The saliva testing stoush between Rako Science and the Ministry of Health

Friday, 20 August 2021

Covid-19 measures like vaccine certificates and testing will become the “new norm” for travel, Otte says.

“About 30 days ago we noticed the Delta variant, that came out of India, was spreading rapidly throughout Europe and the United States,” Rako Science executive director Leon Grice says.

His audience is biting into canapés at The Cloud on Auckland’s waterfront just before Lisa Carrington takes to the water at the Tokyo Olympics on the big screen. The event is being held to celebrate Rako’s efforts in getting the NZ Olympic team tested for Covid-19 as per pre-departure requirements, but Grice’s message is more about the future of New Zealand’s fight with Covid-19.

“The rate of increase in some of these countries far surpassed the rate of increase in previous variants that were driving the surges.”

He tells his audience vaccinating people with the measles vaccine can protect the unvaccinated with herd immunity, but with the delta variant this may not be possible.

* Covid-19: Only 386 saliva tests carried out on quarantine staff since January

There are different methods of saliva collection with very different results for each type.

* Covid-19: 17 new cases of virus in managed isolation, 12 from India flight

* Covid-19: Saliva tests may have a place at the border, but not in the community

It is increasingly looking like the vaccines can bring deaths and hospitalisations right down, but are less effective at making sure you don’t pass Covid-19 on to others.

Covid-19 Response Minister Chris Hipkins explained that saliva testing will be offered as part of routine testing at the border from June.

He argues this means the only way to truly protect everyone might be a combination of both vaccines and testing, in effect, “rings” of regular testing around our border workers and others to find cases early, protect those members of the public for whom the vaccines just won’t work.

A week later at a Wellington café that imagery of protective rings has morphed into a “perimeter”, but this time the issue is more immediate, a potential breach at the ports where unvaccinated workers may have been exposed to Covid-19.

At that stage, just last week, Covid-19 Response Minister Chris Hipkins revealed 44 per cent of approximately 1000 port workers had not received a single jab of the vaccine, causing a surge of panic.

Grice says we can’t test frequently because nasal swabs are so invasive, and take longer to process. He argues a system of frequent saliva testing could allow us to isolate cases at the border earlier, even before we find out about an accidental breach of Covid-19 protocols.

Anne Wyllie says New Zealand should be aiming for testing capacity of 100,000 PCR tests per day.

Just over a week later hundreds, if not thousands, of people were queueing up for Covid-19 tests with lines snaking around the block in Auckland, ten hour wait-times just to get swabbed, and perhaps even some people deciding they would rather stay home, skip the fuss, and not bother.

Grice is an advocate for saliva testing, a type of testing which is becoming more widespread around the world, if only because the alternative is too painful to do regularly enough to stay on top of increasingly virulent strains of Covid-19.

The test largely involves drooling into a spoon then tipping your saliva into a tiny container, it doesn’t necessarily need qualified medical professionals to administer the way someone sticking a nasal swab through your nose does.

A Royal College of Pathologists of Australia survey conducted in June found New Zealanders were 20 percentage points less likely to take Covid-19 tests than our Australian counterparts. A majority of New Zealanders surveyed, 64 percent, actively chose not to get tested even though they had cold and flu symptoms.

Covid-19 response minister Chris Hipkins too is no fan of Covid-19 nasal swabs: “Having had a nasal swab I know it’s not a hugely pleasant experience,” he told a press conference in May, “Those who are doing it frequently, and regularly, I think we all owe a great thanks to.'

The science behind it has been around for nearly a year. Anne Wyllie, a New Zealand scientist at Yale University found saliva testing could be just as effective as the more painful nasal swab kind, and potentially better at early detection. The working theory is the virus may form in the saliva glands first before making its way to the back of the throat.

Domestically there have been a growing chorus of calls to start using it. The Simpson Roche report into a Covid-19 outbreak last year, delivered to the Government in late September, advises “all efforts should be made to introduce saliva testing as soon as possible”, and by December Grice’s company Rako Science was emailing the Ministry of Health (MOH) to tell them they intended to start saliva testing in January.

MOH’s tender process for saliva testing started in March. The original tender documents indicated it wanted a company to be able to roll out saliva testing by the middle of April.

Needless to say, things didn’t quite go according to plan.

Instead, the Ministry of Health group manager Covid-19 testing and supply Darryl Carpenter tells Stuff via a written statement that a “phased roll-out” of saliva testing actually started on August 11.

“The Ministry of Health’s team are working closely with PCBUs [Persons Conducting Business or Undertaking] and border agencies to support them through the process to make saliva testing available over the coming weeks.”

