ID NOW is a leading molecular point-of-care platform in the United States, trusted by hospitals, physician offices, and urgent care clinics nationwide. 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 . 3 0 obj Sign up to receive valuable updates from Abbott. %%EOF Do not remove swab. All rights reserved. G D J r 0~0 b ^ H &. Abbott Diagnostics Scarborough, Inc. - ID NOW COVID-19. ^ ` r ` r O ! Cholestech LDX Analyzer. 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. We are committed to providing expert caresafely and effectively. Check with your local representative for availability in specific markets. *For Product Labeling documents, such as the Package Insert, Quick Reference Guide, SDS sheets and CLSI documents, please visit our e-IFU website. b. 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. There are templatesin the, Competency frequency: Initial training, 6-months, and annually thereafter. <>/XObject<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 720 540] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Risk Assessment. Peel off adhesive liner from the right edge of the test card. 798 0 obj <> endobj Based on your current location, the content on this page may not be relevant for your country. Title: Abbott ID Now Competency Assessment Effective date: 29/10/2022 Author: A. Bromley Checked by: M. Ribeiro Approved by: M. Ribeiro Page 1 of 1 Title: COPY hb```b``Vb`e``fd@ A+&fZlU7. a. 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. endstream endobj 4486 0 obj <>/Metadata 132 0 R/Outlines 299 0 R/PageLayout/OneColumn/Pages 4479 0 R/StructTreeRoot 362 0 R/Type/Catalog>> endobj 4487 0 obj <>/ExtGState<>/Font<>/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 4488 0 obj <>stream REDUCING RISK BY DIAGNOSING WITH RELIABLE RAPID TEST. IN REAL WORLD TESTING, ID NOW ACCURATE, RELIABLE. Close and securely seal the card. ID NOW is significantly faster than other molecular methods and more accurate than conventional rapid tests. 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. Specimen handling and collection training 7. This website is governed by applicable U.S. laws and governmental regulations. 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. b. If your non-waived laboratory is . ID NOW PERFORMANCE, FROM RESEARCHERS IN THE FIELD. 1. 0 <>>> RXqGfhdP)bkfhp.F!0!\ % d,W+EB9,g053051%2973b[2 wg Hi@ (n@Z(13~?V@1& The website you have requested also may not be optimized for your specific screen size. 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. Wxyh[} P"%"l0T( hbbd```b``Z"Ig6D&Hw0LH40{7U W ;|zFg`` {yJ 4485 0 obj <> endobj For in vitro diagnostic use only. PPE training 6. 0 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: How TO USE SOLUTION If surfaces are dirty, they should first be cleaned with detergent or soap and waterprior to disinfection with HALT solution. Rotate (twirl) swab shaft 3 times CLOCKWISE (to the right). How advanced molecular testing technology detects novel coronavirus. ID NOW COVID-19. The ID NOW test has emerged as a critical part of the fight against COVID-19, allowing fast diagnosis with results in minutes. Not all products are available in all regions. Insert the (+) or (-) control swab into BOTTOM HOLE and firmly push upwards so that the swab tip is visible in the TOP HOLE. 178 0 obj <>/Filter/FlateDecode/ID[<301DDEECFAA1D3498BAA66861BB1A194><151D3900F17130438FFBD093DE37C0D5>]/Index[158 36]/Info 157 0 R/Length 101/Prev 91471/Root 159 0 R/Size 194/Type/XRef/W[1 3 1]>>stream ID NOW PERFORMANCE, FROM RESEARCHERS IN THE FIELD Reliable test results depend on many factors, conformity to test design. Find out more about this innovative technology and its impact here. endstream endobj startxref 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. Please see ID NOW Instrument User manual for additional operating environment requirements. ` ` ` ` ` 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 ! Ensure your site has a valid CLIA ceritificate on file. ! 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. 884 0 obj <>stream to analyze our web traffic. Creation of SOP for COVID-19 testingusing the Abbott ID NOW analyzer. Get the latest news on COVID-19, the vaccine and care at Mass General. xn@%YgRP,X$cH"\xM(V7xwf1~b6@ggf3| "`4*0_|4(o@$ez'a!paK"/{|*_Dv4ISe4m)+ (BLUE) and G3+ (BLUE) are now considered high complexity tests due to lack of FDA categorization. CONDUCTING RESEARCH DURING THE COVID-19 PANDEMIC 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. SOP for Abbott ID NOW COVID-19 Point of Care Testing. %%EOF This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. For full functionality of this site it is necessary to enable JavaScript. The device is connected to a CONNECT Universal Gateway using an ethernet cable 3. 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. 10/19/2020. At Physicians Immediate Care, ID NOW helps them slow the spread of COVID-19. ID NOW is a leading molecular point-of-care platform in the United States, trusted by hospitals, physician offices, and urgent care clinics nationwide. Preform a Quality Control Test and/or patient test on self/coworker with Super User Supervision 8. Gateway transmits test data via secure cellular connectivity to a secure Abbott-hosted, cloud-based server 4. Point-of-care tests are critical to help fight the novel coronavirus pandemic. 