Covid-19 false test results.

The request was successful.

Dear Royal Berkshire NHS Foundation Trust,

How many of the following  have been identified in the hospital-

Cases of false positive Covid-19 tests?
Cases of false negative Covid-19 tests?

Did false readings appear singularly, in clusters or both?
When were the cases of false readings identified? Please give dates.

Was research done in to why false readings were found?

If so, was the reason-

Human error in taking the swab?
Lab error in processing the swab?
Equipment error?
Another reason?

Thank you.

Joseph Treehorn

FOI, Royal Berkshire NHS Foundation Trust

Dear Requester,

We acknowledge your enquiry under the Freedom of Information Act.  I will
look into your request and respond within 20 working days from receipt of
your request.

Yours sincerely,

Freedom Of Information Team
Royal Berkshire NHS Foundation Trust
Tel: 0118 322 6743/7405
Email: [Royal Berkshire NHS Foundation Trust request email]

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FOI, Royal Berkshire NHS Foundation Trust

Dear Joseph,

In order for us to gather the information for your request, please could you clarify the time frame for which you are asking?

Yours sincerely,

Freedom Of Information Team
Royal Berkshire NHS Foundation Trust
Tel: 0118 322 8514
Email: [Royal Berkshire NHS Foundation Trust request email]

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Dear Royal Berkshire NHS Foundation Trust,

Would it be possible to let me know for the whole pandemic please? So March 20 until now if possible.

Thank you.

Joe

FOI, Royal Berkshire NHS Foundation Trust

Dear Joseph,

 

In response to your Freedom of Information request, the information below
has been provided by Berkshire & Surrey Pathology Services as the Trust
does not hold this information.  There have been a total of 24 cases of
false positives and 15 cases of false negatives.

There was a cluster of 6 false positives between 19/03/2021 and 20/03/2021
due to incorrect auto release of results following amplicon contamination.

There was a cluster of 10 false positives between 08/10/2021 and
16/10/2021 due to suspected contamination.

 

The other false readings appeared singularly, dates and reasons are
provided in the table below:

 

Error Cause of error Date
False human error 07.10.20
negative
likely low
False viral load and 11.10.21
negative methodological
differences
False human error 13.10.20
negative
False human error 5.1.21
negative
False human error 29.1.21
negative
False technical 31.1.21
negative problem
False human error 29.3.21
negative
False human error 16.4.21
negative
False human error 4.6.21
negative
False human error 10.7.21
negative
False human error 20.7.21
negative
False human error 21.7.21
negative
False human error 30.7.21
negative
False human error 9.8.21
negative
False human error 12.8.21
negative
False human error 17.10.21
positive
False human error 24.12.20
positive
False human error 3.1.21
positive
False Wrong patient 22.1.21
positive ID on sample
False human error 29.1.21
positive
False human error 31.1.21
positive
False human error 4.6.21
positive
False Wrong patient 11.8.21
positive ID on sample

 

 

Yours sincerely,

 

Freedom Of Information Team

Royal Berkshire NHS Foundation Trust

Tel: 0118 322 8514

Email: [1][Royal Berkshire NHS Foundation Trust request email]

 

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Dear Royal Berkshire NHS Foundation Trust,

Thank you for the information.
Unfortunately, I can't read the list you sent, as the table formatting has not worked in your reply. Please will you send it again as a PDF or document of some sort?
I was also hoping for information from March 2020 to now, as I asked before, but you have accidentally sent me information from March 2021 until now, please will you send it again?
The other thing is that, from what I can read there were only 3 false tests in 2020, as I know that is a mistake, it would be great if you would send again with correct formatting so I can read it properly please.

Thank you.

Joe

FOI, Royal Berkshire NHS Foundation Trust

1 Attachment

Dear Joe,

We apologies that you could not read the table, please find it in the attached spreadsheet.
Your queries regarding the data provided will be raised with Berkshire & Surrey Pathology Services and we will provide you with a response to this as soon as possible.

