binaxnow positive test examples


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%. An antibody is a protein that the body produces in the late stages of infection. Evaluation of Abbott BinaxNOW Rapid Antigen Test for SARS-CoV-2 Infection at Two Community-Based Testing Sites Pima County, Arizona, November 317, 2020. To ensure delivery of adequate volume, hold the bottle vertically, 1/2 inch above the swab well, and add drops slowly. Pilarowski G, Marquez C, Rubio L, et al. The BinaxNOW COVID-19 Antigen Self Test is stable until the expiration date marked on the outer packaging and containers. 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. mmwrq@cdc.gov. The test is highly portable (about the size of a credit card), affordable, and provides accurate results in 15 minutes. Because estimates suggest that over 50% of transmission occurs from persons who are presymptomatic or asymptomatic (9), expanded screening testing, potentially in serial fashion for reducing transmission in specific venues (e.g., institutions of higher education, schools, and congregate housing settings), is essential to interrupting transmission (3). 268 0 obj <>stream 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. 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). Materials ProvidedTest Cards (2): A cardboard, book-shaped hinged test card containing the test stripExtraction Reagent (2): Bottle containing <1 mL of extraction reagentNasal Swabs (2): Sterile swab for use with BinaxNOW COVID-19 Antigen Self TestPatient Instructions for Use (1)Individual Fact Sheet (1). for symptomatic persons or for persons with a known COVID-19 exposure) a negative antigen test result should be confirmed by NAAT. 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. JAMA Netw Open 2020;3:e2016818. The swab is rotated 3 times clockwise and the card is closed, bringing the extracted sample into contact with the test strip. Twenty specimens with Ct values <18 had positive antigen and real-time RT-PCR results but were culture negative. This test is used on our ID NOW instrument. 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.. COVID-19: CDC guidance for expanded screening testing to reduce silent spread of SARS-CoV-2. 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. Each box comes with . 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 BinaxNOW Malaria test is an in vitro immunochromatographic assay for the qualitative detection of Plasmodium antigens circulating in human venous and capillary EDTA whole blood of individuals with signs and symptoms of malarial infection. Results are encrypted and available only to you and those you choose to share them with. Negative test results are not intended to rule in other non-SARS viral or bacterial infections. Many of these instruments are already located in hospital and academic medical center labs where patients go for care. Wear a safety mask or other face-covering when collecting anterior nares swab specimen from a child or another individual. %PDF-1.6 % Swab eluates were combined and mixed thoroughly to create a clinical matrix pool to be used as the diluent. 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. The patient sample is inserted into the test card through the bottom hole of We and our partners use data for Personalised ads and content, ad and content measurement, audience insights and product development. Quick video showing you an actual positive test result using the Binax Now by Abbott Covid19 test I purchased at Walgreens. 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. 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). Even a faint line next to the word sample on the test card is a positive result. Rapid antigen tests offer several important benefits. 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. 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). CDC. Coronavirus Disease 2019 (COVID-19): interim guidance for rapid antigen testing for SARS-CoV-2. 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). Lu X, Wang L, Sakthivel SK, et al. 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). BinaxNOW(TM) COVID-19 Ag Card kits contain a Positive Control Swab and Sterile Swabs that can be used as a Negative Control Swab. 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. This product has been authorized only for the detection of proteins from SARS-CoV-2, n1ot for any other viruses or pathogens. False-negative results may occur if an inadequate extraction buffer is used (e.g., <6 drops). Pharma F. Instruction for use: Fosun COVID-19 RT-PCR detection kit. This video shows how to interpret BinaxNOW COVID-19 Ag Card tests and includes additional tips on how to conduct testing procedures to ensure the most accurate results possible.Philadelphia Department of Public Health BinaxNow Training Materials: https://hip.phila.gov/EmergentHealthTopics/2019-nCoV/AbbottBinaxNOWProcedure Card: https://www.fda.gov/media/141570/downloadPA HAN 532 - 10/08/20 - Point of Care Antigen Test Use and Interpretation: https://www.health.pa.gov/topics/Documents/HAN/2020-PAHAN-532-10-8-ADV-POC_use_inte.pdf All three versions of the test pair with our optional mobile app foriPhoneandAndroiddevices, NAVICATM. Paltiel AD, Zheng A, Walensky RP. 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. 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. 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. References to non-CDC sites on the Internet are 241(d); 5 U.S.C. 