Covid-19: Importer says it has 3.5 million rapid antigen tests but can't get approval from Ministry of Health
An importer of rapid antigen tests says the Ministry of Health is not acting fast enough to ensure there is enough testing kits in the country for when the next Covid-19 outbreak occurs.
Health experts say rapid antigen tests will be a critical tool for managing Covid-19 in New Zealand in the future, with traditional PCR testing capacity expected to be overrun by an outbreak of the Omicron variant.
In Australia, where a wave of Omicron infections is showing no signs of slowing, a nationwide shortage of rapid antigen tests resulted in long queues for PCR testing, overwhelming testing centres.
A spokesman from the New Zealand Ministry of Health said there were 5.5 million rapid antigen tests in the country. It also has 20 million on order, which will arrive in batches over the next six months.
There are currently four rapid antigen tests the Ministry of Health has approved for import, supply, and use in New Zealand.
Any companies wanting to have their tests added to the approved list must go through an application process.
TBI Diagnostics NZ director Vasco Kovacevic says his company is one of those trying to get tests approved by the ministry.
It had 20,000 rapid antigen test kits sitting in an Auckland storage facility waiting for clearance from the Ministry of Health and another 3.5 million ready to be dispatched from China which could arrive in New Zealand within a matter of days, he said.
He said he filed an application for approval of the kits in mid-December but was yet to receive a response from the Ministry of Health about where the application was at despite trying to contact the ministry on numerous occasions.
The Ministry of Health spokesman said it had received a large volume of applications for authorisation and was working through them.
Applications received just prior to the holiday were being acknowledged by receipt this week, he said.
Kovacevic said he was frustrated Ministry of Health officials went on holiday at such a critical time in the pandemic.
“The lack of action that I am seeing currently really makes me question some of the decisions our government has taken during this pandemic.”
Terry Taylor, president of the New Zealand Institute of Medical Laboratory Science, said there were a lot of companies wanting to import millions of rapid antigen tests, and the Ministry of Health needed to fast track the approval process.
“There does need to be some fast track assessment, but it needs to be rigorous,” Taylor said.
When rapid antigen tests for Covid-19 first hit the market in 2020 New Zealand’s medical profession successfully advocated having them banned from entering the country, he said.
At the time the tests were highly unreliable and not suitable for New Zealand’s elimination strategy, he said.
But with the tests now more reliable and New Zealand having moved away from elimination, combined with the likelihood of an Omicron outbreak soon, the use of rapid antigen tests became more practical, he said.
“When the virus becomes endemic it doesn't matter if you miss a few positives.”
Taylor said when that happened New Zealand's testing labs would quickly become overrun without widespread use of rapid antigen tests and more targeted use of PCR tests.
“We need a robust plan for deciding who is going to get the PCR test.
“We do not want queues and queues of cars of asymptomatic people clogging it up for the people that really need it.”
New Zealand labs were processing about 15,000 to 20,000 Covid-19 PCR tests per day, which made up about 5 per cent of our lab’s workloads, he said.
If there were a major outbreak it could increase to between 50,000 and 100,000 PCR tests per day, at which point labs would become overrun, he said.
“When we get our labs inundated we’re going to need some serious assistance out in the community.”
Rapid antigen tests offer a much faster turnaround than a laboratory PCR test (about 15 mins compared to two to five days).
They are not as accurate at detecting Covid-19 as PCR tests and a positive rapid antigen test result must still be confirmed with a PCR test, the Ministry of Health says.
National’s Covid-19 response spokesman Chris Bishop said the Government needed to make sure there was a good stock of rapid tests in New Zealand and to liberalise the rules around their use.
“We mustn’t get into a situation like Australia, where there are reports of shortages of rapid tests in various places.”
Rapid antigen tests have been available to the public at pharmacies since mid-December, with tests administered under the supervision of pharmacy staff.
Pharmacies providing rapid antigen tests for domestic travel purposes are listed on Healthpoint.
If a person has flu-like symptoms or symptoms associated with Covid-19 or is a close or casual contact for Covid-19, rapid antigen testing should not be used, and the person should go immediately for a PCR test, the ministry says.
Taylor said that advice made sense when there were low levels of Delta in the community but when Omicron was widespread the messaging and criteria for a PCR test would need to change.