Tuesday 12 October 2021

Further, on taking tests

On Monday, I managed to get a submission in on the Government's awful proposal to give itself the power to requisition tests and testing materials. Was a bit of a rush job, but it's a bit of a rushed legislative process. I hadn't known about it much before a hasty blog post on it on Friday

The submission alludes to a few problems in giving the Ministry of Health authority to set quality standards for testing, which the legislation also does, in addition to letting the Ministry take Rako's tests. 

My column at Newsroom, written after the submission, also goes through the problems. Currently gated. [Update: ungated]

A snippet:

If the Government wanted more testing capacity, it could have contracted for that capacity. And it still could. But over the past year, the ministry has repeatedly rebuffed Rako’s offers to provide testing. The Ministry of Health also told Rako not to maintain any extra testing capacity for the Government as its services would not be needed.

Shifting from a view that Rako’s testing was not needed, to that they are so necessary that they could warrant requisitioning, seems somewhat incoherent.

Once the Government has the ability not only to requisition materials away from prudent labs, paying only some deemed market value for the effectively stolen supplies, but also the ability to force those labs to ignore existing contracts and to provide testing for the State instead, bad things happen.

Existing clients would see the obvious threat to the security of their continued ability to undertake testing. That makes contracts less valuable. Labs can purchase sufficient supplies to tide them through shortages and international shipping delays. They cannot purchase sufficient supplies to ensure that they have enough left in the event that the Government decides to requisition all of the testing materials or all of the testing capacity.

And if the biggest thief in Wellington, whose offers are impossible to refuse, sees your prudential stockpile of testing materials as tempting, what incentive do labs have to maintain those stockpiles in the first place? After all, the Government could well instead decide to requisition someone else’s supplies on your behalf, come the crisis.

When all is done, we have a Ministry of Health that, after spending most of the past year seemingly doing its best to thwart Rako Science’s provision of accurate saliva-based, PCR Covid testing, and after telling Rako that its services would not be required for the public health effort, is now preparing simply to take Rako’s testing capacity through requisitioning powers. While saying it hopes not to need to use such powers.

It is not right. It will have repercussions for security of contracting and investing in New Zealand. And it will hinder the Covid response.

Dileepa Fonseca provides further very helpful detail in a piece today at Stuff. It's truly a must read, spectacular scoop. Leaked ESR test validation details, Ministry insider comments on the debacles. 

Here's how it starts. It goes on at length, and only gets worse for the Ministry.

A leaked study into saliva testing shows the Ministry of Health is still trying to figure out how accurate various types of saliva tests are as the Delta strain starts to take hold in Auckland.

The first stated objective of the leaked Institute of Environmental Science and Research (ESR) study is to compare different PCR saliva testing methods used on border workers by Asia Pacific Healthcare Group (APHG) and its partner laboratories.

However, it is the second objective of the ESR study that has people like Yale school of public health saliva testing expert Anne Wyllie worried.

That objective is “to generate clinical sample testing validation data from Covid-19 volunteers for the testing laboratories as requested by IANZ [International Accreditation New Zealand]”.

Wyllie was leaked the data by concerned scientists, and says there are no circumstances under which data gleamed through the study should be used to validate saliva tests.

“This is a preliminary, exploratory study. If APHG is basing their clinical diagnostic claims off of this – this is not at all robust or reliable, and not true validation.”

A spokesman for APHG wouldn’t comment on whether the data from this study had been used for validation purposes, or as part of their previous public statements on the accuracy of their saliva tests.

“We are not interested in commenting further on clinical validation except to say that our labs have had our work on that recognised by IANZ.”


“Why is there no clarity in the data that was used for validation? Why no clarity on which tests are being used for saliva? Why all the secrecy,” Wyllie says.

“Every lab in the US has to tell all its patients which test it is testing with and all that data is publicly available.”

The Ministry of Health argues testing validation data is the property of private laboratories and there is no requirement such results be published.

The Ministry of Health set the RFP for saliva-based PCR testing. 

The Ministry of Health could easily have set a requirement that any provider have a validated test, or get its test validated, and provide all data from that validation. 

The Ministry of Health chose not to do that. 

And then the Ministry of Health says "Oh, well that data is property of the labs so we can't ask for it." 

The Ministry of Health absolutely should not be able to set standards on Covid testing. 

Dileepa continues:

The authenticity of the documents, which were published just last month, have been confirmed by a senior Government official, who claims the whole saliva testing roll-out has been mismanaged by Ministry of Health officials right from the start. The official has requested anonymity.

All of this is part of a long-running saga with Rako Science, which was the first to achieve diagnostic validation for their saliva test, but was passed over for a $60m border worker saliva testing contract in favour of Asia Pacific Healthcare Group, which hadn’t been similarly validated at the time.

“They’ve got themselves into a situation with Rako [Science] and I don’t think they know how to manage their way out of it,” the official says.

An IANZ spokesman said it would normally assess things like Covid-19 tests against a fixed set of international standards, however these standards had been modified by the Ministry of Health’s clinical advisory teams.

”We do not set the accreditation criteria, we simply assess the labs against the criteria that are provided to us.

“Because of the rapidly changing nature of the Covid-19 testing environment, these criteria have been informed/modified by MOH clinical advisory teams composed of experts.”

And on the Ministry's competence in setting standards:

The Covid response bill before Parliament will allow the Ministry of Health to requisition testing supplies, and unilaterally set standards, something a senior government official says is equally worrying.

An official who spoke to Stuff sees the new law as dangerous because of the lack of understanding about this type of testing within the Ministry of Health itself.

“There just seems to be so many individual commercial interests now ... it’s hard to find somebody who is not conflicted.”

The official believes ministry officials didn’t understand what they were procuring when the saliva testing contract went out to tender. That meant officials focused on more easy-to-understand issues like the number of collection points available.

“It’s unconscious incompetence. It’s the people at the Ministry of Health in charge of a large procurement programme,” the official says. 

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