PCR testing efficacy and veracity

Sue Grey made this Official Information request to Chris Hipkins

Response to this request is long overdue. By law Chris Hipkins should have responded by now (details and exceptions). You can complain to the Ombudsman.

From: Sue Grey

Dear Chris Hipkins,

Please could you provide copies of all information held by you or on your behalf (eg by Min Health or any advisor) information about the PCR test for Covid including:
A) it's efficacy, veracity and reliability;
B) the genetic sequence that the covid PCR test identifies and the source of this material
C) the sequenced genetic code for SARs-Cov2 / the causative agent of covid-19 - including any variations for different strains
D) the sequenced genetic code for influenza virus
E) the sequence of mRNA used in the Pfizer and any other mRNA Vax that are being considered for use in NZ
F) Any analysis of the reliability or otherwise of PCR testing for Covid 19
G) Any analysis of whether the PCR test will or may give a positive result for those exposed to any of the proposed Covid vaccinations
H) assessment of any other criteria used or considered for assessing reliability of PCR Covid testing for identifying Covid 19 and/ or distinguishing it from other infectious agents or artificially created substances including assessment against established medical protocols such as Koch's postulates
I) Any other information to show how reliably the PCR test protocol used in NZ identifies the disease known as Covid 19 and any factors which may affect reliability.

Being in mind the heavy reliance on PCR testing by NZ government including for important policy decisions and decisions which affect freedoms of NZers, please could you provide this information urgently.

Thank you

Sue Grey LLB( Hons). BSc( Biochemistry & Microbiology) RSHDipPHI

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From: C Hipkins (MIN)
Chris Hipkins

Thank you for your email.

 

Please accept this as acknowledgement that your email has been received by
my office.

 

You can refer to the following websites for more information about
COVID-19 including managed isolation.

 

·       For information on COVID-19, including the latest updates, go
to [1]covid19.govt.nz

·       For information on managed isolation, including exemptions from
managed isolation, go to [2]miq.govt.nz

·       You can Healthline free on 0800 611 116 for health advice and
information

 

Where can people go for help?

 

Anyone with queries about changes to international flights returning to
New Zealand should email [3][email address] with a copy of their
original flight ticket and their voucher, and details of the new flight
number. This email is monitored 24/7.

 

You can also submit an enquiry via the [4]MIQ website.

 

We appreciate your patience. 

 

Thanks again.

Authorised by Chris Hipkins MP, Parliament Buildings, Wellington

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References

Visible links
1. https://covid19.govt.nz/
2. https://www.miq.govt.nz/
3. mailto:[email address]
4. https://www.miq.govt.nz/about/contact-us/

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Brian Sandle left an annotation ()

For anyone who missed it the WHO have made a statement in January on testing, indicating a lot should be redone:
WHO Information Notice for IVD Users 2020/05
Nucleic acid testing (NAT) technologies that use polymerase chain reaction (PCR) for detection of SARS-CoV-2
20 January 2021 Medical product alert Geneva
Product type: Nucleic acid testing (NAT) technologies that use polymerase chain reaction (PCR) for detection of SARS-CoV-2

Date: 13 January 2021

WHO-identifier: 2020/5, version 2

Target audience: laboratory professionals and users of IVDs.

Purpose of this notice: clarify information previously provided by WHO. This notice supersedes WHO Information Notice for In Vitro Diagnostic Medical Device (IVD) Users 2020/05 version 1, issued 14 December 2020.

Description of the problem: WHO requests users to follow the instructions for use (IFU) when interpreting results for specimens tested using PCR methodology.

Users of IVDs must read and follow the IFU carefully to determine if manual adjustment of the PCR positivity threshold is recommended by the manufacturer.

WHO guidance Diagnostic testing for SARS-CoV-2 states that careful interpretation of weak positive results is needed (1). The cycle threshold (Ct) needed to detect virus is inversely proportional to the patient’s viral load. Where test results do not correspond with the clinical presentation, a new specimen should be taken and retested using the same or different NAT technology.

WHO reminds IVD users that disease prevalence alters the predictive value of test results; as disease prevalence decreases, the risk of false positive increases (2). This means that the probability that a person who has a positive result (SARS-CoV-2 detected) is truly infected with SARS-CoV-2 decreases as prevalence decreases, irrespective of the claimed specificity.

Most PCR assays are indicated as an aid for diagnosis, therefore, health care providers must consider any result in combination with timing of sampling, specimen type, assay specifics, clinical observations, patient history, confirmed status of any contacts, and epidemiological information.

Actions to be taken by IVD users:

Please read carefully the IFU in its entirety.
Contact your local representative if there is any aspect of the IFU that is unclear to you.
Check the IFU for each incoming consignment to detect any changes to the IFU.
Provide the Ct value in the report to the requesting health care provider.
Contact person for further information:

Anita SANDS, Regulation and Prequalification, World Health Organization, e-mail: rapidalert@who.int

References:

1. Diagnostic testing for SARS-CoV-2. Geneva: World Health Organization; 2020, WHO reference number WHO/2019-nCoV/laboratory/2020.6.

2. Altman DG, Bland JM. Diagnostic tests 2: Predictive values. BMJ. 1994 Jul 9;309(6947):102. doi: 10.1136/bmj.309.6947.102.
https://www.who.int/news/item/20-01-2021...

https://www.who.int/news/item/20-01-2021...

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