Recall of portable rapid testing devices scuttles plans for use in rural Alberta
A recall on a COVID -19 rapid testing product puts Alberta’s plan to deploy the devices in rural communities on hold, as 96 new cases and one death were reported in the province Sunday.
Concerns about the swabs that would be used with a portable, hand-held DNA analysis device developed by Ottawa-based Spartan Bioscience were raised by Health Canada, which is limiting the company’s product to research use only until the problem is resolved. According to the company, Spartan is recalling its product voluntarily and will study its sampling method and swab.
Alberta Health Services intended to use the device in rural and remote communities to eliminate the need for samples to travel to Calgary or Edmonton. AHS announced in March a $9.5-million partnership with Spartan to acquire Spartan Cubes, which would speed up test results.
The recall comes after the federal government approved the devices in April. On Friday, Health Canada made Spartan aware of its concerns, which are not related to the accuracy or analytical performance of the test reagents and devices, said Spartan.
No one from Spartan was made available Sunday to speak about the implications of the recall.
AHS spokesman Kerry Williamson said AHS and Alberta Precision Laboratories have suspended the work being done to evaluate the rapid testing devices. The evaluation results will be submitted to Health Canada.
“AHS has received a small number of the devices and has been working to validate them before any use in clinical settings. None of the kits have been deployed for use in Alberta,” Williamson said in a statement.
Spartan has shipped 5,500 tests nationally for validation to provincial and federal government health agencies.
Despite the setback, Williamson said AHS’S testing capability remains strong with current processes.
“We are able to more than meet the current demand for COVID -19 testing,” Williamson said.
Alberta’s relaunch strategy relies heavily on the province’s ability to expand and maintain high levels of testing. Premier Jason Kenney last week unveiled the phased relaunch plan, which he said puts Albertans’ safety first by gradually reopening closed businesses and services to get people back to work.
This phased approach will work only if the effects of reopening can be carefully analyzed through expanded test results.
On average in April, 3,000 Albertans were tested for the novel coronavirus each day.
Alberta did expand its testing capacity to 7,000 tests a day by the end of April, but Dr. Deena Hinshaw, Alberta’s chief medical officer of health, said current demand has not required the province to make full use of that capacity.
AHS anticipates testing capacity to climb to more than 10,000 tests each day by mid-may, according to Hinshaw.
The provincial government on Sunday reported another 96 cases and one COVID -19 death, at a Calgary continuing-care centre.
The province has recorded 5,766 cases of COVID -19 and 2,713 confirmed recoveries since the first verified case in early March, according to the Alberta government’s daily update. AHS completed 3,728 tests in the past 24 hours.
Calgary remains the epicentre of cases in Alberta, with 3,842 total cases and 62 of the 95 total deaths.
Several Calgary continuing-care centres have experienced outbreaks. A resident in his 80s at the Intercare Brentwood Care Centre was reported to have died from COVID-19 on Sunday.
Of the total number of provincial cases, 615 have been at continuing-care facilities. Sixty-seven, or just over 70 per cent, of the 95 total deaths in Alberta have been residents at these facilities.
In Sunday’s update, the provincial government also provided details about the Abtracetogether app, which they expect will “enhance current manual contact tracing and capacity, and facilitate early detection to help reduce the spread of the virus and better protect Albertans.”
The app, which is voluntary to use, enables AHS to contact Albertans more quickly if they are at risk.
“Secure contact tracing is a cornerstone of Alberta’s Relaunch Strategy,” the government said in the news release.
Since its launch, the app has attracted more than 86,000 registered users, and some of the early technical issues with the registration code that some users experienced have been resolved.