2.3 Procurement, development and distribution of testing technologies

Te hoko, te whakawhanake me te tohatoha o ngā hangarau whakamātautau

2.3.1 Introduction | Kupu whakataki

In this chapter we consider key decisions that affected the ability of private organisations to acquire, develop or distribute testing tools and technologies during 2021 and 2022. We do not consider the procurement, development or distribution of non-pharmaceutical materials and tracing technologies (such as masks, PPE or the NZ COVID Tracer app). As mentioned in Part 1, the most significant decisions about these topics were made and implemented before the period under review in Phase Two; they were addressed in the Phase One report. ⁵⁹³

2.3.2 Testing technologies | Hangarau whakamātautau

 
Polymerase Chain Reaction (PCR) tests were the first form of test available in New Zealand and were the most accurate. They require swabs taken from the upper part of the throat behind the nose. PCR tests need to be administered by health professionals and processed in laboratories.

Rapid Antigen Tests (RATs) are a less accurate alternative to PCR tests and were widely used overseas to test for COVID-19 from early in the pandemic. They offer convenience and speed by providing for point-of-care testing and giving results within 15 minutes.

Other forms of tests emerged during the course of the pandemic, including portable rapid PCR tests and loop-mediated isothermal amplification (LAMP) point-of-care tests. These generally had high accuracy but were more expensive than RATs and some required technical expertise to use correctly.

2.3.3 New Zealand's experience with COVID-19 testing | Te wheako o Aotearoa ki te whakamātautau KOWHEORI-19

 
Testing had been a vital component of the Government's pandemic response since early 2020 and was critical to the process of identifying and managing outbreaks. For much of 2021, New Zealand relied almost solely on PCR testing technology, as it was widely agreed to be the most accurate. The requirement for professionals to swab and process tests automatically limited the capacity of the testing system, which struggled to manage demand during outbreaks. Long queues – sometimes lasting many hours – were not uncommon at testing stations during outbreaks, ⁵⁹⁴ and there could be delays in getting results. The need to travel to testing sites for swabs also made it hard for some groups and individuals to access tests.⁵⁹⁵

In April 2020, the New Zealand Government (through Medsafe) had banned the importation, supply and use of RATs in New Zealand, because health experts advised that a successful elimination strategy needed highly accurate tests. They were also concerned about the poor quality of some RAT kits available overseas.

When the Government decided to replace the elimination strategy with a suppression and mitigation approach, it created scope for a different approach to testing, where convenience and speed became more important. Accuracy diminished in importance.

During this period, there was high pressure on the PCR testing system due to the Delta outbreak. For example, testing at the Auckland boundary was reduced in mid-November 2021 because of the 'increased demand this is placing on laboratories.⁵⁹⁶ Capacity constraints led to processing 'backlogs and delays, compromising early outbreak containment.⁵⁹⁷

At the same time, there was growing demand – particularly from firms – for access to alternative testing technologies such as RATs, so that they could protect their staff and customers and ensure service continuity.⁵⁹⁸ Yet access to these tests remained tightly controlled until early 2022. Some firms managed to acquire RATs ahead of formal exemptions, only to receive orders from the Ministry of Health to cease using them and destroy any remaining tests.⁵⁹⁹ One firm we engaged with reported being offered RATs by a credible international provider who would later supply them for New Zealand's community testing response. The firm had to reluctantly decline the offer.

The Ministry of Health sought to boost PCR testing capacity in late 2021. However, the official PCR testing system was ultimately overwhelmed in early 2022, following the arrival of Omicron. The average time to process samples grew from 13 hours on 23 January 2022 to 143 hours on 4 March 2022.⁶⁰⁰ Auckland exceeded its testing capacity limits in February. An internal Ministry of Health briefing on 20 February 2022 noted that the region had experienced a 'range of between 20–25k PCR samples per day last week, with only 15k PCR test capacity per day, leaving a daily accumulation of up to 10k per day backlog.⁶⁰¹ By 27 February, 82,000 tests nationwide were outstanding by more than 48 hours.⁶⁰² The national laboratory network ultimately decided not to process 32,000 samples more than five days old because of their diminishing clinical viability.⁶⁰³

Following a Government decision on 24 February 2022, RATs became the 'primary COVID-19 testing diagnostic tool for most of the population.⁶⁰⁴ All remaining restrictions on the import, manufacture, supply, sale, packing or use of exempted tests were removed the same day.⁶⁰⁵ Even after RATs had been exempted from the ban and were authorised for use, the country's testing problems were not over. Long queues for supplies of RATs formed in some places.⁶⁰⁶ Some ran out of RATs completely.⁶⁰⁷ Supplies offered through private retailers also came under pressure, with some stores limiting the numbers of tests individuals could buy,⁶⁰⁸ others running out,⁶⁰⁹ and some charging high prices.⁶¹⁰ However, these pressures eased as orders placed earlier began to arrive in the country.

The Inquiry's Phase One report found that 'limited forward planning and flexibility caused problems…such as the shift in COVID-19 testing from PCR to RAT tests.⁶¹¹

2.3.4 The Government's key decisions: when, why and how they were made | Ngā whakatau matua a te Kāwanatanga: te wā, te take, me te āhua i whakatauria ai

 
The Government took a number of decisions affecting testing technologies over the period of our review. Our Terms of Reference require us to focus on decisions that have 'a potential or actual significant impact on large numbers of people' and on the 'impact of private sector involvement or non-involvement.⁶¹² We have therefore focused on the decisions that we assessed as being significant for the private sector's involvement – in particular, its ability to access and use testing technologies.

Table 6: Key decisions on testing technologies
Date	Decision	Decision maker
9 April 2021	Extending the ban on the importation, manufacture, supply, sale, packing and use of COVID-19 point-of-care tests	Minister for COVID-19 Response
11 November 2021	Moving from the sole use of Polymerase Chain Reaction (PCR) testing to a graduated introduction of Rapid Antigen Tests (RATs)	Associate Minister of Health
Between 20 August 2021 and 22 September 2022	Authorising rapid antigen tests for community and private use	Director-General of Health
20 January 2022	Approving businesses to directly import approved point-of-care tests	Director-General of Health

 

2.3.4.1 Extending the ban on COVID-19 point-of-care tests | Te whakawhānui i te aukati mō ngā whakamātautau 
KOWHEORI-19 ā-wāhi-maimoa

 
On 9 April 2021, Hon. Chris Hipkins as the Minister for COVID-19 Response made an Order extending the ban on the importation, manufacture, supply, sale, packing and use of COVID-19 point-of-care tests. The Order defined such tests as those that tested individuals for COVID-19 infection or immunity and produced a result without analysis at a laboratory.

