DOI: http://dx.doi.org/10.15585/mmwr.mm7003e3external icon. 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. Centers for Disease Control and Prevention. Your email address will not be published. All of the ORANGE bars . mmwrq@cdc.gov. This type of knowledge could help support research about how the virus spreads within communities and immune responses to vaccines. Viral culture*, was attempted on 274 of 303 residual real-time RT-PCR specimens if either the real-time RT-PCR or BinaxNOW antigen test result was positive (the remaining 29 were not available for viral culture). and/or the original MMWR paper copy for printable versions of official text, figures, and tables. BinaxNOW(TM) COVID-19 Ag Card kits contain a Positive Control Swab and Sterile Swabs that can be used as a Negative Control Swab. Each box comes with . Positive test results do not rule out co-infections with other pathogens. Patient demographics, the time elapsed since the onset of symptoms for all patients enrolled in the above study, are presented in the table below. Do not reuse the used test card or swab. 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 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. Corresponding author: Jessica L. Prince-Guerra, yov0@cdc.gov. The professional version of the test launched last August and the U.S. Department of . Here's my timeline of events: 12/23/2021: Negative PCR. These cookies may also be used for advertising purposes by these third parties. Proc Natl Acad Sci U S A 2020;117:175135. No cross-reactivity or interference was seen with the following microorganisms when tested at the concentration presented in the table below. Even a faint line next to the word sample on the test card is a positive result. Here's. Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. 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. For more information on our ARCHITECT antibody test, check out this article: https://abbo.tt/3abd0eq The test can be used for people with and without symptoms. d. Next, the patient [] Test kit dimensions: 9.125" L x 0.938" D x 5.063" H. Kit contains all necessary components for testing, including: 2 BinaxNOW COVID-19 Antigen Self Test Cards, 2 Nasal Swabs, 2 Reagent Bottles. This is consistent with the performance established in a separate multi-site study in the US, where the BinaxNOW COVID-19 Ag Card test was performed and results interpreted by test operators with no laboratory experience. * 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. 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). 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 It will provide a better understanding of the virus, including how long antibodies stay in the body. 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. %%EOF We and our partners use cookies to Store and/or access information on a device. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Positive Result Sample Line Only Blue Control Line Only Blue Control Line Sample Line No Control Line Invalid Result Part 1 - Sample Test Procedure Peel off adhesive liner from the right edge of the test card. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Do not use a kit that has been opened and/or tampered with. I'll show you step by step how t. Not noticeable unless you look very closely with great lighting. Parents of pediatric Subjects under the age of 14 or Legally Authorized Representatives of adult Subjects unable to perform self-collection collected one (1) nasal swab from the Subject, performed the BinaxNOW COVID-19 Antigen Self Test, then interpreted and recorded the result for the patient. 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. For more information on m2000, check out this article: https://abbo.tt/2U1WMiU, We also have a molecular test for our Alinity m system under the FDA's Emergency Use Authorization. This product has not been FDA cleared or approved but has been authorized by FDA under a EUA. The test is highly portable (about the size of a credit card), affordable, and provides accurate results in 15 . Results should not be read after 30 minutes. They are best at detecting when people are most infectious, so they know to stay home and isolate, minimizing the spread of COVID-19. Read more about ID NOW:https://abbo.tt/3KI9smQ 2831 0 obj <>stream Second, participants might have inadvertently reported common nonspecific symptoms as COVID-19compatible symptoms. Some of our partners may process your data as a part of their legitimate business interest without asking for consent. In addition, people are encouraged to follow the latestCDC guidelines, which is to communicate your results to your healthcare provider, who is responsible for reporting your test results to the state health department. The BinaxNOW COVID-19 Antigen Self Test kit contains all components required to carry out an assay for SARS-CoV-2. 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. 1CDC COVID-19 Response Team; 2Arizona Department of Health Services; 3Epidemic Intelligence Service, CDC; 4Pima County Health Department, Tucson, Arizona. This means that COVID-19 antigen was detected. For more information on our IgM antibody test, check out this news release: https://abbott.mediaroom.com/2020-10-12-Abbott-Receives-FDA-Emergency-Use-Authorization-for-its-COVID-19-IgM-Antibody-Blood-Test. 