Overview
NRL is now testing samples using our in-house HTLV-1 Proviral Load (PVL) Assay, with the service being fully funded by the Department of Health, Disability and Aging. The assay has been included in our NATA accreditation as a Class 3 In-Vitro Diagnostic (IVD), reinforcing our commitment to delivering high-quality, reliable monitoring of HTLV-1 infection which is endemic in the Central Australian Aboriginal population. Using multiplex qPCR-based technology, the assay provides accurate quantification of HTLV-1 viral DNA in blood samples, with results delivered within 5 working days upon specimen receipt. These results allow clinicians to advise patients on the risks of transmitting the virus, particularly from mother to child during breastfeeding, allowing the planned adoption of strategies to minimise the chances of spreading this lifelong viral infection to infants.
The testing service directly supports the Australian Clinical Guidelines on HTLV-1, which were developed and implemented by the National Aboriginal Community Controlled Health Organisation (NACCHO) in 2025 in response to community calls for action on HTLV-1.
This is a significant development for NRL and strengthens our capacity to support clinicians and patients requiring HTLV-1 monitoring across regional, remote and very remote Australia.
Contact our team for more
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Details
The NRL In-House HTLV-1 proviral load (PVL) Assay is an in-vitro nucleic acid amplification test for quantification of Human T lymphotropic type 1 (HTLV-1) viral DNA integrated within genomic DNA (gDNA) obtained from cells of blood from patients already established to have been exposed to virus by HTLV-1 serology. The assay incorporates the quantitative assessment of both an HTLV-1 target sequence as well as an internal human control sequence by qPCR.
This assay is not intended for use as an aid in diagnosis or confirmatory assay for HTLV-1 and is developed as a Class 3 IVD for monitoring HTLV-1 infection.
Specimen Requirements- 4mL or 8mL of Whole Blood collected in EDTA and transported at ambient temperature (15 – 25°C) within 7 days post collection.
- 4mL or 8 mL Whole Blood collected in BD Vacutainer® CPT™ Mononuclear Cell Preparation Tube – Sodium Citrate centrifuged according to tube manufacturer’s IFU. Centrifuged tubes should be stored and transported chilled and on their sides, to be received within 7 days of collection.
- A minimum of 200uL of Buffy Coat, PMBC (resuspended in 100µL of PBS per 1mL of whole blood processed), cerebrospinal fluid (CSF) and Bronchoalveolar Lavage (BAL) samples transported frozen on dry ice post collection.
Turnaround Time5 working days upon specimen receipt.
Reference Ranges- Limit of Detection of Assay: 5.8 copies/reaction
- Limit of Quantification of Assay: 12.5 copies/reaction
Reporting unitsHTLV-1 copies/105 cells (% proviral load)
More informationNRL can perform HTLV-1 Serology for confirmation of exposure to HTLV-1 prior to HTLV-1 PVL Assay. If this is required, whole blood within an EDTA tube needs to be received within 72h of collection. Alternatively, serum or plasma can be used for HTLV-I Serology testing.
