlier isolation of infectious persons. Testing frequency was determined by the LHD and changed as the outbreak progressed. The findings in this investigation are subject to at least five limitations. Let MedTech Dive's free newsletter keep you informed, straight from your inbox. 45 C.F.R. Abbott's BinaxNOW Covid-19 Antigen Self-Test. A recent study of 731 people found that the Abbott BinaxNOW rapid tests performed about . A total of 342 different staff participated in testing rounds 1 through 6. For every 100,000 people who test negative and truly don't have the infection, we would expect to . positives observed were attributable to manufacturing issues, as suggested by the authors. that detection of these variants is missed by RTPCR targeting S/ORF genes, making RTPCR and less accurate reference standard. The FDA has classified the recall of the software for this test as a Class I recall, the most serious type of recall. perhaps the more concerning limitation, given that they are used to "clear" persons for return to work, school, or clinical practice. Real-time RT-PCR remains a more sensitive test for identifying persons that might be infectious, and our results support the current recommendation that rRT-PCR (or another nucleic acid amplification test) should be used in outbreak situations to confirm BinaxNOW-negative results (2). 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. remind us that it is important to ensure that tests are stored and used within the temperature range specified by the manufacturer. FDA is asking users to consider "retesting positive patient specimens performed in the last two weeks with an alternate authorized test." Digital capabilities will be the next big inflection driving growthfor GEs newly independent healthcare business. Twenty specimens with Ct values <18 had positive antigen and real-time RT-PCR results but were culture negative. Additional rounds of testing were needed to monitor ongoing transmission and determine when the outbreak had ended. The conclusion of this Research Letter is that there arent many false positives. The .gov means its official.Federal government websites often end in .gov or .mil. 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). CDC twenty four seven. The study reports that among 903,408 biweekly rapid antigen tests performed over a 39-week period between January 11, 2021 and October 13, 2021, 1,322 were positive. doi:10.1001/jama.2021.24355. The implications of silent transmission for the control of COVID-19 outbreaks. T, Schildgen 2023 American Medical Association. FDA is advising users to view positive results as "presumptive" and consider retesting using another product. 2021;27(11):2761-2767. https://doi.org/10.3201/eid2711.211449. Since then, FDA has granted revisions to the EUA, most recently. part 56; 42 U.S.C. B, Schildgen These tests included Abbott's BINAXNow, which the New York Times reported was being thrown away at a manufacturing facility in Maine at a point early in the summer when COVID-19 infections had dipped. In dual-positive pairs, the median time between rRT-PCR specimen collection date and results reported date was 4 days (range 16 days). Fact check:Pregnant women do receive vaccines, but more study needed on COVID-19 shot. There is a chance that any test can give you a false positive result. | 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 U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers of a potential for false positive results due to the software associated with the Alinity m SARS-CoV-2 AMP Kit, List Number 09N78-095, and Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096. A few weeks later, cases started spiking again, as the highly infectious Delta variant spread. Main results. 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. It's a pleasure to be with you today. URL addresses listed in MMWR were current as of . That said, if your rapid test gives a positive result, you should assume you probably have COVID and isolate until you follow up with another type of test, like PCR. False positives A false positive means that your results show a positive test even though you don't actually have a COVID-19 infection. CEO Robert Ford picked out the rollout of the analyzer as a driver of growth in Abbott's underlying diagnostics business in July. Viral culture, although more biologically relevant than real-time RT-PCR, is still an artificial system and is subject to limitations. Positive viral culture is further evidence of the presence of infectious virus, so these findings might indicate that some BinaxNOW false-negative participants were not infectious at the time of specimen collection (i.e., they had low viral RNA load at the beginning or end of their infection trajectory) (12). Since the start of the COVID-19 pandemic, over 1 billion COVID-19 tests have been performed in the U.S. CRO. The Altmetric Attention Score for a research output provides an indicator of the amount of attention that it has received. 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. Effectiveness of Abbott BinaxNOW Rapid Antigen Test for Detection of SARS-CoV-2 Infections in Outbreak among Horse Racetrack Workers, California, USA. Centers for Disease Control and Prevention. This low false-positive rate is consistent with results from Pilarowski et al. CDC is not responsible for the content But you have to use them correctly. Rapid tests more accurately provided a positive COVID-19 result when administered during the first week of symptoms. 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).