"Clinical" sensitivity and specificity for the detection of SARS-CoV-2.
Mark Bailey made this Official Information request to Ministry of Health
Ministry of Health did not have the information requested.
From: Mark Bailey
Dear Ministry of Health,
On February 24 2021, Dr Kelvin Watson (Group Manager, COVID-19 Testing and Supply
COVID-19 Health System Response) made the following statement in response to a request for official information:
"SARS-CoV-2 RT-PCR testing used in our accredited medical diagnostic laboratories have undergone rigorous validation for specific performance characteristics that include analytical and clinical sensitivity and specificity for the detection of SARS-CoV-2."
https://fyi.org.nz/request/14341/respons...
Can you please provide further explanation for this statement. Analytical sensitivity and specificity has been established for detecting genetic sequences purported to come from SARS-CoV-2. However Dr Watson's statement that the clinical sensitivity and specificity has been established for SARS-CoV-2 is incorrect. Clinical implies diagnostic, which relates to a condition. His statement looks like he has conflated the test with the condition. Or is he claiming that the diagnostic sensitivity and specificity of the tests for the condition "COVID-19" have been established? If so, can you please provide the scientific paper(s) where this was established.
The guidelines and terminology relating to performing and analysing RT-PCR are outlined in "The MIQE Guidelines: Minimum Information for Publication of Quantitative Real-Time PCR Experiments" state:
"Analytical sensitivity refers to the minimum number of copies in a sample that can be measured accurately with an assay, whereas clinical sensitivity is the percentage of individuals with a given disorder whom the assay identifies as positive for that condition."
"Analytical specificity refers to the qPCR assay detecting the appropriate target sequence rather than other, nonspecific targets also present in a sample. Diagnostic specificity is the percentage of individuals without a given condition whom the assay identifies as negative for that condition."
https://academic.oup.com/clinchem/articl...
Yours faithfully,
Dr Mark Bailey
From: OIA Requests
Kia ora Mark,
Thank you for your email. To provide further explanation:
The analytical sensitivity and specificity of assays used in New Zealand
diagnostic laboratories have been determined by the laboratories and/or
the manufacturers.
The clinical sensitivity and specificity of assays for the detection of
SARS-CoV-2 in COVID-19 infected individuals has been determined in
numerous settings globally.
The Ministry of Health does not conduct any studies or research regarding
this. There are many individual studies and several systematic reviews
available for your reference on this topic. Further information can be
found at the following link:
[1]https://pubmed.ncbi.nlm.nih.gov/?term=co...
Under section 28(3) of the Act you have the right to ask the Ombudsman to
review any decisions made under this request. The Ombudsman may be
contacted by email at: [email address] or by calling 0800 802
602.
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [email address]
--------------------------------------------------------------------------
From: Mark Bailey <[FYI request #15780 email]>
Sent: Monday, 14 June 2021 11:59
To: OIA Requests <[email address]>
Subject: Official Information request - "Clinical" sensitivity and
specificity for the detection of SARS-CoV-2.
Dear Ministry of Health,
On February 24 2021, Dr Kelvin Watson (Group Manager, COVID-19 Testing and
Supply
COVID-19 Health System Response) made the following statement in response
to a request for official information:
"SARS-CoV-2 RT-PCR testing used in our accredited medical diagnostic
laboratories have undergone rigorous validation for specific performance
characteristics that include analytical and clinical sensitivity and
specificity for the detection of SARS-CoV-2."
[2]https://scanmail.trustwave.com/?c=15517&...
Can you please provide further explanation for this statement. Analytical
sensitivity and specificity has been established for detecting genetic
sequences purported to come from SARS-CoV-2. However Dr Watson's
statement that the clinical sensitivity and specificity has been
established for SARS-CoV-2 is incorrect. Clinical implies diagnostic,
which relates to a condition. His statement looks like he has conflated
the test with the condition. Or is he claiming that the diagnostic
sensitivity and specificity of the tests for the condition "COVID-19" have
been established? If so, can you please provide the scientific paper(s)
where this was established.
The guidelines and terminology relating to performing and analysing RT-PCR
are outlined in "The MIQE Guidelines: Minimum Information for Publication
of Quantitative Real-Time PCR Experiments" state:
"Analytical sensitivity refers to the minimum number of copies in a sample
that can be measured accurately with an assay, whereas clinical
sensitivity is the percentage of individuals with a given disorder whom
the assay identifies as positive for that condition."
"Analytical specificity refers to the qPCR assay detecting the appropriate
target sequence rather than other, nonspecific targets also present in a
sample. Diagnostic specificity is the percentage of individuals without a
given condition whom the assay identifies as negative for that condition."
[3]https://scanmail.trustwave.com/?c=15517&...
