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Epub December 26, 2020. The BinaxNOW COVID-19 Antigen Self Test is a rapid lateral flow immunoassay for the qualitative detection of SARS-CoV-2 directly from anterior nasal swabs, without viral transport media. Required fields are marked *. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. This product has not been FDA cleared or approved but has been authorized by FDA under a EUA. Cross-reactivity and potential interference of BinaxNOW COVID-19 Antigen Self Test was evaluated by testing 37 commensal and pathogenic microorganisms (8 bacteria, 14 viruses, 1 yeast, and pooled human nasal wash) that may be present in the nasal cavity. However, a negative result does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. CHECK OUT THESE HELPFUL LINKS. 552a; 44 U.S.C. This means the COVID-19 antigen was detected. Made sure to read about "even a faint line" but like you, I almost immediately hit very positive. 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. Antigen tests can be an important tool in an overall community testing strategy to reduce transmission. Positive agreement of the BinaxNOW compared a PCR assay was "99/117, 84.6% (95% CI: 76.8% . endstream
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Data transmitted in the app is encrypted and users only share name, birthdate, phone number, zip code and email address which is used for creating your personal profile in the app. HOW WERE YOU ABLE TO DEVELOP TESTS SO QUICKLY? While developing an accurate and reliable test normally takes years, our expert team of scientists worked around the clock to compress the timeframe down to weeks. US CDC real-time reverse transcription PCR panel for detection of severe acute respiratory syndrome coronavirus 2. The first-of-its-kind app, available at no charge, allows people who test negative to get a temporary digital health pass that's renewed each time the person has a negative test. For P. jirovecii one area of sequence similarity shows 45% homology across 18% of the sequence, making cross-reactivity in the BinaxNOW COVID-19 Antigen Self Test highly unlikely. Health and Human Services. Positive results do not rule out bacterial infection or co-infection with other viruses. Individuals who test positive with the BinaxNOW COVID-19 Antigen Self Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary. Positive: A positive specimen will give two pink/purple colored lines. All kit components are single-use items. ** Ct values from the N1 viral nucleocapsid protein gene region from real-time RT-PCR were compared only for specimens that were analyzed with the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel for detection of 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
Twenty specimens with Ct values <18 had positive antigen and real-time RT-PCR results but were culture negative. 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. Do not use a kit that has been opened and/or tampered with. WILL YOUR RAPID TESTS BE AVAILABLE IN DRIVE-THRUS OR FOR AT-HOME USE? An erratumhas been published. %%EOF
Specimens with low levels of antigen may give a faint Sample Line. External Positive and Negative Controls: Good laboratory practice suggests the use of positive and negative controls to ensure that test reagents are working and that the test is correctly performed. URL addresses listed in MMWR were current as of
HOW TO: A Guide for the BinaxNOW COVID-19 Self Test Abbott 41.1K subscribers 213K views 6 months ago Finally: a fast, proven and trusted COVID-19 test that is readily available to the. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html. False-negative results may occur if specimen swabs are not twirled within the test card. ID NOW is a lightweight and portable instrument (the size of a toaster), that allows testing to occur near the patient to get rapid molecular results including physicians' offices, urgent care settings, and hospital emergency departments. In a clinical context, real-time RT-PCR provides the most sensitive assay to detect infection. Learn more about ARCHITECT here: https://abbo.tt/3abd0eq, Learn more about Alinity i here: https://abbo.tt/2SWCvtU. On January 19, 2021, this report was posted online as an MMWR Early Release. Due to the relatively small sample size for the home use clinical study, the BinaxNOW COVID-19 Ag Card . Virus was recovered from 96 (35.0%) of 274 analyzed specimens that were positive by either test, including 85 (57.8%) of 147 with concordant positive results and 11 (8.9%) of 124 with false-negative BinaxNOW antigen test results. 