antibody testing | Medicine Matters https://www.medicinematters.ca Breaking news and analysis about clinical medicine, research and healthcare delivery Sun, 11 Oct 2020 22:45:13 +0000 en-US hourly 1 https://wordpress.org/?v=5.5.1 https://www.medicinematters.ca/wp-content/uploads/2020/05/cropped-favicon-32x32.png antibody testing | Medicine Matters https://www.medicinematters.ca 32 32 Medical regulator shuts down private COVID-19 and antibody tests in B.C. https://www.medicinematters.ca/medical-regulator-shuts-down-private-covid-19-and-antibody-tests-in-b-c/?utm_source=rss&utm_medium=rss&utm_campaign=medical-regulator-shuts-down-private-covid-19-and-antibody-tests-in-b-c https://www.medicinematters.ca/medical-regulator-shuts-down-private-covid-19-and-antibody-tests-in-b-c/#respond Fri, 25 Sep 2020 00:24:55 +0000 https://www.medicinematters.ca/?p=903 The College of Physicians and Surgeons of B.C. issued a cease and desist order to a private, mobile lab company that offers in-home or office COVID-19 tests along with antibody tests. The company has not faced the same action in Alberta and Ontario.

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BY PAMELA FAYERMAN

The College of Physicians and Surgeons of B.C. (CPSBC) ordered a mobile lab company doing private COVID-2019 antibody testing in homes and offices to shut down in this province.

The service – which was incredibly popular since so many people want to know if they have immunity to COVID, violated the medical regulator’s rules so the private pay service has stopped in B.C. while in Alberta and Ontario, it carries on.

The Alberta company charges $80 for COVID-19 antibody tests and $120 for the PCR swabs tests that check for active virus.

“Our phone and emails have been non-stop from B.C. residents asking for testing but I am not going to defy a directive from the CPSBC until I am invited back in,” said Mike Kuzmickas, president of Ichor.

The Alberta-based start-up is still offering the home or office-based service to customers in Ontario and Alberta where ndividuals and companies can request both COVID swabs and blood-based antibody tests.

“We were operating in Vancouver and Kelowna for a very short period of time but then I was contacted and sent a cease and desist from the College… and in a (subsequent) phone call, they explained to me why I was asked to leave the province:

“The only people who can perform phlebotomy in BC must be associated with an accredited BC lab; we are not.

“The only tests that can be offered in B.C. must be from accredited B.C. labs; our offerings are either from the U.S. or from Alberta.

And only B.C. physicians can requisition tests inside B.C.; our medical director is from Alberta.”

The College took action against Ichor after my story about its novel services. The article is the second most popular piece I’ve written since starting this website at the beginning of May. That suggests there’s a pent-up demand for private antibody testing since it is not available to the general population; only groups selected by government-funded researchers for studies are offered such tests.

Antibody testing shows whether individuals have had a past COVID-19 infection but weren’t tested because they were either asymptomatic or couldn’t access testing in the first few months of the pandemic. Having serology testing – as antibody testing is also known – can offer some clarity or peace of mind about whether individuals might have some immunity. But as experts have pointed out, antibodies may only circulate in the body for a short time – sometimes as little as weeks.

Ichor (pronounced eye-core) Blood Services charges $75 for the home or office visit plus $120 for the antibody test. The COVID-19 test is also available at $190. A requisition from a physician is required.

Kuzmickas said he believes his company is “still the only small-cap private company offering antibody testing in Alberta and Ontario (but) I know the provincial labs are starting to catch up, DynaCare in Ontario is offering it now and we will be switching over to an Alberta test here in a couple of weeks as well.”

He said in Alberta, there are loads of private companies seeking testing for their employees.

“We have also secured small commercial leases in Calgary and Edmonton to set up clinical spaces for testing visitors from out of the city, or larger groups, and will be operational with these in October.”

Watch a video of Kuzmickas describing his company’s services here.

