The Practicability of the Xpert HCV Viral Load Fingerstick Point-of-Care Assay in Primary Care Settings.

David Petroff,Jan Kramer,Olaf Bätz,Johannes Wiegand,Katrin Jedrysiak,Thomas Berg

doi:10.3390/v13112327

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.

Highlights

Five years ago, the World Health Organization presented a strategy for eliminating chronic hepatitis C virus (HCV) infection by the year 2030 [1]
The HCV care continuum is further impaired, because HCV-RNA-positive patients are usually referred from primary care to the secondary care of hepatologists or infectious disease specialists: Follow-up data of an HCV screening project with primary care physicians showed that subsequent
In order to eliminate HCV infection, several key factors have been identified in highincome countries, including political will, financing a national program, implementing monitoring of existing programs, screening, awareness, and linkage to care [15]

Summary

Introduction

The World Health Organization presented a strategy for eliminating chronic hepatitis C virus (HCV) infection by the year 2030 [1]. Models show the importance of adequate treatment uptake with modern direct antiviral agents [3], which led to the wide use of interferon-free antiviral therapies in clinical practice: German registry data show sustained virological response rates of 97% and favorable tolerability of various treatment regimens [4]. These major achievements should be accompanied by screening and linkage-to-care programs [3]. The HCV care continuum is further impaired, because HCV-RNA-positive patients are usually referred from primary care to the secondary care of hepatologists or infectious disease specialists: Follow-up data of an HCV screening project with primary care physicians showed that subsequent

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