Key Program Components
The Australian Hepatitis C Point of Care Testing Program provides a comprehensive training and quality assurance framework to ensure safe, accurate, and compliant point-of-care testing across all participating sites. The framework encompasses protocol training, operator certification, ongoing quality monitoring, and integrated IT connectivity solutions to maintain the highest standards of patient care and data integrity while minimizing workflow disruption.
Protocol Training
Duration: Approximately 1.5 hours
All sites are required to participate in protocol training conducted by the Kirby Institute. Training will be delivered by a live remote session or self-paced recorded training slides covering study procedures, data management, and regulatory requirements.
GeneXpert Operator Training
Duration: Approximately 8 hours across multiple days
Nominated site operators receive comprehensive training for finger-stick point-of-care HCV RNA testing in accordance with TGA requirements. The program combines self-paced online learning with remote theoretical and practical sessions, and includes training quality evaluation through competency surveys.
Training Components:
Online learning:
- Self-paced learning modules
- Self-administered competency surveys
Live remote sessions:
- Theoretical training
- Practical training
Operators receive full certification to perform finger-stick point-of-care HCV RNA testing upon successful completion of all training requirements in accordance with TGA requirements.
Rapid Antibody Operator Training
Duration: Approximately 2 hours
Nominated site staff can complete certification for antibody point-of-care testing. This involves self-paced online learning modules and a live remote practical training and competency assessment with staff from either the Flinders University International Centre for Point-of-Care Testing or for sites in NSW with the St Vincent's AMR teams to confirm competency.
Online learning modules:
Core modules:
- Infection Control for Point-of-Care Testing
- Quality Control Procedures for Point-of-Care Testing
Device-specific modules:
- Point-of-care testing for HCV using Abbott BIOLINE HCV Antibody Test
- Point-of-care testing for HCV using INSTI HCV Antibody Test
- Point-of-care testing for HIV using DETERMINE HIV Early Detect Test*
- Point-of-care testing for HBV using Abbott DETERMINE Surface Antigen 2 Test*
*Sites not using HIV or HBV devices may exclude those modules.
Live remote session:
- Practical training and competency assessment
A certificate of completion is issued upon successful completion of the practical assessment.
Quality Assurance Program
Robust quality assurance systematically evaluates operator competency, monitors for contamination, and verifies that instruments are functioning properly and detecting samples correctly to ensure reliable and accurate results. The program, established through collaborations between the Kirby Institute, Flinders University, St. Vincent's Hospital, and the National Reference Laboratory, ensures compliance with best practice laboratory and regulatory standards.
Internal and External Quality Assurance assessments are mandatory for all sites involved in point-of-care testing.
Internal Quality Assurance
GeneXpert platform competency panel testing
Frequency: Monthly
Format: Known positive and negative samples
Antibody test devices competency panel testing for relevant devices used at the site
Frequency: Twice-yearly
Format: Known positive and negative samples
External Quality Assurance
Assessment for both GeneXpert platform and the relevant antibody test devices
Frequency: Six-monthly
Format: Four blinded samples per assessment
Connectivity and IT Solutions:
We are integrating IT solutions with the GeneXpert platform and point-of-care testing results into electronic health service environments to minimize workflow disruptions and reduce manual tasks for staff. We have begun implementing IT and connectivity systems to meet real-world program requirements, addressing automation of public health laboratory notifications across multiple jurisdictions.
The program continues to expand clinical integration through data transfer to electronic medical records, ensuring timely and accurate recording and reporting for clinical and public health needs. This approach draws upon systems successfully implemented by the Kirby Institute/Flinders University, NSW Pathology, and St. Vincent's Hospital for point-of-care testing in STI and COVID-19 programs.