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Pilot study of the Xpert hepatitis C virus VL fingerstick assay in the intended use setting
Katy Keylis1,2, Manzhen Chen3, Annabelle St Pierre4
1Viral Hepatitis Care Network (VIRCAN), University Health Network, Toronto, Ontario, Canada.
Background:
Integrating hepatitis C virus (HCV) point-of-care (POC) RNA testing into community settings is essential to achieving World Health Organization elimination targets. However, the preparation required for end users to operate the Xpert HCV VL Fingerstick assay remains unclear.
Purpose:
To determine whether end users can independently review the Instructions for Use (IFU) and accurately perform testing without additional training.
Methodology:
A single-arm ease-of-use study was conducted in Ontario, Canada with nurses practicing incommunity settings serving priority HCV populations. Eligible participants included registered practical nurses, registered nurses, and nurse practitioners without prior experience using the assay. Participants reviewed the IFU, completed a knowledge questionnaire, performed the assay under observation, completed an ease-of-use questionnaire, and were invited to interviews. Feasibility outcomes were analyzed descriptively.
Results:
Nine participants (seven registered nurses and two nurse practitioners) were enrolled. The mean knowledge score was 99%, exceeding the prespecified benchmark (≥78%). Test interpretations were correct in 100% of cases using spiked samples, and no critical user errors were observed. Minor challenges occurred during noncritical tasks, reflected in some Likert-scale responses, although the overall workflow was rated as simple.
Conclusions:
Community-based nurses successfully conducted POC HCV RNA testing using only the IFU, demonstrating feasibility for implementation.
Implications:
Minimal training requirements may facilitate scale-up of HCV POC testing in nursing-led community settings, particularly for underserved populations. Reduced training could lower costs and logistical barriers while supporting decentralized, low-barrier diagnosis. Quality-assurance processes and optional competency-based training may further promote consistent performance and broader implementation.
