We also saw 100% interpretive concordance between the two assays in our validation of nearly 200 samples. However the population used for validation was largely PCR positive patients and pre-COVID stored samples so very different to the population we are now using the assay in.
Hayley
-----Original Message-----
From: Clinical biochemistry discussion list [mailto:[log in to unmask]] On Behalf Of ACB-CLIN-CHEM-GEN automatic digest system
Sent: 23 June 2020 00:07
To: [log in to unmask]
Subject: ACB-CLIN-CHEM-GEN Digest - 21 Jun 2020 to 22 Jun 2020 (#2020-149)
There are 5 messages totaling 903 lines in this issue.
Topics of the day:
1. AQMLM Zoom meeting on Accreditaton
2. Changes to Royal Mail postal requirements
3. Comparisons between the Roche and Abbott SARS-CoV-2 antibody assay (3)
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Date: Mon, 22 Jun 2020 09:51:17 +0100
From: Jonathan Middle <[log in to unmask]>
Subject: AQMLM Zoom meeting on Accreditaton
Hi
There is still time to register for our Zoom meeting at *11:00 on Thursday
25th June 2020*. The Theme is* "UKAS Accreditation during the COVID-19
Crisis"*.
The meeting will be hosted by AQMLM Directors and *Ben Courtney* from UKAS
will be in attendance to answer questions.
Please visit our Forthcoming Events <http://www.aqmlm.org.uk/forthcoming>
page for details, or use our Contact <http://www.aqmlm.org.uk/contact> form
to make enquiries.
Thank you
Jonathan Middle
Chair
--
AQMLM Home <http://www.aqmlm.org.uk>
AQMLM Covid-19 <http://www.aqmlm.org.uk/covid-19>
STEM <https://www.stem.org.uk>
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Date: Mon, 22 Jun 2020 10:00:12 +0100
From: Paul Thomas <[log in to unmask]>
Subject: Changes to Royal Mail postal requirements
This is a warning that the Royal Mail is clamping down on the use of the Business Response Service for the return of patient specimens. The Royal Mail indicate that this is the result of costs of providing the service and the risk of breakage of the items once they are processed through our letters sorting machines.
There is a requirement to migrate to the Tracked Return service to provide a solution for such items. As you may anticipate this service is considerably more expensive although these are not formal quotes I am expecting the cost to increase from £0.85 to £2.15 for the 48 hour service a massive % increase.
The Royal Mails response is that the service has the benefit of being tracked through the network and enhanced management information that they will share with us.
My difficulty is I have no idea when a sample is posted so any tracking is of no practical benefit to me and I have no requirement for additional management information. The other issue is all the samples have a unique bar code so the preparation of the material for dispatch becomes more complex.
I am using the service for the return of FIT collection devices; Royal Mail acknowledge that these are exempt from the PI650 regulation and do not require UN3373 packing which makes this requirement even more difficult to understand. The collection devices are designed to withstand high pressure and the buffer deactivates any pathogens in the sample. These samples also go through the system as large letters and as a consequence to not go thorough the standard letter sorting machines.
If you do not engage with Royal Mail they may suspend your current licence/fine you £3.50 for each item you continue to send and after 30 days they will increase the cost of the business return service to the track returned service.
I assume that people are using the business return service for other sample types and applications. To me this has been an additional problem to deal with during the current pandemic; some people may feel it is a monopoly provider using this as an opportunity to push this through now.
If anybody wishes to respond directly to my please use [log in to unmask]
Paul
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Date: Mon, 22 Jun 2020 09:57:07 +0000
From: "Hart, Tanya" <[log in to unmask]>
Subject: Re: Comparisons between the Roche and Abbott SARS-CoV-2 antibody assay
In collaboration with Portsmouth, we ran 127 samples through both assays and saw 100% concordance. There were 9 samples in the 1-5 range in the Roche assay. Covid-positive samples were all 21d+ after onset. We were also able to compare the Roche assay with other IgG and IgM assays, and the Roche assay showed equal or superior sensitivity to the IgM assays, though this was only with a small number of samples.
