Fact Sheet for Healthcare Providers, Updated December 16, 2020. The User follows instructions for Patient testing as outlined in the package insert and BinaxNOW COVID-19 Ag Card Procedure Card: . For BinaxNOW, it's between 35.6 and 86 F and the test should be kept within this range. Perform the BinaxNOW COVID-19 Ag Card test, following the package insert instructions. Antigen covid tests in stock. This over-the-counter home test is . Store between 35.6-86 F (2-30 C) until use. The patient sample is inserted into the test card through the bottom hole of the swab well, and 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. For any questions pertaining to the BinaxNOW COVID-19 Ag Card or NAVICA, please contact the Abbott Technical Services Team at 1-800-257-9525 between 8 a.m and 8 p.m. EST Monday-Friday or email ts.scr@abbott.com. DO NOT touch the card If the test is conducted properly, the control line will change from blue to pink. a product inset and the reagent packaged in either a dropper bottle or break off vial. BINAXNOW COVID-19 Ag Card Home Test: a breakthrough antigen test . Hovering 1/2 inch above the TOP HOLE, slowly add 8 DROPS to the TOP HOLE of the . Abbott Laboratories emerged early on in the pandemic as a leading test maker for the virus that causes COVID-19.Now, the company is going on the defensive after The New York Times reported Friday that the company instructed workers at its Westbrook, ME-based factory to discard materials used for making its rapid COVID-19 test, the BinaxNOW.. Hold Extraction Reagent bottle vertically. Product Name: BinaxNOW COVID-19 Antigen Self Test (2 test for serial testing) Explanation: A simple test for COVID-19 infection detection, with quick results just at your home. BinaxNow Covid-19 Antigen Self Test BINAXNOW COVID-19 AG CARD HOME TEST (PN 195-100) - INSTRUCTIONS FOR USE . BinaxNOW COVID-19 Ag Card kits contain a positive control swab and sterile swabs that can be used as a negative control. - +. BinaxNow COVID-19 Antigen Self Test . All test components should be at room temperature . The 15-minute BinaxNOW COVID-19 Ag Card Home Test is a complete at-home solution to rapid COVID-19 testing. 120007069 v01 09/20 BinaxNOW . Abbott . The BinaxNOWTM COVID-19 Ag Card is a lateral flow immunoassay intended for the qualitative . Abbott Labs Binax NOW rapid COVID antigen test contains a chemical reagent classified by the EPA as a Category I toxin known as sodium azide. Abbott BinaxNOW COVID-19 Ag Card Home Test, Enabled by eMed, utilizes a digital platform to virtually guide the user through the test process from beginning to end. Procedure for BinaxNOW Swab Controls: Open the test card just prior to use, lay it flat, and perform assay as follows. to the . Once the drops have been placed in the well, the swab should be placed in the BinaxNOW COVID-19 Ag Card immediately. 2. SELF-TEST KITS ADMINISTERED IN OTHER FORMAL WORKPLACES a. a bottle of extraction reagent, patient collection swabs, a silver-wrapped positive control swab, a blank swab to be . Note : This product is not returnable- all sales are final What's in BinaxNOW COVID-19 Ag Card box: 40 test cards 40 nasal swabs Positive control swab Reagent bottle Package insert Procedure card 40 patient COVID-19 Fact Sheets HCP COVID-19 Fact Shee Kits within the Box & Pallets Price 1 Pallet = (640 Box) = (6400 Kits) 289.99 (Per Box) 2 Pallets = (1280 Box) = (12800 Kits) 279.99 (Per Box . Test Card: 40 cards with test strips. Kit Details. . TM. Patient Samples require 6 drops of Extraction Reagent. The swab is rotated 3 times clockwise and the DO NOT . TOP HOLE . Each BinaxNOW Ag Tests comes in a test "Kit" which includes 40 individually wrapped cardboard, book-shaped hinged Test Cards containing the test strip, as well as 40 collection swabs, and one 10mL bottle of extraction reagent. Extraction Reagent (1): Bottle containing 10 mL of extractionreagent . Insert the nasal swab into the nostril exhibiting the most drainage or congestion Using gentle rotation, push the swab until resistance is met At the level of the nasal turbinates Less than one inch into nostril Rotate the swab 5 times or more against the nasal to the . of the swab well. 2 ct box . Contents: 2 BinaxNOW Covid-19 test cards; 2 nasal swabs; 2 reagent bottles. Used for