Associate Health Minister Dr Ayesha Verrall. Photo / Alex Burton
Associate Health Minister Dr Ayesha Verrall. Photo / Alex Burton
New Zealand Customs has picked up its pace in seizing Covid-19 rapid antigen tests (RATs) at the border, despite its acceptance of the results of the same tests for proof of Covid-19 negative status by travellers entering the country.
As of the end of March, Customs said it had seizedmore than 70,000 Covid-19 RATs since last November (also known as point-of-care tests); incidents of seizure rose to 327 in March, up from 189 in February and 33 in January.
The importation into New Zealand of Covid-19 rapid test kits is limited to 14 products approved by the Ministry of Health (MoH), not including rebrands of the same product. No molecular Lamp tests, which are generally considered more accurate than antigen tests, are approved.
The number of Covid tests available in New Zealand is considered very low by international standards; for example, the EU has a mutually recognised list (for public health purposes) of close to 200 rapid tests.
However, for pre-departure testing, travellers entering New Zealand can use any type of Covid-19 test approved for use by authorities in the country in which their journey began, of which there are hundreds. Lamp tests are accepted.
David (not his real name) is among the hundreds of New Zealanders who've had their Covid tests seized by Customs. The Herald has reviewed his correspondence with government ministries and agreed not to use his real name because the importation of point-of-care Covid tests, not approved by the Ministry of Health, is an offence under the Covid-19 Public Health Response Act.
David's mother is undergoing cancer treatment and her ability to fight infection is very low; he had hoped to test himself before visiting her with Lucira Check It home tests, which are approved in countries including the US, Canada and Singapore, though not in New Zealand.
Lucira uses a process called Lamp or RT-Lamp (reverse transcription loop-mediated isothermal amplification). In North America and elsewhere, the reliability of the process is broadly considered similar to PCR testing (PCR and RT-Lamp processes are both molecular) and more reliable than antigen tests.
David, an Auckland-based professional working in financial services, read the Health Order that bans the importation of these tests to New Zealand and believed he qualified for an exemption under the provisions allowed.
In early February, he applied to the director general of health, Ashley Bloomfield, for special permission to import and use 10 Lucira tests.
A Lucira Check It Covid test. Photo / Alex Burton
Clause 8 of the Health Order, described as "authorisations and exemptions", says the director general may authorise anyone to deal with point-of-care tests in any of the ways otherwise prohibited if they are persuaded that certain broad conditions are met, including that the activity "not pose a material risk to the public health response to Covid-19…"
In a process David described as "nonsensical" and "daft", his application was declined.
For new point-of-care devices "individual use is not authorised" by the director general, the determination said.
David pointed out twice in subsequent correspondence with the MoH's Covid-19 National Laboratory Testing Team that his application sought the director general's exemption to this prohibition. He was ultimately advised to apply again.
In the meantime, his 10 Lucira tests arrived in New Zealand and were seized by Customs.
David also wrote directly to both Bloomfield and his local MP Chloe Swarbrick. He has not heard back from either of them.
The Herald asked the Ministry of Health how many exemption applications it has turned down and approved for the importation of unauthorised Covid-19 point-of-care tests since late last year, when demand for rapid tests began to rise considerably and outstrip supply.
A spokesperson for the ministry said the questions would only be considered for response through its long time-frame OIA process; an answer is due next month at the earliest.
The spokesperson also declined, outside the OIA process, to disclose if and when the ministry received independent, international test data to support Lucira's application for approval in New Zealand: the FDA in the United States approved the company's tests in late 2020, and Health Canada approved them in 2021.
Earlier this month, Verrall announced that Lucira is part of a pilot project to consider its use in New Zealand. Results are not expected until August; in the meantime the test remains otherwise banned, though the company applied for New Zealand approval in January.
Terry Taylor, president of the New Zealand Institute of Medical Laboratory Science, said laboratories have the ability to trial new Covid tests inside a week, and that he "can't understand" why the Lucira approval process is being spun out for over six months.
A spokesperson for Customs said the department is unable to discuss individual consignments, but confirmed that it seized 69 shipments of Lucira tests in the three months to the end of April.
To date, no Lamp tests have been approved for use in New Zealand.