Tanya
Tanya Hart PhD FRCPath
Principal Clinical Scientist
Department of Clinical Biochemistry
Poole and Royal Bournemouth Hospitals
From: Clinical biochemistry discussion list [mailto:[log in to unmask]] On Behalf Of Gavin Murdock
Sent: 21 June 2020 21:38
To: [log in to unmask]
Subject: Comparisons between the Roche and Abbott SARS-CoV-2 antibody assay
Hi all
We were able to participate in a sample exchange with a lab running the Abbott assay (we use the Roche assay) which has allowed us to look at the concordance between the Roche and Abbott antibody assays.
There were only 21 samples in total.
In summary:
* All the samples negative by the Roche assay were negative by the Abbott assay
* All the strongly positive samples by the Roche assay (defined as > 60 COI in this sample) were also positive by the Abbott assay.
* Disagreement appears to be over what I would describe as weak positives. These were samples with results on the Roche assay in the range 1 - 5 COI. They were all, apart from one, negative by the Abbott assay.
I believe that the Abbott assay is specific for IgG nucleocapsid antibodies whilst the Roche assay should detect all nucleocapsid antibody isotypes. This seems like one obvious reason for the discrepancy.
I thought I'd share to add to the data in this area.
I'll be interested to see what the EQA schemes show.
A lab in Vienna has posted the results of its comparison of the Roche, Abbott and DiaSorin assays - https://doi.org/10.1101/2020.06.04.20117911
Regards,
Gavin
------ACB discussion List Information-------- This is an open discussion list for the academic and clinical community working in clinical biochemistry. Please note, archived messages are public and can be viewed via the internet. Views expressed are those of the individual who posts and they are solely responsible for all message content. The ACB does not monitor posts. ACB Web Site http://www.acb.org.uk Green Laboratories Work http://www.laboratorymedicine.nhs.uk List Archives http://www.jiscmail.ac.uk/lists/ACB-CLIN-CHEM-GEN.html List Instructions (How to leave etc.) http://www.jiscmail.ac.uk/
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Please note, archived messages are public and can be viewed via the internet. Views expressed are those of the individual who posts and they are solely responsible for all message content. The ACB does not monitor posts.
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Date: Mon, 22 Jun 2020 10:56:03 +0000
From: "SHARROD-COLE, Hayley (THE ROYAL WOLVERHAMPTON NHS TRUST)"
<[log in to unmask]>
Subject: Comparisons between the Roche and Abbott SARS-CoV-2 antibody assay
Dear Collective,
We have also been able to run some comparisons between the Roche and Abbott assays and have also seen discordant interpretation in the samples identified as 'weak positives' on the Roche assay. Samples in this region are typically negative by the Abbott assay. For our lab this could equate to detection of 5% fewer 'positive' results than a Roche lab.
The numerical values from the Roche assay are up to 10 fold higher in 'positive' samples which I don't think can be explained solely by the different antibody isotype detection by the two assays, although I accept the knowledge of the immune response to this virus is not yet fully understood.
Does anyone have any thoughts on this?
Hayley
Hayley Sharrod-Cole FRCPath
Principal Clinical Scientist
Black Country Pathology Services
Supporting: The Royal Wolverhampton NHS Trust
-----Original Message-----
From: Clinical biochemistry discussion list [mailto:[log in to unmask]] On Behalf Of ACB-CLIN-CHEM-GEN automatic digest system
Sent: 22 June 2020 00:05
To: [log in to unmask]
Subject: ACB-CLIN-CHEM-GEN Digest - 20 Jun 2020 to 21 Jun 2020 (#2020-148)
There is 1 message totaling 96 lines in this issue.
Topics of the day:
1. Comparisons between the Roche and Abbott SARS-CoV-2 antibody assay
------ACB discussion List Information--------
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Please note, archived messages are public and can be viewed via the internet. Views expressed are those of the individual who posts and they are solely responsible for all message content. The ACB does not monitor posts.
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----------------------------------------------------------------------
Date: Sun, 21 Jun 2020 21:38:10 +0100
From: Gavin Murdock <[log in to unmask]>
Subject: Comparisons between the Roche and Abbott SARS-CoV-2 antibody assay
Hi all
We were able to participate in a sample exchange with a lab running the
Abbott assay (we use the Roche assay) which has allowed us to look at the
concordance between the Roche and Abbott antibody assays.
There were only 21 samples in total.
In summary:
- All the samples negative by the Roche assay were negative by the
Abbott assay
- All the strongly positive samples by the Roche assay (defined as > 60
COI in this sample) were also positive by the Abbott assay.