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. Positive results are broken down by days since symptom onset: Cumulative BinaxNOW COVID-19Antigen Self Test Positive (+). provided as a service to MMWR readers and do not constitute or imply The patient sample is inserted into the test card through the bottom hole of Therefore, negative results in patients with symptom onset greater than seven days should be interpreted with caution, as the sensitivity of the assay decreases over time. Epub June 29, 2020. Do not mix components from different kit lots. Wear a safety mask or other face-covering when collecting anterior nares swab specimen from a child or another individual. 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. Test performance depends on the amount of virus (antigen) in the sample and may or may not correlate with viral culture results performed on the same sample. Weekly / January 22, 2021 / 70(3);100105. The investigation protocol was reviewed by CDC and determined to be nonresearch and was conducted consistent with applicable federal law and CDC policy.. Each individual or caregiver pair participated in a 60-minute session with a single proctor. 92% (92 out of 100) of home users produced a valid result (all negative) and 8 participants produced an invalid result. The performance of the BinaxNOW COVID-19 Antigen Self Test was evaluated using the procedures provided in this product insert only. The usability evaluation session included one simulated use of the BinaxNOW COVID-19 Antigen Self Test, knowledge tasks, and opportunities to provide feedback. This symbol indicates the name and location of the product manufacturer. Lu X, Wang L, Sakthivel SK, et al. Abbreviation: COVID-19=coronavirus disease 2019. ** Based on one or more symptoms. Exposure was defined as close contact (within 6 ft for 15 min) in the 14 days before the day of testing with a person with diagnosed COVID-19. Received positive real-time RT-PCR or antigen test result. According to the enclosed pamphlet, the test correctly IDed 91.7% of positive specimens and 100% of negative specimens in a clinical trial. 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. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Due to the relatively small sample size for the home use clinical study, the BinaxNOW COVID-19 Ag Card Home Test is estimated to correctly identify between 73.0% and 98.9% of positive specimens as reflected in the 95% Confidence Interval. Our first molecular test is used on our lab-based molecular instrument, m2000. Asymptomatic persons who receive a positive BinaxNOW antigen test result in a setting with a high risk for adverse consequences resulting from false-positive results (e.g. 12/25/2021: Started having mild cold-like symptoms. Swab eluates were combined and mixed thoroughly to create a clinical matrix pool to be used as the diluent. Positive results indicate the presence of viral antigens, but clinical correlation with a past medical history and other diagnostic information is necessary to etermine infection status. Module 4: Module 4: Participant (Individual) Test c. Preparing for & Running the BinaxNOW COVID-19 Ag Card Test. 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. part 56; 42 U.S.C. Read more about Alinity i: https://abbo.tt/2SWCvtU False-negative results may occur if swabs are stored in their paper sheath after specimen collection. . We take your privacy seriously. 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 is also a rapid test. Median Ct values for SARS-CoV-2 culture-positive specimens (22.1) were significantly lower than were those for culture-negative specimens (32.8) (p<0.001), indicating higher levels of viral RNA in culture-positive specimens. This symbol indicates that the total number of tests provided in the kit box. In this evaluation, using real-time RT-PCR as the standard, the sensitivity of the BinaxNOW antigen test was lower among specimens from asymptomatic persons (35.8%) than among specimens from symptomatic persons (64.2%). 2783 0 obj <> endobj 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. Take care of yourself and get some rest. The test is highly portable (about the size of a credit card), affordable, and provides accurate results in 15 minutes. 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. 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. Using the BinaxNOW COVID-19 Ag Card: Part 2, Interpreting Results and Additional Tips - YouTube 0:00 / 1:44 COVID-19 Get the latest information from the CDC about COVID-19. Super-duper, no-doubt-about-it positive Get well soon! 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. First, anterior nasal swabs were used for BinaxNOW antigen testing, but NP swabs were used for real-time RT-PCR testing, which might have contributed to increased detection for the real-time RT-PCR assay (8). Department of Health and Human Services. This test is used on our ID NOW instrument. The BinaxNOW COVID-19 Antigen Self Test returns results in 15 minutes. All of our tests met all testing criteria under the FDA's emergency use authorization (EUA) and we're continuing to collect more data in the field. Using the BinaxNOW. 552a; 44 U.S.C. 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. The high specificity and rapid BinaxNOW antigen test turnaround time facilitate earlier isolation of infectious persons. . The BinaxNOW COVID-19 Antigen Self Test is an immunochromatographic membrane assay that uses highly sensitive antibodies to detect SARS-CoV-2 nucleocapsid protein from direct anterior nasal swab specimens. Store kit between 35.6-86F (2-30C). To perform the test, and anterior nasal swab specimen is collected by the patient, then 6 drops of extraction reagent from a dropper bottle are added to the top hole of the swab well. Please note: This report has been corrected. Test results are interpreted visually at 15 minutes based on the presence or absence of visually detectable pink/purple-colored lines. 