SOP for Abbott ID NOW COVID-19 Point of Care Testing. Updated as of 12/08/2022 . All rights reserved. Any person depicted in such photographs is a model. Facility will conduct COVID-19 antigen testing with the Abbott BinaxNOW COVID-19 Tests as outlined by the manufacture, CMS, CDC and FDA. The General Hospital Corporation. Specimen handling and collection training 7. Instrument User Manual. Abbott's approach to research and development of COVID-19 diagnostic tests. General Coronavirus (COVID-19) It is a high critical result. Abbott ID Now Covid19 QC & Patient Results Log Negative Ok Barcode Negative Barcode Negative They have been authorized by the FDA under an emergency use authorization for use by authorized laboratories. 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 . Creation of SOP for COVID-19 testingusing the Abbott ID NOW analyzer. Abbott: ID NOW COVID-19 Test -Clinical Procedure for Symptomatic Testing-Policy and Procedure Date Effective: June 24, 2021 . BinaxNOW COVID-19 . Abbott - A Leader in Rapid Point-of-Care Diagnostics. 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. Specimen Collection, World Health Organization (WHO) Coronavirus (COVID-19), U.S. Food & Drug Administration 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. 0
_____The patient test result displays 423mg/dl. 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. 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. *For Product Labeling documents, such as the Package Insert, Quick Reference Guide, SDS sheets and CLSI documents, please visit our e-IFU website. Close and securely seal the card. 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. Learn how Abbott utilizes unique isothermal nucleic acid amplification technology. Contact Sales Technical Support Overview Benefits Helpful Documents Your employee ID number, which can be scanned into the meter using the barcode on your ID badge. Risk Assessment. ID NOW is a leading molecular point-of-care platform in the United States, trusted by hospitals, physician offices, and urgent care clinics nationwide. 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. 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. 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. Sign up to receive valuable updates from Abbott. The easy to use ID NOW platform is designed for near-patient, point-of-care use . hb```b``Vb`e``fd@ A+&fZlU7. %%EOF
*For Product Labeling documents, such as the Package Insert, Quick Reference Guide, SDS sheets and CLSI documents, please visit our e-IFU website. For in vitro diagnostic use only. 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. Check with your local representative for availability in specific markets. Learn how to use the Strep A 2 test by watching this product demonstration. Title (Mr/Mrs/Miss/Dr): Surname: Position: Forename(s): . 821 0 obj
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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. 2023 Abbott. Testing location should be reviewed to ensure minimal traffic for testing location, separate room if possible, location should be near asink and eyewashstation. Timely results enable healthcare professionals to make appropriate and more efficient treatment and infection control decisions. endstream
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,_;#TG@Vpy P%3+dRX'01PiB#BL HP1J%fBQ(C%KBA)P)A A Leader in Rapid Point-of-Care Diagnostics. POC I-STAT Training/Competency Checklist: 4/15/2021: POC Bassett Clinics and Tests Chart. ID NOW COVID-19 and ID NOW COVID-19 2.0 have not been FDA cleared or approved. <>>>
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. 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. This test is to be performed only using respiratory specimens collected from individuals who are . endstream
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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 . and the IQCP must contain the three required elements (Risk Assessment, Quality Control Plan, and . ` ` ` ` ` 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 ! endstream
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<. 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. ID NOW. Do not remove swab. ID NOW delivers results in minutes where they're needed most during COVID-19. 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 device is connected to a CONNECT Universal Gateway using an ethernet cable 3. Pediatrics Vol. We are committed to providing expert caresafely and effectively. ^ ` r ` r O ! 112 No. It is greater than 423. . Influenza A & B Package Insert. As long as the barcode on the ID band scans, it is acceptable to use for testing. Not all products are available in all regions. EUA supports flexible near patient testing environments. Learn about the many ways you can get involved and support Mass General. POC Abbott ID Now QC Log: 2/18/2021: POC HemoCue Hgb QC Log (Form will be sent by POC with QC Material.) Why is it important to make sure the patient ID band is replaced when a patient is transferred in from other facility? Alternatively, click YES to acknowledge and proceed. 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. BinaxNOW Influenza A&B Card 2. REDUCING RISK BY DIAGNOSING WITH RELIABLE RAPID TEST 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. Laboratory Biosafety Based on your current location, the content on this page may not be relevant for your country. Rotate (twirl) swab shaft 3 times CLOCKWISE (to the right). The Point of Care Testing Procedure Manual contains the approved procedures for safe and effective operation of POCT procedures by MGH POCT providers. ID NOW IS A COMPLETE GAME-CHANGER FOR TESTING. The ID NOW COVID-19 test returns positive results in 13 minutes or less to enable immediate clinical decisions during the first patient visit. et al. xn@%YgRP,X$cH"\xM(V7xwf1~b6@ggf3|
