ID NOW IS A COMPLETE GAME-CHANGER FOR TESTING. Preform a Quality Control Test and/or patient test on self/coworker with Super User Supervision 8. This test has not been FDA cleared or approved. ID NOW COVID-19 Testing Questions Answered | Abbott U.S. 2023 Abbott. ID NOW uses a liquid solution designed to deactivate the virus and break it apart to expose the RNA. 2. 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. Not all products are available in all regions. ID NOWis a rapid, instrument-based, isothermal system for the qualitative detection of infectious diseases. PDF VDH Abbott BinaxNOW Train the Trainer - Virginia Department of Health Explore fellowships, residencies, internships and other educational opportunities. %%EOF PDF Abbott ID NOW - Training Procedure for Symptomatic Testing - Yukon The ID NOW COVID-19 assay is now available for use on the ID NOW platform under U.S. Food and Drug Administration Emergency Use Authorization (EUA). ID NOW PERFORMANCE, FROM RESEARCHERS IN THE FIELD. hb``b``101G3020cdeY99E)3~H310pf ce`LqX` ! O ! b. %PDF-1.5 lcKjs.&g$=HP^CGB*oWSXu4V?Tjilp?yTT)#JL-dyB~&%fomy:qIJ. collected, please refer to our Privacy Policy. 4485 0 obj <> endobj If your non-waived laboratory is . Z{sB[u.j(t\G#Hu F+Aal+ 5N# J FzPxT, JdA5dr.u+%c6l+"jQP) #u(FJ #uVDHi"zDLQyhE.3 &ztxFJ)1`l5td#z$ z%HJG R{8djdlRg U]S[W_PX"YHE.ud]$"YH6E)MldS$"gdF3\|NMVEw^:&V?jr+8^"MB"r;*i(. POC:Piccolo Electrolyte Panel Reagent/QC Log: . a. %%EOF GDPR Statement (last updated: May 2018) | California Transparency in Supply Chains Act | Declaration for California Compliance Law. Testing location should be reviewed to ensure minimal traffic for testing location, separate room if possible, location should be near asink and eyewashstation. POC Abbott ID Now QC Log: 2/18/2021: POC HemoCue Hgb QC Log (Form will be sent by POC with QC Material.) Procedure Specimen Collector Competencies Specimen Collectors are required to complete the following competencies to ensure they have a basic understating of the Abbott Binax Nowtm COVID-19 test: 1. BinaxNOW COVID-19 . 821 0 obj <>/Filter/FlateDecode/ID[<328C757F408E7C41BFC7E242F2973DD0>]/Index[798 87]/Info 797 0 R/Length 112/Prev 216100/Root 799 0 R/Size 885/Type/XRef/W[1 3 1]>>stream Close and securely seal the card. See themost recent editionsof our newsletter. They have been authorized by the FDA under an emergency use authorization for use by authorized laboratories. Frequently Asked Questions (FAQs), Abbott i- STAT . Check with your local representative for availability in specific markets. Learn all about the ID NOW Instrument and installation by following these video modules. 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. %%EOF Standard Universal Precautions should be adhered toat all times, Office of Clinical and Preventive Services - 08N34 A&B, Office of the Director/Congressional and Legislative Affairs Staff - 08E37A, Office of the Director/Diversity Management and Equal Employment Opportunity Staff - 08E61, Office of the Director/Executive Secretariat Staff - 08E86, Office of the Director/Public Affairs Staff - 08E73, Office of Direct Service and Contracting Tribes - 08E17, Office of Environmental Health and Engineering - 10N14C, Office of Information Technology - 07E57B, Office of Resource Access and Partnerships - 10E85C, Office of Urban Indian Health Programs - 08E65C, U.S. Department of Health and Human Services, Exit Disclaimer: You Are Leaving www.ihs.gov, National Laboratory Professionals Council (NLPC), 120006456 v01 ID NOW COVID-19 CLSI More Packet, Shared templates - SOP, Training, and other implementation documents, Occupational Safety and Health Administration (OSHA), MMWR Good Laboratory Practices for CLIAWaived sites, 120004872 v04 ID NOW Performance Best Practices, Abbott ID NOW COVID19 Test Validation Form, COVID 19 Competency Assessment Mod High Complex, SCRSDS-0196 v4 Alere and ID NOW Positive and Negative Controls, SCRSDS-0275 v1 ID NOW COVID-19 Test Base SDS-US, TB000041 v1.0 Important Product Notice ID NOW COVID, Barcode Label COVID_19 QC Patients Results Log, ID NOW COVID-19 