Test Overview
Test Methodology

Cepheid GeneXpert Xpress- RT PCR

Test Usage

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.

Fact Sheet for Healthcare Providers: "https://www.fda.gov/media/136313/download"
Fact Sheet for Patients:" https://www.fda.gov/media/136312/download"

Reference Range *

Not Detected for influenza A, influenza B, respiratory syncytial virus, and SARS-CoV-2

Test Limitations

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.

Test Details
Days Set Up
Performed during normal operational hours of the designated POC testing areas.
Analytic Time

Approximately; 30 minutes for positive results, and 30-50 minutes for determination of negative results.

Soft Order Code
P4PLX
MiChart Code
SARS-CoV-2 (COVID-19), Flu A/B and RSV by PCR, Point of Care Nasopharyngeal
Laboratory
Point of Care
Section
Point of Care
Specimen Requirements
Collection Instructions

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….

Special Handling

For best results samples should be tested immediately following collection.

Rejection Criteria
1. Specimen source other than nasopharyngeal swab is rejected. Throat swab, nasal swabs, nasal or nasopharyngeal wash/aspirate, and sputum are NOT acceptable and will be rejected.
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.
Storage Temperature
Specimens can be stored at room temperature (15 - 30°C) for up to 8 hours and refrigerated (2-8 C°) up to seven days until testing is performed on the GeneXpert.
Additional Information

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

Billing
CPT Code
0241U
LOINC
95941-1
NY State Approved
No