The Order was made under section 11 of the COVID-19 Public Health Response Act 2020. Medsafe had made the original ban in April 2020 under section 37 of the Medicines Act for a maximum period of one year. But as the Medicines Act did not provide for the ban to be renewed, the Minister made the April 2021 Order under the COVID-19 Response Act .

Before deciding to extend the ban, the Ministetherefore received advice from the Ministry of Health via three briefings. The first, on 28 January 2021, sought agreement to:

• continue the prohibition on the 'importation, manufacture, supply, sale or use of antigen and antibody POC [point-of-care] tests under the COVID-19 Public Health Response Act (the COVID-19 Act)'
• prohibit the 'importation, manufacture, supply, sale or use of molecular and other types of POC tests under the COVID-19 Act' and
• ensure 'acceptable POC tests (including antigen, antibody and molecular) can be approved in certain circumstances (eg, labs)⁶¹³

In the second briefing, the Ministry sought agreement to consult on a draft Order with the Prime Minister, Minister of Health and Minister of Justice as required under the COVID-19 Public Health Response Act 2020.⁶¹⁴ A further briefing on 9 April provided a final version of the Order for the Minister to sign.⁶¹⁵ The Minister accepted all the Ministry of Health's advice, and the Order came into force on 22 April 2021.

In the briefings, officials expressed concern that the absence of continued controls would undermine the elimination strategy, by allowing 'low-quality, inaccurate or counterfeit POC [point-of-care] kits … [to enter] New Zealand.⁶¹⁶ Inaccurate tests would mislead patients and the public, and could increase risky behaviours, accelerating COVID-19 outbreaks and spread. Such tests would also undermine the highly accurate PCR testing system and would compromise processes for recording test results and tracing contacts. This would make detection and management of positive cases difficult in the public health system.⁶¹⁷

The officials' advice focused primarily on managing risks to the elimination strategy. It also considered ensuring effective and equitable access to testing, and te Tiriti o Waitangi considerations. They examined other ways to achieve these outcomes (such as relying on the Medicines Act 1981 and consumer protection laws). However, officials did not consider these options would be likely to achieve the intended objectives. A section 11 Order under the COVID-19 Public Health Response Act 2020 was therefore the preferred option. They advised that such an Order would maintain confidence in the reliability and accuracy of New Zealand's COVID-19 test results, while retaining the ability to approve point-of-care tests as the technology improved. An Order would integrate easily into the national public health system, while being consistent with the New Zealand Bill of Rights Act 1990, they noted. An Order was not time-bound but could be regularly reviewed.⁶¹⁸

Although the Order made explicit provision for the Director-General to exempt from the ban any point-of-care tests that were assessed as being 'sufficiently accurate and reliable',⁶¹⁹ no action was taken to begin approving tests until August 2021 and a structured framework and process for evaluating tests was not developed until November 2021 (section 2.3.4.3).

2.3.4.2 Moving from sole use of PCR testing to introducing RATs | Te neke atu i te whakamahi takitahi i ngā whakamātautau PCR ki te whakaurunga o ngā RAT

 
On 11 November 2021, the Associate Minister of Health agreed to the Ministry starting a 'phased roll-out of rapid antigen testing'. Three months earlier, Cabinet had already decided to move to risk-based border settings and (between 27 September and 18 October 2021) to adopt the COVID-19 Protection Framework. Over the same period, the Ministry of Health and other parties had trialled RATs in selected environments, including some hospitals and businesses.⁶²⁰

On this basis, the Ministry sought approval on 5 November to roll out RATs in three phases, starting with pilots (Phase 1), followed by high-risk healthcare settings and then a wider rollout to agencies and business (Phase 2), and finally community use (Phase 3).⁶²¹ The Associate Minister accepted the Ministry's advice but wanted faster action on the rollout of RATs to the community, especially isolated communities with low vaccination rates. The Minister also asked the Ministry to keep exploring the option of rapid PCR testing, because its higher sensitivity made it potentially more useful than RATs in some health and aged residential care settings.⁶²² The Minister for COVID-19 Response, responding to advice the Ministry gave on 18 November 2021, reiterated the need for a clear timeframe for the rollout of RATs.⁶²³

2.3.4.3 Authorising RATs for community and private use | Te whakamana i ngā RAT mō te whakamahi ā-hāpori, ā-tūmataiti hoki

 
This series of decisions aimed to ensure quality RATs were available in sufficient volumes to meet anticipated demand. This required exempting sufficiently accurate tests from the April 2021 ban.

This process was carried out between 20 August 2021 and 22 September 2022, with the Director-General of Health authorising 25 specified RATs for community use.

To help determine which RATs should be authorised, Government established the COVID-19 Testing Technical Advisory Group in August 2021 to 'provide rapid, independent, and practical advice to the Director-General of Health on testing technologies and paradigms, to inform New Zealand's COVID-19 response and the work to reconnect Aotearoa New Zealand to the world.'⁶²⁴ The Group first endorsed an evaluation framework for deciding which tests should be exempted from the ban (prepared by the Ministry of Health's National Laboratory Testing Team) on 12 November 2021,⁶²⁵ then a second version on 20 January 2022.⁶²⁶ Subsequent versions of the framework – prepared by the Group Manager Testing and Supply, and the Manager Science & Technical Advisory at the Public Health Agency – were approved by the Director-General of Health on 15 February 2022 and 16 September 2022.⁶²⁷

The evaluation framework's overarching objective was to ensure that 'any test approved to use in New Zealand is of high quality and consistently provides reliable results and aligned to the public health response efforts.⁶²⁸ Decision-makers therefore needed to approve tests that had high degrees of sensitivity (ability to correctly identify those with the disease) and specificity (ability to correctly identify those without the disease) and shelf lives longer than 12 months.

The first version of the framework required applicants to provide evidence of independent validation studies showing 80 percent sensitivity and 97 percent specificity; approvals or authorisations from at least two recognised international agencies; and acceptable quality standards for source, manufacture, storage and stability.⁶²⁹ Other decision-making considerations included how readily test results could be integrated into existing information technology infrastructure or data reporting systems; ease of use; costs, benefits and savings; and equity and te Tiriti o Waitangi implications.⁶³⁰ Later versions, recognising constraints in the international supply market, reduced the requirement for evidence of approval or authorisation to one international agency, and extended the list of recognised agencies.⁶³¹ The second revision (February 2022) strengthened the requirement for evidence demonstrating quality standards; refined criteria for assessing equity, Treaty considerations and clinical performance; and removed the cost-benefit analysis test.⁶³² It also provided for a resubmission process,⁶³³ and for limited scope authorisation (valid for only six months) for testing solutions in the early stage of development.⁶³⁴

