Abbott Rapid Dx North America LLC Respiratory Test Kit ID NOW™ Molecular Diagnostic Respiratory Syncytial Virus Test (RSV) Nasopharyngeal Swab Sample 24 Tests CLIA Waived - KT/1 - 435000-KT

TEST KIT, RSV ID NOW

Features

• ID NOW™ RSV detects the RSV virus in nasopharyngeal (NP) swab samples using Alere’s proprietary Molecular In Minutes™ isothermal nucleic acid amplification technology (iNAT)
• ID NOW™ i RSV is a rapid (less than 15 minutes), instrument-based isothermal test for the qualitative detection of RSV A and RSV B from nasopharyngeal swabs and nasopharyngeal swabs eluted in viral transport media
• It is comprised of a Sample Receiver, containing elution buffer, a Test Base, comprising two sealed reaction tubes, each containing a lyophilized pellet, a Transfer Cartridge for transfer of the eluted sample to the Test Base
• The reaction tubes in the Test Base contain the reagents required for amplification of RSV A and RSV B, respectively, as well as an internal control
• Intended for use as an aid in the diagnosis of RSV in children <18 years and adults ≥60 years in conjunction with clinical and epidemiological risk factors