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Xpert® Xpress CoV-2/Flu plus (10-test kit)
XPRSCOV2/FLU-10
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Verification Guide
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Quick Reference Guide
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1. Which sample types can be used with Xpert® Xpress CoV-2/Flu plus?
1. Which sample types can be used with Xpert® Xpress CoV-2/Flu plus?
Nasopharyngeal swab and anterior nasal swab specimens collected from individuals with signs and symptoms of respiratory tract infection can be used with this test.
2. Which collection devices can be used with Xpert® Xpress CoV-2/Flu plus?
2. Which collection devices can be used with Xpert® Xpress CoV-2/Flu plus?
Nylon flocked swabs, viral transport medium (VTM), Universal Transport Medium (UTM) and eNAT® Molecular Transport Medium are compatible for use with this test.
The following materials are examples of those that are compatible with the Xpert Xpress CoV-2/Flu plus test:
Nasopharyngeal Sample Collection Kit for Viruses
· Copan UTM® 3C057N (Flexible Minitip Flocked Swab with UTM Medium)
· Copan eNAT Molecular Collection and Preservation Medium P/N 6U074S01 (Flexible Minitip Flocked Swab with eNAT Medium)
· BD Becton Dickinson Universal Viral Transport Kit P/N 220531 (Flexible Minitip Flocked Swab with UVT Medium)
Nasal Sample Collection Kit for Viruses
· Copan UTM 3C064N (Regular Flocked Swab with UTM Medium)
· Copan eNAT Molecular Collection and Preservation Medium P/N 6U073S01 (Regular Flocked Swab with eNAT Medium)
Alternatively, swabs and transport media can be obtained separately:
· Nylon flocked swab (Copan P/N 502CS01, 503CS01)
· Viral transport medium, 3 mL (Copan P/N 3C047N, Remel M4RT or Remel M5)
3. Which external quality control (QC) material options are available for Xpert® Xpress CoV-2/Flu plus?
3. Which external quality control (QC) material options are available for Xpert® Xpress CoV-2/Flu plus?
There are two external controls identified in the IFU from ZeptoMetrix for this test: NATFRC-6C-IVD (positive control) and NATCV9-6C-IVD (negative control). For appropriately certified labs (e.g., CLIA certification to perform moderately complex testing), other vendors offer alternative quality control materials in addition to the ZeptoMetrix controls listed in the IFU. If a laboratory sources alternative external QC materials, it is their responsibility to ensure that material performs as expected with this test. External controls should be used in accordance with local and state accrediting organizations, as applicable.
4. Do you have any guidelines for verification studies of the Xpert® Xpress CoV-2/Flu plus?
4. Do you have any guidelines for verification studies of the Xpert® Xpress CoV-2/Flu plus?
Before going live with a new test, a verification study may be necessary. Please refer to your relevant laboratory accreditation regulations for verification requirements. A verification guide that describes the preparation of contrived positive specimens (prepared by spiking commercial reference material into negative specimens) is available for download in the Product Resources > Technical Documentation section of this webpage. The decision to perform verification studies and the level of verification required is at the discretion of the laboratory director and should be conducted according to applicable regulations.
5. How can customers obtain the ADF or package insert for the Xpert® Xpress CoV-2/Flu plus?
5. How can customers obtain the ADF or package insert for the Xpert® Xpress CoV-2/Flu plus?
To reduce waste, Cepheid will provide electronic copies of Instructions for Use (IFU) and Assay Definition Files (ADF). The IFUs, ADFs, and ADF import instructions for this test are available for download here. A CD containing the ADF is also being provided with each customer’s first order of XPRSCOV2/FLU-10. Customers who would like to order additional copies may fill out the CD ADF request form.
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