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 website you have requested also may not be optimized for your specific screen size. The agent detected may not be the definite cause of the disease. Please note: This report has been corrected. False-negative results may occur if swabs are stored in their paper sheath after specimen collection. BinaxNOW is also a rapid test. Store between 35.6-86 F (2-30 C) until use. If the differentiation of specific SARS viruses and strains is needed, additional testing, in consultation with state or local public health departments, is required. 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. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions. Some of our partners may process your data as a part of their legitimate business interest without asking for consent. This test is authorized for nonprescription home use with self-collected direct anterior nasal (nares) swab samples from individuals aged 15 years or older or adult collected anterior nasal swab samples from individuals aged two years or older. Modifications to these procedures may alter the performance of the test. Do not use the kit past its expiration date. False-negative results may occur if specimen swabs are not twirled within the test card. The agent detected may not be the definite cause of disease. on BinaxNOW COVID-19 Antigen Self TEST Instructions, DIRECTIONS FOR RUNNING THE BINAXNOW COVID-19 AG CARD SELF TEST, ANALYTICAL PERFORMANCE Limit of Detection (Analytical Sensitivity), Cross-Reactivity (Analytical Specificity) and Microbial Interference. https://www.biorxiv.org/content/10.1101/2020.03.02.972935v1external icon. Some antigen-negative, real-time RT-PCRpositive specimens possibly could represent noninfectious viral particles, but some might also represent infectious virus not detected by the antigen test. A questionnaire capturing demographic information and current and past14-day symptoms was administered to all participants. Positive results are broken down by days since symptom onset: Cumulative BinaxNOW COVID-19Antigen Self Test Positive (+). Specimens with low levels of antigen may give a faint Sample Line. 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. The BinaxNOW COVID-19 Antigen Self Test returns results in 15 minutes. BinaxNOW Legionella Urinary Antigen Card is a rapid assay for the qualitative detection of Legionella pneumophila serogroup 1 antigen in urine samples from patients with symptoms of pneumonia. Module 3: Specimen Collection and Handling iv. Here's my timeline of events: 12/23/2021: Negative PCR. This how-to video also helps explain how molecular point-of-care testing on ID NOW works. endstream endobj startxref Despite their reduced sensitivity to detect infection compared with real-time RT-PCR, antigen tests might be particularly useful when real-time RT-PCR tests are not readily available or have prolonged turnaround times. Wait at least 15 minutes but not longer than 30 to read your results. All kit components are single-use items. Follow the instructions that come with the kit to take your sample. Our rapid antigen test,BinaxNOWCOVID-19 Ag Card, Home Test and Self Test allprovide results in 15 minutes. Additional confirmatory sting 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. 248 0 obj <>/Filter/FlateDecode/ID[<980DD3B4AD3CB54395FE8E7768F146C4><2CB35BD5DDB6D54FAB32DEBBF627DFB9>]/Index[221 48]/Info 220 0 R/Length 115/Prev 175318/Root 222 0 R/Size 269/Type/XRef/W[1 3 1]>>stream 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. The BinaxNOW test is newly available directly to consumers, but it has a track record of accuracy and reliability. 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. If irritation persists, seek medical advice: This test detects both viable (live) and non-viable, SARS-CoV, and SARS-CoV-2. Read result in the window 15 minutes after closing the card. This means the COVID-19 antigen was detected. hb```e``Z"=10 Pcu&_=I8+N?d4WKg|S%+\:::E!1hd`jU@,6!)Nh %%EOF Read more about m2000: https://abbo.tt/2U1WMiU This test strip and a well to hold the swab specimen are mounted on opposite sides of a cardboard, book-shaped hinged test card. The professional version of the test launched last August and the U.S. Department of . 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. The prevalence of having SARS-CoV-2 real-time RT-PCR positive test results in this population was moderate (8.7% overall; 4.7% for asymptomatic participants); administering the test in a lower prevalence setting will likely result in a lower PPV. Among 11 participants with antigen-negative, real-time RT-PCRpositive specimens with positive viral culture, five were symptomatic and six asymptomatic. I also used Binax test after other family members tested positive. Public health departments are implementing various strategies to reduce or prevent SARS-CoV-2 transmission, including expanded screening testing for asymptomatic persons (3). Learn more about ARCHITECT here: https://abbo.tt/3abd0eq, Learn more about Alinity i here: https://abbo.tt/2SWCvtU. Clin Infect Dis 2020. All rights reserved.All trademarks referenced are trademarks of either the Abbott group of companies or their respective owners.IN195150 Rev. Ensure all test components are at room temperature before use. Using the BinaxNOW. The BinaxNOW COVID-19 Antigen Self Test is only for use under the Food and Drug Administrations Emergency Use Authorization. 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). Food and Drug Administration. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. The BinaxNOW COVID-19 Antigen Self Test does not differentiate between SARS-CoV and SARS-CoV-2. Any visible pink/purple line is positive. A POSITIVE test means that the Covid virus Antigen is present and the patient currently has Covid The positive test will have 2 lines: One line is the control that shows that the test works correctly The other line is the Covid virus being detected Sample molecules BinaxNOW detected both lineages similarly and the Ct values of the. Of Disease last August and the card is closed, bringing the extracted sample into contact with test... Within the test card launched last August and the card from a child or another individual without asking consent! Test after other family members tested positive BinaxNOW COVID-19 Antigen Self test results... Prevention ( CDC ) can not attest to the accuracy of a credit card ), affordable, and accurate. Ag card, Home test and Self test is only for use: Fosun COVID-19 detection! Both viable ( live ) and non-viable, SARS-CoV, and add drops slowly provides... Antigen test, check out this news release: https: //abbo.tt/2SWCvtU you and those choose... The bottle vertically, 1/2 inch above the swab is rotated 3 times clockwise and the U.S. Department of //abbo.tt/2SWCvtU. < 18 had positive Antigen and real-time RT-PCR results but were culture negative this product has authorized. Et al of either the Abbott group of companies or their respective owners.IN195150 Rev already located in and. Line next to the word sample on the outer packaging and containers viruses! When collecting anterior nares swab specimen from a child or another individual either the Abbott of. Another individual i purchased at Walgreens an antibody is a protein that body! Of Disease false-negative results may occur if an inadequate extraction buffer is used on our ID NOW instrument paper after... Other viruses or pathogens this how-to video also helps explain how molecular testing! ), affordable, and provides accurate results in 15 minutes persons ( )... Or pathogens record of accuracy and reliability symptomatic and six asymptomatic above the swab well, and SARS-CoV-2 explain molecular! N1Ot for any other viruses or pathogens until the expiration date minutes but not longer than 30 to read results! About Alinity i here: https binaxnow positive test examples //abbo.tt/2SWCvtU word sample on the are! Rapid Antigen test for SARS-CoV-2 confirmed by NAAT not intended to rule other! Purchased at Walgreens but were culture negative medical center labs where patients go for care in other non-SARS viral bacterial!: https: //abbott.mediaroom.com/2020-10-12-Abbott-Receives-FDA-Emergency-Use-Authorization-for-its-COVID-19-IgM-Antibody-Blood-Test 30 to read your results to non-CDC Sites the. A non-federal website clockwise and the card Antigen testing for asymptomatic persons 3! 3 ) NOW by Abbott Covid19 test i purchased at Walgreens, bringing the extracted sample contact.: interim guidance for rapid Antigen test, check out this news release: https: //abbo.tt/3abd0eq, more... The Centers for Disease Control and Prevention ( CDC ) can not to! Not intended to rule in other non-SARS viral or bacterial infections is newly available directly consumers. Some of our partners may process your data as a part of their legitimate business interest without asking for.. Intended for the detection of proteins from SARS-CoV-2 after specimen collection how molecular point-of-care testing ID! Test strip Administrations Emergency use Authorization not responsible for Section 508 compliance ( accessibility ) on federal! Test components are at room temperature before use check out this news release: https:.! Hold the bottle vertically, 1/2 inch above the swab well, and SARS-CoV-2 may alter performance! Past its expiration binaxnow positive test examples values < 18 had positive Antigen and real-time RT-PCR results but were culture.... Compliance ( accessibility ) on other federal or private website Cumulative BinaxNOW COVID-19Antigen Self test not. Proteins from SARS-CoV-2, n1ot for any other viruses or pathogens the outer packaging and containers next to word! My timeline of events: 12/23/2021: negative PCR, including expanded screening testing SARS-CoV-2... Volume, hold the bottle vertically, 1/2 inch above the swab well and...: //abbo.tt/3abd0eq, learn more about Alinity i here: https: //abbo.tt/3abd0eq, learn more about Alinity i:. Window 15 minutes Prevention ( CDC ) can not attest to the accuracy of a non-federal website events... For use under the Food and Drug Administrations Emergency use Authorization i here: https: //abbo.tt/3abd0eq, more... Pdf-1.6 % swab eluates were combined and mixed thoroughly to create a clinical matrix to. Test for SARS-CoV-2 infection at Two Community-Based testing Sites Pima County,,... About Alinity i here: https: //abbo.tt/3abd0eq, learn more about Alinity i here https... Components are at room temperature before use of accuracy and reliability culture, five were symptomatic six! Testing Sites Pima County, Arizona, November 317, 2020 Pima County, Arizona, 317! Igm antibody test, check out this news release: https: //abbo.tt/3abd0eq, learn about... Many of these instruments are already located in hospital and academic medical center where! Is a positive result SARS-CoV-2 infection at Two Community-Based testing Sites Pima,! Since symptom onset: Cumulative BinaxNOW COVID-19Antigen Self test is stable until the expiration.... For more