 

Email: [email protected]

 

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Dr. Bonnie Henry made a special exemption order for COVID-19 research https://www.medicinematters.ca/dr-bonnie-henry-made-a-special-exemption-order-for-covid-19-research/?utm_source=rss&utm_medium=rss&utm_campaign=dr-bonnie-henry-made-a-special-exemption-order-for-covid-19-research https://www.medicinematters.ca/dr-bonnie-henry-made-a-special-exemption-order-for-covid-19-research/#respond Fri, 17 Jul 2020 23:42:28 +0000 https://www.medicinematters.ca/?p=531 Dr. Bonnie Henry thought a study was so important that she ordered private labs to share blood specimens for COVID-19 antibody study

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BY PAMELA FAYERMAN

A new blood study done on unsuspecting patients who attended LifeLabs in March or May has revealed that less than one percent of Greater Vancouver residents had been infected with COVID-19.

The study is being referred to as the first in Canada to provide evidence of coronavirus prevalence/antibodies in the general population. What the authors of the study done by UBC, the BC Centre for Disease Control, LifeLabs, and public health experts like Provincial Health Officer Dr. Bonnie Henry do not reveal in their yet-to-be-peer-reviewed study is what had to happen in order for them to even launch the study.

Dr. Eleni Galanis said in an interview that for several years, private labs have not allowed B.C. researchers to “re-purpose” blood samples from patients for “other purposes” including studies. The practice was halted when a patient complained after discovering their blood had been used for research without their explicit consent.

So researchers asked Dr. Henry to allow for an exemption and she granted it, Galanis said, because she recognized it was “important work.”

Dr. Bonnie Henry

Researchers have no way of knowing whose blood was used since every sample that was analyzed for the presence of COVID-19 antibodies was anonymous. Researchers essentially got the leftovers of blood specimens from 1,754 individuals after the lab used what they needed.

Another interesting aspect to the study is that patients in the March time period were likely going to labs for more routine lab work while patients in May, going for lab tests during a pandemic, probably had more serious concerns since physicians’ offices have been closed to all but the most pressing complaints. And many people avoided seeking medical care in the first months of the pandemic.

In the same interview, I asked Galanis about how COVID cases are counted in more unusual circumstances than when an individual has symptoms and seeks testing. For instance, if a patient rushed to hospital after a car accident, or for any other non-COVID related cause, then tests positive for COVID after their admission, is that considered a COVID case? Yes.

And if an asymptomatic individual learns they have COVID because of contact tracing, they are also added to the COVID counts. But if a patient with many complex medical problems (co-morbidities) along with COVID dies, is their death a COVID death or attributable to something else?

That is a trickier scenario and as it turns out, a timely consideration since public health experts are now working with Vital Statistics to determine how such deaths should be classified.

The exercise involves taking a close look at the cause of death information physicians have put on death certificates to check for discrepancies that may tilt the cause of death away – or even towards – COVID after reviews are done.

“We’re in the midst of this reconciliation process,” she said, noting that some patients whose deaths were attributed to COVID had multiple underlying diseases like diabetes and heart or lung disease. “These are difficult cases to resolve,” she said. But for the purposes of statistical data, it’s an important exercise.

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Private, mobile lab service offering $195 COVID-19 antibody tests in these Canadian cities https://www.medicinematters.ca/private-mobile-lab-service-offering-195-covid-19-antibody-tests-in-these-canadian-cities/?utm_source=rss&utm_medium=rss&utm_campaign=private-mobile-lab-service-offering-195-covid-19-antibody-tests-in-these-canadian-cities https://www.medicinematters.ca/private-mobile-lab-service-offering-195-covid-19-antibody-tests-in-these-canadian-cities/#respond Fri, 03 Jul 2020 01:14:35 +0000 https://www.medicinematters.ca/?p=456 UPDATE OCTOBER/2020 British Columbia residents can no longer access this private testing service because, as I recently wrote here, medical regulators in B.C. have ordered the company to stop offering the service. It is still available in Alberta and Ontario. BY PAMELA FAYERMAN If you live in Toronto, Vancouver, Calgary, or Edmonton, a private mobile […]

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UPDATE OCTOBER/2020 British Columbia residents can no longer access this private testing service because, as I recently wrote here, medical regulators in B.C. have ordered the company to stop offering the service. It is still available in Alberta and Ontario.

BY PAMELA FAYERMAN

If you live in Toronto, Vancouver, Calgary, or Edmonton, a private mobile lab company is offering to draw your blood to have it tested for antibodies to COVID-19.

