Message from the Director

Welcome to the website of the National Serology Reference Laboratory, Australia (NRL^TM).

As part of the Australian Government's HIV and AIDS Strategy, the NRL was established in 1985 to evaluate newly devised HIV tests and assure accurate interpretation of HIV test results. Since that time, its quality assurance methods have been devised and refined then expanded into a comprehensive Quality Assurance (QA) Programme for HIV, HTLV and HCV serology including nucleic acid testing and HIV antiretroviral resistance testing. More recently QA for tests and testing of other infectious organisms have been added to the QA repertoire. Components of the programme include Performance Evaluation, Serology Specificity Monitoring, Serology Screening Information, Quality Control Programmes, External Quality Assessment Schemes, Tertiary Reference Testing and Consulting Services. More recently, the programme has been applied to tests used to assess HIV viral load using nucleic acid amplification techniques as well as to other serology. NRL has devised internet systems so that its programmes can be presented accurately and reported on in a timely fashion.

While expanding its QA Programme, the NRL has also sought, and gained, certification/accreditation for its Quality Management System. We are now accredited to the ISO-15189 standard and certified to ISO-9001, as well as being licenced to GMP guidelines in required areas. Our External Quality Assessment Scheme is accredited to ILAC Guide 13. Our safety management is certified to AS 4801. The experience gained from developing our Quality Management System has enabled NRL staff to act as consultants in this area. Our quality assurance procedures can be presented as a package to assist laboratories to monitor and demonstrate their own quality management.

In future, the NRL will endeavour to extend its services to all eligible and appropriate laboratories and to all diagnostic systems. Quality assurance will be offered to laboratories other than those testing for HIV and Hepatitis. Our international programmes will undergo further development in order to maintain and strengthen its position as a WHO Collaborating Centre and to enhance its position as an Australian Centre of Excellence. Efforts will continue to be made to offer quality assurance for other diagnostic systems in addition to Measles, Rubella and Chlamydia trachomatis. The NRL will also strive to develop its research activities.

Operation of the NRL is funded by the Population Health Division and the Acute Care Division, Australian Department of Health and Ageing. Laboratory evaluations of new or modified HIV and HCV kits are contracted to the NRL by the Therapeutic Goods Administration (TGA). Other services are supplied according to individual contracts. The NRL is supported by it's Host Institution, St. Vincent's Institute under the care of St. Vincent's Hospital Melbourne, a Sisters of Charity Health Service facility. The NRL is guided by a Management Advisory Committee and a Scientific Advisory Committee.

Elizabeth M. Dax Director