Yours sincerely,

Freedom Of Information Team
Royal Berkshire NHS Foundation Trust
Tel: 0118 322 8514
Email: [Royal Berkshire NHS Foundation Trust request email]

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Dear Royal Berkshire NHS Foundation Trust,

Thank you for the spreadsheet.
While you wait for the updated data, please will you provide me with the false positives and false negatives information from POCT test, SAMBA etc., as so far you have given me only false results from lab tests?

Thank you.

Joe

FOI, Royal Berkshire NHS Foundation Trust

1 Attachment

Hi Caroline,
Draft response for approval.
Information provided by BSPS. Breaches 22/10/2021.
Many thanks,
Mikaela

Dear Joe,

In response to your queries, please find the requested information below that was provided by Berkshire & Surrey Pathology Services.

Yours sincerely,

Freedom Of Information Team
Royal Berkshire NHS Foundation Trust
Tel: 0118 322 8514
Email: [Royal Berkshire NHS Foundation Trust request email]

POCT SAMBA and POCT Liat:
There were 15 false negatives and 8 false positives – data provided in the table attached. Human error in result reporting was the cause in 19 of these, 2 were results reported on the wrong patient due to sample mislabelling, 1 was due to methodological differences and likely low viral load, and 1 due to a technical problem on the analyser. All false negative and false positive results occurred as isolated events.

Virology (Panther):
A review of amended reports when the test code has been added reveals 16 false positives in the Covid-19 laboratory at SPH. The first cluster of 10 were between 8/10/20 until 16/10/20 due to suspected contamination The second cluster of 6 were between 19/3/21 until 20/3/21 due to incorrect auto release of results following amplicon contamination.

Molecular (Genesig):
No amended reports were identified from molecular testing at Royal Surrey County Hospital.

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FOI, Royal Berkshire NHS Foundation Trust

1 Attachment

Dear Joe,

In response to your queries, please find the requested information below that was provided by Berkshire & Surrey Pathology Services.

Yours sincerely,

Freedom Of Information Team
Royal Berkshire NHS Foundation Trust
Tel: 0118 322 8514
Email: [Royal Berkshire NHS Foundation Trust request email]

POCT SAMBA and POCT Liat:
There were 15 false negatives and 8 false positives – data provided in the table attached. Human error in result reporting was the cause in 19 of these, 2 were results reported on the wrong patient due to sample mislabelling, 1 was due to methodological differences and likely low viral load, and 1 due to a technical problem on the analyser. All false negative and false positive results occurred as isolated events.

Virology (Panther):
A review of amended reports when the test code has been added reveals 16 false positives in the Covid-19 laboratory at SPH. The first cluster of 10 were between 8/10/20 until 16/10/20 due to suspected contamination The second cluster of 6 were between 19/3/21 until 20/3/21 due to incorrect auto release of results following amplicon contamination.

Molecular (Genesig):
No amended reports were identified from molecular testing at Royal Surrey County Hospital.

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Dear Royal Berkshire NHS Foundation Trust,

Thanks for the getting back to me.

I'm quite unclear on a few areas.
Does RBH send all tests that it has done out for verification to Berkshire & Surrey Pathology Services, so POCT, SAMBA tests as well as Virology PCT and other types which are done in the hospital are then sent for verification, or are some not sent or sent to a different lab? If all tests are checked like this, did that checking start from March 2020?
There are some date errors in what you sent, eg 11/10/21, 17/10/21, please will you resend the correct dates and confirm the rest of the dates you gave are correct?
In the "date" column of what you sent, does that refer to the date the test was taken, the date the test was verified, the date the test went to the lab,  or the date the error was found?
Have I understood properly that the total number of false negative and false positive tests from March 2020 to now is 39 across all test types and there were no other false results at all?
Also have I understood properly that there were only 13 false results in 2020 in total and 26 in total in 2021? Do you happen to know how many test were done in total in the pandemic at the hospital?
Please will you confirm that what you have supplied is the complete set of all false negatives and false positives for RBH from the start of the pandemic for all types of Covid-19 tests?
There are some pieces of jargon I am not familiar with, please will you explain what is SPH? And what is "amended reports when the test code has been added"? Also what does "Breaches" mean?
Please will you let me know how Royal Surrey County Hospital relates?
Please will you let me know if Liat is the same as FABCO?

