Paltiel AD, Zheng A, Walensky RP. Even a faint line next to the word "sample" on the test card is a positive result. 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. O, Mathes 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). Fierce Biotech. Could Frequent Testing Help Squelch COVID-19? DOI: http://dx.doi.org/10.15585/mmwr.mm7003e3external icon. Antigen tests can be an important tool in an overall community testing strategy to reduce transmission. Prices. the rollout of the analyzer as a driver of growth in Abbott's underlying diagnostics business in July. There was an unexpected error. On the day of testing, a facility administrative employee conducted registration and collected demographic data, including self-reported race and ethnicity. 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. 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. Early on, it would sometimes take days to weeks to get your results. Pinninti S, Trieu C, Pati SK, et al. Dr. Hanan Balkhy. Using real-time RT-PCR as the standard, four false-positive BinaxNOW antigen test results occurred, all among specimens from asymptomatic participants. 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. Why bother with a test that is not so different from flipping a coin? Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2020. 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. ID NOW picked up 21 of those positive patients, demonstrating 91.3% sensitivity and 100% specificity. Initial data validation was completed at the point of collection. * 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). Get the free daily newsletter read by industry experts. During this period Canada reported roughly 1.7 million confirmed cases of COVID in a population of 38 million (4.5% of the population). Report any issues with using COVID-19 tests to the FDA. Terms of Use| 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). for symptomatic persons or for persons with a known COVID-19 exposure) a negative antigen test result should be confirmed by NAAT. This number conflicts with data previously collected from the racetrack physician as part of a prospective cohort drug trial on this same population which, out of an enrolled cohort of 113 BinaxNOW-positive staff, identified 60 (53%) persons who were symptomatic at the time of testing (14). These cookies may also be used for advertising purposes by these third parties. CDC is not responsible for the content (5), we also calculated performance by using Ct <30 to define rRT-PCRpositive specimens. Keywords: Abbott ID Now; COVID-19; SARS-CoV-2; nasopharyngeal and nasal swabs; validation. Of those specimens, 51 resulted in positive virus isolation. . part 46, 21 C.F.R. 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 For details, see FDA Actions below. Although the sensitivity of the BinaxNOW antigen test to detect infection was lower compared with real-time RT-PCR, it was relatively high among specimens with positive viral culture, which might reflect better performance for detecting infection in a person with infectious virus present. All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. 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. 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%). I consult for the biopharma industry, although I have never consulted in the field of SARS-CoV-2 testing. Validation of an At-Home Direct Antigen Rapid Test for COVID-19. 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. 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. 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 . The Food and Drug Administration (FDA) has expanded its recall of Ellume at-home COVID-19 tests due to potential false-positive results. Performance was better among symptomatic persons, specimens with cycle threshold (Ct) <30 (suggestive of higher viral loads), and specimens with positive viral cultures (38). 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. Clin Infect Dis 2020. There were only 0.15% positive results in this sample. Rapid tests more accurately provided a positive COVID-19 result when administered during the first week of symptoms. 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. even in this symptomatic group, the false negative rate is less than 1 out of 50 negative tests. In outbreak situations in which access to laboratory rRT-PCR services is limited, it might be reasonable to act on BinaxNOW-positive results and forgo rRT-PCR confirmation. 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. In mid-June, Joanna Dreifus hit a pandemic . 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. Previous studies of BinaxNOW compared with rRT-PCR have demonstrated a high negative percent agreement (NPA) (99.4%100%) but variable positive percent agreement (PPA) (52.5%89.0%). 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. BinaxNOW rapid antigen test results and viral culture results among 100 real-time reverse transcription PCRpositive specimens with cycle threshold <30 among staff at a horse racetrack, California, USA, NovemberDecember 2020. Of the 127 rRT-PCRpositive specimens, we attempted virus isolation and culture for all 100 specimens with Ct <30. T, Schildgen doi:10.1001/jama.2021.24355. When the pretest probability for receiving positive SARS-CoV-2 test results is elevated (e.g. Accuracy: 84.6% for detecting covid-19 infections, 98.5% for correctly identifying covid-19 negatives This is the. 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. https://cdn.ymaws.com/www.cste.org/resource/resmgr/ps/positionstatement2020/Interim-20-ID-02_COVID-19.pdfpdf iconexternal icon. T, Nishihara far too serious to allow misleading or faulty tests to be distributed. 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. Figure 1. endorsement of these organizations or their programs by CDC or the U.S. , Kanji clinical laboratory staff and healthcare providers about the risk of false positive results with two Abbott Laboratories tests for COVID-19. 