Yours faithfully,
Dr Mark Bailey
-------------------------------------------------------------------
This is an Official Information request made via the FYI website.
Please use this email address for all replies to this request:
[FYI request #15780 email]
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to Ministry of Health? If so, please contact us using this form:
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References
Visible links
1. https://pubmed.ncbi.nlm.nih.gov/?term=co...
2. https://scanmail.trustwave.com/?c=15517&...
3. https://scanmail.trustwave.com/?c=15517&...
4. https://scanmail.trustwave.com/?c=15517&...
5. https://scanmail.trustwave.com/?c=15517&...
hide quoted sections
From: Mark Bailey
Dear OIA Requests,
I have been sent a link that provides 12,657 results that appear to have been generated from someone simply entering "covid 19 laboratory diagnosis" into the PubMed search engine. This does not provide any evidence that "The clinical sensitivity and specificity of assays for the detection of SARS-CoV-2 in COVID-19 infected individuals has been determined in numerous settings globally". In addition I am concerned that the person providing the link does not understand that clinical (diagnostic) sensitivity and specificity relates to the condition "COVID-19" not "the detection of SARS-CoV-2".
The Ministry of Health's website also conflates analytical and diagnostic aspects of PCR test when it states: "A recent laboratory study found that different COVID-19 testing kits correctly detected COVID-19 in samples more than 95% (and frequently 100%) of the time."
https://www.health.govt.nz/our-work/dise...
There is nowhere on the Ministry's site which demonstrates how the clinical accuracy of the PCR tests have been established.
I'm well aware of scientific databases such as PubMed and again I request that the Ministry provide one specific research publication leading them to determine the diagnostic sensitivity and specificity of the PCR tests they are relying on for diagnosing the condition "COVID-19".
Yours sincerely,
Dr Mark Bailey
From: OIA Requests
Kia ora Mark,
As noted in our previous email, the Ministry does not conduct studies or
research into PCR testing. The analytical sensitivity and specificity of
assays used in New Zealand diagnostic laboratories have been determined by
the laboratories and/or the manufacturers.
The clinical sensitivity and specificity of assays for the detection of
SARS-CoV-2 in COVID-19 infected individuals has been determined in
numerous settings globally.
Under section 28(3) of the Act you have the right to ask the Ombudsman to
review any decisions made under this request. The Ombudsman may be
contacted by email at: [email address] or by calling 0800 802
602.
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [email address]
------------------------------------------------------------------------
From: Mark Bailey <[FOI #15780 email]>
Sent: Wednesday, 16 June 2021 16:47
To: OIA Requests <[email address]>
Subject: Re: Official Information request - "Clinical" sensitivity and
specificity for the detection of SARS-CoV-2.
Dear OIA Requests,
I have been sent a link that provides 12,657 results that appear to have
been generated from someone simply entering "covid 19 laboratory
diagnosis" into the PubMed search engine. This does not provide any
evidence that "The clinical sensitivity and specificity of assays for the
detection of SARS-CoV-2 in COVID-19 infected individuals has been
determined in numerous settings globally". In addition I am concerned that
the person providing the link does not understand that clinical
(diagnostic) sensitivity and specificity relates to the condition
"COVID-19" not "the detection of SARS-CoV-2".
The Ministry of Health's website also conflates analytical and diagnostic
aspects of PCR test when it states: "A recent laboratory study found that
different COVID-19 testing kits correctly detected COVID-19 in samples
more than 95% (and frequently 100%) of the time."
[1]https://www.health.govt.nz/our-work/dise...
There is nowhere on the Ministry's site which demonstrates how the
clinical accuracy of the PCR tests have been established.
I'm well aware of scientific databases such as PubMed and again I request
that the Ministry provide one specific research publication leading them
to determine the diagnostic sensitivity and specificity of the PCR tests
they are relying on for diagnosing the condition "COVID-19".
Yours sincerely,
Dr Mark Bailey
-----Original Message-----
Kia ora Mark,
Thank you for your email. To provide further explanation:
The analytical sensitivity and specificity of assays used in New Zealand
diagnostic laboratories have been determined by the laboratories and/or
the manufacturers.
The clinical sensitivity and specificity of assays for the detection of
SARS-CoV-2 in COVID-19 infected individuals has been determined in
numerous settings globally.
The Ministry of Health does not conduct any studies or research regarding
this. There are many individual studies and several systematic reviews
available for your reference on this topic. Further information can be
found at the following link:
[1]https://pubmed.ncbi.nlm.nih.gov/?term=co...
Under section 28(3) of the Act you have the right to ask the Ombudsman to
review any decisions made under this request. The Ombudsman may be
contacted by email at: [email address] or by calling 0800 802
602.