"`4*0_|4(o@$ez'a!paK"/{|*_Dv4ISe4m)+ 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. PORTABLE, RELIABLE AND RAPID, WITH RESULTS ON THE SPOT, ALL IN THE ! 1 0 obj
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. Larger POC platforms, such as the Cepheid GeneXpert Xpress, another example of a POC device that can be used for COVID -19, are often based in hospitals and medical centers. 10/19/2020. 4 0 obj
All rights reserved. Any person depicted in such photographs is a model. 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. How advanced molecular testing technology detects novel coronavirus. Perform the testing using all 9's as the patient ID. %
For full functionality of this site it is necessary to enable JavaScript. ! . Insert the (+) or (-) control swab into BOTTOM HOLE and firmly push upwards so that the swab tip is visible in the TOP HOLE. Here are the instructions how to enable JavaScript in your web browser. Peel off adhesive liner from the right edge of the test card. Safe Care CommitmentGet the latest news on COVID-19, the vaccine and care at Mass General.Learn more. 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. RXqGfhdP)bkfhp.F!0!\
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Get the latest news on COVID-19, the vaccine and care at Mass General. For full functionality of this site it is necessary to enable JavaScript. Properly used, ID NOW very effective, Abbotts John R. Hackett Jr. tells CNN. RAPID TESTING CAN GET PEOPLE THE RIGHT TREATMENT. endobj
Competency Sheet. For more information about these cookies and the data
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). Check with your local representative for availability in specific markets. Information for Laboratories 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. We use cookies and other tools to enhance your experience on our website and
Abbott Diagnostics Scarborough, Inc. - ID NOW COVID-19. %PDF-1.5
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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. Please review our privacy policy and terms & conditions. %PDF-1.5
All surfaces must REMAIN WET FOR 10 MINUTES for maximum disinfection. 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. Your Social Security Number c. All 9's (99999999) Abbott - A Leader in Rapid Point-of-Care Diagnostics. G D J r 0~0 b ^ H &. A Leader in Rapid Point-of-Care Diagnostics. SoToxa Mobile Test System. 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. PPE training 6. 21. 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. 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. O ! How TO USE SOLUTION If surfaces are dirty, they should first be cleaned with detergent or soap and waterprior to disinfection with HALT solution. This study will enroll approx 2882 participants under the age of 18 at 15 pediatric emergency centres across Canada.
They have higher throughput Facility-based platforms . Point-of-care tests are critical to help fight the novel coronavirus pandemic. Please see ID NOW Instrument User manual for additional operating environment requirements. Customer uses existing API to pull data into customer LIS/EHR where applicable The ID NOW test has emerged as a critical part of the fight against COVID-19, allowing fast diagnosis with results in minutes. Gateway transmits test data via secure cellular connectivity to a secure Abbott-hosted, cloud-based server 4. 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. SOP/POCT/69/2 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. hb```b``Ve`e``efd@ A+E- 158 0 obj
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2/27/2020. Alternatively, click YES to acknowledge and proceed. b. Running a Patient Test. Based on your current location, the content on this page may not be relevant for your country. to analyze our web traffic. Our unique ID NOW isothermal nucleic acid amplification technology provides molecular results in just minutes, allowing you to make effective clinical decisions sooner. 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 There are templatesin the, Competency frequency: Initial training, 6-months, and annually thereafter. 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. collected, please refer to our Privacy Policy. Initial Competency Assessment Test Page 2 of 4 7. ID NOW is significantly faster than other molecular methods and more accurate than conventional rapid tests.
