For in vitro diagnostic use. Others cobas Strep A IVD cobas® Strep A RMD-Liat-STREPA-001 Nucleic acid test for use on the cobas® liat system 07 341 911 190 7 341 911 190 07341911190 7341911190 07341911190 KIT COBAS LIAT STREP A cobas Strep A 00875197005622 Reagents, kits 1 pack 20 tests true The cobas® Strep A nucleic acid test for use on the cobas® Liat® System (cobas® Strep A) is a qualitative in vitro diagnostic test for the detection of Streptococcus pyogenes (Group A β-hemolytic Streptococcus, Strep A) in throat swab specimens from patients with signs and symptoms of pharyngitis. The cobas® Strep A assay utilizes nucleic acid purification and polymerase chain reaction (PCR) technology to detect Streptococcus pyogenes by targeting a segment of the Streptococcus pyogenes genome. en The cobas® Strep A nucleic acid test for use on the cobas® Liat® System (cobas® Strep A) is a qualitative in vitro diagnostic test for the detection of Streptococcus pyogenes (Group A β-hemolytic Streptococcus, Strep A) in throat swab specimens from patients with signs and symptoms of pharyngitis. The cobas® Strep A assay utilizes nucleic acid purification and polymerase chain reaction (PCR) technology to detect Streptococcus pyogenes by targeting a segment of the Streptococcus pyogenes genome. The cobas® Strep A nucleic acid test for use on the cobas® Liat® System is intended for professional use in a clinical laboratory setting or point-of-care (POC) location. en The cobas® Strep A assay is an automated in vitro diagnostic test for the qualitative detection of Strep A DNA in throat swab specimens. The sample-to-result time is ~15 minutes. The assay is performed on the cobas® Liat® System. The System automates and integrates sample purification, nucleic acid amplification, and detection of the target sequence in biological samples using real-time PCR. The assay targets a well-conserved region of the Strep A genome. An Internal Process Control (IPC) is also included. The IPC is present to control for adequate processing of the target bacteria through all steps of the assay process and to monitor the presence of inhibitors in the sample preparation and PCR. The cobas® Liat® Analyzer consists of an instrument with integrated software for running tests and analyzing the results. The System consists of the Analyzer and a single-use disposable cobas® Strep A assay tube that contains the nucleic acid purification and PCR reagents, and hosts the sample preparation and PCR processes. Other than adding the sample to the cobas® Strep A assay tube, no reagent preparation or additional steps are required. Because each cobas® Strep A assay tube is self-contained, the risk of cross-contamination between samples is reduced. en

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