CLIA waived laboratories, authorized personel. Show More Show Less. 22. of the swab well. Hovering 1/2 inch above the TOP HOLE, slowly add 8 DROPS to the top hole a. Discover the fast, proven and reliable COVID-19 antigen test that is readily available over-the-counter at retailers across the country. This rapid-result test is for personal use. This test has received FDA-EUA for self-testing without transporting the samples or results to a lab or etc. BinaxNOW COVID -19 Antigen Self Test instructions for use are provided as a paper copy within the test kit, available digitally via we bsite link . This test is a lateral flow immunoassay that is designed for the detection . About the Producer Abbott Diagnostics Scarborough Inc. DO NOT touch the card with the dropper tip while dispensing. Hold Extraction Reagent bottle vertically Hovering 1/2 inch above the . Accessed 12.21.2020 . . a product inset and the reagent packaged in either a dropper bottle or break off vial. Procedure for BinaxNOW Swab Controls . Nasal Swabs (2): Sterile swab for use with BinaxNOW COVID -19 Antigen Self Test . . Buy BinaxNOW CLIA Waived Online 40 Tests / Box. And we chose to store individual components, many of which have been in short supply during the pandemic - such as reagent bottles, cardboard packaging, swabs, nitrocellulose strips, and even paper labeling - so that we could have them in the event that we needed to scale back up, which is exactly what's happening now. Extraction Reagent (1): Bottle containing 7.5 mL of extraction reagent. . Use authorization only. The BinaxNOW COVID-19 test is a lateral flow test that detects the presence of protein antigens from SARS-CoV -2 in . BinaxNOW CLIA waived test for sale. Effective Date: 9/2020 | Revision Date: . Technical Support Advice Line Further information can be obtained from your distributor, or by contacting Technical Support on: US +1 800 257 9525 ts.scr@abbott.com 1. Directions For use under emergency. A: The test kit and the reagent should be stored between 2-30C (35-86F). then 6 drops of extraction reagent from a dropper bottle are added to the top hole of the swab well. Follow Steps 2 -4 of the Test Procedure shown. . Abbott BinaxNow AGCard 40 Pack 195-000 Box Contents: The contents below are per a box (40 Tests): Test Cards (40): A cardboard, book-shaped hinged test card containing the test strip. 1. . This test is authorized for non -prescription. Hold Extraction Reagent bottle vertically Hovering 1/2 inch above the . Note: Only partially used and unused reagent solution bottles provided in the Abbott BinaxNOW Self-Test Kits that contain reagent must be managed as HW in Germany and Italy only, as described in Paragraph 2. The patient sample is inserted into the test card through . Hold Extraction Reagent bottle vertically hovering inch above the TOP HOLE, slowly add 8 DROPS to the TOP HOLE of the swab well. The BinaxNOW COVID-19 Ag Card kit is stable until Detection of BA 2. Kits must be stored at 2-30C. eMed's test includes a verified lab report in 15 minutes, online 24 . Please reach out to Abbott directly. Through an exclusive agreement with Abbott, the eMed digital health platform provides greater access to BinaxNOW Home Test, the first virtually-guided, at-home COVID-19 rapid antigen test. This may contaminate the bottle. Insert sample or control swab into BOTTOM HOLE and firmly push upwards so that the swab tip is visible in the TOP HOLE. Store between 35.6-86 degrees F (2-30 . DO NOT touch the card with the dropper tip while dispensing. Hold Extraction Reagent bottle vertically. For use under emergency. PDF Instructions: English | Spanish Code of Federal Regulations Title 40 Chapter I Subchapter E Part 156 Subpart D 156.62 [11] BinaxNOW . 2 | P a g e Nasal Swabs (40): Sterile swabs for use with BinaxNOW COVID-19 Ag Card test BinaxNOW is the . Negative Control Swab: 1 each -individually wrapped for single use. . $440 for 40 Tests ($11 Per Test) MOQ: 40 Tests. For Use Under an Emergency Use Authorization (EUA) Only . 1990-2022, DocXellent, Inc 257 Main Street, Norwich Connecticut, USA 06360 www.docxellent.com | Login Help | Email Support Most Popular. touch the card with the dropper tip while dispensing. 8 DROPS. 