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Xpert® HCV
Point-of-care hepatitis C RNA test that enables same-day linkage to care
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GXHCV-CPAK
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The Need
- Under diagnosis of HCV remains one of the most significant barriers to HCV elimination and public health with only 49%– 55% of people with chronic HCV disease aware of their infection status.1
- A diagnostic algorithm for HCV infection that requires multiple tests and multiple clinical appointments results in patients being lost before being treated.2
- Simplifying the diagnostic pathway can shorten time to treatment, reduce loss to follow up, and prevent the risk of onward transmission. 2
- Tests that detect active HCV infection, performed in CLIA waived settings have the potential to reach more people and improve overall diagnosis and linkage to care rates.1
1 Page and Feinberg. What Hepatitis C Virus (HCV) Diagnostic Tools Are Needed to Advance Diagnosis of Current HCV Infection in Outreach Settings and in a Nonclinical Setting? JID 2024, https://doi.org/10.1093/infdis/jiad269
2 Applegate TL, Fajardo E, Sacks JA. Hepatitis C Virus Diagnosis and the Holy Grail. Infect Dis Clin North Am. 2018;32(2):425-445. doi:10.1016/j.idc.2018.02.010
2 Applegate TL, Fajardo E, Sacks JA. Hepatitis C Virus Diagnosis and the Holy Grail. Infect Dis Clin North Am. 2018;32(2):425-445. doi:10.1016/j.idc.2018.02.010
The Solution
- Xpert HCV is a CLIA waived test that can be performed using a fingerstick capillary whole blood sample in point-of-care settings. The test can be used to determine the HCV infection status of individuals at risk of HCV with or without antibodies to HCV, and can therefore be utilized as part of a one-step testing algorithm for active HCV infection.
- Xpert HCV can be used as part of a “test and treat” model of care, potentially saving time between initial evaluation and treatment initiation, retaining more patients in care, and has the ability to increase the number of infections cured.
The Impact
- Simplifies HCV diagnosis: Xpert HCV detects viral RNA and does not require antibody testing, enabling a one-step testing algorithm for detection, speeding up the time to treatment and reducing the number of patients lost to follow up3
- Improves access to testing for those at highest risk: HCV RNA point-of-care testing can be delivered in settings to reach and diagnosis individuals at highest risk of infection3
- Increases diagnosis and linkage to care: same-day results can increase uptake of treatment, reduce risk of transmission and prevent loss to follow up
3 WHO, Updated Recommendations on Simplified Service Delivery and Diagnostics for Hepatitis C Infection Policy Brief 2022. https://iris.who.int/bitstream/hand le/10665/357086/9789240052697-eng.pdf?sequence=1
Product Resources
Product Information
Package Inserts & MSDS
Frequently Asked Questions
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.
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.
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.
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.
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.
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.
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).
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
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.
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.
Verification is not required for tests run at sites operating under a CLIA Certificate of Waiver.
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.
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.
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.
