Invited Product Profile – GeneXpert Xpress System for Respiratory Testing

Abstract

Abstract Viral and bacterial respiratory infections represent a significant source of morbidity and mortality in the United States. Lateral flow immunoassays, frequently used to detect influenza, respiratory syncytial virus (RSV), and streptococcus group A infections, yield lower sensitivity (50%–70%) than testing other methods and often require culture confirmation for patients who test negative. The Clinical Laboratory Improvement Amendments–waived GeneXpert Xpress platform offers point-of-care influenza, RSV, and streptococcus group A nucleic acid amplification testing in a variety of health care settings. The system requires minimal training, and the user interface provides straightforward step-by-step video instructions that illustrate each phase of the testing procedure. The universal cartridge design allows simple sample loading that minimizes hands-on time and risk of contamination as well as the need for additional staff training. Test results generated by the Xpress System have high sensitivity and specificity and are available in 18 to 30 minutes. Together these features make the GeneXpert Xpress an attractive option to provide simple, rapid, and effective point-of-care testing to identify influenza, RSV, and streptococcus group A infections to better inform patient management and treatment decisions.