Technical Brief April 2020-Sample Type Labeling UpdateV2, SCRSDS-0274 v1 ID NOW COVID-19 Elution Buffer SDS-US. Reliable test results depend on many factors, conformity to test design. FAQ # Description of Change . At remote locations, testing is done using an ID NOW analyzer 2. Our uniqueID NOWisothermal nucleic acid amplification technology provides molecular results in just minutes, allowing you to make effective clinical decisions sooner. INVESTORS. The ID NOW platform combines the benefits of speed and accuracy for the fastest molecular results in the market. Perform the testing using all 9's as the patient ID. DIFFERENCE-MAKING INNOVATION. Enter your email address to receive Abbott Edge. EUA supports flexible near patient testing environments. Timely results enable healthcare professionals to make appropriate and more efficient treatment and infection control decisions. 2 0 obj ! Why is it important to make sure the patient ID band is replaced when a patient is transferred in from other facility? 1. Laboratory Requirements | COVID-19 - Laboratory Medicine Positive and Negative Control Swabs. 4 0 obj The products and information contained herewith may not be accessible in all countries, and Abbott takes no responsibility for such information which may not comply with local country legal process, regulation, registration and usage. Isolation Precautions in Healthcare Settings Alternatively, click YES to acknowledge and proceed. The intuitively designed ID NOW instrument can have a positive impact in any healthcare setting. ID Now Test Base Safety Data Sheet. Specimen Collection, World Health Organization (WHO) Coronavirus (COVID-19), U.S. Food & Drug Administration 0 Let us help you navigate your in-person or virtual visit to Mass General. 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. Pediatrics Vol. The SOP should encompass information pertaining to instructions for reporting and documenting results, notification of positive results, appropriate PPE usage and cleaning procedures, quality control, etc. ID NOW is a leading molecular point-of-care platform in the United States, trusted by hospitals, physician offices, and urgent care clinics nationwide. COVID-19 RAPID TESTS: READY WHEN EVERY MINUTE COUNTS. Bonner, A.B. Abbott - A Leader in Rapid Point-of-Care Diagnostics. b. Abbott ID Now - Training/Orientation Trainee: Date of Training: Test Name: COVID-19/SARS CoV-2 : Trainer: This document is used to verify that the Trainee responsible for running the COVD-19 test has reviewed the Online Training modules and received sufficient training to include the following: PORTABLE, RELIABLE AND RAPID, WITH RESULTS ON THE SPOT, ALL IN THE %PDF-1.6 % RUH Pathology Services | Point of Care Testing It is a high critical result. endstream endobj startxref <8uFy6]Z+4\``wty/YPXQ.Fy5*Wv=?iC{u^nje(}a,_oMp1=;g=P#g|NerC?[=[2UraNy6?S\0CI~'+xMy5 SoToxa Mobile Test System. %PDF-1.5 % Learn all about the ID NOW Instrument and installation by following these video modules. Find out more about this innovative technology and its impact here. We are committed to providing expert caresafely and effectively. 1 0 obj 1. We have remained at the forefront of medicine by fostering a culture of collaboration, pushing the boundaries of medical research, educating the brightest medical minds and maintaining an unwavering commitment to the diverse communities we serve. Specimen handling and collection training 7. POC I-STAT Training/Competency Checklist: 4/15/2021: POC Bassett Clinics and Tests Chart. PDF Table of Contents - Yukon Rotate (twirl) swab shaft 3 times CLOCKWISE (to the right). ID NOW COVID-19. SOP/POCT/69/2 In the context of an evolving digitally-oriented library and/or information science (LIS) discipline and framed by Andrew Abbott's Chaos of Disciplines theory, this article presents an epistemological overview of evolving competency requirements for a global digital information environment and the implications of this for future LIS education. A simple, reliable and secure connectivity and reporting solution, offering ID NOW COVID-19 test reporting within 24 hours for decentralized environments to help you manage data for CARES Act requirements without infrastructure burden. ID NOW COVID-19 and ID NOW COVID-19 2.0 have not been FDA cleared or approved. <>/XObject<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 720 540] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> DOCX Abbott BinaxNOW Testing Competency - Training Checklist endobj <> Abbott: ID NOW COVID-19 Test -Clinical Procedure for Symptomatic Testing-Policy and Procedure Date Effective: June 24, 2021 . 884 0 obj <>stream 10/19/2020. PDF Barcode Label COVID 19 QC Patients Results Log - Indian Health Service ID NOW COVID-19 2.0. hb```b``Vb`e``fd@ A+&fZlU7. For i-STAT test cartridge information and intended use, refer to individual product pages or the cartridge information (CTI/IFU) in the i-STAT Support area. DOC COPY - Royal United Hospital GoHealth Urgent Care: Rapid test kept COVID-19 patient from boarding plane. REDUCING RISK BY DIAGNOSING WITH RELIABLE RAPID TEST. Information for Laboratories A Leader in Rapid Point-of-Care Diagnostics. Our unique ID NOW isothermal nucleic acid amplification technology provides molecular results in just minutes, allowing you to make effective clinical decisions sooner. Do not remove swab. Laboratory Biosafety _____The patient test result displays 423mg/dl. Facility will conduct COVID-19 antigen testing with the Abbott BinaxNOW COVID-19 Tests as outlined by the manufacture, CMS, CDC and FDA. Here are the instructions how to enable JavaScript in your web browser, One Abbott solution for patient testing, result capture and data reporting, Isolation Precautions in Healthcare Settings, Emergency Use Authorization of Medical Products and Related Authorities. ID NOW is a rapid, instrument-based, isothermal system for the qualitative detection of infectious diseases. As long as the barcode on the ID band scans, it is acceptable to use for testing. ID NOW: THE FOREFRONT OF COVID-19 TESTING. Sign up to receive valuable updates from Abbott. %PDF-1.5 % The portable, rapid molecular ID NOW COVID-19 test has emerged as a critical part of this arsenal, allowing fast diagnosis with results in 13 minutes or less in a variety of locations such as physicians' offices, urgent care clinics and other point-of-care locations. hbbd```b``Z"Ig6D&Hw0LH40{7U W ;|zFg`` {yJ and the IQCP must contain the three required elements (Risk Assessment, Quality Control Plan, and . Wxyh[} P"%"l0T( POC Maintenance Record : 2/13/2023: POC Regional Health Centers and Tests Chart. a. SOP for Abbott ID NOW COVID-19 Point of Care Testing. Facility-based platforms . Learn how to use the test by watching the COVID-19 demonstration video. PDF SARS - CoV - 2 (COVID19) Fact Sheet- - Centers for Disease Control and The device is connected to a CONNECT Universal Gateway using an ethernet cable 3. ! ` ` ` ` ` t t t 8 8 t CP 4 J ( r r r > O O O O O O O Q T O ` O ` ` r r 4 O ! It is greater than 423. . BinaxNOW Influenza A&B Card 2. CONDUCTING RESEARCH DURING THE COVID-19 PANDEMIC *For Product Labeling documents, such as the Package Insert, Quick Reference Guide, SDS sheets and CLSI documents, please visit our e-IFU website. Please see ID NOW Instrument User manual for additional operating environment requirements. Template log sheetscan be found under the Abbott IFU, Test Product Insert, CLSI folder >, Training of all users on the Abbott ID NOW analyzer using the 8 modules provided by Abbott, Competency of individuals need to be assessed using the appropriate requirements per your CLIA certificate, accrediting organizational requirements and/or local policyrequirements. Not all products are available in all regions. For in vitro diagnostic use only. Copyright 2007-2023. The instrument then amplifies the virus hundreds of millions of times to make it more easily detectable and determine at a molecular level whether the sample is positive or negative. Each Abbott ID NOW COVID-19 test cartridge comes with a swab and all the necessary reagents. i-STAT Operator Training Checklist i -STAT Competency Assessment 6-Month/Annual