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 The intuitively designed ID NOW instrument can have a positive impact in any healthcare setting. %PDF-1.6
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2023 Abbott. %%EOF
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INVESTORS. ID NOW Ellution Buffer. 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. US Centers for Disease Control (CDC) Coronavirus (COVID-19) Webpages 4485 0 obj
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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: Z{sB[u.j(t\G#Hu F+Aal+ 5N# J
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z%HJG R{8djdlRg U]S[W_PX"YHE.ud]$"YH6E)MldS$"gdF3\|NMVEw^:&V?jr+8^"MB"r;*i(. 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) Sign up to receive valuable updates from Abbott. 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. This test has not been FDA cleared or approved. Determine HIV-1/2 Ag/Ab Combo. 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. 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. Search for condition information or for a specific treatment program. Get the latest news, explore events and connect with Mass General. This website is governed by applicable U.S. laws and governmental regulations. REDUCING RISK BY DIAGNOSING WITH RELIABLE RAPID TEST. Learn how Abbott utilizes unique isothermal nucleic acid amplification technology. Ensure your site has a valid CLIA ceritificate on file. Competency must be verified by competent trainer, by performing the testing procedure outlined by Abbott. b. Photos displayed are for illustrative purposes only. Creation of SOP for COVID-19 testing using the Abbott ID NOW analyzer. Isolation Precautions in Healthcare Settings The SOP should encompass information pertaining to instructions for reporting anddocumentingresults, notification ofpositive results,appropriate PPE usage andcleaning procedures, quality control, etc. Learn all about the ID NOW Instrument and installation by following these video modules. Reliable test results depend on many factors, conformity to test design. c. Send the completed POC Corrected Report Form to the lab. At Physicians Immediate Care, ID NOW helps them slow the spread of COVID-19. ID NOWis a rapid, instrument-based, isothermal system for the qualitative detection of infectious diseases. 2. Wxyh[} P"%"l0T( Learn about simple, reliable and secure connectivity and reporting for ID NOW COVID-19 testing. endstream
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a. Let us help you navigate your in-person or virtual visit to Mass General. Healthcare Professionals Information CONDUCTING RESEARCH DURING THE COVID-19 PANDEMIC Reporting of results (per Abbott Instructions for Use) should include: Reporting of false-positives and false-negatives and other significant deviations from performance characteristics to Abbott and FDA. New and Improved Speed, Performance and Efficiency. 884 0 obj
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(BLUE) and G3+ (BLUE) are now considered high complexity tests due to lack of FDA categorization. POC:Piccolo Electrolyte Panel Reagent/QC Log: . 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. GDPR Statement (last updated: May 2018) | California Transparency in Supply Chains Act | Declaration for California Compliance Law. a. <>
At Physician's Immediate Care, same high confidence in accuracy of results. ID NOW'S MOLECULAR TESTING IS "GOLD STANDARD". Explore fellowships, residencies, internships and other educational opportunities. Learn how to use the test by watching the COVID-19 demonstration video. ID NOW is a leading molecular point-of-care platform in the United States, trusted by hospitals, physician offices, and urgent care clinics nationwide. ID NOW PERFORMANCE, FROM RESEARCHERS IN THE FIELD. ! ID NOW uses a liquid solution designed to deactivate the virus and break it apart to expose the RNA. ID NOW COVID-19 2.0. The Abbott ID NOW is an example of a mobile molecular POC device for COVID -19. endobj
Please click NO to return to the homepage. 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. 798 0 obj
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Not all products are available in all regions. b.
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MoreCDC guidelinesfor COVID-19 can be found using the following links. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. Emergency Use Authorization of Medical Products and Related Authorities. Photos displayed are for illustrative purposes only. Abbott requires new usersto perform 1 positive and 1 negative/blank test controls prior to testing. Positive and Negative Control Swabs. For in vitro diagnostic use only. endobj
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At remote locations, testing is done using an ID NOW analyzer 2. POCT ID Now User Training, Competency and Assessment Booklet. ID NOW: THE FOREFRONT OF COVID-19 TESTING. Our uniqueID NOWisothermal nucleic acid amplification technology provides molecular results in just minutes, allowing you to make effective clinical decisions sooner. stream
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. Frequently Asked Questions (FAQs), Abbott i- STAT . For American Family Care, ID NOW is vital tool to helping its community. 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. %PDF-1.5
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What does this mean? Enter your email address to receive Abbott Edge. COVID-19 RAPID TESTS: READY WHEN EVERY MINUTE COUNTS.
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. ID Now Test Base Safety Data Sheet. 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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Fellowship Memphis Pastor Dies, Shaw Afb Security Forces Phone Number, Glossier Market Share, Examples Of Hegemony In Schools, Xbox Verified Symbol Copy And Paste, Articles A