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Health authorities are looking for ways to restrict the import and sale of coronavirus antibody test kits in New Zealand.
A shameful mistake follows in the UK, where the government ordered millions of tests only to find they were not working well enough to be used.
The tests use a blood sample to detect antibodies produced by the body in response to the coronavirus. Because antibodies can take some time to detect, testing has been promoted primarily as a way to identify people who have been previously infected, not as a way to identify current cases.
ALDEN WILLIAMS / THINGS
Laboratory tests in New Zealand require people to take samples to look for the genetic material of the virus.
They have been told that they are useful to see how widely Covid-19 has spread and to allow healthcare workers in particular to return to work knowing that they had been infected and that they now likely had immunity.
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Dr. Ian Town, chief scientific adviser to the Ministry of Health, said he knew that many antibody tests were being developed, but was concerned that the tests had not been shown to be reliable or useful in several countries.
JOSEPH JOHNSON / COSAS
Dr. Ian Town, chief scientific adviser to the Ministry of Health, says the ministry is looking for options to restrict the import and sale of antibody test kits until there is evidence of their accuracy.
The ministry had no plans to launch rapid antibody test kits in New Zealand until there was more information on their reliability, he said.
It was also looking for options to restrict the import and sale of test kits, which could be done under the Drug Act.
“The ministry is looking to use this provision to help ensure that test kits are fit for purpose and used appropriately,” Town said.
Currently, a premarket evaluation or approval is not required for companies seeking to import antibody test kits.
The Crown ESR research institute was reviewing more than 70 antibody tests, but had already ruled out many because they were unreliable, Town said.
Laboratory tests in New Zealand for Covid-19 look for the genetic material of the virus, not the antibodies. Town said there was reliable evidence available to everyone who needed it.
Regen Cellular, a Queenstown-based stem cell research company, sent out a press release in late March saying it had thousands of rapid antibody test kits on the way from China, with the ability to obtain up to 200,000 per week.
The tests could yield results in 15 minutes and were 96 percent accurate, the company said. A laboratory was not needed, and a nurse could administer the test by pricking the finger.
Regen’s website now says the company has the first rapid antibody tests in New Zealand. After independent tests were conducted on the tests, the company said it planned to sell the kits in boxes of 20 for $ 775.
The website also includes a promotional video, which includes edited comments from Dr. Ashley Bloomfield, Director General of Health, who talks about the benefits of antibody testing in general. His comments saying the tests are in development and not as accurate as other tests were not included.
Regen CEO Emma Hart said the company had offered to provide the government with its test kits for evaluation and that it had provided all of its clinical data. An answer provided to Stuff shows that the offer was not accepted.
“We are not selling antibody kits until the tests are complete,” Hart said. “The tests are carried out at a specialized infection and immunity facility.”
The ministry did not respond to questions about Bloomfield’s comments used in the promotional video.
Town said the ministry understood that the companies wanted to help with efforts to fight Covid-19, but this was best accomplished through a collaborative effort to obtain the correct equipment and supplies.
