Spartan Bioscience, maker of a new Covid-19 test designed to deliver results within an hour, has recalled its product after Health Canada restricted its use.
The NWT government has said Spartan’s rapid tests – one of two types purchased by the territory – will be crucial to the easing of pandemic restrictions across the territory.
Dr Kami Kandola, the territory’s chief public health officer, said fast-turnaround tests will give her greater confidence in declaring areas to be free of Covid-19. That could lead to fewer restrictions related to gatherings and the reopening of some businesses.
However, Health Canada on Sunday said Spartan’s new tests don’t seem reliable enough.
In a statement, the federal agency said it had “placed conditions on the company’s authorization to restrict the use of the product to research use only until adequate evidence of clinical performance can be provided.”
Spartan said it had been told of the problem by Health Canada on Friday. The news was first reported by Le Journal de Montréal.
According to the company, the issue lies not with the device or test itself but with the “proprietary swab” that accompanies it.
“Consequently, Spartan will be voluntarily recalling its Covid-19 product and performing additional clinical studies to assess the sampling method and proprietary swab,” the company said on its website.
Spartan said it had so far shipped 5,500 of the tests to federal, provincial, and territorial buyers “for validation” – in other words, to check that they work.
“Spartan will be working as quickly as possible to address the concerns and bring its test to market,” the company said.
It’s not clear how many, if any, of the tests the NWT has yet received. The territorial government has been approached for comment.
Dr Kandola and her team had planned to use Spartan’s tests at regional centres or take them to communities as needed.
A separate type of new and faster Covid-19 test, Xpert Xpress, is already on the ground in the territory and going through validation of its own in Yellowknife. That type of test is expected to be available imminently and delivers results in around 45 minutes.
However, some patients may still be forced to use older testing methods that require shipping of samples to Alberta and an average wait time of four days.
That’s because there is a shortage of supplies for the Xpert Xpress tests, so its use will be prioritized by NWT healthcare staff.