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Thursday 15 April 2010


Should we be self-testing for HIV?

Posted in: HIV
By GayNZ.com Daily News staff - 7th November 2009

Part one of a three-part feature series

An importer of home test kits for HIV is pitted against the NZ AIDS Foundation as it encourages New Zealand retailers to stock the first in its projected series of home test kits for sexually transmitted infections.


ez-trust-hiv-kit.jpg
Head Start Testing says its EZ-Trust kits, which give a result within a few minutes, will save lives by reaching out to people who aren't testing through the usual sexual health centres. The AIDS Foundation believes that without expert guidance and support users of the home test kits may be headed for disaster. It yesterday called Head Start Testing "irresponsible and unprofessional" for distributing the product.

80 per cent of new, locally contracted HIV infections in New Zealand are detected amongst gay and bi men. According to the latest available annual figures, 91 men learned in 2008 that they have contracted HIV, reflecting a strongly resurgent HIV epidemic with infection detection rates not seen since the first avalanche of diagnoses in the mid 1980s.

An HIV diagnosis used to be an automatic death sentence, but with advances in medications, some of which have unpleasant or even debilitating side-effects, an AIDS-related death is no longer such an inevitability. Likewise, testing for the presence of HIV, or more accurately the antibodies created by the body's struggling immune system when HIV is present, has become more straightforward. Last year the NZAF was at the forefront of NZ sexual health agencies by introducing a 'rapid test' system. A prick on the finger, a droplet of blood on a nifty little test kit and a few minutes wait can deliver an indication of the likely presence, or absence, of HIV. Sadly, it's not actually that straightforward.


LEGALITIES AND APPROVALS

Until now such kits have been exclusively used in a professional setting with pre- and post-test counseling and support instantly on tap. But they are increasingly available over the internet and, now, over the counter in New Zealand if
Head Start Testing has its way.

Is it legal to sell an HIV self-test kit in a non-healthcare or non-pharmacy setting? Apparently so. The NZAF advises that rapid HIV tests are considered a `medical testing device` and as such are not regulated by Med Safe, the government agency responsible for approving medications.
Head Start Testing acknowledges its Singapore-manufactured kit has not yet been assessed and approved by any New Zealand health authority. But "we are seeking endorsements now," it says. Asked if it has discussed its product and marketing with any health authorities, such as the Ministry of Health or the AIDS Foundation, Head Start's Mike Colwill says his company is "currently in discussions with authorities and organisations now regarding relevant issues related to this product."


A QUALITY PRODUCT?

Head Start says their kits are of high quality and are reliable. "We have selected the best quality product from a reputable supplier," Colwill says, claiming that the results are better than 99% accurate. "This product was 400% higher in cost price than its nearest competitor," he adds.
 
Asked if those claims stack up, the NZAF sounds a note of caution. "The test itself is not one of which the NZAF has knowledge. It is not mentioned in any research materials that we have seen from the US Federal Drug Administration, the World Health Organisation or any other body," says Eamonn Smythe, NZAF Director Positive Health Services.  "It may be a legitimate test but the distributors we have for Uni-gold and those for the Determine test, the two best testing kits in the world, only sell to health professionals, and never to end users." A promotional sheet from the manufacturer says the kit complies with the international ISO 13485 medical device standard.


DESPERATELY SEEKING ASSURANCE

 
Can a one-off test like EZ-Trust, which is packaged in a single test box, give any reliable assurance that a person is free of HIV infection? "No," says Smythe. "The test currently available in New Zealand cannot offer this assurance. Rapid tests are testing for an antibody response that will be present in 3 months in 80% of cases. All tests conducted in New Zealand regardless of whether they are a rapid test or Elisa, which is used by GPs and Sexual Health Services, are predictive tests. A second type of test called Western Blot must be undertaken for confirmation."

That window of invisibility is an important part of the emerging controversy and worth reflecting on. A person infected with HIV may not develop antibodies for three months or so after being infected. During that time they can pass on HIV yet no currently available test will detect the virus. Only when the immune system begins to become overwhelmed by the virus and starts producing billions of HIV-specific antibodies can the tests detect those antibodies and thus indicate the presence of HIV.

All an HIV test can do is indicate whether a person contracted HIV more than three months, or so, ago. Head Start acknowledges this in a single page supplementary guide it has produced to be handed out with its pre-packaged single-test kit. After guiding purchasers to two websites,
Wikipedia and the site of an organisation focused on delivery of HIV services to developing nations, for information, Head Start merely advises the user to make themselves familiar with "the HIV detection window period which can be up to three months." Further down they advise the user of their kit to seek "urgent confirmation" of a positive test by contacting a medical professional.


