8-9 April 2000. In Australia, testing kits for HIV and Hepatitis C must be registered on the Australian Register of Therapeutic Goods prior to their being commercially distributed. Evaluations are conducted using characterised samples either solely at the NRL or in collaboration with other testing sites. The number and type of samples used for evaluation depends on the purpose for which the kit will be used once registered.
Assays are registrable in one of several different categories which reflect the kit's intended use.
Conditions of registration are applied to kits by the Therapeutic Goods Administration. The conditions relate to quality assurance, the type of samples a kit can be used to test and the laboratories to which a kit may be distributed. The NRL maintains a large bank of characterised samples from which to draw samples for evaluations. Where possible, common samples are included in sequential evaluations so that comparative data of performance between assays can be accumulated. An example of such data is shown in Figure 1.