There have been growing calls for more Covid-19 testing options.

That means saliva testing, something which should be old news, is actually new news. The story of why is a year-long saga between MOH, an established pathology provider who actually won the contract, and a company which just doesn’t seem to want to shut up about saliva testing.

The Gold Standard

Associate professor for Victoria University of Wellington’s school of biological sciences Janet Pitman says saliva testing can produce comparably accurate results which are just as good as those you get from a nasal swab, although she acknowledges the public perceives otherwise.

She says the misunderstanding has largely been driven by politicians and officials confused by the wide variety of saliva testing methods out there.

“The problem with saliva testing is that there’s so many tests on the market, and they all vary, and some of them are really, really good and some of them are not so good.

Rako Science’s test came out of a University of Illinois study for saliva testing, called the covidSHIELD. It is different from the one associated with Wyllie’s work at Yale, but the two methods use similar principles.

Grice says they got into the saliva testing business through their research relationship with the University of Illinois after noticing the distinct advantage saliva testing offered: early detection.

Nasal swabs are thought to be better at picking up Covid-19 infections in their later stages.

The University of Illinois conducted 2.3m tests on 46,000 people and nearly 7000 of them tested positive for Covid-19. Of these, the covidSHIELD test identified 85 per cent of them before they became infectious.

To bring the process over to New Zealand, Grice says, Rako knew it would need to get the test diagnostically validated, validated using real-world samples of Covid-19. The test was validated by Pitman, who compared test results from saliva and nasal swabs imported from the United States.

Both tests were similarly accurate, with the saliva test detecting an early infection that wasn’t detected in the nasal swab and with the saliva test failing to detect a late-stage infection that was picked up in the nasal swab sample.

When Rako attempted to bring its test to the attention of the ministry, it was met with a lukewarm reception, then called in for a presentation in February.

Rako Science’s chief science officer Stephen Grice says the scepticism expressed by MOH officials at their February meeting was understandable, because every good scientist is a sceptic, but turned his attention to making the case at the government tender stage where the Government was looking for someone to administer a $60m saliva-based surveillance testing contract for its border workforce.

Procurement within ministries is tough for smaller firms, especially when it comes to new ideas. The information technology sector in particular has expressed its frustration with risk-averse procurement managers who pick recognised brand names over less well known firms.

At the end of the February tender a much more well-established provider was chosen over Rako Science, the Asia Pacific Healthcare Group, a respected company that conducts much of the pathology testing in New Zealand.

Except in this instance they didn’t actually have a diagnostically validated saliva test.

Instead of importing or using real-world samples of Covid-19 APHG would check a test using samples of saliva artificially “spiked” with Covid-19, which Carpenter says means the test has 'technical validation” rather than diagnostic validation.

“Technical validation which confirms that, analytically, the tests used work to detect Covid-19 has been completed for all the saliva tests in use in the Asia Pacific Health Group laboratories,” Carpenter says.

This is something both Pitman and the two Grices have a big problem with. They argue the only way to check a test really works in the real world is to test it against real world samples.

Yet despite their objections APHG was awarded the contract, sparking a public war of words which only escalated after official information act requests revealed officials had questioned the accuracy of Rako’s saliva testing methods without giving them a chance to respond.

The two sides declared something of a truce last month with a statement where the ministry accepted many of Rako’s claims around the effectiveness of its test, although the statement makes it clear this is an acceptance of the company’s claims, not an endorsement of Rako Science.

Stephen Grice says at the very least the ministry should simply have set a standard for testing and created a panel of potential firms able to deliver to it.

Since the tender was awarded, New Zealand’s saliva testing roll-out has fallen further and further behind that original schedule.

Leon Grice says an accurate saliva test is not just about the test itself, but your whole procedure around it, including how you collect the samples and treat them. Rako just had a head start in figuring it out and overseas links to a university that is a leader in it.

The “secret sauce” in Rako’s procedure is one used to heat the saliva samples in a water bath for 30 minutes at 95 degrees celsius.

This does three things, first, it renders the virus harmless – which makes the samples easier to hand, second, it denatures enzymes in saliva that might interfere with the polymerase chain reaction (PCR) test used on saliva, and third, it cracks open the virus and makes the RNA available for PCR machines, which takes out a time-consuming RNA extraction process.

All of this combined allows a much faster test turnaround time. Some of the big users of this test are people flying out to Europe, where people often need a valid PCR test result 48 hours before they enter a European country.

With Rako’s test they can take a test in the morning, and get their test result in the afternoon just in time for their flight.

“We’ve always wanted to be part of the solution, and we didn’t have to be part of the main solution,” Leon Grice says.