Thank you.

Joe

FOI, Royal Berkshire NHS Foundation Trust

Dear Joe,

In response to your questions, please see the below responses that have been provided by Berkshire & Surrey Pathology Services.

Yours sincerely,

Freedom Of Information Team
Royal Berkshire NHS Foundation Trust
Tel: 0118 322 8514
Email: [Royal Berkshire NHS Foundation Trust request email]

Does RBH send all tests that it has done out for verification to Berkshire & Surrey Pathology Services, so POCT, SAMBA tests as well as Virology PCT and other types which are done in the hospital are then sent for verification, or are some not sent or sent to a different lab? If all tests are checked like this, did that checking start from March 2020?
All testing methods used within BSPS at RBH are performance-verified before being put into clinical use. Confirmation is only required on results that are not conclusive and can take place in POCT, the main Virology lab, or externally to BSPS.

There are some date errors in what you sent, eg 11/10/21, 17/10/21, please will you resend the correct dates and confirm the rest of the dates you gave are correct?
11/10/21 should have read 11/10/20
17/10/21 should have read 17/10/20

In the "date" column of what you sent, does that refer to the date the test was taken, the date the test was verified, the date the test went to the lab, or the date the error was found?
Sample date. This is data from the rapid testing service so all samples tested and reported within hours of being taken.

Have I understood properly that the total number of false negative and false positive tests from March 2020 to now is 39 across all test types and there were no other false results at all?
To the best of our knowledge, yes.
It is noted that there is no gold standard diagnostic test for SARS-Cov-2 infection, which is diagnosed or excluded by a combination of PCR testing, clinical judgement and radiology. PCR testing is the best test available, and there are methodological differences and pre-analytical and analytical factors that result in discrepancies and “false results” depending on your criteria. PCR tests can remain positive for 3 months after active infection – this would be a false positive for current infectivity, but is a true positive for recent infection.
False results can only be picked up in the clinical context – the only way to truly assess false results is by case-by-case clinical review of results in the context of the presentation, symptoms and signs, radiological findings, other test results including any community tests and subsequent tests as well as any antigen testing (this is not applicable at RBH to our knowledge) as well as related pathology tests which can be abnormal in covid-19 disease. Laboratory services alone cannot, in this context, judge whether a result is a false positive or negative.

Also have I understood properly that there were only 13 false results in 2020 in total and 26 in total in 2021?
To the best of our knowledge, yes.
It is noted that there is no gold standard diagnostic test for SARS-Cov-2 infection, which is diagnosed or excluded by a combination of PCR testing, clinical judgement and radiology. PCR testing is the best test available, and there are methodological differences and pre-analytical and analytical factors that result in discrepancies and “false results” depending on your criteria. PCR tests can remain positive for 3 months after active infection – this would be a false positive for current infectivity, but is a true positive for recent infection.
False results can only be picked up in the clinical context – the only way to truly assess false results is by case-by-case clinical review of results in the context of the presentation, symptoms and signs, radiological findings, other test results including any community tests and subsequent tests as well as any antigen testing (this is not applicable at RBH to our knowledge) as well as related pathology tests which can be abnormal in covid-19 disease. Laboratory services alone cannot, in this context, judge whether a result is a false positive or negative.

Do you happen to know how many test were done in total in the pandemic at the hospital?
From 20/03/2020 to 03/09/2021: 234,252

Please will you confirm that what you have supplied is the complete set of all false negatives and false positives for RBH from the start of the pandemic for all types of Covid-19 tests?
To the best of our knowledge, yes.
It is noted that there is no gold standard diagnostic test for SARS-Cov-2 infection, which is diagnosed or excluded by a combination of PCR testing, clinical judgement and radiology. PCR testing is the best test available, and there are methodological differences and pre-analytical and analytical factors that result in discrepancies and “false results” depending on your criteria. PCR tests can remain positive for 3 months after active infection – this would be a false positive for current infectivity, but is a true positive for recent infection.
False results can only be picked up in the clinical context – the only way to truly assess false results is by case-by-case clinical review of results in the context of the presentation, symptoms and signs, radiological findings, other test results including any community tests and subsequent tests as well as any antigen testing (this is not applicable at RBH to our knowledge) as well as related pathology tests which can be abnormal in covid-19 disease. Laboratory services alone cannot, in this context, judge whether a result is a false positive or negative.

