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Lib­er­als order mil­lions of un­ap­proved rapid test

Roll­out de­layed by Health Canada anal­y­sis

- Ryan Tumilty Health · Medicine · Canada News · Ottawa · Health Canada · Abbott, Virginia · United States of America · Michelle Rempel · Justin Trudeau · University of Toronto · Toronto · Foundation for Innovative New Diagnostics · France · Germany · South Dakota · South Korea · Abbott Laboratories

OT­TAWA • The Lib­eral govern­ment an­nounced plans Tues­day to buy 7.9 mil­lion rapid COVID tests, even though they have not yet been ap­proved by Health Canada.

With cases ris­ing, test­ing lines grow­ing and de­lays pil­ing up for re­sults, the op­po­si­tion wants to know why more of the rapid tests aren’t al­ready avail­able to Cana­di­ans.

But ex­perts cau­tion rapid tests can’t be seen as a sil­ver bul­let be­cause many sac­ri­fice ac­cu­racy for speed­ier re­sults.

The 7.9 mil­lion tests an­nounced on Tues­day are from Ab­bott, a U. S. firm that has been selling its ID Now sys­tem since the early months of the pan­demic. The test com­bines nasal swabs with a toaster-sized ma­chine that can get a re­sult in 13 min­utes. The test is still await­ing Health Canada’s ap­proval and the pur­chase is con­di­tional on Ab­bott get­ting that sign-off.

Pro­cure­ment Min­is­ter Anita Anand said, “Th­ese rapid tests will aid in meet­ing the ur­gent de­mand from prov­inces and ter­ri­to­ries to test Cana­di­ans and re­duce wait times for re­sults, which is key to re­duc­ing the spread of the virus.”

Con­ser­va­tive health critic Michelle Rem­pel Gar­ner said Health Canada’s ap­proval process is mov­ing far too slow and leav­ing Cana­di­ans be­hind.

“We still have no clar­ity on when th­ese types of tests will be widely avail­able to Cana­di­ans. We have no de­liv­ery or dis­tri­bu­tion date, even though the tests are in use in other parts of the world,” she said. “How many schools have had to close be­cause we didn’t have this ca­pa­bil­ity? How many hours were lost as work­ing par­ents had to stand in line for a test?”

Cur­rently, there are 91 COVID- 19 tests be­ing re­viewed by Health Canada ac­cord­ing to the agency’s web­site. None of the tests are home- based, but sev­eral could be used in doc­tor’s of­fice or clin­ics, with­out the need for lab­o­ra­to­ries.

Dr. Supriya Sharma, a se­nior ad­viser at Health Canada, said they are mov­ing as quickly as they can, but they have to be sure the tests are ac­cu­rate be­fore Cana­di­ans start us­ing them.

“A test that pro­vides too many false neg­a­tive re­sults may lead to in­di­vid­u­als not iso­lat­ing as they should, and po­ten­tially more peo­ple be­ing ex­posed to the virus. And a test that pro­vides too many false pos­i­tive re­sults could lead to peo­ple need­lessly self iso­lat­ing.”

Sharma said many of the com­pa­nies ap­ply­ing to Canada for ap­proval haven’t pro­vided im­por­tant in­for­ma­tion like user man­u­als for their de­vices or de­tails about the nose swabs used as part of the test.

A test Health Canada ap­proved early in the pan­demic from an Ot­tawa com­pany was re­called due to is­sues with the swab used to col­lect the sam­ple.

Sharma said tests that are avail­able in other coun­tries are made by com­pa­nies that haven’t ap­plied in Canada yet. She said while they look to other coun­tries like the U. S., Canada has its own stan­dards and reg­u­la­tions the depart­ment has to fol­low.

Rem­pel Gar­ner said the govern­ment shouldn’t be wait­ing for com­pa­nies to come to Canada, but should seek them out.

“At a time when ev­ery coun­try in the world is proac­tively try­ing to ac­quire and de­velop th­ese tech­nolo­gies to pro­tect their peo­ple, Justin Trudeau’s cabinet is con­tent to say, ‘ We’re let­ting them come to us’.”

Health Min­is­ter Patty Ha­jdu said they have added sup­port to the ap­proval process, but they can’t politi­cize the re­views.