Between August 2021 and September 2022, the evaluation framework informed the decisions made by the Director-General of Health (or the Acting Director-General) to exempt specified tests from the point-of-care test ban. They acted on the advice of the Ministry of Health's Group Manager Testing and Supply and, from July 2022, the Public Health Agency; both had used the framework in developing their advice. Generally, exemption decisions were made promptly once advice became available. However, the process of evaluating tests and developing advice was time- and resource-intensive. This was, in part, due to the design of the evaluation system. Unlike regulators in other jurisdictions, the Ministry of Health did not limit who could apply for an exemption to import or use a certain test.⁶³⁵ As a result, about 600 applications were received, the vast majority before March 2022.⁶³⁶ These included applications for tests developed by New Zealand firms.⁶³⁷ An independent review of the early 2022 backlog in processing PCR tests noted a 'significant and growing backlog of applications' to approve RATs.⁶³⁸

2.3.4.4 Allowing businesses to directly import approved point-of-care tests | Te whakaaetanga kia kawemai tikatia e ngā pakihi ngā whakamātautau ā-wāhi maimoa kua whakamanatia

 
On 20 January 2022, the Director-General of Health agreed to allow a range of organisations, including all New Zealand-based businesses with a New Zealand Business Number, to import approved point-of-care tests themselves.⁶³⁹ These organisations had been permitted to purchase approved tests from 14 December 2021, but only from six authorised medical suppliers. However, advice to the Director-General on 18 January 2022 noted that many smaller companies had 'been unable to access rapid antigen tests, as the larger authorised importing companies have not wanted to deal with them'⁶⁴⁰ The Ministry was also concerned that requiring organisations to only purchase tests through authorised suppliers could be interpreted as 'supporting anti-competitive practices.⁶⁴¹

Although businesses were able to access rapid antigen tests earlier than the general public, they entered the global market at the same time that many governments (including New Zealand's) were attempting to procure large volumes of RATs for community use. Competition for tests was stiff and, on more than on occasion, Ministry of Health officials asked suppliers to prioritise orders for New Zealand's public health response.⁶⁴² This led to accusations in the media that the New Zealand Government had 'commandeered' orders for tests made earlier by the private sector.⁶⁴³ However, these accusations were later found to be inaccurate, when medical suppliers confirmed that they had fulfilled purchases in the order they had been placed and that the Government's purchases had not impacted other customers.⁶⁴⁴

2.3.5 Our assessment of key decisions | Tā mātou aromatawai i ngā whakatau matua

2.3.5.1 Decision-makers were well-informed on technical matters, but not on longer-run consequences or choices | I mārama pai ngā kaiwhakatau ki ngā take hangarau, engari kāore rātou i tino mōhio ki ngā pānga o te wā roa

 
On one level, the decisions to extend the ban on the importation, manufacture, supply, sale, packaging and use of COVID-19 point-of-care tests, and to authorise suitably accurate point-of-care tests for community use, were well-supported by evidence. The policy of retaining PCR as New Zealand's main testing technology was consistent with local and international advice. Experts, including from the World Health Organization, had identified PCR as the 'gold standard' for COVID-19 testing.⁶⁴⁵ The decisions to authorise the use of specific point-of-care tests were also informed by robust and thorough technical advice.

Yet we found little indication in the evidence we gathered that decision-makers or advisors gave much consideration in advance to the testing strategies and technologies that should be used in the post-elimination strategy environment. The move to allow RATs was taken late and was driven primarily by Cabinet's decision to exit the elimination strategy. As Dr Ian Town, the Ministry of Health's Chief Science Advisor, told us, the 'Ministry took a strongly precautionary approach and so planning for an exit strategy was triggered mainly by politicians rather than officials.⁶⁴⁶ Implementation of subsequent testing policy decisions took place in an environment of considerable stress, as officials and Ministers sought to contain the Delta outbreak and prepare for the shift to the COVID-19 Protection Framework.

2.3.5.2 Officials and other commentators foresaw significant adverse consequences of key testing decisions  | I matapae ngā āpiha me ētahi atu kaitātari ka puta he pānga kino nui i ngā whakatau matua whakamātautau

 
Officials and others foresaw the significant adverse consequences that could arise from the Government's key testing decisions – such as insufficient testing capacity in peak periods and barriers to entry for innovative testing technologies.

In the early stages of New Zealand's pandemic response, the Office of the Prime Minister's Chief Science Advisor presciently highlighted the difficult trade-offs Government faced in determining its approach to testing: act early and risk expending valuable resources on poorly-performing technologies or delay decisions and risk 'missing out'.⁶⁴⁷ The Office recommended active engagement with the rapidly developing '"Point-of-care" (POC) lateral flow diagnostic space for virus antigen and patient antibody' and observed that decisions about procurement could be 'separated from adoption decisions to preserve optionality'.⁶⁴⁸

Others commissioned to advise the Government urged it to add technologies to New Zealand's testing toolkit more quickly and flagged concerns about slow progress. For example, in September 2020, a review of the Government's surveillance plan and testing strategy led by Sir Brian Roche and Heather Simpson noted the many 'testing and surveillance tools being developed internationally' and said New Zealand should be 'open to incorporating a range of methods into a comprehensive surveillance strategy.⁶⁴⁹

More than a year later, the COVID-19 Testing Technical Advisory Group reviewed the Government's testing approach. The Group's October 2021 report noted New Zealand's 'relative slowness to introduce saliva testing and to prepare for rapid antigen testing' and concluded there was a 'pressing need to ensure that COVID-19 testing is adaptable and fit for purpose.⁶⁵⁰

The COVID-19 Independent Continuous Review, Improvement and Advice Group – established in March 2021 to provide 'independent advice on policy and operational aspects of the Elimination Strategy⁶⁵¹ – made similar comments throughout 2021 and early 2022. It regularly raised concerns about inadequate planning, insufficient attention paid to innovation and slow progress in implementing alternatives to nasopharyngeal PCR tests.⁶⁵²

Voices from outside the public sector also called for greater use of testing and wider access to technologies. Dr Eric Crampton of the New Zealand Initiative, for instance, called for daily saliva-based PCR testing of border workers in February 2021.⁶⁵³ Six months later, he urged the Government to lift the ban on RATs and procure them in large numbers,⁶⁵⁴ while also building PCR testing capacity as a matter of urgency.⁶⁵⁵ The Whānau Ora Commissioning Agency asked the Government in February 2021 to supply RATs in order to 'rapidly identify those in the community with greater need' while preventing 'testing surges from overwhelming diagnostic PCR testing capacity.⁶⁵⁶ Sir Ian Taylor – founder of Animation Research Limited and a prominent advocate for innovation in testing – repeatedly criticised the Government's resistance to alternative testing technologies, which he argued could support both economic recovery and public health goals.⁶⁵⁷

By August 2021, Ministry of Health officials were aware that outbreaks could swamp the PCR testing system, and that greater use of RATs could ease the pressure. In advice to the Director-General on 20 August, seeking approval to import three types of RATs for further evaluation, officials pointed out that using RATs for surveillance testing of specific workforce groups (such as health workers) could reduce the risk of an outbreak overwhelming the PCR testing system.⁶⁵⁸ Similarly, a member of the COVID-19 Testing Technical Advisory Group observed in early September 2021 that 'relying on one type of laboratory test will increase the likelihood of failure and diversity of testing is preferred.⁶⁵⁹

As the Ministry of Health worked on the Government's three-phase strategy for introducing RATs, its Testing and Supply Group recommended that the intermediate phase be as short as possible, or discarded altogether.⁶⁶⁰ This would have sped up the shift to the use of RATs as the primary testing tool. But the Group's advice was not followed, and an independent review of the 2022 backlog of PCR tests found that the duration set for Phase 2 was too long to maintain PCR testing capacity.⁶⁶¹

2.3.5.3 Decisions reflected the advice that was given | I hāngai ngā whakatau i ngā tohutohu i tukuna

 
Although ministers sometimes urged officials to move faster on testing policy and implementation, decisions reflected the advice that was offered by officials.