SUPPORT AND GUIDANCE

Lack of instant and structured support for a newly-diagnosed HIV positive person is another factor at the core of the AIDS Foundation's opposition to home testing. "The NZAF strongly supports professional HIV testing with the provision of pre- and post-testing counseling, provided by the NZAF Regional Services, your local Sexual Health Service, or GP," says Smythe. "Everyone will react in a different way to a positive diagnosis and research shows that without professional pre- and post-test counseling or psychotherapy a positive HIV test might result in depression, self harm, and [even] harm to others whom they think may have infected them."

Smythe also fears possible further transmission of HIV due to a lack of sufficient knowledge about HIV or correct use of condoms and lube, which the NZAF promotes as the only reliable way to prevent the sexual transmission of HIV between men who have anal sex with men. And he says disclosure, who and when to tell, is a significant issue requiring guidance. An ill-considered revelation of one's HIV positive status can result in "stigma and discrimination, and/or depression and isolation." Conversely, there are also issues stemming from lack of disclosure to sex partners and family as well, says Smythe.


DISCLAIMERS AND DISTANCING

A disclaimer message on the EZ-Trust kits briefly explains the three month wait needed before another rapid test is done. "If there has been a possible exposure to infected blood, and the person tests negative for HIV, the test must be repeated in 90 days." There's no mention of that other,  more likely source of infection, semen. "It is imperative that a positive HIV test be followed by Elisa, a Western Blot or PCR test performed by a doctor or clinic to confirm if you are indeed HIV positive." It also acknowledges that no test or test kit is infallible.

Head Start's supplementary information sheet effectively distances the wholesaler and retailer from this whole issue. "By doing this test at home you are electing to test without associated counseling or advice," it states. "It is common practice for trained staff to advise and prepare you about the realities of a positive test result before you test. By testing yourself you are bypassing this assistance." Head Start doesn't even hint at what those realities might be, but it does list the NZAF's AIDS Hotline and the Lifeline phone counseling service as sources of information.

If still in doubt,
Head Start says, the purchaser should seek medical assistance with the test, yet those same medics generally provide HIV testing for free, though GPs charge per visit and will use the Western Blot/Elisa tests which take several days to produce a result. But there may of course be a case for a person who has undertaken their first test in a supportive and informed environment to continue self-testing from time to time at home.

The final lines of
Head Start's information sheet may chill the blood of those who deal with the "realities" of HIV infection: "no warranties or representations, expressed or implied, as to the accuracy" of its information sheet.


TAKING THE BROAD VIEW

Is the way this HIV home test kit, which is likely to retail for around $40 depending on individual retailer markups, is being promoted appropriate?
"Not at all," says Smythe, who views HIV testing through the NZAF's broad mandate to prevent infections and to support those already infected. "There is ample research, anecdotal evidence and the personal experience of every person living with HIV that proves that a positive test for HIV is a shocking, life-changing and often deeply traumatic experience. The NZAF is committed to providing free, professional pre- and post-test counseling and psychotherapy because effective and professional testing and services can  reduce the further spread of HIV, limit the potential trauma that a positive diagnosis may cause."

Clearly on a roll Smythe rattles off more of his organisation's goals around HIV testing: to assist any person with a predictive positive result through the confirmation process; to educate anyone taking an HIV test about the relative risks of different sexual activities and safe sexual behaviour; to provide more information and education to any client with a positive result  in order not only to prevent further spread, but also to facilitate the empowerment of the client. He also lists encouraging the provision of follow-up support and enable a person living with HIV to explore the options available and support them through events such as disclosing their HIV status to their partners, family, friends and employers and the referral of clients to other professional services, if needed, such as mental health and drug and alcohol services. It's a comprehensive, and wordy, set of goals, yet this is an area of work in which the NZAF is rarely if ever criticised.

With all this in mind, Smythe says, the NZAF will be contacting the Singapore-based manufacturer of the kit about "the validity of the test and their decision in choosing to sell to a non-health professional wholesaler." Although he doesn't say so GayNZ.com understands the Foundation has already voiced its concerns directly to
Head Start, but any such representations haven't so far deterred the company from forging ahead to bring HIV self-testing into New Zealand homes.



Tomorrow, in part two of this feature,
Head Start Testing addresses the NZAF's concerns and explains that its objectives include enabling as many people as possible to take an HIV test in order to save lives. And we glance overseas to where several other countries are beginning to grapple with this thorny issue.


[Editor's note, 10/11/09: As GayNZ.com researched this story we addressed our initial enquiry to wholesaler Turkana Trading. Mike Colwill, who responded to those emailed questions, has now clarified that he represents the kit's importer Head Start Testing, not Turkana. Our coverage has been modified to reflect this.)


GayNZ.com Daily News staff - 7th November 2009

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