Edition 5, 2019
NRL’s in-house HTLV Proviral Load Assay for research use only
NRL developed an in-house HTLV proviral load assay to provide testing as part of an NH&MRC project investigating the prevalence and clinical sequelae of HTLV in indigenous communities in central Australia. The assay detects HTLV-including subtype 1c which is Australo-Melanesian strain found in PNG, Solomon Islands, Vanuatu and Australia.
The introduction of the new in-vitro diagnostic (IVD) framework on the 1 July 2017 required all IVDs to be registered on the Australian Register of Therapeutic Goods (ARTG). NRL intended to register the in-house HTLV proviral load assay, however the platform used will soon be obsolete and therefore this assay will no longer be registered in its current format. Consequently, NRL is currently unable to offer this assay for diagnostic or monitoring purposes but does continue to perform the assay for research use only where appropriate ethics approval has been obtained.
NRL is in the process of developing a modified version of this in-house HTLV proviral load assay with the aim of having it registered on the ARTG and will inform clients once it becomes available for routine clinical use.