2.3.5.4 Decisions could have taken more account of experience and practice from comparable jurisdictions | I āhei pea ngā kaiwhakatau te aro nui ake ki ngā wheako me ngā tikanga whakahaere o ngā mana whakahaere ōrite

 
Experience in other countries shows that New Zealand could have used RATs earlier. The World Health Organization issued interim guidance in September 2020 on the use of RATs to diagnose SARS-CoV-2 infection. It emphasised that such tests could be valuable where they offered high performance standards (for sensitivity and specificity) and where PCR-quality tests were unavailable or could not provide timely results.⁶⁶²

Experience in other countries shows that New Zealand could have used RATs earlier.

In many countries, RATs were adopted partly out of necessity. High community transmission was overloading PCR testing services and test results came too late to inform decisions, often with disastrous consequences for COVID-19 case numbers and transmission. Alternatives to PCR tests – most commonly RATs – had been deployed at scale in other countries from early in the pandemic, including in the United States from May 2020,⁶⁶³ and Canada⁶⁶⁴ and the United Kingdom⁶⁶⁵ later that year.

Some jurisdictions which adopted a broadly similar pandemic response to New Zealand (trying to prevent the virus entering and then aiming to stamp out cases when they appeared) were more active and prompt in introducing RATs. Singapore piloted their use in October 2020 to manage outbreaks amongst migrant workers⁶⁶⁶ and they became mandatory for cargo drivers entering the country via checkpoints in January 2021.⁶⁶⁷ From late August 2021, the Singaporean government distributed free RAT packs to every household and to staff and students of pre-schools and schools.⁶⁶⁸ It also made RATs available to eligible individuals through 100 vending machines located across the island in late September 2021.⁶⁶⁹

However, other 'low-COVID' countries, such as South Korea⁶⁷⁰ and Taiwan⁶⁷¹ had a similar experience to New Zealand, only abandoning their reliance on PCR tests during 2022 in the face of high Omicron caseloads. The speed and timing of Australia's introduction of RATs was closest to that of New Zealand. Limited pilots took place in 2021, mainly in the aged care and healthcare sectors,⁶⁷² and people could purchase approved RATs from retail stores from November 2021.⁶⁷³ PCR remained Australia's main testing technology until January 2022, when high volumes overwhelmed capacity and RATs were introduced for community use instead.⁶⁷⁴

2.3.5.5 In lacking enough preparation and strategic agility, decisions did not strike a reasonable balance between public health goals and minimising disruption | Nā te kore whakarite me te kore āheinga rautaki, kāore ngā whakatau i eke ki te taurite tika i waenga i ngā whāinga hauora tūmatanui me te whakaiti i te raruraru

 
Until late 2021, the Government maintained an unwavering commitment to an elimination strategy that relied on PCR tests. This approach, coupled with a lack of planning for alternative future strategies,⁶⁷⁵ delayed decisions on RATs and meant New Zealand entered the market for RATs at a time of high global demand and tough competition for available supplies.

The decisions to retain PCR as the primary testing method and limit access to other technologies were intended to minimise disruption, by ensuring that the public health system used the most accurate tools to test and trace infections. As noted earlier, during this period ministers and officials were very concerned that, without sufficiently robust public health measures in place, New Zealand could experience a large and uncontrollable outbreak of COVID-19. The assumption was that PCR tools were the best to effectively contain outbreaks. Although this was the case for earlier variants, these tools on their own were insufficient to contain Delta and Omicron outbreaks.

In holding on to PCR as long as they did, decision-makers actually increased, rather than minimised, disruption. The lack of alternatives put the public PCR system under immense strain and exposed its fragility during the Delta and Omicron outbreaks. This limited capacity also led some organisations to lose faith in the public testing system. During the Delta outbreak, several Taranaki iwi decided instead to train their own volunteers to administer saliva-based PCR tests that were processed by private provider Rako Science.⁶⁷⁶ This iwi-led initiative helped identify and contain an outbreak at Eltham School on 15 December 2021.⁶⁷⁷ The Taranaki District Health Board paid for these tests after the Ministry of Health declined.⁶⁷⁸

Similarly, Te Whānau o Waipareira partnered with Rako Science in August 2021 to offer saliva-based PCR testing to its workers and community members. This service helped ensure staff did not spread COVID either in the workplace or at home. It also gave a testing option for people (such as those with disabilities and the homeless) who found it difficult to access the public drive-in PCR testing stations.⁶⁷⁹ Some large firms and not-for-profit organisations also paid for private testing services to ensure extra layers of surveillance and protection for their staff, clients and businesses.⁶⁸⁰

Finally, while the framework developed to evaluate point-of-care tests for approval was very thorough and robust, it was too conservative and slow. The open eligibility to apply meant that the Ministry of Health's technical advisors faced large numbers of applications, which led to backlogs. When the Ministry of Health led a review of the approval system in August 2022, it found it was 'largely fit for purpose for self-administered RATs, but not other [point-of-care test] … modalities.⁶⁸¹ In the event, almost all the approved tests were RATs. Only one LAMP test (Lucira) was approved, in March 2022.⁶⁸² Some participants in the review said that the system was inflexible and overly prescriptive. Some also considered that the requirements for approval were unclear and did not account for process or product innovation in point-of-care tests. At the same time, there were delays in processing and approving applications.⁶⁸³ In his interview with us, the Ministry of Health's Chief Science Advisor Dr Ian Town observed that, upon reflection, New Zealand 'could have relied on the Australian assessments of rapid antigen testing technologies to a greater extent.⁶⁸⁴

We therefore concur with the findings made in Phase 1 of the Inquiry that:

[m]ore effective and efficient COVID-19 testing would have been achieved if there had been more pragmatic use of alternatives to PCR tests (alongside PCR testing, when higher accuracy was needed) and earlier planning for the rollout of RAT tests… the benefits of RAT testing should have been seen in advance as outweighing their lower accuracy, and planned for by ordering and stockpiling tests in advance of when they were needed to be deployed.⁶⁸⁵

2.3.6 Summary assessments | Ngā whakarāpopototanga aromatawai

 
Key decisions on testing technologies were well-informed on technical matters, but not on longer-term strategic choices and consequences. In particular, there was not enough attention given in advance to the testing tools and strategies that should be applied following the end of the elimination strategy. Officials and other commentators foresaw problems and consequences arising from the government's conservative approach to the testing technology and strategy and urged changes, but these calls were either not heeded or were picked up too late.

