At home HIV test kits risk false results, says peak body for general practice

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The Royal Australian College of General Practitioners is alarmed by the Government’s announcement to lift restrictions preventing the manufacture and sale of HIV home test kits, saying HIV testing should be conducted under the supervision of a qualified healthcare professional.

Despite advice from the RACGP outlining the dangers associated with such a move, the Federal Government yesterday announced that companies are now able to apply to the Therapeutic Goods Administration (TGA) for approval to manufacture and supply consumers with HIV home test kits.

RACGP Vice-President, Adjunct Associate Professor Frank Jones said there is a real danger associated with patients receiving a positive result at home without appropriate support and information from a medical professional.

“Failure to miss a HIV infection can have serious consequences, so tests are keyed for high sensitivity and have the potential to lead to a false positive rate of around 1-2%.

“In a low prevalence country like Australia, single rapid tests – such as these at home test kits – are more likely to show a false positive than a true positive.

“There is enormous potential for unnecessary patient distress as a consequence of inaccurate results without adequate follow-up with a medical professional.

“Point of care testing in general practice, sexual health clinics and other professionally supported services is the safest way to improve access to testing and mitigate against risks of HIV transmission.

“If the Government is serious about curbing the rate of HIV in the Australian community, they should focus on increasing the availability of point of care testing.

“We have seen significant improvements in HIV treatment and management in recent years and general practice is better equipped than ever to take a larger role in the ongoing management of HIV,” said A/Prof Jones.

It is well known patients from marginalised groups, who face multiple barriers to accessing primary healthcare, are less likely to follow-up with their GP for discussion and confirmatory testing.

“Patients should be in the presence of a qualified healthcare professional when learning of HIV results and point of care testing is an important step toward increasing at-risk populations coming forward.

“This move is pushing GPs out of the loop and lack of knowledge of a patient’s HIV status is extremely dangerous,” said A/Prof Jones.

The RACGP seriously urges the Government to immediately reverse this decision and instead, focus on reducing barriers to accessing primary healthcare and increasing point of care testing capabilities.

If this decision is not abandoned, the RACGP demands the TGA ensure suppliers provide comprehensive accompanying information outlining the possibility of a false positive and a strong recommendation for immediate follow up with a GP.

Source:  http://www.racgp.org.au/yourracgp/news/media-releases/hiv-test-kits/