“We have dou­bled our peo­ple. And we’ve sped up our pro­cesses to re­view tests and grant de­ci­sions quickly within 40 days of an ap­pli­ca­tion.”

The Ab­bott test the govern­ment pur­chased is a real time poly­merise chain re­ac­tion (PCR) test, as are many of the oth­ers await­ing ap­proval. They are sim­i­lar to the tests health de­part­ments are us­ing across the coun­try, though sev­eral promise quicker re­sults by us­ing spe­cial anal­y­sis machines.

PCR tests use sam­ples from nose swabs and then dur­ing the lab process any pres­ence of the virus is boosted, al­low­ing even low level in­fec­tions to stand out. The tests can find peo­ple who have the virus, but may have no or few symp­toms.

“It’s am­pli­fy­ing it. That’s the re­ac­tion that’s hap­pen­ing and so even if you have small amounts of vi­ral DNA, us­ing the PCR, you’ll find it and de­tect it,” said Ash­leigh Tuite, an in­fec­tious dis­ease epi­demi­ol­o­gist at the Univer­sity of Toronto.

But Ab­bott and other com­pa­nies have also de­vel­oped anti­gen tests, which can also pro­vide fast re­sults and don’t re­quire a lab­o­ra­tory or spe­cial equip­ment.

The anti­gen tests work like preg­nancy tests, re­quir­ing a lit­tle bit of fluid, usu­ally from a nose swab, which is placed on a re­ac­tive sub­stance and de­liv­ers re­sults in 15 to 30 min­utes with lines ap­pear­ing on the test in­di­cat­ing a pos­i­tive or neg­a­tive re­sult.

Sharma said they are look­ing at sev­eral anti­gen tests, but it was only on Tues­day that the govern­ment posted a min­i­mum stan­dard, which is a test that ac­cu­rately iden­ti­fies pos­i­tive cases at least 80 per cent of the time.

Tuite said it is im­por­tant to know anti­gen tests do have lim­i­ta­tions, be­cause they don’t am­plify the virus the way PCR tests do.

“It’s go­ing to find peo­ple when they’re quite in­fec­tious and when they’re gen­er­at­ing a lot of virus, but it’s not go­ing to find if you were in­fected two weeks ago, but you’re no longer shed­ding a lot of virus.”

The Foun­da­tion for In­no­va­tive New Di­ag­nos­tics, an NGO that fo­cuses on get­ting di­ag­nos­tic tests to de­vel­op­ing coun­tries an­nounced a plan Mon­day to ship up to 120 mil­lion rapid COVID


tests. France and Ger­many an­nounced they would buy mil­lions of the tests as part of the ar­range­ment that will also send the tests to the de­vel­op­ing world.

The foun­da­tion’s anti­gen tests are com­ing from Ab­bott and SD Biosen­sor from South Korea. Both firms are still wait­ing for Health Canada ap­proval.

SD biosen­sor test stresses its test is for peo­ple hav­ing symp­toms. All of the 115 peo­ple the com­pany tested in a trial to prove the ef­fi­cacy were show­ing symp­toms be­fore the nasal swabs were ad­min­is­tered. Ab­bott’s anti­gen test is also de­signed to de­tect peo­ple who are symp­to­matic and the com­pany warns the test alone does not con­firm a di­ag­no­sis.

“Neg­a­tive re­sults don’t pre­clude SARS- COV-2 in­fec­tion and they can­not be used as the sole ba­sis for treat­ment or other man­age­ment de­ci­sions,” reads the in­for­ma­tion sheet on the prod­uct.

Tuite said just be­cause anti­gen tests are used for peo­ple show­ing symp­toms doesn’t mean they can’t be ef­fec­tive.

“If you’re think­ing about test­ing as a way to in­ter­rupt trans­mis­sion, then you don’t need to worry so much about miss­ing the peo­ple who are not very in­fec­tious,” she said.

She said if the tests were widely avail­able they could po­ten­tially be use­ful in set­tings like schools or among essen­tial work­ers.

“It’s not go­ing to be per­fect, but the idea is, if you use it widely enough, if you use it fre­quently enough, it will have an ef­fect at the pop­u­la­tion level.”

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