CDC withdraw request to FDA for Emergency use authorisation of RT-PCR tests
Miriam Lakua made this Official Information request to Ministry of Health
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From: Miriam Lakua
Dear Ministry of Health,
After December 31, 2021, CDC will withdraw the request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, the assay first introduced in February 2020 for detection of SARS-CoV-2 only. CDC is providing this advance notice for clinical laboratories to have adequate time to select and implement one of the many FDA-authorized alternatives.
Link - https://www.cdc.gov/csels/dls/locs/2021/...
My questions for MOH is - were you aware and what date were you made aware of this change?
Yours faithfully,
Miriam Lakua
From: OIA Requests
Kia ora Miriam,
Thank you for your email. Your query has been passed onto the COVID-19
response team for a response.
You can expect a reply from the team directly in due course.
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [email address]
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From: COVID-19 Response
Kia ora Miriam,
Thank you for getting in touch with the Ministry of Health with your
query, and apologies for our delayed response. We are working through
large volumes of queries at present but we do appreciate your patience.
The Ministry of Health's testing team were first made aware of this on 27
July 2021. This withdrawal is for the CDC PCR diagnostic panel that as
first introduced under the FDA Emergency Use Authorisation. The NZ
diagnostic labs have all transitioned to using other assays, over the last
year. This withdrawal does not impact the PCR testing undertaken by NZ
diagnostic laboratory.
We hope that this information is helpful for you and wish you all the
best.
Ngâ mihi nui
COVID-19 Response and Co-ordination Team
Ministry of Health
Do your bit to keep New Zealand COVID free; practice good hygiene
(includes washing your hands often and coughing into your
elbow), sign into places using the NZ COVID Tracer app, if you’re
unwell stay home and get tested.
show quoted sections
This is an Official Information request made via the FYI website.
Please use this email address for all replies to this request:
[FOI #16454 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:
[2]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:
[3]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.
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References
Visible links
1. https://scanmail.trustwave.com/?c=15517&...
2. https://scanmail.trustwave.com/?c=15517&...
3. https://scanmail.trustwave.com/?c=15517&...
From: Miriam Lakua
Dear COVID-19 Response,
Thank you, please list the other assays you have transitioned to over the last year.
Yours sincerely,
Miriam Lakua
From: COVID-19 Response
Kia Ora,
Thank you for your email to the Ministry of Health COVID Response Team.
We are currently experiencing high volumes of enquiries and apologise for
any delays getting back to you.
If this is an emergency and you or some else’s life is in danger please
call 111.
If you have an urgent medical query please call your usual healthcare
provider or Healthline on 0800 611 116 or for COVID-19 related queries
0800 358 5453.
Our standard business hours are 8:00am to 6:00pm Monday - Friday.
This inbox is monitored for urgent queries over the weekend.
Thank you for your patience.
COVID-19 Health System Response
Ministry of Health
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From: COVID-19 Response
Kia ora Miriam,
Thank you for your further correspondence to the Ministry of Health, and
apologies for our delayed response. We are working through large volumes
of queries at present but we do appreciate your patience.
We have forwarded your query below onto the relevant teams and are still
waiting for a response, but we will endeavour to get in touch with you
again as soon as we have the information needed to answer your question.
We appreciate your continued patience in the meantime.
Ngā mihi nui
COVID-19 Response and Co-ordination Team
Ministry of Health
Do your bit to keep New Zealand COVID free; practice good hygiene
(includes washing your hands often and coughing into your
elbow), sign into places using the NZ COVID Tracer app, if you’re
unwell stay home and get tested.
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From: Miriam Lakua <[FOI #16454 email]>
Sent: Thursday, 7 October 2021 6:27 AM
To: COVID-19 Response <[email address]>
Subject: Re: EMIS 21947 Official Information request - CDC withdraw
request to FDA for Emergency use authorisation of RT-PCR tests
Dear COVID-19 Response,
Thank you, please list the other assays you have transitioned to over the
last year.
Yours sincerely,
Miriam Lakua
show quoted sections
From: COVID-19 Response
Kia ora Miriam,
Thank you for your patience while we awaited information from other team
to assist in answering your query, we do apologise for the delay.
Our testing team have advised that the following assays and targets are
currently used:
Assays
Abbott
AusDx Resp Path C
AusDx SARS/inf/RSV
BD
Cobas SARS-CoV-2
Dnature Multiplex
Drosten
GeneXpert
GeneXper/Flu/RSV assay
LightMix E.gene
LightMix RDRP
Panther Fusion
Perkin Elmer
Thermofisher Taqpath
VIRSeek Ident2
VIRSeek Mplex
VIRSeek Screen
Targets
Orf1a
Orf8
E
N
N1
N2
Orf
RdRP
S
We hope that this information is helpful for you, and wish you all the
best.
Ngā mihi nui
COVID-19 Response and Co-ordination Team
Ministry of Health
Do your bit to keep New Zealand COVID free; practice good hygiene
(includes washing your hands often and coughing into your
elbow), sign into places using the NZ COVID Tracer app, if you’re
unwell stay home and get tested.
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From: COVID-19 Response <[email address]>
Sent: Tuesday, 16 November 2021 2:48 PM
To: Miriam Lakua <[FOI #16454 email]>
Subject: Re: EMIS 21947 Official Information request - CDC withdraw
request to FDA for Emergency use authorisation of RT-PCR tests
Kia ora Miriam,
Thank you for your further correspondence to the Ministry of Health, and
apologies for our delayed response. We are working through large volumes
of queries at present but we do appreciate your patience.
We have forwarded your query below onto the relevant teams and are still
waiting for a response, but we will endeavour to get in touch with you
again as soon as we have the information needed to answer your question.
We appreciate your continued patience in the meantime.
Ngā mihi nui
COVID-19 Response and Co-ordination Team
Ministry of Health
Do your bit to keep New Zealand COVID free; practice good hygiene
(includes washing your hands often and coughing into your
elbow), sign into places using the NZ COVID Tracer app, if you’re
unwell stay home and get tested.
--------------------------------------------------------------------------
From: Miriam Lakua <[FOI #16454 email]>
Sent: Thursday, 7 October 2021 6:27 AM
To: COVID-19 Response <[email address]>
Subject: Re: EMIS 21947 Official Information request - CDC withdraw
request to FDA for Emergency use authorisation of RT-PCR tests
Dear COVID-19 Response,
Thank you, please list the other assays you have transitioned to over the
last year.
Yours sincerely,
Miriam Lakua
show quoted sections
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