7. TEST KITS

An objective of this project was to establish mechanisms to use EQA data to help monitor quality of test kits.

In collaboration with IVD Australia and the Therapeutic Goods Administration the RCPA QAP developed a framework to manage situations when an IVD is identified in the EQA to be performing significantly different to other IVDs.

Performance Monitoring Process for Commercial IVDs (Figure 4)

Data returned to the RCPA Quality Assurance Programs, from time to time identifies test kits or methodologies (in vitro diagnostic medical devices or IVDs) performing outside acceptable levels of performance, or significantly different from other IVDs. This can be identified when a group of participants are seen to be performing significantly different.

IVDs identified as performing outside acceptable levels of performance, are reviewed by the Program Performance Review Committee (PRC). A representative from IVD Australia will be invited to review these findings with the PRC. If these findings are considered of significant concern, manufacturing companies or their sponsors will be notified to enable them to investigate further. The Therapeutic Goods Administration (TGA) will also be advised to enable more rigorous pre‐market testing of similar IVDs. Any results released in this instance would not disclose the identification of individual laboratories. Ordinarily participants would be able to view performance of all test kits, in the reports.

For IVDs found to be performing outside acceptable levels of performance, the Performance Review Committee report and any discussions with manufacturers, their sponsors or TGA are referred to the RCPA QAP Board for formal review.