Cepheid GeneXpert Xpress- RT PCR
The Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV assay is a rapid, real-time RT-PCR test intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) viral DNA in either nasopharyngeal swab, nasal swab or nasal wash/aspirate specimens collected from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. The Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.
Not Detected for influenza A, influenza B, respiratory syncytial virus, and SARS-CoV-2
1.Performance of the Xpert SARS-CoV-2 has only been established in nasopharyngeal swab specimens. Specimen types other than nasopharyngeal swab may give inaccurate results. A false negative result may occur if a specimen is improperly collected, transported, handled.
2. A false negative result may occur if a specimen is improperly collected, transported, or handled. False negative results may also occur if inadequate numbers of organisms are present in specimen.
3. As with any molecular test, mutations within the target regions of the Xpert Xpress SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus could affect primer and/or probe binding resulting in failure to detect the presence of virus.
4. This test cannot rule out diseases caused by other bacterial or viral pathogens.
Approximately; 30 minutes for positive results, and 30-50 minutes for determination of negative results.
Gently insert mini-tipped flocked nasopharyngeal swab (swab on flexible plastic shaft) through the nostril and into the nasopharynx, reaching the posterior nasopharynx. Gently rotate swab, then remove, and break swab off into tube of transport media. Make sure the swab is fully immersed in the transport media, and that the shaft is short enough to completely tighten the cap. For best results testing should be performed immediately after collection. Obtaining columnar epithelial cells will enhance reliability of viral detection. Please see CDC for current sample collection guidance: https://www.cdc.gov/coronavirus/2019-nCoV/lab/guidelines-clinical-speci….
For best results samples should be tested immediately following collection.
2. Specimens not in viral transport medium or saline.
3. Specimens that have been at room temperature longer than 8 hours.
4. Specimens that lack two patient identifiers.
For more test specific information, please refer to the test procedure found on the Michigan Medicine POC website: https://www.pathology.med.umich.edu/point-of-care