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. The alert about false positives applies to both Alinity products. Most staff identified as Hispanic (62.0%) (Table 1). The kits used are Hotgen's Novel Coronavirus 2019-nCoV Antigen Test, INDICAID's COVID-19 Rapid Antigen Test, BGI's GLINE-2019-nCoV Ag, Wondfo 2019-nCoV Antigen Test, Hecin's 2019-nCoV . If 58% were confirmed there were 767 screen-detected cases of infection (6.6% of the study cohort). These findings could inform testing protocols used to contain future outbreaks of COVID-19 in nonhealthcare workplaces. [Skip to Navigation] Coronavirus Disease 2019 (COVID-19): interim guidance for rapid antigen testing for SARS-CoV-2. 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. and/or the original MMWR paper copy for printable versions of official text, figures, and tables. T, Fukumori Assessment of SARS-CoV-2 screening strategies to permit the safe reopening of college campuses in the United States. 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 . BinaxNOW showed NPA and PPV of 100%. 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. 241(d); 5 U.S.C. 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. These reports have focused on community testing sites and outbreaks in healthcare facilities. Abbott's tests run on its Alinity automated molecular diagnostics analyzer. Ford previously said launching the platform with the, Curative is among the companies to adopt the platform. We are talking to Dr. Hanan Balkhy today, who's going to explain testing for COVID-19. Pharma F. Instruction for use: Fosun COVID-19 RT-PCR detection kit. Among asymptomatic participants, 48 (1.9%) received a positive BinaxNOW antigen test result, and 123 (4.7%) received a positive real-time RT-PCR test result. Rose, PhD1; John C. Neatherlin, MPH1; Mark Anderson, MD1; Paul A. Rota, PhD1; Margaret A. Honein, PhD1; William A. Bower, MD1 (View author affiliations). Dr. Surasi is an Epidemic Intelligence Service Officer with the Center for Surveillance, Epidemiology, and Laboratory Services, Centers for Disease Control and Prevention. Thank you for taking the time to confirm your preferences. 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. We rate the claim that a glass of Coca-Cola returned positive on a rapid COVID-19 test as . Taken aback by the result, healthcare providers at BAH ordered another test, which was evaluated using the hospital's newly-acquired Abbott ID NOW testing machine, a rapid, molecular point-of . Sunny Hostin and Ana Navarro were cleared to return to The View Monday after the co-hosts made a dramatic exit from the show on Friday. to sell a version of Alinity that tests for SARS-CoV-2, two types of influenza and respiratory syncytial virus. In total, 769 valid, paired rRT-PCR and BinaxNOW antigen test results were reported and analyzed. 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 outbreak was discovered by the contact tracing efforts of the local health department (LHD), the City of Berkeley Public Health Officer Unit. This study reports that 1103 health care workers were RADT positive and that corresponding RTPCR was positive only in 641 (58%) cases. Rapid antigen tests (RATs) can substantially contribute to the prevention of community transmission, but their further assessment is required . False positives aren't common, but they can. 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. Drafting of the manuscript: Gans, Goldfarb. After receiving reports of false results from its own test, Curative asked FDA to revoke its, Abbott first received FDA emergency use authorization for its Alinity m SARS-CoV-2 AMP test in May 2020. Epub December 26, 2020. 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 m Resp-4-Plex AMP Kits, and the associated recall is to correct the software. Our comparison supports immediate isolation for BinaxNOW-positive persons and confirmatory testing for negative persons. Cookies used to make website functionality more relevant to you. All of the false-positive test results from these 2 workplaces were drawn from a single batch of Abbotts Panbio COVID-19 Ag Rapid Test Device. 4 reasons your rapid COVID-19 test might show a false result. Weekly / January 22, 2021 / 70(3);100105. 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). et al. Jessica L. Prince-Guerra, PhD1; Olivia Almendares, MSPH1; Leisha D. Nolen, MD, PhD1; Jayleen K. L. Gunn, PhD1; Ariella P. Dale, PhD1,2,3; Sean A. Buono, PhD1; Molly Deutsch-Feldman, PhD1,3; Suganthi Suppiah, PhD1; LiJuan Hao, MD1; Yan Zeng, MS1; Valerie A. Stevens1; Kristen Knipe, MS1; Justine Pompey, PhD1; Christine Atherstone, PhD1,3; David P. Bui, PhD1,3; Tracy Powell, PhD1; Azaibi Tamin, PhD1; Jennifer L. Harcourt, PhD1; Patricia L. Shewmaker, PhD1; Magdalena Medrzycki, PhD1; Phili Wong, MS1; Shilpi Jain, PhD1; Alexandra Tejada-Strop, MS1; Shannon Rogers, MS1; Brian Emery1; Houping Wang, PhD1; Marla Petway, MPH1; Caitlin Bohannon, PhD1; Jennifer M. Folster, PhD1; Adam MacNeil, PhD1; Reynolds Salerno, PhD1; Wendi Kuhnert-Tallman, PhD1; Jacqueline E. Tate, PhD1; Natalie J. Thornburg, PhD1; Hannah L. Kirking, MD1; Khalilullah Sheiban, MD4; Julie Kudrna, MPA4; Theresa Cullen, MD4; Kenneth K. Komatsu, MPH2; Julie M. Villanueva, PhD1; Dale A. Across the U.S., 7.1% of tested samples were positive in the latest CDC data. We used the paired BinaxNOW and rRT-PCR results to calculate the BinaxNOW PPA, NPA, negative predictive value (NPV), and positive predictive value (PPV), using Ct <37 to define rRT-PCRpositive specimens. False positive rapid antigen tests for SARS-CoV-2 in the real-world and their economic burden. Consider retesting positive patient specimens performed in the last two weeks with an alternate authorized test. Participants ranged in age from 10 to 95 years (median=41 years) with 236 (6.9%) aged 1017 years, 1,885 (55.1%) aged 1849 years, 743 (21.7%) aged 5064 years, and 555 (16.2%) aged 65 years. A box containing a 5-minute test for COVID-19 from Abbott Laboratories is pictured during the daily briefing on the novel coronavirus, COVID-19, in the Rose Garden of the White House on March 30. 