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The Practicability of the Xpert HCV Viral Load Fingerstick Point-of-Care Assay in Primary Care Settings
David Petroff1, Olaf Bätz2, Katrin Jedrysiak2
1Clinical Trial Centre, University of Leipzig, 04107 Leipzig, Germany.
Insights
Hepatitis C Virus (HCV) screening in primary care using the Xpert HCV viral load point-of-care assay showed low detection rates and interpretability issues. Further evaluation is needed before recommending it for widespread HCV screening.
Area of Science:
- Hepatology
- Infectious Diseases
- Point-of-Care Diagnostics
Background:
- Linkage to care is a major barrier to Hepatitis C Virus (HCV) elimination.
- The current two-step HCV testing pathway leads to patient attrition.
- Primary care settings are crucial for expanding HCV screening access.
Purpose of the Study:
- To evaluate the practicability of immediate HCV diagnosis using the fingerstick Xpert HCV viral load point-of-care assay in primary care.
- To assess the diagnostic performance of the Xpert HCV assay compared to central laboratory testing.
- To gather primary care physician feedback on the Xpert HCV test's usability.
Main Methods:
- The Xpert HCV viral load point-of-care assay was implemented across 10 primary care practices.
- A total of 622 patients were recruited for the study.
- Central anti-HCV and HCV-RNA testing served as the gold standard for comparison.
Main Results:
- The Xpert test had a validity rate of 87.8% (546/622 patients).
- The assay yielded 2 false-positive results and failed to detect HCV-RNA in 4 out of 5 anti-HCV positive cases.
- Primary care physicians generally rated the test's practicability as good (81%), although a single practice accounted for most negative ratings.
Conclusions:
- The Xpert HCV viral load point-of-care assay demonstrated challenges in diagnostic performance and interpretability within the primary care setting.
- While physician acceptance was adequate, the test's limitations necessitate further evaluation before recommending it for HCV screening.
- Improving linkage to care and diagnostic accuracy are essential for HCV elimination efforts.
Abstract:
Linkage to care presents one obstacle toward eliminating HCV, and the current two-step pathway (anti-HCV, followed by HCV-RNA testing) results in the loss of patients. HCV screening was tested in the primary care setting with the fingerstick Xpert HCV viral load point-of-care assay to analyze the practicability of immediate diagnosis. Anti-HCV (Cobas) and HCV-RNA (Cobas Amplicor version 2.0, only performed if anti-HCV was positive) were analyzed centrally as the gold standard. The Xpert assay was performed by 10 primary care private practices. In total, 622 patients were recruited. Five individuals (0.8%) were anti-HCV positive, and one was HCV-RNA positive. The Xpert test was valid in 546/622 (87.8%) patients. It was negative in 544 and positive in 2 cases, both of whom were anti-HCV negative. The HCV-RNA PCR and the Xpert test were both negative in 4/5 anti-HCV-positive cases, and the individual with HCV-RNA 4.5 × 106 IU/mL was not detected by the Xpert test. Primary care physicians rated the Xpert test practicability as bad, satisfactory, or good in 6%, 13%, and 81%, respectively, though 14/29 (48%) bad test ratings were assigned by a single practice. Despite adequate acceptance, interpretability and diagnostic performance in primary care settings should be further evaluated before its use in HCV screening can be recommended.
