All rights reserved. endobj The intuitively designed ID NOW instrument can have a positive impact in any healthcare setting. 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. hbbd```b``y"gH sd`Wu0y LnOYc $FZ ' H (bt{ I 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. 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. 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 ID NOW COVID-19 and ID NOW COVID-19 2.0 have not been FDA cleared or approved. Bonner, A.B. Your Social Security Number c. All 9's (99999999) 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. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. %PDF-1.5 % Close and securely seal the card. The website you have requested also may not be optimized for your specific screen size. At remote locations, testing is done using an ID NOW analyzer 2. 2 0 obj hbbd```b``+A$S+p=d`LN @E0 D2&$cV"sB#ZKGI:G0 {+ Get the latest news on COVID-19, the vaccine and care at Mass General. The ID NOW COVID-19 assay is a qualitative, rapid molecular test that utilizes an isothermal nucleic acid amplification technology to detect nucleic acid from the SARS-CoV-2 viral RNA. a. GDPR Statement (last updated: May 2018) | California Transparency in Supply Chains Act | Declaration for California Compliance Law. Point-of-care tests are critical to help fight the novel coronavirus pandemic. q.UV+Soeo6[\}J'.p&LuJ-wZeo,;?7*Z@AUP }43*!4 yBH &3LVnu"M%A`I$X4 M%!J'r-YZdiI3e,9Y:3tf3Cg #`d0FH02 F#H$8, K#H$8, @g,9:$@tL33GgBg#`1. Abbott - A Leader in Rapid Point-of-Care Diagnostics. SoToxa Mobile Test System. 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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