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Testing devices and reagents currently used on P.E.I. for delivering results of coronavirus testing have been employed despite not appearing on a list of devices approved by Health Canada for COVID-19 testing.

P.E.I. Health officials reached by The Guardian last week did not explain the absence of diagnostic devices on a list of those that have federal approval but insisted the appropriate Health Canada approval has been obtained.

In an email to The Guardian, Health Canada said a reagent kit developed by BD, a medical technology company, was approved April 19 for use with a diagnostic device known as BD Max. Department of Health and Wellness staff informed The Guardian on April 15 that the province has been using the BD Max diagnostic device for processing COVID-19 test results.

Another diagnostic test kit, developed by Altona diagnostic, currently being used for COVID-19 testing on P.E.I., is only allowed for internal use and research purposes. An email from a Department of Health and Wellness official sent April 15 said an Altona diagnostic kit was being used for live COVID-19 testing.

“Testing is being done by the microbiology division at (Queen Elizabeth Hospital) and the all lab staff at (Prince County Hospital). The kit is called Altona and is being launched in collaboration with a major hospital laboratory in Toronto,” read the email.

The Altona diagnostic kit has not been approved for testing by Health Canada and no application for approval been made by the company.

A third testing device used on P.E.I., the GeneXpert automated system developed by Cepheid, did receive approval from Health Canada on March 24, 2020. The company website says the device can return results of COVID-19 tests in 45 minutes.

Testing devices used for COVID-19 on P.E.I.

GeneXpert system, produced by Cepheid

Approved by Health Canada March 24, 2020.

BD MAX System, diagnostic device by BD

Device approved by Health Canada August 31, 2012.

Reagents for BD MAX System, lab-based test

Reagents for system approved April 19, 2020.

RealStar PCR kit, produced by Altona Diagnostic

Used with BD MAX system. Use restricted to research purposes. "Not for use in diagnostic procedures," according to Altona website.

King Fisher Flex Specimen extractor, produced by Thermofisher Scientific

A lab-based test produced by Thermofisher was approved by Health Canada on March 18

Health Canada warns against the use of un-approved testing devices.

“Only diagnostic tests authorized by Health Canada can be imported into or sold in Canada. Unauthorized tests have not been reviewed by Health Canada and their accuracy has not been validated,” a Health Canada official said in an email.

Last week, provincial health officials announced local labs can do almost all COVID-19 diagnostic testing without the aid of off-Island labs.

P.E.I. has been later than all other provinces to develop the capacity to produce results of COVID-19 testing and has dealt with delays in receiving testing results from off-Island labs. Since the pandemic began, results had been sent to the National Microbiology Lab in Winnipeg or the QEII microbiology lab in Halifax.

An email from Health Canada said the P.E.I. lab was contacted about the use of the Altona Diagnostic kit.

“The department contacted the Prince Edward Island provincial laboratory to confirm that Altona’s PCR kit was marketed and sold to them for research purposes and internal use only. Based on the information obtained to date, no non-compliance with the Medical Device Regulations was found,” the email from Health Canada said.

P.E.I.'s Chief Health Officer Heather Morrison during a media briefing on Monday, April 20, 2020. - Submitted

But in an interview on Friday, chief public health officer Dr. Heather Morrison said the Altona diagnostic test is being used with the BD Max system for obtaining COVID-19 test results. She did not mention using the kits for research purposes.

“With the BD Max, it employs a diagnostic test called Altona and that's the test that's used at the hospital for sick kids, St. Mike's hospital in Toronto,” Morrison said.

"It's an extremely sensitive test and the BD Max machine itself can test up to 80 clinical samples every three hours."

Morrison said Halifax’s Queen Elizabeth II Hospital microbiology lab and the National Microbiology Lab in Winnipeg have validated the process used on the machine in P.E.I. She said as of April 16, negative results from both the BD Max machine, using the Altona kits, and the GeneXpert system no longer require confirmation from an off-Island lab. Positive results do still require confirmation, as these results are considered presumptive and will still require confirmation from either the Winnipeg or Halifax labs.

"All our tests yesterday and last night are all from the BD MAX, unless there were a few on the GeneXpert," Morrison said.

Morrison said the GeneXpert system has a capacity to process the results of 250 tests per week while the BD Max has the capacity to produce results of 800 tests per week.

Morrison said all testing devices used in the province have received approval from Health Canada.

But when asked why the BD Max system or the Altona kit did not appear on the list of approved COVID-19 diagnostic devices on the Health Canada website, Morrison said she did not know.

"I can't answer that. We have a medical microbiologist who is super qualified, certified (Royal College of Physicians and Surgeons of Canada) trained."

Microbiologist Greg German is overseeing provincial testing of COVID-19.

FEDERAL APPROVAL

A follow-up email from the province said the BD Max system received Health Canada approval in 2012 but did not elaborate on approval for the reagents used with the system or about the approval date for the Altona Diagnostic kits. Federal approval of COVID-19 testing devices began on March 18, 2020.

P.E.I.’s provincial lab began processing COVID-19 tests on April 2 and had the capacity for 60 tests at that time.

The local lab tests at that time prioritized health-care workers and residents of long-term care homes.

On Thursday, Morrison announced P.E.I. labs would begin using another device, on loan from the Atlantic Veterinary College, to process COVID-19 tests. The device was manufactured by Thermofisher Scientific. Thermofisher COVID-19 testing kits obtained early approval from Health Canada on March 18.

Morrison has said P.E.I. labs now have the capacity to process the results of 2,000 tests per week.

Public Health officials across Canada have spoken about expanding population testing over the coming weeks, as public health restrictions ease. Canada's Chief Health Officer Theresa Tam has said Canada's daily testing capacity will need to be tripled.

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