i-STAT Competency Written Test i-STAT INR Finger stick Training and Assessment Record i-STAT Cartridge Room Temperature Log i-STAT Corrective Action Log i-STAT Record of Receipt/QC Log HemoCue Hemoglobin Procedure HemoCue Hemoglobin Job Aid HemoCue Training Checklist 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. Customer uses existing API to pull data into customer LIS/EHR where applicable Abbott ID Now Covid19 QC & Patient Results Log Negative Ok Barcode Negative Barcode Negative Properly used, ID NOW very effective, Abbotts John R. Hackett Jr. tells CNN. Photos displayed are for illustrative purposes only. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. endstream endobj 159 0 obj <. ID NOW COVID-19 Testing | Abbott U.S. - Abbott Laboratories Photos displayed are for illustrative purposes only. Emergency Use Authorization of Medical Products and Related Authorities. Please review our privacy policy and terms & conditions. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product . Point-of-Care Testing Products | Abbott Point of Care The ID NOW COVID-19 test returns positive results in 13 minutes or less to enable immediate clinical decisions during the first patient visit. endobj Competency Exam Initial Competency Semi-annual Competency Annual Competency (CY: _____) Follow up This exam is to be performed upon Initial Orientation & Training and Competency; twice in the first year of practice; and annually thereafter. RXqGfhdP)bkfhp.F!0!\ % d,W+EB9,g053051%2973b[2 wg Hi@ (n@Z(13~?V@1& Point Of Care Forms - Bassett Healthcare Network Clinical Laboratories Examples of these additional precautions include personal protective equipment (PPE), such as a surgical mask or face shield, or other physical barriers, like a splash shield. PDF BinaxNOW COVID-19 Competency Exam - SFGH-POCT For American Family Care, ID NOW is vital tool to helping its community. Influenza A & B Package Insert. 193 0 obj <>stream Check with your local representative for availability in specific markets. POCT ID Now User Training, Competency and Assessment Booklet. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott. In the fight against COVID-19, having multiple tests for different settings and stages of a person's infection is key, from high-volume laboratory capabilities to fast solutions that give results on the spot, from tests that detect the active virus to tests that detect antibodies in people who were previously infected. The ID NOW test has emerged as a critical part of the fight against COVID-19, allowing fast diagnosis with results in minutes. Your employee ID number, which can be scanned into the meter using the barcode on your ID badge. 2/27/2020. Based on your current location, the content on this page may not be relevant for your country. 798 0 obj <> endobj Ensure your site has a valid CLIA ceritificate on file. What does this mean? ID NOW'S MOLECULAR TESTING IS "GOLD STANDARD". ID NOW PERFORMANCE, FROM RESEARCHERS IN THE FIELD Reliable test results depend on many factors, conformity to test design. Alternatively, click YES to acknowledge and proceed. . Cholestech LDX Analyzer. The General Hospital Corporation. endstream endobj startxref The products and information contained herewith may not be accessible in all countries, and Abbott takes no responsibility for such information which may not comply with local country legal process, regulation, registration and usage. ID NOW COVID-19 | Abbott Point of Care The Abbott ID NOW is an example of a mobile molecular POC device for COVID -19. For i-STAT test cartridge information and intended use, refer to individual product pages or the cartridge information (CTI/IFU) in the i-STAT Support area. A Leader in Rapid Point-of-Care Diagnostics. We offer diagnostic and treatment options for common and complex medical conditions. Peel off adhesive liner from the right edge of the test card. PDF FACT SHEET: Implementation of Abbott ID NOW COVID-19 - APHL ID NOW | Abbott Point of Care xn@%YgRP,X$cH"\xM(V7xwf1~b6@ggf3| "`4*0_|4(o@$ez'a!paK"/{|*_Dv4ISe4m)+ Apply HALT solution to hard, non-porous