Ministers and senior officials faced difficult trade-offs in balancing the goals of having both accurate and accessible tests. However, decisions could have taken more account of experience and developments in comparable jurisdictions, particularly with regard to the use of rapid antigen tests. Although decision-makers sought to minimise disruption by continuing to prioritise the most accurate testing technologies, this decision actually increased disruption. The PCR testing system was under immense strain, to the point where it was overwhelmed in early 2022 and the slowness in approving alternatives and allowing firms to import tests themselves meant that, in late 2021 and early 2022, some people lacked easy access to a reliable test to help them decide on actions such as self-isolating or returning to work.

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⁵⁹³ NZ Royal Commission of Inquiry into COVID-19 Lessons Learned: Phase One, Main Report (2024), Part 2 Section 5.3, https://www.covid19lessons.royalcommission.nz/reports-lessons-learned/main-report/parttwo/5-3-what-happened-public-health
NZ Royal Commission of Inquiry into COVID-19 Lessons Learned: Phase One Main Report (2024), Part 3 Section 10.1, https://www.covid19lessons.royalcommission.nz/reports-lessons-learned/main-report/partthree-moving-forward/10-1-overview
NZ Royal Commission of Inquiry into COVID-19 Lessons Learned: Phase One Main Report (2024), Part 3, Section 11.1, https://www.covid19lessons.royalcommission.nz/reports-lessons-learned/main-report/partthree-moving-forward/11-1-overview-of-the-recommendations 

⁵⁹⁴ Melanie Earley, Lucy Xia and Sapeer Mayron, 'COVID-19: Long queues at Auckland's testing centres after community cases', Stuff (18 August 2021), https://www.stuff.co.nz/national/health/coronavirus/300385346/covid19-long-queues-at-aucklands-testing-centres-after-community-cases
Charlotte Cook, 'Wellingtonians rush to get Covid-19 tests as region moves to alert level 2', Radio New Zealand (24 June 2021), https://www.rnz.co.nz/news/national/445407/wellingtonians-rush-toget-covid-19-tests-as-region-moves-to-alert-level-2 

⁵⁹⁵ Professor Philip Hill and Dr Debbie Ryan on behalf of the COVID-19 Independent Continuous Review, Improvement and Advice Group, Review of the Auckland February 2021 COVID-19 outbreak and New Zealand's current COVID-19 outbreak response capability (4 June 2021), https://www.dpmc.govt.nz/sites/default/files/2023-01/IAG3-Review-of-the-Auckland-February-2021-COVID-19-Outbreak-and-NewZealands-current-COVID-19-Outbreak-Response-Capability.pdf, p 12

⁵⁹⁶ Ministry of Health, COVID-19 Public Health Risk Assessment for Alert Level Consideration: Delta Outbreak August 2021, Auckland (18 November 2021)

⁵⁹⁷ The COVID-19 Independent Continuous Review, Improvement and Advice Group, Observations from the recent Delta outbreak and their impact on Reconnecting New Zealanders (23 September 2021), https://www.dpmc.govt.nz/sites/default/files/2023-01/DO02-Observations-from-the-Recent-DeltaOutbreak-and-their-Impact-on-Reconnecting-New-Zealanders_23-Sept-2021.pdf, p 6

⁵⁹⁸ Radio New Zealand, 'Coalition of 25 companies want to import 370,000 rapid antigen tests – but need permission' (6 October 2021), https://www.rnz.co.nz/news/business/453032/coalition-of-25-companieswant-to-import-370-000-rapid-antigen-tests-but-need-permission

⁵⁹⁹ NZ Royal Commission of Inquiry into COVID-19 Lessons Learned: Phase Two, engagement with chief executives from port companies across Aotearoa New Zealand (6 May 2025)

⁶⁰⁰ Ministry of Health, COVID-19 PCR testing figures (14 June 2022), https://www.health.govt.nz/system/files/2022-06/proactive_release_-pcr_testing_figures.pdf, Table 3

⁶⁰¹ Ministry of Health, Director-General of Health, Memo: National laboratory network unable to process PCR samples older than 5 days (20 February 2022), https://www.health.govt.nz/system/files/2022-06/dg_memo_final.pdf, p 1

⁶⁰² Allen and Clarke, COVID-19 PCR Testing Backlog: Rapid Review (4 May 2022), https://www.health.govt.nz/system/files/2022-06/pcr_testing_rapid_review_final_-_jr_v2.pdf, p 8

⁶⁰³ Ministry of Health, DG Memorandum: National laboratory network unable to process PCR samples older than 5 days (20 February 2022), https://www.health.govt.nz/system/files/2022-06/dg_memo_final.pdf
Allen and Clarke, COVID-19 PCR Testing Backlog: Rapid Review (4 May 2022), https://www.health.govt.nz/system/files/2022-06/pcr_testing_rapid_review_final_-_jr_v2.pdf, p 8

⁶⁰⁴ Ministry of Health, Memo: National guidance for access to Rapid Antigen Testing (RAT) February 2022 (28 February 2022)

⁶⁰⁵ New Zealand Gazette, Full exemption of certain COVID-19 point-of-care tests under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 (24 February 2022), https://gazette.govt.nz/notice/id/2022-go587

⁶⁰⁶ Jake Kenny, 'COVID-19: "Gobsmacking" queues at Christchurch's RAT collection site', Stuff (3 March 2022), https://www.stuff.co.nz/national/health/coronavirus/127944619/covid19-gobsmacking-queues-at-%20christchurchs-rat-collection-site
1 News, 'Long lines for RATs in Wellington leaves people frustrated' (28 February 2022), https://www.1news.co.nz/2022/02/28/long-lines-for-rats-in-wellington-leaves-people-frustrated/

⁶⁰⁷ Sabihan Hyde, 'Covid-19 Omicron outbreak: Hawke's Bay runs out of 126,000 RATs in 48 hours', Hawkes Bay Today (7 March 2022), https://www.nzherald.co.nz/hawkes-bay-today/news/covid-19-omicronoutbreak-hawkes-bay-runs-out-of-126000-rats-in-48-hours/LOKPUUA6S35B2F5DXE5BKGNAU4/