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. CDC twenty four seven. Users are referred to the electronic PDF version (https://www.cdc.gov/mmwr) A rapid COVID-19 test swab being processed. The ideal temperature to store rapid antigen COVID-19 test kits is between 59 and 86 degrees Fahrenheit. The timing . The culture showed evidence of cytopathic effects and had presence of SARS-CoV-2 RNA as detected by real-time RT-PCR in the first passage culture, but viral recovery was not two Ct values lower than the corresponding clinical specimen Ct. Antigen test results: 88 positive and 48 negative; median Ct values indicated with black line: 22.0 for antigen-positive specimens and 33.9 for antigen-negative specimens. 2023 American Medical Association. BinaxNOW demonstrated better concordance with positive viral culture results (88.2%) than with positive rRT-PCR results (43.3%). The false-positive rate for a PCR test is close to zero, though. 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. We take your privacy seriously. 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. provided as a service to MMWR readers and do not constitute or imply 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. CDC. Cells with positive cytopathic effect were tested by rRT-PCR to confirm presence of SARS-CoV-2. . Corresponding author: Jessica L. Prince-Guerra, yov0@cdc.gov. Since the beginning of the pandemic, we've more than tripled the availability of ID . 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A few weeks later, cases started spiking again, as the highly infectious Delta variant spread. 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. Abbott says it is making tens of millions of BinaxNow tests per month. More than 2 million tests made by the company that were . Testing among symptomatic participants indicated the following for the BinaxNOW antigen test (with real-time RT-PCR as the standard): sensitivity, 64.2%; specificity, 100%; PPV, 100%; and NPV, 91.2% (Table 2); among asymptomatic persons, sensitivity was 35.8%; specificity, 99.8%; PPV, 91.7%; and NPV, 96.9%. 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). 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). During this period, Canada had two significant waves. Customers can self-administer the. Sect. Before sharing sensitive information, make sure you're on a federal government site. 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. Performance characteristics of a rapid severe acute respiratory syndrome coronavirus 2 antigen detection assay at a public plaza testing site in San Francisco. The sites offered SARS-CoV-2 testing to anyone in the community who wanted testing. Funding/Support: The CDL RSC was founded with financial support from 12 corporations: Air Canada, CPP Investments, Genpact, Loblaw Companies Limited, Magna, MDA, Maple Leafs Sports & Entertainment Partnership, Nutrien, Rogers, Scotiabank, Shoppers Drug Mart, and Suncor and received funding from the Safe Restart Agreement from the Government of Canada (Health Canada). Customize your JAMA Network experience by selecting one or more topics from the list below. Fierce Healthcare. There were 903408 rapid antigen tests conducted for 537 workplaces, with 1322 positive results (0.15%), of which 1103 had PCR information. Another false-positive problem for a SARS-CoV-2 antigen test in Japan. For cultures, 200 L of patient specimen was diluted 1:1 with diluent containing 0.75% bovine serum albumin, and 50 L was added to 8 replicate wells in a 96-well plate containing confluent Vero-81 cells at 37C with 5% CO2. Get free COVID-19 test kits through health insurance, Medicare or local health clinics. 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. We attribute this attrition to the logistical obstacles of staff getting to the testing site or to staff leaving their jobs during the outbreak. The authors assume that all RADT-positive/RTPCR-negative samples are false positives (42%). URL addresses listed in MMWR were current as of 1CDC COVID-19 Response Team; 2Arizona Department of Health Services; 3Epidemic Intelligence Service, CDC; 4Pima County Health Department, Tucson, Arizona. You will be subject to the destination website's privacy policy when you follow the link. "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. 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. Administrative, technical, or material support: Gans, Goldfarb, Agrawal, Sennik. 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). See, Voluntary reports can be submitted through, Generally, as specified in a test's EUA, device manufacturers must comply with the applicable, Health care personnel employed by facilities that are subject to the. * 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. 552a; 44 U.S.C. 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. Statistical analyses were performed using SAS (version 9.4; SAS Institute). et al. The LHD decided to use BinaxNOW as a supplement to rRT-PCR to more quickly identify SARS-CoV-2positive employees for isolation. Please use the form below to submit correspondence to the authors or contact them at the following address: Krishna Surasi, State of California Department of Public Health, 850 Marina Bay Pkwy, Bldg P, 3rd Fl, Richmond, CA 94804, USA. All data collected before June 26 and presumptive positive screen results and PCR test results reported before September 15 were externally verified through an audit process by participant organizations. 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. The exact binomial method was used to calculate 95% CIs. 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. 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.. (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. The alert about false positives applies to both Alinity products.
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