133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T+64 4 496 2000
Virginia Crawford
By email:
[FYI request #14341 email]
Ref:
H202100581
Dear Virginia Crawford
Response to your request for official information Thank you for your request under the Official Information Act 1982 (the Act) to the Ministry of Health
(the Ministry) on 1 February 2021.
I will respond to each part of your request in turn.
Could you please direct me to the document that stipulates this (40 Ct), as my understanding
is that the number of cycles can be anything from 20 onwards, with a MAXIMUM of 40, not
that it SHOULD be 40.
The Ministry does not hold a document that stipulates COVID-19 tests should run for 40 cycles. As a
result, this part of your request is refused under section 18(e) of the Act.
I can confirm that PCR assays for all COVID-19 tests run for 40 cycles in IANZ accredited New
Zealand laboratories. This is stipulated by the manufacturer instructions who have performed
extensive validation and verification of their assay and is built into the analyser software utilised to
perform testing
Further to my request above, I would like to draw your attention to the PCR handbook:
https://scanmail.trustwave.com/?c=15517&d=7N2M4E37OifIgUaV1imqp5PfDBk_HAMO24F4
nn1R_w&u=https%3a%2f%2fwww%2egene-quantification%2ede%2freal-time-pcr-handbook-
life-technologies-update-flr%2epdf If you look at page 25, you will see at the bottom of the
page, the following: "For Research Use Only. Not for use in diagnostic procedures.” Should
the PCR process be used for testing Covid-19?
The statement “For Research Use Only. Not for use in diagnostic procedures.” applies to assays and
procedures undergoing development and are used for research purposes only, as the performance
characteristics of the assay or product has not yet been established for diagnostic purposes. 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.
I trust this information fulfils your request. 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.
Please note that this response, with your personal details removed, may be published on the Ministry
website at:
www.health.govt.nz/about-ministry/information-releases/responses-official-information-
act-requests. Yours sincerely
Dr Kelvin Watson
Group Manager, COVID-19 Testing and Supply
COVID-19 Health System Response
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