⁶⁰⁸ Rob Stock, 'Price war beckons as The Warehouse starts selling rapid antigen tests', Stuff (1 March 2022), https://www.stuff.co.nz/business/127925681/price-war-beckons-as-the-warehouse-starts-sellingrapid-%20antigen-tests?rm=a

⁶⁰⁹ Dileepa Fonseka, 'Confessions of a car boot RAT dealer' (5 March 2022), https://www.stuff.co.nz/business/127939700/confessions-of-a-car-boot-rat-dealer

⁶¹⁰ Consumer NZ, 'Consumer NZ finds big price differences on Rapid Antigen Tests for sale' (2 March 2022), https://www.consumer.org.nz/articles/consumer-nz-finds-big-price-differences-on-rapid-antigen-testsfor-sale

⁶¹¹ NZ Royal Commission of Inquiry into COVID-19 Lessons Learned: Phase One, Main Report (2024), Part 2 Section 5.7, https://www.covid19lessons.royalcommission.nz/reports-lessons-learned/main-report/parttwo/5-7-what-we-learned-looking-back

⁶¹² Royal Commission of Inquiry (COVID-19 Lessons) Amendment Order (No 2) 2024, Schedule 2 cl 4, https://www.legislation.govt.nz/regulation/public/2024/0177/latest/LMS984331.html

⁶¹³ Ministry of Health, Briefing: Regulation of COVID-19 Point of Care Testing under COVID-19 Act (28 January 2021), https://www.health.govt.nz/system/files/2022-05/20210098_briefing.pdf, p 1

⁶¹⁴ Ministry of Health, Briefing: COVID-19 Public Health Response (Point-of-Care Tests) Order 2021 for consultation (19 March 2021)

⁶¹⁵ Ministry of Health, Briefing: COVID-19 Public Health Response (Point-of-Care Tests) Order for Signature (9 April 2021)

⁶¹⁶ Ministry of Health, Briefing: Regulation of COVID-19 Point of Care Testing under COVID-19 Act (28 January 2021), https://www.health.govt.nz/system/files/2022-05/20210098_briefing.pdf, p 1

⁶¹⁷ Ministry of Health, Briefing: Regulation of COVID-19 Point of Care Testing under COVID-19 Act (28 January 2021), https://www.health.govt.nz/system/files/2022-05/20210098_briefing.pdf, p 2

⁶¹⁸ Ministry of Health, Briefing: Regulation of COVID-19 Point of Care Testing under COVID-19 Act (28 January 2021), https://www.health.govt.nz/system/files/2022-05/20210098_briefing.pdf, p 7
Indeed, regular review of Orders was a requirement under section 14(5) of the COVID-19 Public Health Response Act: https://legislation.govt.nz/act/public/2020/0012/138.0/LMS344189.html

⁶¹⁹ COVID-19 Public Health Response (Point-of-care Tests) Order 2021, as made, cl 9, https://legislation.govt.nz/regulation/public/2021/0066/7.0/LMS451457.html

⁶²⁰ Comments written by Associate Minister of Health on Ministry of Health, Briefing: Rapid antigen testing: position statement and plan for phased rollout (5 November 2021)

⁶²¹ In practice, the rollout was modified several times so the three eventual phases differ in detail from the original decision.

⁶²² Comments written by Associate Minister of Health on Ministry of Health, Briefing: Rapid antigen testing: position statement and plan for phased rollout (5 November 2021)

⁶²³ Comments written by Minister for COVID-19 Response on Ministry of Health briefing, Report back on four rapid antigen test pilots (18 November 2021), https://www.health.govt.nz/system/files/2022-12/20212476_briefing.pdf, p 5

⁶²⁴ Ministry of Health, Terms of Reference: COVID-19 Testing Technical Advisory Group (25 August 2021), https://fyi.org.nz/request/17035/response/66125/attach/4/H202113614%20Documents.pdf, p 4

⁶²⁵ Ministry of Health, Memo: COVID-19 Point of Care Test Selection Criteria and Evaluation (12 November 2021)

⁶²⁶ Ministry of Health, Memo: Seeking an authorisation to add three rapid antigen tests to the approved list under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 (24 January 2022)

⁶²⁷ Ministry of Health, Memo: COVID-19 Point of Care Test Selection Criteria and Evaluation Version 3.0 (14 February 2022)
Ministry of Health, Memo: Evaluation Framework Criteria for Multiplex Test Devices That Detect SARS-CoV-2 (9 September 2022)

⁶²⁸ Ministry of Health, Memo: Point of Care Test Selection Criteria and Evaluation (12 November 2021)

⁶²⁹ Ministry of Health, Memo: Point of Care Test Selection Criteria and Evaluation (12 November 2021)

⁶³⁰ Ministry of Health, Memo: Point of Care Test Selection Criteria and Evaluation (12 November 2021)

⁶³¹ Ministry of Health, Memo: COVID-19 Point of Care Test Selection Criteria and Evaluation Version 3.0 (14 February 2022)

⁶³² Ministry of Health, Memo: COVID-19 Point of Care Test Selection Criteria and Evaluation Version 3.0 (14 February 2022)

⁶³³ Ministry of Health, Memo: COVID-19 Point of Care Test Selection Criteria and Evaluation Version 3.0 (14 February 2022)

⁶³⁴ Ministry of Health, Memo: COVID-19 Point of Care Test Selection Criteria and Evaluation Version 3.0 (14 February 2022)

⁶³⁵ Ministry of Health, response to production order issued by NZ Royal Commission of Inquiry into COVID-19 Lessons Learned: Phase Two under section 20 of the Inquiries Act 2013 (7 March 2025)

⁶³⁶ Ministry of Health, response to production order issued by NZ Royal Commission of Inquiry into COVID-19 Lessons Learned: Phase Two under section 20 of the Inquiries Act 2013 (7 March 2025)

⁶³⁷ Health New Zealand | Te Whatu Ora, Memo: COVID-19 Point of Care Test application and evaluation of the Liberty 16 and SalivaDirect COVID Detection Kit (Ubiquitome) (12 October 2022)

⁶³⁸ Allen and Clarke, COVID-19 PCR Testing Backlog: Rapid Review (4 May 2022), https://www.health.govt.nz/system/files/2022-06/pcr_testing_rapid_review_final_-_jr_v2.pdf, p 36

⁶³⁹ Ministry of Health, Memo: Seeking an authorisation for expanding import, supply, and distribution under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 (18 January 2022)

⁶⁴⁰ Ministry of Health, Memo: Seeking an authorisation for expanding import, supply, and distribution under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 (18 January 2022)

⁶⁴¹ Ministry of Health, Memo: Seeking an authorisation for expanding import, supply, and distribution under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 (18 January 2022)

⁶⁴² Ministry of Health, Memo: Timeline on rapid antigen testing (8 February 2022)

