HIV kits to have support info
July 11, 2014
THE Therapeutic Goods
Administration (TGA) has
confirmed that the projected
self-testing HIV kits, approved for
supply to the public (PD 09 Jul),
will have support and counselling
information included.
A TGA spokeswoman said the
tests would be expected to be
supplied with clear, easy to use
instructions on how to use the test
correctly and interpret results.
“It is expected that instructional
material provided with a test
would also include information on
how to access appropriate support
services such as counselling and
follow-up medical consultation.”
She said it was expected the tests
would be available through various
channels, including pharmacies.
In a Facts and Questions
published yesterday, the TGA said
self-tests would also be expected
to have information that positive
results from a self-test required
confirmatory laboratory testing as
false positive results could occur.
The Royal Australian College
of General Practitioners has
previously said it was alarmed
about the move to allow supply
of the kits, given the possibility of
patient distress at a false positive
result without appropriate support
and information (PD 10 Jul).
The TGA said there was a number
of options for how support
services would be provided in
Australia but “the specific details
and approach would be addressed
within a commercial supplier’s
proposal to TGA.”
IVD Australia spokesperson Peter
Harman said it had not been made
clear from the department what
information would be required
from manufacturers.
Other testing kits, such as
the Alere HIV-1/2, required the
manufacturer to provide training
and support services, he said.
IVD supported the supply of
self-testing kits but believed
they should come with a 24 hour
counselling service provided by
the Department, he said.
Harman said he would expect the
public would not see kits available
for at least six months, given the
process to list on the ARTG.
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