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. Frequently Asked Questions (FAQs), Abbott i- STAT . 21. The Abbott ID NOW is an example of a mobile molecular POC device for COVID -19. Based on your current location, the content on this page may not be relevant for your country. It is a high critical result. ID NOW delivers results in minutes where they're needed most during COVID-19. Learn all about the ID NOW Instrument and installation by following these video modules. endobj 2/27/2020. Pediatrics Vol. Abbott: ID NOW COVID-19 Test -Clinical Procedure for Symptomatic Testing-Policy and Procedure Date Effective: June 24, 2021 . Bonner, A.B. hb``b``101G3020cdeY99E)3~H310pf ce`LqX` ! Here are the instructions how to enable JavaScript in your web browser. Check with your local representative for availability in specific markets. ! Your Social Security Number c. All 9's (99999999) SOP/POCT/69/2 At remote locations, testing is done using an ID NOW analyzer 2. Search for condition information or for a specific treatment program. A Leader in Rapid Point-of-Care Diagnostics. ID NOW IS A COMPLETE GAME-CHANGER FOR TESTING. Copyright 2007-2023. ID NOW uses a liquid solution designed to deactivate the virus and break it apart to expose the RNA. POCT ID Now User Training, Competency and Assessment Booklet. 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. REDUCING RISK BY DIAGNOSING WITH RELIABLE RAPID TEST ID NOW delivers results in minutes where they're needed most during COVID-19. and the IQCP must contain the three required elements (Risk Assessment, Quality Control Plan, and . Emergency Use Authorization of Medical Products and Related Authorities. POC I-STAT Training/Competency Checklist: 4/15/2021: POC Bassett Clinics and Tests Chart. The ID NOW COVID-19 rapid test delivers high-quality molecular positive results in as little as 5 minutes, targeting the coronavirus (COVID-19) RdRp Gene. ID NOW. Explore fellowships, residencies, internships and other educational opportunities. The ID NOW COVID-19 test returns positive results in 13 minutes or less to enable immediate clinical decisions during the first patient visit. Timely results enable healthcare professionals to make appropriate and more efficient treatment and infection control decisions. b. It is greater than 423. . Instrument User Manual. Let us help you navigate your in-person or virtual visit to Mass General. What does this mean? 112 No. POC Abbott ID Now QC Log: 2/18/2021: POC HemoCue Hgb QC Log (Form will be sent by POC with QC Material.) The General Hospital Corporation. Abbott - A Leader in Rapid Point-of-Care Diagnostics. 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. Alternatively, click YES to acknowledge and proceed. 1. Any person depicted in such photographs is a model. We use cookies and other tools to enhance your experience on our website and Intended for U.S. residents only. %PDF-1.6 % ID NOW Ellution Buffer. Our unique ID NOW isothermal nucleic acid amplification technology provides molecular results in just minutes, allowing you to make effective clinical decisions sooner. 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. 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. Abbott ID Now Covid19 QC & Patient Results Log Negative Ok Barcode Negative Barcode Negative 0 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. The easy to use ID NOW platform is designed for near-patient, point-of-care use . %PDF-1.5 % 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. *For Product Labeling documents, such as the Package Insert, Quick Reference Guide, SDS sheets and CLSI documents, please visit our e-IFU website. 2023 Abbott. hb```b``Ve`e``efd@ A+E- 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 The SOP should encompass information pertaining to instructions for reporting anddocumentingresults, notification ofpositive results,appropriate PPE usage andcleaning procedures, quality control, etc. 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. We offer diagnostic and treatment options for common and complex medical conditions. Learn about the many ways you can get involved and support Mass General. POC Maintenance Record : 2/13/2023: POC Regional Health Centers and Tests Chart. 2 0 obj Title (Mr/Mrs/Miss/Dr): Surname: Position: Forename(s): . Safe Care CommitmentGet the latest news on COVID-19, the vaccine and care at Mass General.Learn more. 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). See themost recent editionsof our newsletter. A Leader in Rapid Point-of-Care Diagnostics. Specimen Collection, World Health Organization (WHO) Coronavirus (COVID-19), U.S. Food & Drug Administration As long as the barcode on the ID band scans, it is acceptable to use for testing. <> Competency Sheet. %PDF-1.5 Competency must be verified by competent trainer, by performing the testing procedure outlined by Abbott. stream et al. 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. Alternatively, click YES to acknowledge and proceed. lcKjs.