⁶⁴³ Anneke Smith, Govt 'commandeered' 100k RAT order – company, Radio New Zealand (26 January 2022), https://www.rnz.co.nz/news/political/460254/govt-commandeered-100k-rat-order-company

⁶⁴⁴ Ministry of Health, Memo: Timeline on rapid antigen testing (8 February 2022)

⁶⁴⁵ Office of the Prime Minister's Chief Science Advisor, Rapid Review: Testing for COVID-19 (30 March 2020), https://www.dpmc.govt.nz/sites/default/files/2022-04/PMCSA-20-03_COVID-19-Testing-Landscape-Final.pdf, pp 2, 7
NZ Royal Commission of Inquiry into COVID-19 Lessons Learned: Phase Two, written statement from Dr Ian Town (1 May 2025)

⁶⁴⁶ NZ Royal Commission of Inquiry into COVID-19 Lessons Learned: Phase Two, written statement from Dr Ian Town (1 May 2025)

⁶⁴⁷ Office of the Prime Minister's Chief Science Advisor, Rapid Review: Testing for COVID-19 (30 March 2020), https://www.dpmc.govt.nz/sites/default/files/2022-04/PMCSA-20-03_COVID-19-Testing-Landscape-Final.pdf, p 2

⁶⁴⁸ Office of the Prime Minister's Chief Science Advisor, Rapid Review: Testing for COVID-19 (30 March 2020), https://www.dpmc.govt.nz/sites/default/files/2022-04/PMCSA-20-03_COVID-19-Testing-Landscape-Final.pdf, p 2

⁶⁴⁹ Heather Simpson and Brian Roche, Report of the Advisory Committee to Oversee the Implementation of the New Zealand COVID-19 Surveillance Plan and Testing Strategy (28 September 2020), https://www.dpmc.govt.nz/sites/default/files/2023-01/Final_Report-of-Advisory-Committee-to-Oversee-theImplementation-of-the-....pdf, para 93

⁶⁵⁰ COVID-19 Testing Technical Advisory Group, A Rapid Review of COVID-19 Testing in Aotearoa New Zealand (4 October 2021), https://www.beehive.govt.nz/sites/default/files/2021-10/COVID-19%20Testing%20Rapid%20Review%20Report.pdf, p 2

⁶⁵¹ Cabinet Paper, Ministerial Advisory Group: COVID-19 Independent Continuous Review, Improvement and Advice Group (25 March 2021), https://www.dpmc.govt.nz/sites/default/files/2023-01/IAG1-MinisterialAdvisory-Group-COVID-19-Independent-Continuous-Review-Improvement-and-Advice-Group-CAB-21-MIN-0055.pdf, p 2

⁶⁵² Department of the Prime Minister and Cabinet, Briefing: COVID-19 Independent Continuous Review, Improvement and Advice Group: Feedback on MOH Papers (14 April 2021), https://www.dpmc.govt.nz/sites/default/files/2023-01/DA01-14042021-COVID-19-Independent-Continuous-Review-Improvementand-Advice-Group-CICRIAG-Feedback-on-MOH-Papers.pdf
COVID-19 Independent Continuous Review, Improvement and Advice Group, Observations from the Recent Delta Outbreak and their impact on Reconnecting New Zealanders (23 September 2021), https://www.dpmc.govt.nz/sites/default/files/2023-01/DO02-Observations-from-the-Recent-DeltaOutbreak-and-their-Impact-on-Reconnecting-New-Zealanders_23-Sept-2021.pdf
Department of the Prime Minister and Cabinet, COVID-19 Independent Continuous Review, Improvement and Advice Group Minutes (2 November 2021), https://www.dpmc.govt.nz/sites/default/files/2023-01/COVID-19-Independent-Continuous-Review-Improvement-and-Advice-Group-02112021.pdf, p 2

⁶⁵³ Dr Eric Crampton, 'We are missing the obvious at the border' (16 February 2021), https://www.nzinitiative.org.nz/reports-and-media/opinion/we-are-missing-the-obvious-at-the-border/

⁶⁵⁴ Dr Eric Crampton, 'Ban on antigen COVID testing must end' (31 August 2021), https://www.nzinitiative.org.nz/reports-and-media/opinion/new-opinion-81/

⁶⁵⁵ Dr Eric Crampton, 'Get it done' (20 August 2021), https://www.nzinitiative.org.nz/reports-and-media/opinion/new-opinion-74/

⁶⁵⁶ Whānau Ora Commissioning Agency, Herenga Tāngata: Whānau Ora response to COVID-19 Delta and Omicron (August 2022), https://whanauora.nz/assets/resources/WOCA-Herenga-Tangata-COVID19-DeltaOmicron-Response-Report-0822-Digital-FINAL.pdf, p 46

⁶⁵⁷ Sir Ian Taylor, 'The Covid test offered to NZ last year that we need', Otago Daily Times (1 February 2022), https://www.odt.co.nz/opinion/sir-ian-taylor-covid-test-offered-nz-last-year-we-need

⁶⁵⁸ Ministry of Health, Memo: Seeking urgent authorisation under the COVID-19 Public Health Response Point-of-care Tests Order 2021 for import of point-of-care rapid antigen testing devices (20 August 2021)

⁶⁵⁹ Ministry of Health, COVID-19 Testing Technical Advisory Group Minutes (09 September 2021)

⁶⁶⁰ Allen and Clarke, COVID-19 PCR Testing Backlog: Rapid Review (4 May 2022), https://www.health.govt.nz/system/files/2022-06/pcr_testing_rapid_review_final_-_jr_v2.pdf, p 21

⁶⁶¹ Allen and Clarke, COVID-19 PCR Testing Backlog: Rapid Review (4 May 2022), https://www.health.govt.nz/system/files/2022-06/pcr_testing_rapid_review_final_-_jr_v2.pdf, p 3

⁶⁶² World Health Organization, Antigen-detection in the diagnosis of SARS-CoV-2 infection using rapid immunoassays: Interim guidance (11 September 2020), https://iris.who.int/bitstream/handle/10665/334253/WHO-2019-nCoV-Antigen_Detection-2020.1-eng.pdf, p 2

⁶⁶³ U.S. Food and Drug Administration, 'Coronavirus (COVID-19) update: FDA Authorizes First Antigen Test to Help in the Rapid Detection of the Virus that Causes COVID-19 in Patients' (9 May 2020), https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-antigen-testhelp-rapid-detection-virus-causes

⁶⁶⁴ Public Services and Procurement Canada, 'Government of Canada signs new agreement for COVID-19 rapid tests', (6 October 2020), https://www.canada.ca/en/public-services-procurement/news/2020/10/government-of-canada-signs-new-agreement-for-covid-19-rapid-tests.html

