NRL News

Edition 5, 2019

NRL News

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 assay was initially developed for use with buffy coats obtained from whole blood but has also been adapted for other sample types including Dried Blood Spots and Cerebrospinal Fluid.

 

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.

Contact Us

 Address: 4th Floor, Healy BuildinNRL

4th Floor, Healy Building

41 Victoria Parade

Fitzroy VIC 3065

Australia

Fax: +61 3 9418 1155

Phone: +61 3 9418 1111

Email: info@nrlquality.org.au

Social Media

  • Twitter Social Icon
  • LinkedIn Social Icon

NRL is designated a WHO Collaborating Centre for Diagnostics and Laboratory Support for HIV and AIDS and Other Blood-borne Infections