Background:
In December 2012 the Therapeutic Good Administration (TGA) approved the first point of care test (PoCT) for Human Immunodeficiency Virus (HIV) for use in Australia. The Alere Determine HIV Combo test is now registered for use as a preliminary screening test. All reactive results must be confirmed through referral to a National Association of Testing Authorities (NATA) accredited medical testing laboratory.
The TGA has placed a number of strict conditions around the use of the device. It is licensed for use in laboratories accredited by the National Association for Testing Authorities (NATA) or by trained health professionals working for certain organisations under specific conditions. Training and administration must be in accordance with the requirements of the National HIV Testing Policy.
The presentation will focus on the following issues currently being addressed to ensure the successful implementation of HIV point of care testing in Australia and sumarise:
• Development of national training and accreditation standards for PoCT operators
• Establishment of relationships between PoCT services and HIV testing laboratories
• Resolution of implications for laboratories and their role in confirmatory testing
• Test site accreditation/endorsement
• Development of National Pathology Accreditation Advisory Council (NPAAC) regulations
• Current sites performing HIV PoCT.
Conclusion:
The presentation will conclude by reviewing the next steps currently underway between various stakeholders, including:
• Whether it is feasible for the NATA/RCPA accreditation program to cover HIV PoCT
• The role of states and territories in quality assurance of publicly funded HIV PoCT services, and
• Consideration of the quality arrangements for HIV PoCT facilities which only have non-medical practitioner staff.