100% (99 out of 99) of the home (individual and caregiver) participants correctly understood that failure to follow the test steps correctly would potentially lead to an invalid or inaccurate result or would require another test or consultation with a healthcare provider. Select CVS and Walgreens are using ID NOW in drive-thru settings in the U.S. You can find ID NOW in your local areahere, and BinaxNOW COVID-19 Self Tests in retailers near youhere. Do not dip the swab into the liquid reagent or other liquid before inserting the swab into the nose. What you ate . The BinaxNOW COVID-19 Antigen Self Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. 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). Atlanta, GA: US Department of Health and Human Services; 2020. The sponsor also submitted a usability study for the eInstruction. This how-to video also helps explain how molecular point-of-care testing on ID NOW works. Rose, PhD1; John C. Neatherlin, MPH1; Mark Anderson, MD1; Paul A. Rota, PhD1; Margaret A. Honein, PhD1; William A. Bower, MD1 (View author affiliations). It can also be performed at home using a virtually guided service in partnership with eMed. What are the implications for public health practice? 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). The virus can cause mild to severe respiratory illness and has spread globally, including in the United States. hmS8}+ftIH\KK }$JP]) +i%k];eE* J$,*d#j3[Y&5vD{i4X| vr4=! 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). However, if you test positive or test negative but have symptoms of COVID-19 it is recommended that you get an PCR test to confirm your results. The performance of this test has not yet been clinically validated for use in patients without signs and symptoms of respiratory infection or for serial screening applications, and performance may differ in these populations. Next, the patient [] You can find more information on BinaxNOW COVID-19 Ag Card and NAVICA here. Individuals who test positive with the BinaxNOW COVID-19 Ag Card should self-isolate and seek follow up care with their . Each individual or caregiver pair participated in a 6-minute session with a study moderator. The high specificity and rapid BinaxNOW antigen test turnaround time facilitate earlier isolation of infectious persons. Positive test results do not rule out co-infections with other pathogens. . Unlike a lot of other at-home Covid tests, this one has a. Persons who know their positive test result within 1530 minutes can isolate sooner, and contact tracing can be initiated sooner and be more effective than if a test result is returned days later. Second, participants might have inadvertently reported common nonspecific symptoms as COVID-19compatible symptoms. Learn more about m2000 here: https://abbo.tt/3b8bASF, Alinity m systems have the ability to run high volumes of up to 1,080 tests in 24 hours, helping to meet the increasing demand for testing. I also used Binax test after other family members tested positive. These cookies may also be used for advertising purposes by these third parties. provided as a service to MMWR readers and do not constitute or imply
part 46.102(l)(2), 21 C.F.R. Molecular tests that run on our m2000 system are already located in hospital and academic medical center labs, and reference laboratories, where patients are presenting for care. The BinaxNOW COVID-19 Antigen Self Test does not differentiate between SARS-CoV and SARS-CoV-2. 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. 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%). Results will be available 15 minutes after starting the test. Invalid: If no lines are seen, if just the Sample Line is seen, or the Blue Control Line remains blue, the assay is . False-negative results may occur if an inadequate extraction buffer is used (e.g., <6 drops). Positive ResultA positive test result for COVID-19 indicates that antigens from SARS-CoV-2 were detected, and the patient is very likely to be infected with the virus and presumed to be contagious. The website that you have requested also may not be optimized for your screen size. and/or the original MMWR paper copy for printable versions of official text, figures, and tables. NP swabs were stored in phosphate buffered saline at 39F (4C) and analyzed within 2448 hours by real-time RT-PCR using either the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel for detection of SARS-CoV-2 (5) (2,582 swabs) or the Fosun COVID-19 RT-PCR Detection Kit (6) (837 swabs). For more information on ID NOW check out this article: https://abbo.tt/2UT36cN. The test is highly portable (about the size of a credit card), affordable, and provides accurate results