Source: Radio New Zealand
New Zealanders are buying home tests that may be no more accurate than flipping a coin. 123rf
New Zealanders are buying home tests for pregnancy, herpes, chlamydia and more that may be no more accurate than flipping a coin.
The tests, which give on-the-spot results, are called invitro devices used at point of care – and include RATS (rapid antigen tests) and urine pregnancy kits.
They had surged in popularity since the Covid pandemic but a paper in the New Zealand Medical Journal Friday said they were largely unregulated.
Last year, over-the-counter RAT tests for chlamydia, gonorrhoea and herpes-2 were “vigourously advertised and sold” in New Zealand.
But, they had not been verified, and overseas evidence on similar kits showed they performed poorly, the paper said.
In 2021, a pregnancy test was withdrawn for showing a high rate of false positives. In 2016, one that had been used professionally gave too many false negatives or inconclusive results.
One of the report authors, pathologist Samarina Musaad, said having inaccurate or inconsistent tests could have serious impacts.
For example, a false negative pregnancy test may mean some people could not make informed choices about their care – or they might have a procedure or medication that was not safe for pregnancy.
A false positive could be very disappointing – or cause a lot of anxiety – depending on people’s situations, she said.
A cabinet paper to former Health Minister Shane Reti last year said there were “low performance devices” available online and from major retailers but there was no public information about the volume being sold.
One test had a false negative rate of between 37 and 88 percent, the cabinet paper said.
“Given many STIs are asymptomatic even while the person is infectious, a false negative result may lead to a person and their sexual partners being falsely reassured that they do not have an infection and may affect their sexual behaviours in a way that increases the risk of transmission,” it said.
Musaad said the examples showed better regulation was needed.
“There are huge concerns from many clinicians that these tests are little more than the flip of a coin,” she said.
Many tests were easily available online at sites like Amazon and Ali Express.
On one hand, it was good for consumers to have choice but they also needed to be able to make an informed decision, Musaad said.
Under the current rules, anyone could bring anything into the country and use it, she said.
Sub-standard tests had sometimes also made their way into health clinics and found to be inaccurate when tested in labs, she said.
At the moment, Pharmac could fund tests for use even when they had not been approved as safe and reliable by Medsafe – something that needed to change, Musaad said.
Regulations minister David Seymour said Medsafe could not approve every product available, particulary if they were from international sellers.
But, Pharmac had its own procedures for assessing which tests would be funded, including expert advice about their suitability, he said.
People should make safe decisions when buying the tests, he said.
“For example, purchasing [point of care tests] from pharmacies is much safer than purchasing them online, because Medsafe can recall unsafe or ineffective products and remove them from shelves,” he said.
There was work underway into an approval process for the tests before they came into the country, he said.
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– Published by EveningReport.nz and AsiaPacificReport.nz, see: MIL OSI in partnership with Radio New Zealand
