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"Dangerous" home HIV test kit still on sale

Mon 21 Feb 2011 In: New Zealand Daily News View at Wayback

Home HIV test kits, on sale to be used in unsupervised and unsupported environments, are still on the market despite continuing calls from the country's two biggest HIV and AIDS organisations for them to be completely withdrawn. The NZ AIDS Foundation says the sale of the kits by a "dodgy" firm to "vulnerable people" is "a desperate attempt to make money." Body Positive has urged the company to "look to its conscience." Both organisations say the use of the kits without proper back-up is valueless and even dangerous and must stop. However, Head Start Testing has continued to market the kits and the Ministry of Health's medications watchdog Medsafe has merely asked the company to remove its claim that the kits are "Medsafe approved." The Ministry appears powerless to intervene in Head Start's promotion of its test kits, which are available online and have been promoted to retailers. The kit is considered a medical device under the Medicines Act 1981. "But the Act does not require medical devices to go through a pre-market approval process, such as that required for medicines, before they can be supplied on the New Zealand market," says a Ministry spokesperson. "Although Medsafe does not approve medical devices, they monitor the safety of these devices and can order their withdrawal from the market if they pose a risk to public safety." The Ministry has yet to comment on whether the use of the kits in unsupervised and unsupported settings constitutes a safety issue. The Ministry says it is now considering recommendations made in Dr David Miller's recent review of HIV services for people living with HIV in New Zealand, which it  commissioned. "The review suggested that a national discussion about national guidelines and standards for HIV testing and counselling is necessary, in the light of developments in HIV testing technology and the recent availability of testing outside of routine clinical settings." There is as yet no indication of how long that "discussion" might take or how it might address this issue. Meanwhile, the NZ AIDS Foundation and Body Positive are urging anyone thinking of using a home kit to instead approach them for a free, confidential and professionally supported HIV test. Over three quarters of HIV infections diagnosed within New Zealand occur amongst gay and bi men. Head Start Testing has yet to respond to GayNZ.com's questions, sent two weeks ago.    

Credit: GayNZ.com Daily News staff

First published: Monday, 21st February 2011 - 2:20pm

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