in 15 minutes. Module 3: Specimen Collection and Handling iv. Abbott also developed separate lab-based serology blood teststo detect IgM and IgG antibodies that identify if a person has been previously exposed to the virus that causes COVID. Test results were interpreted and recorded by the Subject or other home user and independently by the proctor. The test is highly portable (about the size of a credit card), affordable, and provides accurate results in 15 . Corresponding author: Jessica L. Prince-Guerra, yov0@cdc.gov. mmwrq@cdc.gov. To evaluate the performance of the BinaxNOW rapid antigen test, it was used along with real-time reverse transcriptionpolymerase chain reaction (RT-PCR) testing to analyze 3,419 paired specimens collected from persons aged 10 years at two community testing sites in Pima County, Arizona, during November 317, 2020. BinaxNOW(TM) COVID-19 Ag Card kits contain a Positive Control Swab and Sterile Swabs that can be used as a Negative Control Swab. Negative results are presumptive, do not rule out COVID-19 infection and it may be necessary to obtain additional testing with a molecular assay if needed for patient management. 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.. No cross-reactivity or interference was seen with the following microorganisms when tested at the concentration presented in the table below. SARS-CoV-2 specific antibodies and a control antibody are immobilized onto membrane support as two distinct lines and combined with other reagents/pads to construct a test strip. Keep testing kit and kit components out of the reach of children and pets before and after use. 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). Specificity (99.8%100%) was high in specimens from both asymptomatic and symptomatic groups. Clinical performance characteristics of the BinaxNOW COVID-19 Antigen Self Test were evaluated in an ongoing multi-site prospective study in the U.S. A total of four (4) investigational sites throughout the U.S. participated in the study. Abbott BinaxNOW COVID-19 Ag Card training modules b. Public health departments are implementing various strategies to reduce or prevent SARS-CoV-2 transmission, including expanded screening testing for asymptomatic persons (3). Yes. We have molecular and antigen tests that help detect an active infection of COVID-19, as well as serology tests that help detect antibodies. Individuals who test positive with the BinaxNOW COVID-19 Antigen Self Test should self-isolate and seek follow-up care with their physician or healthcare provider as Importantly, the faster time from testing to results reporting can speed isolation of infectious persons and will be particularly important in communities with high levels of transmission. The sites offered SARS-CoV-2 testing to anyone in the community who wanted testing. To view the purposes they believe they have legitimate interest for, or to object to this data processing use the vendor list link below. The following substances, naturally present in respiratory specimens or that may be artificially introduced into the nasal cavity or nasopharynx, were evaluated with the BinaxNOW COVID-19 Antigen Self Test at the concentrations listed below and were found not to affect test performance. 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. Modifications to these procedures may alter the performance of the test. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change over time. The goal of the usability study was to demonstrate that lay users can use paper instructions or digital (mobile app or website) instructions (i.e., paper Quick Reference Guide (QRG), digital app Quick Reference Instructions (QRI), or website electronic Instructions for Use (EU)) to perform the test steps for the BinaxNOW COVID-19 Antigen Self Test successfully.The study was conducted at usability labs in Chicago, IL, the USA from June 15 June 23, 2021. vivax, Most of our tests may be available through your healthcare provider or at retail pharmacies. Wait at least 15 minutes but not longer than 30 to read your results. Field performance and public health response using the BinaxNOW TM Rapid SARS-CoV-2 antigen detection assay during community-based testing. IS MY INFORMATION SECURE WHEN USING THE NAVICA MOBILE APP? 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. Results from real-time RT-PCR and the BinaxNOW antigen test were compared to evaluate sensitivity, specificity, negative predictive value (NPV), and PPV. Follow the instructions that come with the kit to take your sample. If the patient is experiencing nasal congestion, have them blow his/her nose before swabbing. CDC twenty four seven. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 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. 221 0 obj