surfaces. Get the latest news on COVID-19, the vaccine and care at Mass General. Afinion 2. i-STAT 1 Wireless. PDF XCEED Pro Glucose Meter Competency Assessment Test Key - ProMedica ID NOW Molecular Technology Overview Animation Global (English), California Transparency in Supply Chains Act, Declaration for California Compliance Law, instructions how to enable JavaScript in your web browser, Easy to use with only minimal training requirements, Large visual touchscreen displays results, eliminating transcription errors and the need for printing, Small footprint saves you bench space and can be used in any healthcare setting, Eliminates interpretation and transcription errors, Gives you the confidence to make clinical decisions sooner, Enables prompt initiation of infection control measures, Aids targeted antiviral therapy and Antimicrobial Stewardship, Reliable near-patient testing reduces overall healthcare costs. REDUCING RISK BY DIAGNOSING WITH RELIABLE RAPID TEST ID NOW delivers results in minutes where they're needed most during COVID-19. Learn about simple, reliable and secure connectivity and reporting for ID NOW COVID-19 testing. Abbott's approach to research and development of COVID-19 diagnostic tests. Instrument User Manual. Documentation of maintenance and temperature should be included in the SOP. The ID NOW COVID-19 assay is now available for use on the ID NOW platform under U.S. Food and Drug Administration Emergency Use Authorization (EUA). The easy to use ID NOW platform is designed for near-patient, point-of-care use . 158 0 obj <> endobj Please be aware that the website you have requested is intended for the residents of a particular country or region, as noted on that site. ID NOW is significantly faster than other molecular methods and more accurate than conventional rapid tests. PDF Policy and Procedure This study will enroll approx 2882 participants under the age of 18 at 15 pediatric emergency centres across Canada. Intended for U.S. residents only. *For Product Labeling documents, such as the Package Insert, Quick Reference Guide, SDS sheets and CLSI documents, please visit our e-IFU website. This website is governed by applicable U.S. laws and governmental regulations. Learn how to use the Strep A 2 test by watching this product demonstration. Creation of SOP for COVID-19 testing using the Abbott ID NOW analyzer. 3 0 obj IN REAL WORLD TESTING, ID NOW ACCURATE, RELIABLE. US Centers for Disease Control (CDC) Coronavirus (COVID-19) Webpages This test is to be performed only using respiratory specimens collected from individuals who are . Competency must be verified by competent trainer, by performing the testing procedure outlined by Abbott. Here are the instructions how to enable JavaScript in your web browser. (2003) Impact of the Rapid Diagnosis of Influenza on Physician Decision-Making and Patient Management in the Pediatric Emergency Department: Results of a Randomized, Prospective, Controlled Trial. Please click NO to return to the homepage. Sites would need to ensure the following steps are completed prior to use of the Abbott ID NOW analyzer for patient testing of COVID-19: For diagnostic testing of specimens conducted outside of a BSL-2 laboratory, such as rapid respiratory testing performed at the point of care, use Standard Precautions to provide a barrier between the specimen and personnel during specimen manipulation. At Physician's Immediate Care, same high confidence in accuracy of results. ID NOW. <> We use cookies and other tools to enhance your experience on our website and RAPID TESTING CAN GET PEOPLE THE RIGHT TREATMENT. Healthcare Professionals Information q.UV+Soeo6[\}J'.p&LuJ-wZeo,;?7*Z@AUP }43*!4 yBH &3LVnu"M%A`I$X4 M%!J'r-YZdiI3e,9Y:3tf3Cg #`d0FH02 F#H$8, K#H$8, @g,9:$@tL33GgBg#`1. Point-of-care tests are critical to help fight the novel coronavirus pandemic. Safe Care CommitmentGet the latest news on COVID-19, the vaccine and care at Mass General.Learn more. Anesthesia, Critical Care & Pain Medicine, Billing, Insurance & Financial Assistance, Room Temperature Monitoring Information and