Connect with us

News

Health Canada pauses regulatory approval for COVID-19 rapid test – CBC.ca

Published

 on


Health Canada is restricting the use of a made-in-Canada, rapid COVID-19 test created by Spartan Bioscience after the National Microbiology Lab found problems with the test that made it unreliable. 

“In light of the clinical results, Health Canada has 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,” the federal agency said in an emailed statement sent to CBC, after the story was first reported by Le Journal de Montreal. 

“The Spartan product can continue to be used for research purposes only.”

The portable test was called a “game changer” by health officials because it reportedly could deliver on-location results in under 60 minutes. Further upgrades to the test made by the Ottawa-based company promised to reduce that time down to 30 minutes.

According to Spartan, Health Canada’s concerns stem from the efficacy of the swabs the testing unit uses — and not with the machine itself.

Issue with swabs

The company was first informed by Health Canada about the concerns on Friday.

“The same report indicated no concerns regarding the accuracy and analytical performance of Spartan’s test reagents and portable DNA analyzer device,” said a statement published on the company’s website.

The company said it has already shipped out 5,500 tests nationally, but said it’s voluntarily recalling the product to perform more clinical tests. Most of those units were delivered to the National Microbiology Lab.

“Spartan will be working as quickly as possible to address the concerns and bring its test to market,” the company said. 

Prime Minister Justin Trudeau and Chief Medical Officer Dr. Theresa Tam attend a news conference in Ottawa in May. Tam said the federal government had ordered 40,000 tests per month from Spartan. (Adrian Wyld/The Canadian Press)

The federal government had ordered 40,000 tests a month from Spartan.

“While the Spartan system, the device, performed very well in a laboratory setting — along the specification the manufacturer had provided — it was in the clinical setting, the real-life setting, where it didn’t perform well,” Dr. Theresa Tam, Canada’s chief public health officer, said during a news conference Sunday.  

Canada hopes to begin testing 60,000 people for the virus daily, and Tam said the setback wouldn’t affect that goal. 

She also said the clinical testing done with the Spartan cube wouldn’t have affected the actual diagnoses of any patients.

Dr. Howard Njoo, Canada’s deputy chief of public health, said at the same news conference that he hopes the company can make the necessary adjustments so it can be used in a clinical setting in the future.

Prime Minister Justin Trudeau said on Sunday that some setbacks are expected, given that the federal government has accelerated the approval process for a number of potentially life-saving devices.

“We’ve said from the very beginning, that in this unprecedented crisis we needed to move very, very quickly,” Trudeau said.

“When we do that quickly, there are going to be new facts that come in and situations that evolve that will require shifts in our postures…. Similarly, provinces will have to adjust to new realities and adjust to successes and challenges as they come up.”

Provinces react

Several provinces were planning to use Spartan’s portable testing kits. 

Quebec had ordered 200,000 tests, which were expected to be delivered on May 31. 

The $16-million purchase was conditional upon the approvals of Health Canada, the Public Health Agency of Canada and the National Microbiology Laboratory, the province’s ministry of health and social services said in an email.

Ontario had also placed an order for more than 900,000 of the kits.

WATCH: Chief Public Health Officer Dr. Theresa Tam talks about reopening Canada:

Part 3 of 3 of Rosemary Barton’s exclusive interview with Chief Public Health Officer Dr. Theresa Tam on the WHO’s response to COVID-19, reopening Canada and the personal stresses that come with her job. 11:55

“We are actively engaging with Heath Canada to obtain clarification,” Hayley Chazan, a spokesperson for Ontario Health Minister Christine Elliott, wrote in an email.

“Despite Ontario not yet having used the Spartan tests, we are a leader in Canada in daily testing volumes per capita and rank among the top globally.”

Alberta Health Services (AHS), which announced a $9.5-million contract with the company in late March, said in an email Sunday it had suspended its evaluation of the testing devices following concerns about the technology’s efficacy.

AHS said it had received only a small number of devices to date, and was working to validate them before any use in clinical settings. None of the kits have been deployed for use in Alberta, AHS said.

The company said that provinces have not yet paid in full for the tests they ordered, although some have made a 10 per cent down payment. Spartan said it plans to fulfil all its contractual obligations once the issue with the swab is fixed.

Peter Lin, CBC News medical contributor and family physician, called the setback a “hiccup.”

“You just have to change the swab and go through testing again,” he said.

Lin said the swabs couldn’t reach far enough into a person’s nose to properly test for the virus. 

“So what happened was that their swab is for your mouth. Therefore, it cannot fit all the way up into your nose, and you have to actually go pretty high up in the nose,” the doctor said. “Their swab systems are not able to pick up everything.”

Let’s block ads! (Why?)



Source link

News

Egypt upholds death sentence for 12 senior Muslim Brotherhood figures

Published

 on

Egypt’s highest civilian court on Monday upheld death sentences for 12 senior Muslim Brotherhood figures over a 2013 sit-in which ended with security forces killing hundreds of protesters, judicial sources said.