There are some pieces of jargon I am not familiar with, please will you explain what is SPH?
St Peter’s Hospital, location of the BSPS Virology laboratory.

And what is "amended reports when the test code has been added"?
There is a specific test code that is added to reports requiring amendment.

Please will you let me know how Royal Surrey County Hospital relates?
Location of the BSPS Molecular testing laboratory.

Please will you let me know if Liat is the same as FABCO?
This term was not used in the FOI response.

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Dear Royal Berkshire NHS Foundation Trust,
Thanks for the getting back to me.
Sorry about this, but I'm still unclear on some areas. "Liat" appears in your earlier response and so does "breaches", so I'm wondering what both those things mean, please will you let me know?. The other thing is, is Berkshire & Surrey Pathology Services the only lab RBH uses for all tests, or does RBH do some in house? And do you use any other lab too? If you do some tests in house are they checked for false positives and false negatives?

Thank you.

Joe

Dear Royal Berkshire NHS Foundation Trust,
Are you able to get back to me about the clarification I sent on 7/11/21?

Thank you.

Joe

FOI, Royal Berkshire NHS Foundation Trust

Dear Joe,

We are still waiting to hear back from internal departments regarding your queries, we will provide you with the requested clarification as soon as possible.

Yours sincerely,

Freedom Of Information Team
Royal Berkshire NHS Foundation Trust
Tel: 0118 322 8514
Email: [Royal Berkshire NHS Foundation Trust request email]

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Dear Royal Berkshire NHS Foundation Trust,
Are you able to get back to me about the clarification I sent on 7/09/21, that's coming up to a month now, so I was hoping you would have heard from internal departments by now.

Thank you.

Joe

FOI, Royal Berkshire NHS Foundation Trust

Dear Joe,

We are still seeking some clarity on the information that has been provided us in response to your queries, to ensure that it appropriately answers your questions. We are progressing this and will provide you with a response as soon as possible.

Yours sincerely,

Freedom Of Information Team
Royal Berkshire NHS Foundation Trust
Tel: 0118 322 8514
Email: [Royal Berkshire NHS Foundation Trust request email]

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FOI, Royal Berkshire NHS Foundation Trust

Dear Joe,

In response to your queries please see below.
Liat - a system for processing PCR tests.
Breaches - passes the statutory deadline.
The Berkshire & Surrey Pathology Services process all Covid testing for the hospital.

Yours sincerely,

Freedom Of Information Team
Royal Berkshire NHS Foundation Trust
Tel: 0118 322 8514
Email: [Royal Berkshire NHS Foundation Trust request email]

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Dear Royal Berkshire NHS Foundation Trust,
Thanks for the getting back to me.

Sorry about this, I still don't understand what "Breaches - passes the statutory deadline." means, please will you let me know?

And finally, The Berkshire & Surrey Pathology Services process all Covid testing for the hospital, does this mean they have a lab within the Royal Berks hospital and use their own staff, or do they have a lab somewhere else, or both?

Thank you.

Joe

FOI, Royal Berkshire NHS Foundation Trust

Dear Joe,

Please find the answers to your questions below.

Yours sincerely,

Freedom Of Information Team
Royal Berkshire NHS Foundation Trust
Tel: 0118 322 8514
Email: [Royal Berkshire NHS Foundation Trust request email]

Sorry about this, I still don't understand what "Breaches - passes the statutory deadline." means, please will you let me know?
This is in relation to Freedom of Information compliance, please disregard this as it does not relate to the information you requested.

And finally, The Berkshire & Surrey Pathology Services process all Covid testing for the hospital, does this mean they have a lab within the Royal Berks hospital and use their own staff, or do they have a lab somewhere else, or both?
Berkshire & Surrey Pathology services have advised that they do have a lab on site at Royal Berkshire Hospital but not for routine Covid testing. These are processed at St Peter's Hospital for the whole network.

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