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. Additional confirmatory testing with a molecular test for positive results may also be necessary if there is a low likelihood of COVID-19, such as in individuals without known exposures to COVID-19 or residing in communities with a low prevalence of infection. The performance of the BinaxNOW COVID-19 Antigen Self Test was established with 53 nasal swabs collected from individual symptomatic patients (within 7 days of onset) who were suspected of COVID-19. The website you have requested also may not be optimized for your specific screen size. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Each test includes a swab, a test card, a dropper of reagent solution, and illustrated instructions. Each of the organisms, viruses, and yeast were tested in triplicate in the absence or presence of heat-inactivated SARS-CoV-2 virus (45TCID50/swab). We continue to work closely with our customers around the world to bring testing to where its needed most. Molecular testing: Take a look at this infographic on how coronavirus molecular testing works. Assessment of SARS-CoV-2 screening strategies to permit the safe reopening of college campuses in the United States. This means that COVID-19 antigen was detected. For our rapid antigen tests, BinaxNOW is available in the U.S. and Panbio is available in many countries outside of the U.S. What is the sensitivity and specificity of this test? Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. ^rcvzEr^COk;TH)s}kU;{}6JAw4aL@j'Z889xuq0H}rba+ Ya{V}l@
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RNize2N_ q=@ 8I"JN\zQA9!=ymP+$v$B%2C)wu/A(I~,'i>zNak_.T+8p}Vp{\3EyEE$#y nh eG6^ZT. The EUA is supported by the Secretary of Health and Human Services' declaration that circumstances exist to justify the development of in vitro diagnostics (IVDs) under EUA for the detection and/or diagnosis of 2019-nCoV. d. Super-duper, no-doubt-about-it positive Get well soon! False-negative results may occur if a specimen is improperly collected or handled. It can be used at home, by healthcare professionals at the point-of-care and or at home using a virtually guided service for the detection of antigens that form in the early stage of active infections. https://www.biorxiv.org/content/10.1101/2020.03.02.972935v1external icon. Compatible smartphone includes Apple iPhone running Operation System (iOS): latest major version and two prior major versions (iPhone running iOS v12 or later), and Android Phones: latest major version and two prior major versions (Android phone running Android OS v9 or later). The faster turnaround time of the antigen test can help limit transmission by more rapidly identifying infectious persons for isolation, particularly when used as a component of serial testing strategies. The BinaxNOW COVID-19 Antigen Self Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 infection when tested twice over three days with at least 36 hours between tests. Pilarowski G, Marquez C, Rubio L, et al. Positive results are broken down by days since symptom onset: Cumulative BinaxNOW COVID-19Antigen Self Test Positive (+). A total of 60 lay users, including individuals (n=30) and caregivers (n=30), participated in the study. %PDF-1.6
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in long-term care facilities) should also receive confirmatory testing by NAAT (1). Our antibody and molecular lab tests are available around the world, as well as our ID NOW rapid molecular test. If you have the virus and are asymptomatic, this percentage dips to about 44% to 70%. Weekly / January 22, 2021 / 70(3);100105. They help us to know which pages are the most and least popular and see how visitors move around the site. HOW DO I KNOW IF I NEED TO SEEK OUT ONE OF YOUR TESTS? Virus was recovered from 96 (35.0%) of 274 analyzed specimens that were positive by either test, including 85 (57.8%) of 147 with concordant positive results and 11 (8.9%) of 124 with false-negative BinaxNOW antigen test results. A questionnaire capturing demographic information and current and past14-day symptoms was administered to all participants. Under the observation and coaching of a clinical site staff member trained as a proctor, the Subject self-collected one (1) nasal swab and performed the BinaxNOW COVID-19 Antigen Self Test. The patient sample is inserted into the test card through the bottom hole of the swab well, and firmly pushed upwards until the swab tip is visible through the top hole. Kristen Garcia, Wenli Zhou, Morgan Ross, Lyndsay Wagner, Katherine Collins, Shelby Legendre, Christopher Johnson, Paradigm Laboratories, Tucson, Arizona; Spencer Graves, Pima County Health Department, Tuscon, Arizona; Anastasia Litvintseva, Dennis A. Bagarozzi, Jr., David James Petway, Jr., CDC. You can review and change the way we collect information below. BinaxNOW COVID-19 Ag card (PN 195000)instructions for use. 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. They are best at detecting when people are most infectious, so they know to stay home and isolate, minimizing the spread of COVID-19. Performance of nasal swabs collected from patients without symptoms or other epidemiological reasons to suspect COVID-19 infection or for serial screening, when tested twice over three days with at least 36 hours between tests has not been determined, a study to support use will be completed. Abbott. Our lab serology blood tests running on ARCHITECT and Alinity i systems are used for the detection of antibodies, IgG and IgM, and to identify if a person was previously infected with the virus that causes COVID-19. Use of gloves is recommended when conducting testing. Negative test . Virus was not recovered from any of the three available specimens with false-positive BinaxNOW antigen test results. BinaxNOW COVID-19 Antigen Self Test instructions for use are provided as a paper copy within the test kit, available digitally via website link (www.Bina now-self-test.Abbott) or digitally via the NOVICA app downloaded to a compatible smartphone. Read more about Alinity m: https://abbo.tt/2zrt52N 1 BinaxNOW TM COVID-19 Antigen Self TEST 2 INTENDED USE 3 SUMMARY AND EXPLANATION OF THE TEST 4 PRINCIPLES OF THE PROCEDURE 5 REAGENTS AND MATERIALS 6 PRECAUTIONS 7 STORAGE AND STABILITY 8 DIRECTIONS FOR RUNNING THE BINAXNOW COVID-19 AG CARD SELF TEST 9 RESULT INTERPRETATION 10 PERFORMANCE CHARACTERISTICS In vitro diagnostics EUAs. The BinaxNOW COVID-19 Self-Test arrives with everything you need to collect a sample and get results within 15 minutes. of pages found at these sites. 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. If you would like to change your settings or withdraw consent at any time, the link to do so is in our privacy policy accessible from our home page.. Testing before and after events, school, work or social engagements gives you and your loved ones confidence, especially if you have loved ones who are at a higher risk. 241(d); 5 U.S.C. Read more about m2000: https://abbo.tt/2U1WMiU These tests have been authorized by FDA under EUAs for use by authorized laboratories and have been authorized only for the detection of nucleic acid from SARS-CoV-2 or detection of IgG antibodies against SARS-CoV-2, and not for any other viruses or pathogens. Organizations like employers and schools have the option to use the app to view and verify the information on a mobile device to facilitate safer entry into facilities along with hand-washing, social distancing, enhanced cleaning and mask-wearing. The test is indicated for all people aged 15 years or older and for children as young as 2 years old when samples are collected by an adult. Comment * document.getElementById("comment").setAttribute("id","ad012d2f6cd7dca324a094ff8c3a3da6");document.getElementById("afe6277d1c").setAttribute("id","comment"); Save my name, email, and website in this browser for the next time I comment. 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). To be enrolled in the study, patients had to be presenting at the participating study centers with suspected COVID-19 within 7 days of symptom onset. %PDF-1.6
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References to non-CDC sites on the Internet are
Lu X, Wang L, Sakthivel SK, et al. 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. One of your tests nonspecific symptoms as COVID-19compatible symptoms ; 100105 to read your.. Swabs are not twirled within the test is highly portable ( about size... Globally, including expanded screening testing for asymptomatic persons ( 3 ) a study moderator United States tests be 15. Inserting the swab into the liquid reagent or other liquid before inserting the swab into the nose you NEED collect! A questionnaire capturing demographic information and current and past14-day symptoms was administered to all.. Before swabbing Alinity i here: https: //abbo.tt/2UT36cN our ID NOW rapid molecular test opened and/or tampered with out. Long-Term care facilities ) should also receive confirmatory testing by NAAT ( 1 ) text, figures and! ( L ) ( 2 ), affordable, and tables performed at using... 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