⁶⁶⁵ Medicines and Healthcare products Regulatory Agency, 'MHRA issues exceptional use authorisation for NHS Test and Trace COVID-19 Self-Test device' (23 December 2020), https://www.gov.uk/government/news/mhra-issues-exceptional-use-authorisation-for-nhs-test-and-trace-covid-19-self-test-device

⁶⁶⁶ Calvin Yang, 'Antigen rapid tests piloted for quicker detection of Covid-19 infection among migrant workers', The Straits Times (25 October 2020), https://www.straitstimes.com/singapore/health/antigenrapid-tests-piloted-for-quicker-detection-of-covid-19-infection-among

⁶⁶⁷ Lim Min Zhang, 'Compulsory Covid-19 antigen rapid test to be introduced at Woodlands, Tuas checkpoints from Friday: MTI', The Straits Times, 21 January 2021 (updated 22 January 2021), https://www.straitstimes.com/singapore/compulsory-covid-19-antigen-rapid-test-to-be-introduced-at-woodlands-tuascheckpoints-from

⁶⁶⁸ Johannes Tjendro, 'All households to receive six COVID-19 self-test kits via mail from Aug 28', Channel News Asia (27 August 2021), https://www.channelnewsasia.com/singapore/covid-19-antigen-rapid-testkits-households-pre-schools-primary-schools-moh-2139756
Channel News Asia, 'Distribution of COVID-19 self-test kits to households completed: SingPost' (28 September 2021), https://www.channelnewsasia.com/singapore/covid-19-art-self-test-distributioncomplete-singpost-2206606

⁶⁶⁹ Ministry of Health Singapore, 'Antigen rapid test kits vending machines deployed islandwide and updates to home recovery and travel classifications' (17 September 2021), https://www.moh.gov.sg/newsroom/antigen-rapid-test-kits-vending-machines-deployed-islandwide-and-updates-to-home-recovery-andtravel-classifications_17sep2021

⁶⁷⁰ Channel News Asia, 'South Korea expands rapid testing amid record COVID-19 infections' (3 February 2022), https://www.channelnewsasia.com/asia/covid19-south-korea-expands-rapid-testingrecord-infections-2476936

⁶⁷¹ Hsin Chi, Nan-Chang Chiu, Chung-Chu Chen, Shun-Long Weng, Chi-Hone Lien, Chao-Hsu Lin, Yao-Feng Hu, Wei-Te Lei, Yu-Lin Tai, Liang-Yen Lin, Lawrence Yu-Min Liu, Chien-Yu Lin, 'To PCR or not? The impact of shifting policy from PCR to rapid antigen tests to diagnose COVID-19 during the omicron epidemic: a nationwide surveillance study', Frontiers in public health, Vol.11 (2023), https://doi.org/10.3389/fpubh.2023.1148637

⁶⁷² The Hon Greg Hunt MP, 'Rapid antigen testing to be rolled out in Sydney aged care facilities' (16 August 2021), https://www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/rapid-antigentesting-to-be-rolled-out-in-sydney-aged-care-facilities

⁶⁷³ Melissa Davey, 'Covid rapid antigen tests: how do they work, and can Australians rely on them?, The Guardian (28 October 2021), https://www.theguardian.com/world/2021/oct/29/covid-rapid-antigentests-how-do-they-work-and-can-australians-rely-on-them

⁶⁷⁴ Commonwealth of Australia, Department of the Prime Minister and Cabinet, COVID-19 Response Inquiry Report (Canberra: October 2024), https://www.pmc.gov.au/sites/default/files/resource/download/covid19-response-inquiry-report.pdf, p 209

⁶⁷⁵ NZ Royal Commission of Inquiry into COVID-19 Lessons Learned: Phase One, Main Report (2024), Part 2 Section 2.7, https://www.covid19lessons.royalcommission.nz/reports-lessons-learned/main-report/parttwo/2-7-what-we-learned-looking-back

⁶⁷⁶ Dileepa Fonseka, '"Too little, too late": Allegations Covid-19 testing regime unprepared for Omicron, still weak on much-needed saliva tests', Stuff (21 January 2022), https://www.stuff.co.nz/business/127506084/too-little-too-late-allegations-covid19-testing-regime-unprepared-for-omicron-still-weak-on-muchneededsaliva-tests

⁶⁷⁷ Dileepa Fonseka, '"Too little, too late": Allegations Covid-19 testing regime unprepared for Omicron, still weak on much-needed saliva tests', Stuff (21 January 2022), https://www.stuff.co.nz/business/127506084/too-little-too-late-allegations-covid19-testing-regime-unprepared-for-omicron-still-weak-on-muchneededsaliva-tests

⁶⁷⁸ Dileepa Fonseka, '"Too little, too late": Allegations Covid-19 testing regime unprepared for Omicron, still weak on much-needed saliva tests', Stuff (21 January 2022), https://www.stuff.co.nz/business/127506084/too-little-too-late-allegations-covid19-testing-regime-unprepared-for-omicron-still-weak-on-muchneededsaliva-tests

⁶⁷⁹ Whānau Ora Commissioning Agency, Herenga Tāngata: Whānau Ora response to COVID-19 Delta and Omicron (August 2022), https://whanauora.nz/assets/resources/WOCA-Herenga-Tangata-COVID19-DeltaOmicron-Response-Report-0822-Digital-FINAL.pdf, pp 44–45

⁶⁸⁰ Nikki Mandow, 'The FDA-approved, Kiwi-owned, PCR test technology the Health Ministry wouldn't even look at', Newsroom (10 March 2022), https://newsroom.co.nz/2022/03/10/the-fda-approved-kiwi-ownedpcr-test-technology-the-health-ministry-wouldnt-even-look-at/

⁶⁸¹ Ministry of Health, Briefing: The Future of Point-of-Care Tests Regulation (31 August 2022)

⁶⁸² This was a temporary exemption, to permit Air New Zealand to import and trial the test. Ministry of Health, Memo: Seeking authorisation under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 to grant a temporary exemption for a pilot of the Lucira CHECK-IT COVID-19 Test Kit (21 March 2022). The full exemption was approved on 8 June 2022. New Zealand Gazette, Full Exemption of Certain COVID-19 Point-of-care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 (8 June 2022), https://www.health.govt.nz/system/files/2024-05/lucia-check-it-covid-19-testkit-and-lucira-covid-19-all-in-one-test-kit.pdf

⁶⁸³ Ministry of Health, Briefing: The Future of Point-of-Care Tests Regulation (31 August 2022)

⁶⁸⁴ NZ Royal Commission of Inquiry into COVID-19 Lessons Learned: Phase Two, written statement from Dr Ian Town (1 May 2025)

⁶⁸⁵ NZ Royal Commission of Inquiry into COVID-19 Lessons Learned: Phase One, Main Report (2024), Part 2 Section 5.6, https://www.covid19lessons.royalcommission.nz/reports-lessons-learned/main-report/part-two/5-6-our-assessment