1. BinaxNOW COVID-19 Reagent Safety Data Sheet This document has been prepared in accordance with the SDS requirements of the OSHA Hazard Communication Standard 29 CFR 1910.1200 2020 08 17 EN (English US) 6/6 SECTION 16: Other information This document has been prepared in accordance with the SDS requirements of the OSHA Hazard Communication . 2. 21. The state does not stock individual reagent bottles. BinaxNOW tests from federal allocation and must meet testing requirements issued by CMS based on county-level COVID-positivity rate. reagent from a dropper bottle are added to the top hole of the swab well. The BinaxNOW COVID-19 Antigen Self Test is only for use under the Food and Drug Administration's Emergency Use Authorization. of the swab well. BinaxNOW COVID-19 Ag Card, Abbott Diagnostics Scarborough, Inc. Nasal Swab. The BinaxNOW COVID-19 Ag Card Home Test is an immunochromatographic membrane assay that uses highly sensitive antibodies to detect SARS-CoV-2 nucleocapsid protein from nasal swab specimens. Positive Control Swab (1) : Non-infectious recombinant SARS-CoV-2 nucleocapsid antigen dried onto a swab . PATIENT INTERACTION: REQUISITION & SWABBING Swab the patient or have the patient to self-swab. Hold Extraction Reagent bottle vertically. STEP 1: Determine feasibility of using BinaxNOW COVID-19 cards for surveillance of infection with SARS-CoV-2 in teachers, other school staff, and school children. Do not touch anything including the card with the tip of the bottle. Fact Sheet for Healthcare Providers, Updated December 16, 2020. Use only the correct volume of extraction reagent: no more, no less. For patient samples, add 6 drops. Hold the BinaxNOW COVID-19 Ag reagent vertically inch above the top hole of the card Do not touch the tip of the reagent bottle to the card. Extraction Reagent One2M sodium nitrite with Tween 20; Extraction Reagent Two-0.125M acetic acid with Tween 20; Sterile SwabsDesigned for use in the NOW Strep A Test; Positive Control Swab-Heat inactivated Streptococcus pyogenes Group A dried onto swab; Order Info. Each box has 40 tests, but only ONE reagent bottle so you cannot split a box between multiple locations. Narrow mouth reagent bottle-Taizhou Sun Trine Biotechnology Co. LTD products produced include Preservation tube series, Deep well plate, Narrow mouth reagent bottle, Square media bottle, Pipette pump and other cell culture consumables and virus sampling consumables. 8 DROPS . DO NOT touch the card with the dropper tip while dispensing. Abbott BinaxNOW Point of Care Test (40 Tests/Kit) ($11 per test) quantity. In Stock. Open the reagent bottle (or disposable dropper) and apply the fluid to the TOP HOLE on the righthand side of the opened test card. Extraction Reagent (2): Bottle containing <1 mL of extraction reagent . 1. BinaxNOW. A nasopharyngeal swab is an acceptable swab for use with the BinaxNOW COVID-19 Ag Card. 1 x 7.5 mL extraction reagent bottle with reagent, 40 sterile nasal swabs, 1 positive control swab containing non-infectious recombinant SARS-CoV-2 nucleocapsid antigen, 1 negative control swab, 1 product insert, 1 procedure card: More Info At www.fishersci.com First Comp Agent Login The Abbott reagent does not come in contact with the patient sample specimen. 3. Samples eluted in this solution are not suitable for culture. Swabs in the kit are approved for use with BinaxNOW TM COVID-19 Ag Card. Point Of Care Use. Collecting Nasal Swab 1. Hovering 1/2 inch above the TOP HOLE, slowly add 6 DROPS to the TOP HOLE of the swab well. 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 Test Cards, 2 Nasal Swabs, 2 Reagent Bottles. The BinaxNOW COVID-19 Antigen Self Test is intended for non-prescription self-use and/or, as applicable for an adult lay user testing another person aged 2 years or older in a non-laboratory setting. The BinaxNOW COVID-19 Ag Card is approved by the Food and Drug Administration (FDA) for use in the detection of COVID-19 in individuals who are suspected of COVID-19 . . Extraction Reagent Bottle. BINAXNOW COVID-19 Ag Card Home Test: a breakthrough antigen test . Extraction Reagent: bottle containing 7.5 mL of extraction reagent. Abbott BinaxNow Box Contents: The contents below are per a box (40 Tests): Test Cards (40): A cardboard, book-shaped hinged test card containing the test strip; Extraction Reagent (1): Bottle containing 7.5 