Patients kept in dark on antibody test results

  • Clinical purposes: Ricky Brathwaite, chief executive of the Bermuda Health Council

    Clinical purposes: Ricky Brathwaite, chief executive of the Bermuda Health Council

The island’s health regulator has been accused of withholding results from patients who had private antibody tests for Covid-19.

Helix Lab, where Bermuda’s first on-island coronavirus testing was carried out, has been told by Bermuda Health Council to stop processing the antibody tests, though it was still doing them at the end of last month.

A paediatrician told the mother of one boy who had a test on May 25 that the health council was “apparently preventing Helix from releasing these results either to the patients or their physicians”.

The doctor wrote in a June 1 e-mail seen by The Royal Gazette: “We have spoken to Helix and the results are ready but BHeC has to give permission for their release. We are totally unclear why this is the case.

“Once we have results we will let you know. We have several families in the same situation.”

The doctor sent an update to the mother this week.

It said: “We are in the dark about this as much as you are.”

The physician later added: “Spoke with Helix Labs again. They are still awaiting approval from BHeC to release results. Until that time, our hands are tied.”

The mother said she was unhappy she could not get the results after the doctor ordered the test for her son at her request.

The child did not have coronavirus symptoms but had close contact with confirmed cases at the start of the outbreak.

She said: “The doctor agreed it made sense and ordered the test. Helix processed the test. The Bermuda Health Council is preventing the lab from releasing results.”

The mother added: “It’s just the most odd thing. Why would they be allowed to even bring the test kits in if they are not allowed to do the tests?”

Desiree Spriggs, the doctor who runs Helix Lab, declined to comment and referred questions to the health council.

Ricky Brathwaite, the health council’s chief executive officer, did not answer questions about whether patients had the right to receive their test results or whether the regulator was withholding results.

He said in an e-mail: “Helix Labs is not approved to do antibody testing and they have been communicated with as such.”

He added BHeC was responsible for approval of lab tests for Covid-19 and had only given permission for antibody testing to the Government’s Molecular Diagnostic Testing Laboratory at Southside, St David’s.

Patients can get a antibody test at Southside using a drop of blood from a finger, along with a polymerase chain reaction swab test, designed to detect coronavirus infections.

Dr Brathwaite said the Southside lab was “exclusively” conducting an epidemiological study for the Government and the council had not approved antibody testing for labs not involved in the survey.

He added that Helix was approved to provide PCR tests and had been given permission to “proceed towards validating their procured antibody tests”.

Dr Brathwaite said: “However, no laboratory has been given approval for any type of clinical testing for antibodies to diagnose disease.

“Antibody testing on a whole is not at this time being used for clinical purposes

“ ... If it is determined by public health that antibody testing is to be used beyond retrospective epidemiological surveillance, then the health council will loosen its current Covid-19 laboratory testing restrictions.”

Dr Brathwaite highlighted a May 6 memo which he said was sent to all labs that said molecular testing, which includes PCR, was the only kind approved for the diagnosis of Covid-19 and that blood serum analysis, which measured antibody responses, “will not receive approval for diagnosis of Covid-19”.

Dr Brathwaite said: “Helix has not informed the council of any antibody tests that have been conducted, either before or after the memo was disseminated.” He added: “If they were doing antibody tests prior to receiving the memo, the health council did not approve of it.

“However, we understand how such tests could have been ordered as Covid has been a fluid situation and guidance is continually being developed and updated. It is therefore the health council’s role to ensure that communication is timely and clear.”

Kim Wilson, the Minister of Health, told the public in April that Helix, along with MDL, was “in the process of implementing antibody testing”.

The Royal Gazette asked the Ministry of Health in May for the antibody results from MDL and any other lab that had carried out the tests.

Only the MDL results were released, which showed that less than 3 per cent of the 1,103 people tested by that time had Covid-19 antibodies.

The ministry confirmed it had collected information from antibody tests carried out at other labs, as well as Southside.

A ministry spokeswoman added this week: “The Ministry of Health, at the time of your original questions, had received some antibody test results from Helix.

“However, Covid is a rapidly evolving situation and the current position is that, as antibody tests cannot be used for diagnostic purposes, the Epidemiology and Surveillance Unit is not collecting individual results.

“The matter of antibody testing was referred to the Bermuda Health Council, as the regulatory body responsible for laboratories, and they have established an approval process for labs wishing to do antibody testing.”

Ms Wilson said at a Covid-19 briefing in early June that she could not “quite answer” when questioned about people who had not been given the results of private antibody tests.

She added: “The Ministry of Health does receive the antibody tests through the MDL. Previously, however, I understand that there may have been one other office that was collecting antibody tests, as in performing themselves, but that was a matter that has been referred to and is being looked at by the health council.”

Dr Brathwaite said: “The matter referred to the council, from the ministry, was in respect of the value for the council in communicating clear guidance to all labs to ensure that everyone is aligned with public health evidence and national testing goals.

“That is what took place and it was made very clear that any testing done for Covid that does not align with those two things — public health evidence and national testing goals — should cease.”

Ms Wilson said on Monday the island had two types of antibody testing. and that “one is being done by the Southside lab and the other one is being done by Helix”.

A ministry spokeswoman explained on Tuesday that Ms Wilson had referred to testing capacity and was aware that Helix was only doing antibody testing as part of a validation process.

The spokeswoman said that Helix was “not yet approved to do consumer testing”.

After this article was published online on Wednesday, the spokeswoman said antibody test results from Helix would be sent to patients’ doctors and that results from Southside were already being shared.

She said all the results from Southside and Helix would be reviewed by the ESU but it was “premature” to make the results public “at this time”.

To view the May 6 memo, click on the PDF link under “Related Media”

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Published Jun 12, 2020 at 8:00 am (Updated Jun 12, 2020 at 8:02 am)

Patients kept in dark on antibody test results

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