How is the Xpert Xpress CoV-2/Flu/RSV plus product different from the existing Xpert Xpress SARS-CoV-2/Flu/RSV product?
Cepheid proactively developed Xpert Xpress CoV-2/Flu/RSV plus with several enhancements compared to Xpert Xpress SARS-CoV-2/Flu/RSV. Key enhancements include the addition of a third gene target for SARS-CoV-2 (RdRP now included in addition to E and N2), to be more robust against mutations. In addition, on-label transport media options now include eNAT.
What sample types and collection devices can be used with Xpert Xpress CoV-2/Flu/RSV plus?
Nasopharyngeal swab and anterior nasal swab specimens in 3mL of viral transport media (UTM/VTM), or 2mL of eNAT.
What are my options for viral transport media for Xpert Xpress CoV-2/Flu/RSV plus?
Meios de transporte viral estão disponíveis em vários fornecedores comerciais que podem usar a terminologia VTM (Vital Transport Medium [Meio de transporte viral]) ou UTM (Universal Transport Medium [Meio de transporte universal]). UTM, VTM, and eNAT are on label.
What external quality control (QC) material options are available for Xpert Xpress CoV-2/Flu/RSV plus?
The listed external controls are Zeptometrix Flu/RSV/SARS-CoV-2 Positive Control (PN: NATFRC-6C) e controle negativo (PN: NATCV9-6C). These are described in the “materials available but not provided” section in the package insert. Please consult with Cepheid’s Technical Support team to inquire about additional commercial options if needed.
What are the requirements for verification and what guidelines do you have for transitioning from Xpert Xpress SARS-CoV-2 and/or Xpert Xpress SARS-CoV-2/Flu/RSV to Xpert Xpress CoV-2/Flu/RSV plus?
Pode ser necessário um estudo de verificação antes de iniciar um novo teste. Siga as exigências regulatórias e laboratoriais ao instituir um novo teste em seu laboratório. 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 Product Resources page (Verification Protocol).
Why isn’t there a CD with the ADF nor a Package Insert in my Xpert Xpress CoV-2/Flu/RSV plus test kit?
Em um esforço para reduzir nossa pegada ambiental, a Cepheid está migrando para produtos sem CD. The package inserts, ADFs and ADF import instructions for the Xpert Xpress CoV-2/Flu/RSV plus are available for download in the Product Resources section. For customers who prefer to obtain the ADFs on a CD, please fill out the CD ADF request using the following link.