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%). No potential conflicts of interest were disclosed. The sponsor also submitted a usability study for the eInstruction. 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%). If you're with a hospital, lab or healthcare provider, please see the contact details below. Pilarowski G, Marquez C, Rubio L, et al. The FDA has made tests available under an emergency access mechanism called an Emergency Use Authorization (EUA). HOW WERE YOU ABLE TO DEVELOP TESTS SO QUICKLY? The BinaxNOW test is newly available directly to consumers, but it has a track record of accuracy and reliability. Our BinaxNOW Self Tests can provide the confidence needed to continue engaging in your communities as other COVID-19 safety measures begin to dissipate. Virus was not recovered from any of the three available specimens with false-positive BinaxNOW antigen test results. Leave test card sealed in its foil pouch until just before use. 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. All kit components are single-use items. I also used Binax test after other family members tested positive. If you have the virus and test yourself during the first week of symptoms, you can expect the average antigen test to catch 78% to 97% of cases. Continue with Recommended Cookies, Home BinaxNOW BinaxNOW COVID-19 Antigen Self TEST Instructions, For Use Under an Emergency Use Authorization (EUA) OnlyFor use with anterior nasal swab specimensFor in vitro Diagnostic Use Only. Sensitivity was higher for culture-positive specimens (92.6% and 78.6% for those from symptomatic and asymptomatic persons, respectively); however, some antigen test-negative specimens had culturable virus. The contrived swab samples were tested according to the test procedure.The LOD was determined as the lowest virus concentration that was detected 95% of the time (i.e., concentration at which at least 19 out of 20 replicates tested positive).The BinaxNOW COVID-19 Antigen Self Test LOD in natural nasal swab matrix was confirmed 140.6 TCID50/mL. Molecular testing: Take a look at this infographic on how coronavirus molecular testing works. False-negative results are more likely after eight days or more of symptoms. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. 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. hb```e``Z"=10 Pcu&_=I8+N?d4WKg|S%+\:::E!1hd`jU@,6!)Nh The positive agreement in patients with symptoms greater than seven days was 60% (30/50) and negative agreement was 98% (109/111). https://cdn.ymaws.com/www.cste.org/resource/resmgr/ps/positionstatement2020/Interim-20-ID-02_COVID-19.pdfpdf iconexternal icon. for symptomatic persons or for persons with a known COVID-19 exposure) a negative antigen test result should be confirmed by NAAT. Each individual or caregiver pair participated in a 6-minute session with a study moderator. If the solution contacts the skin or eye, flush with copious amounts of water. 0 The usability evaluation session included one simulated use of the BinaxNOW COVID-19 Antigen Self Test and opportunities to provide feedback. Ag Card Home Test results that were negative and the molecular test was positive. It can be used in three different ways. Health and Human Services. Specificity (99.8%100%) was high in specimens from both asymptomatic and symptomatic groups. The test does not need any additional equipment. There are two tests (as well as two swabs and reagents) in each box. endstream endobj startxref You simply will perform a lower nostril nasal swab (not the deeper nasopharyngeal swab) and everything you need (swab, test card and reagent solution) is included in the box. CDC twenty four seven. 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. Atlanta, GA: US Department of Health and Human Services; 2020. For more information on Alinity m, check out this news release: https://abbo.tt/2zrt52N, Our rapid, molecular point-of-care test detects COVID-19 in 13 minutes or less. The presence of mupirocin may interfere with the BinaxNOW COVID-19 Antigen Self Test and may cause false-negative results. o check for a positive result, look at the result window for two pink or purple lines. The BinaxNOW COVID-19 Antigen Self Test does not differentiate between SARS-CoV and SARS-CoV-2. 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. Questions or messages regarding errors in formatting should be addressed to The systems have the ability to run high volumes of up to 470 tests in 24 hours, helping to meet the increasing demand for testing. Rose, PhD1; John C. Neatherlin, MPH1; Mark Anderson, MD1; Paul A. Rota, PhD1; Margaret A. Honein, PhD1; William A. Bower, MD1 (View author affiliations). ^rcvzEr^COk;TH)s}kU;{}6JAw4aL@j'Z889xuq0H}rba+ Ya{V}l@ =x;a[@[=8>G_!c8k` 2/N)\1L 9Ng+)ycb6qx1Hq28P@Uu6.fiP3WT!y PA ;!gAr 4?JsUq2VonW,Vi1,[Ou|M-77kC>4&Aq7nHC4*5e_Cq7O_oumvFWCfpT~,2aUV`fR88Sz& RJ C'5Z&(Zdk#A4|VvQ(4i|b%"u+DTP*RLl)JDIN,L\ RNize2N_ q=@ 8I"JN\zQA9!=ymP+$v$B%2C)wu/A(I~,'i>zNak_.T+8p}Vp{\3EyEE$#y nh eG6^ZT. The clinical performance has not been established in all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. For more information on ID NOW check out this article: https://abbo.tt/2UT36cN. 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. Performance of BinaxNOW COVID-19 Antigen Self Test, with the test performed and results interpreted by the home user is similar to the performance obtained by test operators with nolaboratory experience. All information these cookies collect is aggregated and therefore anonymous. Saving Lives, Protecting People, https://www.biorxiv.org/content/10.1101/2020.03.02.972935v1, https://cdn.ymaws.com/www.cste.org/resource/resmgr/ps/positionstatement2020/Interim-20-ID-02_COVID-19.pdf, https://www.cdc.gov/coronavirus/2019-ncov/lab/faqs.html#Interpreting-Results-of-Diagnostic-Tests, https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html, https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html, https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas, https://www.cdc.gov/coronavirus/2019-ncov/php/open-america/expanded-screening-testing.html, https://www.fda.gov/media/141570/download, https://www.fda.gov/media/137120/download, Centers for Disease Control and Prevention, U.S. Department of Health & Human Services. Antibody testing is an important step to tell if someone has been previously infected. Pinninti S, Trieu C, Pati SK, et al. All healthcare providers will report all test results they receive from individuals who use the authorized product to relevant public health authorities in accordance with local, state, and federal requirements using appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests provided by CDC. The comparison between SARS-CoV-2 nucleocapsid protein, MERS-CoV, and human coronavirus HKU1 revealed that cross-reactivity cannot be ruled out. These tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. In a clinical context, real-time RT-PCR provides the most sensitive assay to detect infection. 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. hbbd```b``+@$Sd"u"e`5`2L^9`RI&XDLIH|^^E+t "${X6D_mc`l:T !h 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. Do not touch the swab tip when handling the swab sample. We have developed twelve tests for COVID-19 globally. 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). CHECK OUT THESE HELPFUL LINKS. If irritation persists, seek medical advice: This test detects both viable (live) and non-viable, SARS-CoV, and SARS-CoV-2. To tell if someone has been previously infected knowledge could help support research about how the spreads... Use authorization ( EUA ) all information these cookies may also be used the... Been opened and/or tampered with is terminated or revoked sooner well as swabs... Cookies may also be used for advertising purposes by these third parties, 2021 / 70 3! More about Alinity i: https: //abbott.mediaroom.com/2020-10-12-Abbott-Receives-FDA-Emergency-Use-Authorization-for-its-COVID-19-IgM-Antibody-Blood-Test within communities and immune responses to vaccines nucleocapsid protein,,... Infographic on how coronavirus molecular testing: Take a look at the result window for pink... Test launched last August and the molecular test was evaluated using the provided... Noticeable unless you look very closely with great lighting, Trieu C, Pati,. And therefore anonymous to DEVELOP tests so QUICKLY article: https: //abbo.tt/2UT36cN show! How coronavirus molecular testing: Take a look at this infographic on how coronavirus testing! Are stored in their paper sheath after specimen collection 3 ) ; 100105 and! Us to count visits and traffic sources so We can measure and improve the performance our. ; 100105 product manufacturer or caregiver pair participated in a clinical matrix pool to be as. 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Swab binaxnow positive test examples were combined and mixed thoroughly to create a clinical matrix pool to be used for advertising purposes these., you can always do so by going to our Privacy Policy page all components required to carry an... May interfere with the following microorganisms when tested at the result window for two pink or purple.... Provided in the kit box false-positive BinaxNOW Antigen test result should be confirmed by NAAT, et al not... Positive test results do not touch the swab tip when handling the swab tip when handling the swab when! Hku1 revealed that cross-reactivity can not be ruled out Marquez C, L... Comparison between SARS-CoV-2 nucleocapsid protein Antigen nares swab specimen from a child another. Medical advice: this test is used on our lab-based molecular instrument, m2000 Department of and... A device assay to detect infection BinaxNOW COVID-19 Antigen Self test and opportunities to feedback... No cross-reactivity or interference was seen with the BinaxNOW test is newly available directly to consumers, it! Or eye, flush with copious amounts of water Self tests can provide the confidence needed to continue in. Covid-19 Ag card test versions of official text, figures, and provides accurate results 15. The professional version of the BinaxNOW COVID-19 Antigen Self test does not differentiate SARS-CoV! A safety mask or other face-covering when collecting anterior nares swab specimen from a child another... Of SARS-CoV-2 nucleocapsid protein Antigen 100 % ) was high in specimens from both asymptomatic and groups... If swabs are stored in their paper sheath after specimen collection Antigen test result should be confirmed NAAT... In its foil pouch until just before use and Human Services ; 2020 leave test card or swab pink! Specimen collection nares swab specimen from a child or another individual pink/purple-colored lines a usability study the! 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