The ruling, which cannot be appealed, means the 12 men could face execution pending approval by President Abdel Fattah al-Sisi. They include Abdul Rahman Al-Bar, commonly described as the group’s mufti or top religious scholar, Mohamed El-Beltagi, a former member of parliament, and Osama Yassin, a former minister.

Many Muslim Brotherhood figures have been sentenced to death in other cases related to the unrest that followed the military’s ousting of Brotherhood president Mohamed Mursi in 2013, but the Court of Cassation ordered retrials.

Rights groups have documented a sharp rise in the number of executions in Egypt, with at least 51 carried out so far this year according to Amnesty International.

“Instead of continuing to escalate their use of the death penalty by upholding death sentences following convictions in grossly unfair mass trials Egyptian authorities must immediately establish an official moratorium on executions,” Amnesty said in a statement.

Monday’s ruling relates to a mass trial of hundreds of suspects accused of murder and incitement of violence during pro-Brotherhood protests at Rabaa al-Adawiya square in Cairo in the weeks after Mursi’s overthrow.

In September 2018, an Egyptian criminal court sentenced 75 people to death and issued varying jail terms for more than 600 others. Many defendants were tried in absentia.

Forty-four of those sentenced to death appealed to the Court of Cassation. Thirty-one had their sentences changed to life in prison, while death sentences were upheld for 12 others.

A final defendant, the senior Muslim Brotherhood leader Essam el-Erian, died in prison in Cairo in August 2020. Mursi, Egypt’s first democratically elected president, died in prison in 2019.

The court also upheld jail terms for many other defendants including a life sentence for Mohamed Badie, leader of the outlawed Brotherhood, and a 10-year jail term for Mursi’s son Osama, the judicial sources said.

 

(Reporting by Haitham Ahmed; writing by Mahmoud Mourad; editing by Aidan Lewis, William Maclean and Grant McCool)

Continue Reading

News

Trudeau says he discussed border with Biden, but no deal

Published

 on

Prime Minister Justin Trudeau said on Sunday he has spoken with U.S. President Joe Biden about how to lift pandemic-related border restrictions between the two countries but made clear no breakthrough has been achieved.

U.S. and Canadian business leaders have voiced increasing concern about the ban on non-essential travel in light of COVID-19 that was first imposed in March 2020 and renewed on a monthly basis since then. The border measures do not affect trade flows.

The border restrictions have choked off tourism between the two countries. Canadian businesses, especially airlines and those that depend on tourism, have been lobbying the Liberal government to relax the restrictions.

Canada last week took a cautious first step, saying it was prepared to relax quarantine protocols for fully vaccinated citizens returning home starting in early July.

Trudeau, speaking after a Group of Seven summit in Britain, said he had talked to Biden “about coordinating measures at our borders as both our countries move ahead with mass vaccination.” Canada is resisting calls for the border measures to be relaxed, citing the need for more people to be vaccinated.

The United States is ahead of Canada in terms of vaccination totals.

“We will continue to work closely together on moving forward in the right way but each of us always will put at the forefront the interests and the safety of our own citizens,” Trudeau told a televised news conference when asked the Biden conversation.

“Many countries, like Canada, continue to say that now is not the time to travel,” Trudeau added, though he said it is important to get back to normalcy as quickly as possible.

 

(Reporting by David Ljunggren in Ottawa; Editing by Will Dunham)

Continue Reading

News

Man with 39 wive dies in India

Published

 on

A 76-year-old man who had 39 wives and 94 children and was said to be the head of the world’s largest family has died in north east India, the chief minister of his home state said.

Ziona Chana, the head of a local Christian sect that allows polygamy, died on Sunday, Zoramthanga, the chief minister of Mizoram and who goes by one name, said in a tweet.

With a total of 167 members, the family is the world’s largest, according to local media, although this depends on whether you count the grandchildren, of whom Ziona has 33.

Winston Blackmore, the head of a polygamous Mormon sect in Canada, has around 150 children from 27 wives – 178 people in total.

Ziona lived with his family in a vast, four-story pink structure with around 100 rooms in Baktawng, a remote village in Mizoram that became a tourist attraction as a result, according to Zoramthanga.

The sect, named “Chana”, was founded by Ziona’s father in 1942 and has a membership of hundreds of families. Ziona married his first wife when he was 17, and claimed he once married ten wives in a single year.

They shared a dormitory near his private bedroom, and locals said he liked to have seven or eight of them by his side at all times.

Despite his family’s huge size, Ziona told Reuters in a 2011 interview he wanted to grow it even further.

“I am ready to expand my family and willing to go to any extent to marry,” he said.

“I have so many people to care for and look after, and I consider myself a lucky man.”

 

(Reporting by Alasdair Pal and Adnan Abidi in New Delhi; Editing by Raissa Kasolowsky)

Continue Reading

Trending