mL of extraction reagent; Nasal Swabs (40): Sterile swabs for use with BinaxNOW COVID-19 Ag Card test Open the swab at the stick end. Travel covid test. CT Biotech DUNS number: 036643218. The BinaxNOW COVID-19 antigen card is intended for use for the qualitative detection of the SARS-coV-2 antigen from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. Onboard extraction allows swab to be directly inserted into test card Room temperature storage Includes: 40 cardboard, book-shaped hinged test cards with test strips 1 x 7.5 mL extraction reagent bottle with reagent 40 sterile nasal swabs 1 positive control swab Non-infectious recombinant SARS-CoV-2 nucleocapsid antigen 1 negative control swab Nasal swabs: 40 sterile, single use specimen sampling swabs. then 6 drops of extraction reagent from a dropper bottle are added to the top hole of the swab well. The BinaxNOW (TM) COVID-19 Ag Card is a covid 19 test kit made of disposable test strips, dispenser, sterile swabs, extraction reagent and both positive and negative swabs. Hovering 1/2 inch above the : TOP HOLE, slowly adds : 8 DROPS: to the : TOP HOLE: of the swab well. Hold Extraction Reagent bottle vertically Hovering 1/2 inch above the TOP HOLE, slowly add 8 DROPS to the TOP HOLE of the swab well. The BinaxNOW COVID -19 Ag 2 Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS -CoV-2. CT Biotech DUNS number: 036643218. Reliable. 2. BINAXNOW COVID-19 AG CARD (PN 195 -000) - INSTRUCTIONS FOR USE BinaxNOWTM COVID-19 Ag CARD . Live testing support from eMed Certified Guides ensures improved sample collection and confidence in results. Follow instructions for external controls. Each kit box contains 2 test cards, 2 nasal swabs and 2 reagent bottles. Details . Hovering 1/2 inch above the . BinaxNOW COVID-19 Ag Card, Abbott Diagnostics Scarborough, Inc. . . When used as intended, it is a highly accurate . DO NOT . Stable until the expiration dates marked on outer packaging and . 6 drops of extraction reagent from a dropper bottle are added to the top hole of the swab well. OPTIONAL SELF-REPORT: Capture your results in the NAVICA app for self reporting BinaxNOW COVID-19 Antigen Self Test from Abbott can be used to detect active infection, with or without symptoms. Negative Control Swab: The use of a sterile patient swab ensures appropriate . This test has received FDA-EUA for self-testing without transporting the samples or results to a lab or etc. Use authorization only. Hold Extraction Reagent bottle vertically. We show each step for using the BinaxNOW shallow nasal swab self test which gives COVID-19 test results after 15 minutes. Bulk Purchasing and Enterprise purchasing of at home covid tests. Open the test card just prior to use, lay it flat, and perform assay as follows. DO NOT touch the card . About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . Code of Federal Regulations Title 40 Chapter I Subchapter E Part 156 Subpart D 156.62 [11] BinaxNOW . Hold Extraction Reagent bottle vertically Hovering 1/2 inch above the TOP HOLE, slowly add 8 DROPS to the TOP HOLE of the swab well. www.binaxnow-selftest.abbott. TOP HOLE, slowly add . Buy BinaxNow At Home Covid test. . The participant sample is inserted into the test card through the bottom hole of . See results in just 15 minutes. Accessed 12.21.2020 . Support Contacts. 1. 8 DROPS . . Nasal Swabs (40): Sterile swabs for use with BinaxNOW COVID-19 Ag Card test. A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens. This kit is designed for anterior nasal samples, which should be taken by a medical professional. This BinaxNOW COVID test is the first FDA/EUA-authorized, virtually guided, COVID-19 rapid test with automated results reporting. Nasal Swabs (40): Sterile swabs for use with BinaxNOW. H overing 1/2 inch above the TOP HOLE, slowly add 6 DROPS to the TOP HOLE of the swab well. 2. to the . A: No, the card and reagent are not considered a potential hazard. BinaxNOW is not for use with water or any other foods or liquids. TOP HOLE . 4. Abbott BinaxNOW COVID-19 Ag Card . A small dropper bottle of an extraction reagent is included in the test kit, and only six drops of this fluid are used to prepare the test card. Sodium azide is included in a dropper bottle and is placed on a paper test card in the home test kits.