Copan eNAT® Molecular Collection and Preservation Medium
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The NEW Xpert Xpress CoV-2 plus test provides:
This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, and not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
*With early assay termination for positives, otherwise, the full test runtime is 30 minutes.
Number of Tests: 10Catalog #: XP3SARS-COV2-10
Cepheid developed the Xpert® Xpress CoV-2 plus test with several enhancements compared to the Xpert® Xpress SARS-CoV-2. Key enhancements include:
GeneXpert Dx and Infinity Systems:
GeneXpert Xpress systems (Hub and Tablet):
Viral transport media are available from several commercial vendors who may use the terminology VTM (Viral Transport Medium) or UTM (Universal Transport Medium). Any brand meeting the guidelines for VTM/UTM can be used. UTM, VTM, Saline, and eNAT are on label.
For additional questions regarding SARS-CoV-2 Transport Media options, please refer to the FDA webpage FAQS on Viral Transport Media During COVID-19.
The listed external controls are Zeptometrix External Controls:
These are described in the “materials available but not provided” section of the package insert as the recommended source for external controls. Please consult with Cepheid’s Technical Support team to inquire about other commercial sources for QC material.
Before going live with a new test, a verification study may be necessary. Please follow your laboratory and regulatory requirements when instituting a new test in your laboratory. A verification guide that describes the preparation of contrived positive specimens (prepared by spiking commercial reference material into negative specimens) is available for download on the Cepheid website: Verification Guide.
In an effort to reduce our environmental footprint, Cepheid is moving towards CD-less products. The Package Inserts, ADFs and ADF import instructions for Xpert® Xpress CoV-2 plus are available for download here. For customers who prefer to obtain the ADFs in a CD, please fill out the CD ADF request using the following link: