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Xpert® HCV

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FAQs

1. What is the intended use for the Xpert HCV test?

1. What is the intended use for the Xpert HCV test?

The Xpert HCV test, performed on the GeneXpert® Xpress system, is an automated in vitro reverse transcription polymerase chain reaction (RT-PCR) test for the qualitative detection of hepatitis C virus (HCV) RNA in human fingerstick K2EDTA whole blood from adult individuals at risk and/or with signs and symptoms of HCV infection with or without antibody evidence of HCV infection. Detection of HCV RNA indicates that the virus is replicating and therefore is evidence of active infection. Detection of HCV RNA does not discriminate between acute and chronic states of infection. The Xpert HCV test is not cleared for monitoring patients undergoing treatment or for use in screening blood, plasma, or tissue donors.

2. How does the Xpert HCV test work?

2. How does the Xpert HCV test work?

The Xpert HCV test utilizes an automated in vitro reverse transcription polymerase chain reaction (RT-PCR) to qualitatively detect hepatitis C virus (HCV) RNA. The test requires the use of fingerstick whole blood collected in K2EDTA tubes from human adult individuals at risk and/or with signs and symptoms for HCV infection with or without antibodies to HCV.Please note: The Xpert HCV test is not cleared for monitoring patients undergoing treatment or for use in screening blood, plasma, or tissue donors.

3. Is the Xpert HCV product CLIA waived?

3. Is the Xpert HCV product CLIA waived?

Yes. The Xpert HCV test can be used in a CLIA waived environment. If the HCV test is to be used in a CLIA moderate or high complexity environment, the test needs to be run on GeneXpert Xpress system following the IFU.

4. What systems can be used to perform Xpert HCV testing?

4. What systems can be used to perform Xpert HCV testing?

The Xpert HCV test can be performed on the GeneXpert Xpress systems (catalog number: GXIV-2-CLIA or GXIV-4-CLIA) using GeneXpert Xpress software version 6.4a or higher.

5. What sample types and collection materials can be used with Xpert HCV test?

5. What sample types and collection materials can be used with Xpert HCV test?

Sample Type: 250 - 500uL of fingerstick whole blood collected into K2EDTA tubes. Collection Devices: High-flow lancet and a BD K2EDTA microtainer tube (BD PN: 365974) Please note that only the described sample types and collection devices are validated for use with this test.

6. What is the estimated test run time for Xpert HCV?

6. What is the estimated test run time for Xpert HCV?

The test has an early assay termination feature where detected results can be completed in as soon as 41 minutes. The full run time is 60 minutes.

7. What is included in the Xpert HCV Kit?

7. What is included in the Xpert HCV Kit?

Each kit contains: 10 test cartridges, 20 disposable 100μL transfer pipettes, a CD with the ADF and IFU, a printed version of the IFU and a Quick Reference Instructions (QRI).

8. Is the Xpert HCV for the U.S. the same as the Xpert HCV VL Fingerstick test available outside the U.S.?

8. Is the Xpert HCV for the U.S. the same as the Xpert HCV VL Fingerstick test available outside the U.S.?

No, the Xpert HCV for the U.S. is for qualitative HCV RNA detection and so does not measure HCV viral load. The Xpert HCV test is different than the HCV tests available outside the U.S. The Xpert HCV is a qualitative test and does not provide a viral load result. US-IVD. In Vitro Diagnostic Medical Device. ©2024 Cepheid. | June 2024

9. Are there any specific tips or recommendations to highlight for the Xpert HCV test?

9. Are there any specific tips or recommendations to highlight for the Xpert HCV test?

It is important to follow the instructions provided in the Instructions For Use, as it pertains to sample collection and sample transfer. Deviation from these procedures can lead to cartridge failures.

10. What external quality control (QC) material options are available for Xpert HCV?

10. What external quality control (QC) material options are available for Xpert HCV?

The listed external controls are Zeptometrix External Controls:

  • NATtrol Hepatitis C Virus Negative Control, ZeptoMetrix Corporation catalog number NATHCVNEG-6C-IVD.
  • NATtrol Hepatitis C Virus Positive Control, ZeptoMetrix Corporation catalog number NATHCV-6C-IVD

These are described in the “materials available but not provided” section of the package insert. These controls will be available from ZeptoMetrix once the Xpert HCV test is commercially launched. External controls must be used in accordance with local, state, and federal accrediting organizations' requirements, as applicable.

11. Do you have any guide for verification studies of the Xpert HCV test?

11. Do you have any guide for verification studies of the Xpert HCV test?

Verification is not required for tests run at sites operating under a CLIA Certificate of Waiver.

12. What are the sample storage conditions for Xpert HCV test?

12. What are the sample storage conditions for Xpert HCV test?

Once the fingerstick blood sample is collected into the EDTA microtainer tubes, the storage conditions for the EDTA whole blood sample is 4 hours when kept between 2 °C to 30 °C.

13. What information do I need to LIS interface the Xpert HCV test)?

13. What information do I need to LIS interface the Xpert HCV test)?

For customers currently LIS interfaced for other Cepheid tests, this test should be enabled in the host communication settings of the software, using the suggested default host test code (HCV), then confirming that the test information is being transmitted successfully. Always confirm with the LIS Admin before making any changes to the LIS settings. Additional information regarding LIS interfacing can be found in the LIS guidance for this test.

14. Are the Instructions for Use/Package Insert (IFU/PI) and Assay Definition File (ADF) included in the kit for Xpert HCV test?

14. Are the Instructions for Use/Package Insert (IFU/PI) and Assay Definition File (ADF) included in the kit for Xpert HCV test?

The Instructions for Use (IFU) and Assay Definition Files (ADF) are both included in the kit. A printed copy of the IFU and a printed copy of the Quick Reference Instructions (QRI) are included inside the kit. Also included is a CD which contains the Assay Definition File and the Import instructions for the ADF. For customers who would like to obtain an electronic copy of the IFU the IFU can also be downloaded from the product page upon commercial launch.