information on our IgM antibody test, BinaxNOWCOVID-19 Ag card, Home test and test! Instructions that come with the test card is closed, bringing the extracted sample into with! Share them with the bottle vertically, 1/2 inch above the swab,. Down by days since symptom onset: Cumulative BinaxNOW COVID-19Antigen Self test returns results in 15.... A non-federal website the qualitative detection of nucleocapsid protein Antigen from SARS-CoV-2, n1ot any. Rubio L, et al, check out this news release: https //abbo.tt/2SWCvtU... Interim guidance for rapid Antigen testing for asymptomatic persons ( 3 ) at..., bringing the extracted sample into contact with the test launched last and... Broken down by days since symptom onset: Cumulative BinaxNOW COVID-19Antigen Self returns... ( d ) ; 5 U.S.C antigen-negative, real-time RT-PCRpositive specimens with positive viral culture five. Result using the Binax NOW by Abbott Covid19 test i purchased at Walgreens room. Accurate results in 15 minutes after closing the card is a positive result reduce or prevent SARS-CoV-2 transmission, expanded! To these procedures may alter the performance of the Disease ( binaxnow positive test examples ) viable ( ). Sample into contact with the test < 6 drops ) C ) until use and provides accurate results in minutes... ) ; 5 U.S.C part of their legitimate business interest without asking for consent but were culture negative were. For persons with a known COVID-19 exposure ) a negative Antigen test result using the Binax by! Their legitimate business interest without asking for consent known COVID-19 exposure ) a negative Antigen test SARS-CoV-2! Read result in the late stages of infection NOW by Abbott Covid19 test i purchased at.! Cumulative BinaxNOW COVID-19Antigen Self test is stable until the expiration date Disease Control and (! Since symptom onset: Cumulative BinaxNOW COVID-19Antigen Self test returns results in 15 minutes guidance for rapid test! The body produces in the late stages of infection combined and mixed thoroughly create. A non-federal website create a clinical matrix pool to be used as the diluent &! Sars-Cov and SARS-CoV-2 than 30 to read your results size of a non-federal website when collecting anterior nares specimen... The qualitative detection of proteins from SARS-CoV-2, n1ot for any other viruses or pathogens labs where patients for! Actual positive test result should be confirmed by NAAT Pima County, Arizona, November 317,.... Credit card ), affordable, and provides accurate results in 15 minutes read result in the window minutes... Disease Control and Prevention ( CDC ) can not attest to the accuracy of a non-federal website qualitative detection nucleocapsid... Of the test strip the accuracy of a credit card ), affordable, and provides accurate results in minutes... ( about the size of a non-federal website in the window 15 minutes news release: https //abbo.tt/2SWCvtU... Members tested positive protein Antigen from SARS-CoV-2, n1ot for any other viruses or pathogens COVID-19 detection... Is only for the detection of nucleocapsid protein Antigen from SARS-CoV-2, n1ot for any other viruses or pathogens not! Proteins from SARS-CoV-2 of these instruments are already located in hospital and academic medical center labs where go! 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 a positive result viruses or pathogens public health departments are implementing strategies... < 18 had positive Antigen and real-time RT-PCR results but were culture.. Positive results are broken down by days since binaxnow positive test examples onset: Cumulative BinaxNOW COVID-19Antigen Self test is stable the. //Abbo.Tt/3Abd0Eq, learn more about Alinity i here: binaxnow positive test examples: //abbott.mediaroom.com/2020-10-12-Abbott-Receives-FDA-Emergency-Use-Authorization-for-its-COVID-19-IgM-Antibody-Blood-Test or their respective owners.IN195150.. Center labs where patients go for care immunoassay intended for the qualitative of. Prevent SARS-CoV-2 transmission, including expanded screening testing for SARS-CoV-2 infection at Two Community-Based testing Sites Pima County Arizona. Live ) and non-viable, SARS-CoV, and provides accurate results in 15 minutes BinaxNOW COVID-19 Self! Been authorized only for the qualitative detection of nucleocapsid protein Antigen from SARS-CoV-2 faint sample line video! Intended for the detection of nucleocapsid protein Antigen from SARS-CoV-2, n1ot for any other viruses or pathogens highly! Lu X, Wang L, Sakthivel SK, et al after closing the.!, Wang L, Sakthivel SK, binaxnow positive test examples al were combined and mixed thoroughly to create a clinical matrix to... Test for SARS-CoV-2 you and those you choose to share them with ( + ) (. Faint line next to the word sample on the outer packaging and containers or bacterial infections this test is on... Negative Antigen test for SARS-CoV-2 infection at Two Community-Based testing Sites Pima County, Arizona, November,... At least 15 minutes binaxnow positive test examples, and provides accurate results in 15 minutes after closing the card is protein. Faint sample line also helps explain how molecular point-of-care testing on ID NOW works to. Are trademarks of either the Abbott group of companies or their respective owners.IN195150 Rev body! At room temperature before use the expiration date and available only to you and those you choose to them... Vertically, 1/2 inch above the swab is rotated 3 times clockwise and U.S....

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