- Disagreement appears to be over what I would describe as weak
positives. These were samples with results on the Roche assay in the range
1 - 5 COI. They were all, apart from one, negative by the Abbott assay.
I believe that the Abbott assay is specific for IgG nucleocapsid antibodies
whilst the Roche assay should detect all nucleocapsid antibody isotypes.
This seems like one obvious reason for the discrepancy.
I thought I'd share to add to the data in this area.
I'll be interested to see what the EQA schemes show.
A lab in Vienna has posted the results of its comparison of the Roche,
Abbott and DiaSorin assays - https://doi.org/10.1101/2020.06.04.20117911
Regards,
Gavin
------ACB discussion List Information--------
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------------------------------
End of ACB-CLIN-CHEM-GEN Digest - 20 Jun 2020 to 21 Jun 2020 (#2020-148)
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------------------------------
Date: Mon, 22 Jun 2020 14:57:13 +0100
From: Gavin Murdock <[log in to unmask]>
Subject: Re: Comparisons between the Roche and Abbott SARS-CoV-2 antibody assay
That’s interesting to hear Tanya.
Our sample was small and was more for comparability information ahead of
receiving the EQA samples.
I shared the results because they were unexpected.
Regards,
Gavin
On Mon, 22 Jun 2020 at 10:57, Hart, Tanya <[log in to unmask]> wrote:
> In collaboration with Portsmouth, we ran 127 samples through both assays
> and saw 100% concordance. There were 9 samples in the 1-5 range in the
> Roche assay. Covid-positive samples were all 21d+ after onset. We were also
> able to compare the Roche assay with other IgG and IgM assays, and the
> Roche assay showed equal or superior sensitivity to the IgM assays, though
> this was only with a small number of samples.
>
>
>
> Tanya
>
>
>
>
>
> Tanya Hart PhD FRCPath
>
> Principal Clinical Scientist
>
> Department of Clinical Biochemistry
>
> Poole and Royal Bournemouth Hospitals
>
>
>
>
>
>
>
>
>
> *From:* Clinical biochemistry discussion list [mailto:
> [log in to unmask]] *On Behalf Of *Gavin Murdock
> *Sent:* 21 June 2020 21:38
> *To:* [log in to unmask]
>
> *Subject:* Comparisons between the Roche and Abbott SARS-CoV-2 antibody
> assay
>
>
>
> Hi all
>
>
>
> We were able to participate in a sample exchange with a lab running the
> Abbott assay (we use the Roche assay) which has allowed us to look at the
> concordance between the Roche and Abbott antibody assays.
>
>
>
> There were only 21 samples in total.
>
>
>
> In summary:
>
> - All the samples negative by the Roche assay were negative by the
> Abbott assay
> - All the strongly positive samples by the Roche assay (defined as >
> 60 COI in this sample) were also positive by the Abbott assay.
> - Disagreement appears to be over what I would describe as weak
> positives. These were samples with results on the Roche assay in the range
> 1 - 5 COI. They were all, apart from one, negative by the Abbott assay.
>
> I believe that the Abbott assay is specific for IgG nucleocapsid
> antibodies whilst the Roche assay should detect all nucleocapsid antibody
> isotypes. This seems like one obvious reason for the discrepancy.
>
>
>
> I thought I'd share to add to the data in this area.
>
>
>
> I'll be interested to see what the EQA schemes show.
>
>
>
> A lab in Vienna has posted the results of its comparison of the Roche,
> Abbott and DiaSorin assays - https://doi.org/10.1101/2020.06.04.20117911
>
>
>
> Regards,
>
> Gavin
>
>
>
> ------ACB discussion List Information-------- This is an open discussion
> list for the academic and clinical community working in clinical
> biochemistry. Please note, archived messages are public and can be viewed
> via the internet. Views expressed are those of the individual who posts and
> they are solely responsible for all message content. The ACB does not
> monitor posts. ACB Web Site http://www.acb.org.uk Green Laboratories Work
> http://www.laboratorymedicine.nhs.uk List Archives
> http://www.jiscmail.ac.uk/lists/ACB-CLIN-CHEM-GEN.html List Instructions
> (How to leave etc.) http://www.jiscmail.ac.uk/
>
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------------------------------
End of ACB-CLIN-CHEM-GEN Digest - 21 Jun 2020 to 22 Jun 2020 (#2020-149)
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