Key Study Components
There are various components that make up this study. These include the following:
Protocol Training:
All sites will undergo protocol training run by the Kirby Institute. It will be expected for all site staff working on this project to attend. This meeting will be conducted remotely and will take approximately 1.5 hours.
Operator Training:
Site staff nominated as operators will be provided with comprehensive training. Training will consist of online self-paced learning, self-administered assessments, followed by a remote theoretical and practical training session. The operator will be fully certified to perform finger-stick point-of-care HCV RNA testing as in accordance with TGA requirements.
The total length of time for this training session is approximately 8 hours across multiple days. Please see below for all steps required for operators to be signed off.
Quality Assurance Program:
To ensure the program is operating in compliance with best practice laboratory and regulatory standards, a robust quality assurance framework has been established through collaborations between the Kirby Institute, Flinders University, St. Vincent’s Hospital, and the National Reference Laboratory. Each study site will test a competency panel (a known positive and negative sample) monthly and an external quality assurance panel (five blinded samples) six-monthly to assess the competency of the operator, check for contamination, and ensure the instrument is in working order and correctly detecting samples.
Connectivity and IT Solutions:
Connectivity is the term used to describe the integration of IT solutions to the GeneXpert platform and point-of-care testing into the electronic health service environment. The main goals of connectivity are to minimise disruption to workflow and through reductions in manual tasks for staff ` ensure timely and accurate recording and reporting for clinical and public health needs.
We will implement IT and connectivity systems to meet real-world program, clinical (data transfer to electronic medical records), and public health reporting needs (laboratory notifications), drawing upon systems successfully implemented by Kirby Institute/Flinders University, NSW Pathology, and St. Vincent’s Hospital for point-of-care testing for STIs and COVID-19.