Log sheet, Clinitek Status Training and Competency Assessment, Visual Dipstick Training & CompetencyAssessment, Outpatient (all others) Urine QC Log Sheet, Urine HCG PregnancyTraining & Competency, -STAT Competency Assessment 6-Month/Annual, i-STAT INR Finger stick Training and Assessment Record, HemoCue Docking Station and QC Guidelines, Rapid Strep Training & Competency Assessment, DCA Vantage Maintenance Job Aid (Procedure), DCA Vantage HgbA1C Training & Competency Assessment, DCA Vantage Optical Test Cartridge Result Log, ACT Competency Assessment 6-month/AnnualDocumentation tool, ACT Training & Competency Quiz/ObservationTool-Annual, AVOXimeter Initial Training & Assessment Record, AVOXimeter 6 month and Annual Competency Documentation, Modified GC Screen 6 month and Annual Competency Documentation, Modified GC Screen Quiz and Observation Checklist, Modified GC Screen Alternate Proficiency Result Form, GEM 5000 Competency Documentation-6 month and annual POCT, GEM 5000 Operator Training Checklist POCT, CoaguChek XS Initial Learning and Training Assessment, PPM Competency Assessment Completion Guideline, Quality Control - Reagent Storage, Ordering and Documentation Guide, Joint Commission Preparation Checklist for POCT Site Coordinators. SIZE OF A TOASTER. Watch the replay for multi-disciplinary updates on variant surveillance and testing protocols from Europe to the U.S., and explore COVID-19 testing protocols to optimize patient care and public health readiness with an uncertain upcoming influenza season. All rights reserved. et al. ID NOW Ellution Buffer. All rights reserved. The Point of Care Testing Procedure Manual contains the approved procedures for safe and effective operation of POCT procedures by MGH POCT providers. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. c. Send the completed POC Corrected Report Form to the lab. b. The ID NOW COVID-19 assay is a qualitative, rapid molecular test that utilizes an isothermal nucleic acid amplification technology to detect nucleic acid from the SARS-CoV-2 viral RNA. 4507 0 obj <>/Filter/FlateDecode/ID[<38B5EDDB3DE12F4286DDB68BF53A81A2><158FB707B081FF49B9233C9305EF120D>]/Index[4485 93]/Info 4484 0 R/Length 111/Prev 437721/Root 4486 0 R/Size 4578/Type/XRef/W[1 3 1]>>stream This website is governed by applicable U.S. laws and governmental regulations. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. ID NOW: The Forefront of COVID-19 Testing | Abbott U.S. COVID-19 Transport Tube Product Sheet (English), Cross Division COVID-19 Variant Technical Brief NORAM (English), ID NOW COVID-19 CLSI + More Packet (English), ID NOW COVID-19 Elution Buffer SDS (English), ID NOW COVID-19 Nasal Swab Collection Technical Tips (English), ID NOW COVID-19 Nasopharyngeal Swab Collection Technical Tips (English), ID NOW COVID-19 One Abbott Solution Brochure (English), ID NOW COVID-19 Procedural Control Results and Patient Record (English), ID NOW COVID-19 Procedural Control Results and Patient Record Word (English), ID NOW COVID-19 Product Sheet US (English), ID NOW COVID-19 Throat Swab Collection Technical Tips (English), ID NOW Positive and Negative Control Swabs SDS (English), Technical Brief Current COVID-19 Vaccinations and Detection by Abbott BinaxNOW COVID-19 Ag Card and ID NOW COVID-19 2.0 Assay September 2022 (English), California Transparency in Supply Chains Act, Declaration for California Compliance Law, instructions how to enable JavaScript in your web browser, ID NOW COVID-19 Control Kit (12 pos, 12 neg), Positive results may be detected in as little as 5 minutes, Molecular technology targeting COVID-19 RdRp gene, Designed for near patient testing in a variety of healthcare environments, Direct sample types include: Nasal, Throat, and Nasopharyngeal swabs, Small footprint enables ease of use at point of care, Dimensions - 8.15 W x 5.71 H x 7.64 D (207 mm W x 145 mm H x 194 mm D), Assay kit contains all necessary components for testing to include: 24 tests, swabs for sample collection, pipettes, positive and negative controls.

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