&g$=HP^CGB*oWSXu4V?Tjilp?yTT)#JL-dyB~&%fomy:qIJ. The purpose of the study is to evaluate the clinical sensitivity of buccal swab testing using Abbott ID NOW COVID-19device to detect SARS-CoV-2 infection among children aged 0-<18.0 years old presenting to the emergency department with an indication for SARS-CoV-2 testing as . Get the latest news, explore events and connect with Mass General. Facility-based platforms . Information for Laboratories For more information about these cookies and the data Learn all about the ID NOW Instrument and installation by following these video modules. This test is to be performed only using respiratory specimens collected from individuals who are . Learn how to use the test by watching the COVID-19 demonstration video. endobj Laboratory Biosafety 4 0 obj 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. Positive and Negative Control Swabs. hZmo7+xE,_4m ,_;#TG@Vpy P%3+dRX'01PiB#BL HP1J%fBQ(C%KBA)P)A Creation of SOP for COVID-19 testing using the Abbott ID NOW analyzer. 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. CONDUCTING RESEARCH DURING THE COVID-19 PANDEMIC. General Coronavirus (COVID-19) FAQ # Description of Change . Documentation of maintenance and temperature should be included in the SOP. All rights reserved. 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. 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. hbbd```b``+A$S+p=d`LN @E0 D2&$cV"sB#ZKGI:G0 {+ At Physician's Immediate Care, same high confidence in accuracy of results. ID NOWis a rapid, instrument-based, isothermal system for the qualitative detection of infectious diseases. endstream endobj 159 0 obj <. _____The patient test result displays 423mg/dl. This study will enroll approx 2882 participants under the age of 18 at 15 pediatric emergency centres across Canada. Perform the testing using all 9's as the patient ID. For American Family Care, ID NOW is vital tool to helping its community. Contact Sales Technical Support Overview Benefits Helpful Documents At Mass General, the brightest minds in medicine collaborate on behalf of our patients to bridge innovation science with state-of-the-art clinical medicine. ID NOW is a rapid, instrument-based, isothermal system for the qualitative detection of infectious diseases. 4577 0 obj <>stream NcTSpooR,l3 3. Review of Abbott ID NOW Pre- and Post- Test Information for Clients Document 4. Review Abbott ID NOW COVID -19 POCT Assessment Form for COVID-19- Symptomatic testing document 5. <> ! DIFFERENCE-MAKING INNOVATION. Notification to CMS and yourclinic accrediting organizationof intent to perform COVID-19 testing using the Abbott ID NOW analyzer under the FDA EUA for COVID-19. Updated as of 12/08/2022 . Photos displayed are for illustrative purposes only. Signed Competency Checklist should be maintained in employee's personnel file (see Nasal Swabbing Procedure and Performance of BinaxNOWTM COVID-19 Ag Card Competency Checklist) 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. 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. INVESTORS. They have been authorized by the FDA under an emergency use authorization for use by authorized laboratories. US Centers for Disease Control (CDC) Coronavirus (COVID-19) Webpages Any person depicted in such photographs is a model. OVERVIEW; FINANCIALS; STOCK INFO; . Complete the ID NOW Assessment Form, Maintain competency on the Abbott ID NOW POCT COVID-19 test system, Follow accreditation requirements for patient identification, testing and reporting. The tests have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and 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 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 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 SIZE OF A TOASTER. <8uFy6]Z+4\``wty/YPXQ.Fy5*Wv=?iC{u^nje(}a,_oMp1=;g=P#g|NerC?[=[2UraNy6?S\0CI~'+xMy5 Enter your email address to receive Abbott Edge. Your use of this website and the information contained herein is subject to our Website Terms and Conditions and Privacy Policy: US Citizens | Non-US Citizens. 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. 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. The website that you have requested also may not be optimized for your screen size. Determine HIV-1/2 Ag/Ab Combo. The Point of Care Testing Procedure Manual contains the approved procedures for safe and effective operation of POCT procedures by MGH POCT providers. Each Abbott ID NOW COVID-19 test cartridge comes with a swab and all the necessary reagents. For procedures with a high likelihood to generate aerosols or droplets, use either a certified Class II Biological Safety Cabinet (BSC)oradditional precautions to provide a barrier between the specimen and personnel. Why is it important to make sure the patient ID band is replaced when a patient is transferred in from other facility? O ! The intuitively designed ID NOW instrument can have a positive impact in any healthcare setting. SoToxa Mobile Test System. 2023 Abbott. Reliable test results depend on many factors, conformity to test design. 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. c. Send the completed POC Corrected Report Form to the lab. Healthcare Professionals Information endobj 2. a. Learn how Abbott utilizes unique isothermal nucleic acid amplification technology. This test has been authorized by FDA under an EUA for use by authorized laboratories. 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.
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