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NZAF ramps up opposition to HIV self-test kits

Sat 2 Jan 2010 In: New Zealand Daily News View at Wayback View at NDHA

"Serious concerns" about the efficacy and reliability of HIV rapid screen test offered to adult shops and some gay sex on site venues last year have been passed on to the government's medical device safety authority. Firming up its opposition to the retail sale of the EZ-Trust tests, the NZ AIDS Foundation says it will "continue to work towards the removal of these tests from retail sale in New Zealand." NZAF Executive Director Rachael Le Mesurier says the Foundation has had no response to requests for information from the kit's manufacturer's and has not had a satisfactory response to an offer to meet with the New Zealand importers to discuss the test and its distribution. The Foundation says it contacted the Kit's manufacturers in Singapore "on two separate occasions" to seek information regarding the test’s efficacy and reliability, "but as of yet we have not had this information supplied to us." It is also concerned that the EZ-Trust test is not listed nor approved by the internationally respected US Federal Drug Administration, "unlike the testing kits used by the NZAF," and "we have been unable to source any research data that relates to the test." The NZAF has now raised the issue with Medsafe, the government agency which oversees the regulation  of medicines and medical devices. Eamonn Smythe, NZAF Director Positive Health, offered to meeting with the distributor when the matter first came to the Foundation's attention," according to Le Mesurier. "The importer responded and offered to meet him confidentially. Eamonn said he was happy to meet, but that it would be a matter of record.  He has not received a response." It appears that so far only a handful of the kits have been sold in NZ, understood to be by a single small gay adult retail and mail order outlet. The only gay adult outlet to publicly countenance selling the kits, on condition that more suitable consumer information and support was devised to accompany kit sales, has yet to see such material and has therefore not stocked the single-use kits. The provision of only sketchy pre- and post-test support information was high on the list of NZAF concerns when the kits were first marketed in early November. Le Mesurier says the NZAF "does not support the sale of any HIV test in a non-clinical setting. While we will always supply information regarding HIV risk and testing for HIV, we believe that this information is better delivered within a therapeutic model of care."    

Credit: Daily News staff

First published: Saturday, 2nd January 2010 - 11:00pm

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