The service is designed to satisfy curiosity about whether individuals have had a past COVID-19 infection but weren’t tested because they were asymptomatic or not tested at the time for some other reason. Having serology testing – or antibody testing – can offer some clarity or peace of mind about whether someone is producing an immune response to COVID-19 that might shelter them from re-infection. But as experts have pointed out, how long antibodies remain is still a big question.

Ichor (pronounced eye-core) Blood Services is an Alberta company and it is charging $75 for the home or office visit plus $120 for the antibody test. The COVID-19 test is also available at $190. A requisition from a physician is required for the tests.

Mike Kuzmickas is the president of Ichor. This is what he said in my chat with him:

“What I realized early is that if we will already be in people’s homes drawing blood, there are other services and private tests we can offer.”

Once drawn the blood is sent to a laboratory in Virginia. The mobile lab techs who draw blood are certified and since blood drawing is an invasive procedure, they also have training in first aid and transportation of dangerous goods.

Kuzmickas said: “We put together a partnership with StageZero Life Sciences, which is an Ontario company, with a high complexity lab in Richmond, Virginia. StageZero is an early cancer detection company…we facilitate blood collection for cancer detection tests by working with StageZero, the patient, and the patient’s physician.

“When COVID hit, StageZero was uniquely positioned to pivot into testing, both PCR and Antibody. Through our partnership with StageZero, Ichor is also able to offer these private tests to Canadians who are willing to pay for them. Since this is not our core business, we add a very small markup to the cost of these tests for our effort but are not looking to profit off them. Our goal is to simply offer private tests to people while building our core brand, and the trust that people have in it.”

“The PCR test that StageZero is using is the Thermo Fisher TaqPath test, and for antibody testing they run the BTNX Rapid Response test first, followed by the Beckman Coulter Access test to confirm a positive on an IgG from the BTNX test. The Beckman Coulter test has a sensitivity of 100%, and a specificity of 99.8%, one of the best tests out there. We ship samples once a week … results get back to the patient via a secure portal within 72 hours.”

Antibody (or immunity) testing is controversial because there isn’t yet enough quality evidence to show how valuable it is and some tests are more accurate than others. Rapid (point of care tests) are especially controversial. Ichor is not using a rapid test; it is sending blood to a U.S. lab.

Experts can’t say for sure how long antibodies last after COVID-19 infections and as I reported in my last article, studies are showing that immunity to re-infection may not last long enough to provide true immunity from re-infection. I asked Kuzmickas if customers will receive their results with caveats. He said this in response:

“We have been careful not to use the term immunity nor to make any clear statements around the effectiveness or validity of antibodies. We encourage people to do their own research, just like they would for any other private blood test. If people believe that a vaccine is the answer, which is meant to mimic the virus so the body produces antibodies, then testing positive for antibodies can be considered similar to vaccine response. We are simply giving people the option to get tested in the absence of any government testing plan for the general population.”

Not giving customers any qualifying information is not responsible, in my opinion. Companies that offer health care services – especially during a pandemic – should not rely on customers to do their own Dr. Google research.

If you are considering antibody testing, go here to read about one individual’s experience.

I asked one of B.C.’s top COVID-19 experts – Dr. Mel Krajden – to comment on the private service. Krajden and most other public health experts believe antibody testing isn’t yet ready for prime time and should only be deployed in research protocols or by government-funded scientific bodies. His remarks may help you decide whether this is how you wish to spend $200:

“Offering serology to the general public without the proof that the serology is both accurate and will impact a patient’s outcome is not consistent with good medical care,” said Krajden who is the medical director at the BC Centre for Disease Control public health laboratory.

“The current guidance documents being developed by the Canadian Public Health Laboratory Network, the Association of Medical Microbiology and Infectious Diseases, the Canadian Society of Clinical Chemistry and the Federal COVID Serology Task Force all agree that given current knowledge, serological tests have not yet been shown to correlate with sero-protection (an antibody response capable of preventing infections, after, for example, a vaccination or a previous infection).

“Therefore, a positive serological test result should not be used to change the need for physical distancing, personal protective equipment and to modify workplace activities.”

[email protected]

Twitter: @MedicineMatters

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