The sale and use of rapid antigen-based sexually transmitted infection point of care tests for chlamydia, gonorrhoea, and herpes

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The sale and use of rapid antigen-based sexually transmitted infection point of care tests for chlamydia, gonorrhoea, and herpes

Joint position statement
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Joint position statement from the New Zealand Point of Care Testing Advisory Group (NZ POCT AG), the New Zealand Microbiology Network (NZMN), the New Zealand Sexual Health Society (NZSHS), the Northern Region Point of Care Testing Network (NR POCT Network), and the New Zealand branch of the Australasian Society for Infectious Diseases (NZ ASID)

Joint position statement on the Sale and Use of Antigen based POCT STI kits
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The New Zealand Point of Care Testing Advisory Group (NZ POCT AG), the New Zealand Microbiology Network (NZMN), the New Zealand Sexual Health Society (NZSHS), the Northern Region Point of Care Testing Network (NR POCT Network), and the New Zealand branch of the Australasian Society for Infectious Diseases (NZ ASID) are professional specialist clinical and scientific organisations in New Zealand, with combined expertise in the diagnosis of sexually transmitted infections (STIs) and the use of point of care tests.

Point of care tests are tests that are done outside of a laboratory where the patient is based, for example at home or in a GP clinic. They provide results within minutes and can be very useful to make decisions about treatment, on the spot, there and then. Examples of point of care tests that are fit for purpose are home pregnancy tests and COVID rapid antigen tests (RAT tests).

While some types of point of care tests work very well, others do not. It is important that point of care tests go through an independent safety vetting process before being made available for use but there is currently no regulation in New Zealand that requires this to happen. This allows any company, regardless of the quality of its products, to encourage people to buy and use point of care tests in New Zealand.

The ability to do a rapid STI test for chlamydia and gonorrhoea at home would make life much more convenient for many people, but currently available antigen-based* point of care tests for chlamydia, gonorrhoea, and herpes for home use are unreliable and should not be used, despite what may be stated on the manufacturers’ information. In a person with chlamydia for example, the likelihood of the point of care test being positive is around the same as flipping a coin. Because the test is inaccurate, people with an infection can be falsely reassured when their test shows a negative result. Untreated STIs can lead to longer term health issues, and the person can continue to infect other people.

Because of this, the professional expert groups above advise that these tests should not be promoted, marketed, sold, or used in New Zealand unless vetted and approved by local Medical Laboratory experts. People should instead use the reliable methods of STI testing that are available through primary care, sexual health clinics or Sexual Wellbeing Aotearoa.

The expert groups also strongly recommend that there should be regulation and control of point of care tests so that only safe and reliable tests are provided to Kiwis.

*Antigen is any substance that causes our immune system to react.

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