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [email address]
--------------------------------------------------------------------------
From: Mark Bailey <[FYI request #15780 email]>
Sent: Monday, 14 June 2021 11:59
To: OIA Requests <[email address]>
Subject: Official Information request - "Clinical" sensitivity and
specificity for the detection of SARS-CoV-2.
Dear Ministry of Health,
On February 24 2021, Dr Kelvin Watson (Group Manager, COVID-19 Testing
and
Supply
COVID-19 Health System Response) made the following statement in response
to a request for official information:
"SARS-CoV-2 RT-PCR testing used in our accredited medical diagnostic
laboratories have undergone rigorous validation for specific performance
characteristics that include analytical and clinical sensitivity and
specificity for the detection of SARS-CoV-2."
[2]https://scanmail.trustwave.com/?c=15517&...
Can you please provide further explanation for this statement.
Analytical
sensitivity and specificity has been established for detecting genetic
sequences purported to come from SARS-CoV-2. However Dr Watson's
statement that the clinical sensitivity and specificity has been
established for SARS-CoV-2 is incorrect. Clinical implies diagnostic,
which relates to a condition. His statement looks like he has conflated
the test with the condition. Or is he claiming that the diagnostic
sensitivity and specificity of the tests for the condition "COVID-19"
have
been established? If so, can you please provide the scientific paper(s)
where this was established.
The guidelines and terminology relating to performing and analysing
RT-PCR
are outlined in "The MIQE Guidelines: Minimum Information for Publication
of Quantitative Real-Time PCR Experiments" state:
"Analytical sensitivity refers to the minimum number of copies in a
sample
that can be measured accurately with an assay, whereas clinical
sensitivity is the percentage of individuals with a given disorder whom
the assay identifies as positive for that condition."
"Analytical specificity refers to the qPCR assay detecting the
appropriate
target sequence rather than other, nonspecific targets also present in a
sample. Diagnostic specificity is the percentage of individuals without a
given condition whom the assay identifies as negative for that
condition."
[3]https://scanmail.trustwave.com/?c=15517&...
Yours faithfully,
Dr Mark Bailey
-------------------------------------------------------------------
This is an Official Information request made via the FYI website.
Please use this email address for all replies to this request:
[FYI request #15780 email]
Is [Ministry of Health request email] the wrong address for Official
Information requests
to Ministry of Health? If so, please contact us using this form:
[4]https://scanmail.trustwave.com/?c=15517&...
Disclaimer: This message and any reply that you make will be published on
the internet. Our privacy and copyright policies:
[5]https://scanmail.trustwave.com/?c=15517&...
If you find this service useful as an Official Information officer,
please
ask your web manager to link to us from your organisation's OIA or LGOIMA
page.
This e-mail message has been scanned for Viruses and Content and cleared
by the Ministry of Health's Content and Virus Filtering Gateway
--------------------------------------------------------------------------
References
Visible links
1.
[2]https://scanmail.trustwave.com/?c=15517&...
2.
[3]https://scanmail.trustwave.com/?c=15517&...
3.
[4]https://scanmail.trustwave.com/?c=15517&...
4.
[5]https://scanmail.trustwave.com/?c=15517&...
5.
[6]https://scanmail.trustwave.com/?c=15517&...
-------------------------------------------------------------------
Please use this email address for all replies to this request:
[FOI #15780 email]
Disclaimer: This message and any reply that you make will be published on
the internet. Our privacy and copyright policies:
[7]https://scanmail.trustwave.com/?c=15517&...
If you find this service useful as an Official Information officer, please
ask your web manager to link to us from your organisation's OIA or LGOIMA
page.
-------------------------------------------------------------------
****************************************************************************
Statement of confidentiality: This e-mail message and any accompanying
attachments may contain information that is IN-CONFIDENCE and subject to
legal privilege.
If you are not the intended recipient, do not read, use, disseminate,
distribute or copy this message or attachments.
If you have received this message in error, please notify the sender
immediately and delete this message.
****************************************************************************
--------------------------------------------------------------------------
This e-mail message has been scanned for Viruses and Content and cleared
by the Ministry of Health's Content and Virus Filtering Gateway
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References
Visible links
1. https://www.health.govt.nz/our-work/dise...
2. https://scanmail.trustwave.com/?c=15517&...
3. https://scanmail.trustwave.com/?c=15517&...
4. https://scanmail.trustwave.com/?c=15517&...
5. https://scanmail.trustwave.com/?c=15517&...
6. https://scanmail.trustwave.com/?c=15517&...
7. https://scanmail.trustwave.com/?c=15517&...
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Athina Andonatou left an annotation ()
Great line of questioning. Interested if anything came of it? And if not, at least now there is a paper trail record of what can only be described as wilful ignorance.
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Mark Bailey left an annotation ()
Complaint made to the Ombudsman 18/6/2021
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