Cepheid GeneXpert - RT PCR
The Cepheid Xpert Xpress SARS-CoV-2 assay is a rapid, real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.The Cepheid Xpert Xpress SARS-CoV-2 assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.
Fact sheet for healthcare providers: https://www.fda.gov/media/136313/download
Fact sheet for patients: https://www.fda.gov/media/136312/download
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, or handled.
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