Oireachtas Joint and Select Committees
Wednesday, 9 June 2021
Joint Oireachtas Committee on Transport, Tourism and Sport
Rapid Antigen Testing for Aviation and Travel Sectors: Discussion
Apologies have been received from Senator Craughwell and Deputy Carey.
The purpose of this afternoon's meeting is to discuss rapid antigen testing in relation to aviation and travel. On behalf of the committee, I welcome Dr. Niamh Power, V1 Medical; and Mr. Barry O'Brien, Mr. Simon Osman and Mr. Chris O’Grady, Duelchem Limited. We will also be joined by Dr. Michael Mina, assistant professor of epidemiology, Harvard University.
All witnesses are again reminded of the long-standing parliamentary practice that they should not criticise or make charges against any person, persons or entity by name or in such a way as to make him, her or it identifiable, or otherwise engage in speech that might be regarded as damaging to the good name of the person or entity. If statements are potentially defamatory in respect of an identifiable person or entity, witnesses will be directed to discontinue their remarks. It is imperative that they comply with all such directions. For witnesses attending remotely, outside of the Leinster House campus, there are some limitations to parliamentary privilege. As such, they may not benefit from the same level of immunity from legal proceedings as a witness physically present does. Witnesses participating in this committee session from a jurisdiction outside the State are advised that they should also be mindful of their domestic law and how it may apply to the evidence they give.
Members are reminded of the long-standing parliamentary practice to the effect that they should not comment on, criticise or make charges against a person outside the Houses or an official either by name or in such a way as to make him or her identifiable. I remind members of the constitutional requirement that to participate in public meetings members must be physically present within the confines of the place the Parliament has chosen to sit, namely, Leinster House or the Convention Centre Dublin. Reluctantly, I will not permit a member to participate where he or she is not adhering to this constitutional requirement. Any committee member who attempts to participate from outside of the precincts will, reluctantly, be asked to leave the meeting. In this regard, I ask members participating via Teams to confirm, prior to making their contributions, that they are on the grounds of the Leinster House campus.
For the information of anyone watching this meeting online, Oireachtas Members and witnesses are accessing the meeting remotely, with committee members being in the precincts of Leinster House or the Convention Centre Dublin. Only I, as Chairman, and the staff essential to the running to the meeting are physically present in the committee room. Due to the unprecedented circumstances of Covid-19 and the large number of people attending the meeting remotely, I ask everyone to bear with us should any technical issues arise.
I call on Dr. Niamh Power to make her opening statement.
I call on Dr. Power to make her opening statement. She has approximately five minutes.
Dr. Niamh Power:
I am a graduate of UCD school of medicine, a fellow of the Royal College of Surgeons in Ireland, an airline pilot and a director of V1 Medical. We provide rapid antigen testing at our clinics in Dublin and Cork. Two colleagues and I established V1 Medical in November 2020, as no other facility was offering rapid antigen testing convenient to Dublin Airport, despite many EU countries already accepting antigen testing for travel.
In fact, when the Dutch Government updated its rules on 15 January requiring an antigen test within four hours of departure for every passenger to the Netherlands, including transit passengers, we were still the only company offering rapid antigen testing and were contacted by Dublin Airport Authority, DAA, KLM and Aer Lingus to provide and facilitate their passengers on their flights that day.
We offer a fast and convenient service and a vital service to air and shipping crews and engineering professionals, in particular, who need to travel for essential reasons. Due to unforeseen circumstances, they may need to reschedule or cancel their travel plans at short notice. We have contracts for services with ASL Airlines, Aer Lingus, CityJet, Doyle Shipping Group in Dublin and Cork, Candina Group, as well as several engineering companies. We provide testing with results and certification within 30 minutes using the Roche/SD Biosensor test which is validated by the HSE and on the EU Commission's list of mutually recognised tests.
We have developed robust and efficient procedures to ensure every customer makes his or her flight on time. We provide full flexibility, including refunds up to two hours before appointment time. We accommodate urgent cases, whether it be crews with schedule changes or people who need to travel at short notice due to family illness or bereavement. With more than 60 years of experience in aviation between us, we understand flexibility around travel is key. This is simply not achievable with PCR testing, even without taking into account the much higher cost of PCR.
Ireland is an outlier in the EU and among our most important trading partners with regard to antigen testing. The USA, the UK, Germany, Netherlands, Italy, Poland, Croatia, Bulgaria, Denmark, Norway, Sweden, Czechia, Lithuania, Finland, Luxembourg, Austria and Spain are some of the countries accepting antigen testing for travel. Ireland is the most disconnected country and Dublin the most
disconnected city in Europe, according to Eurocontrol.
As countries across the EU connect with the EU digital Covid certificate and with less than six weeks before Ireland is due to go live on 19 July, we have been unable to obtain any information or guidance on what is required for us to be involved. We want to be prepared, so when the Government is ready to launch this important initiative, we too are ready. Ireland and our aviation, travel and tourism industry cannot afford any further delays. The US and overseas tourist spend is significantly higher than domestic tourist spend, so encouraging staycations will not be enough to save many businesses which depend on foreign tourism.
Our airports, especially Shannon Airport and Cork Airport, are in danger of further losing connectivity. Our slots at Heathrow Airport are not ours - they belong to the International Airlines Group, IAG, which can easily repurpose them for more profitable routes. Dublin Airport, which has been successfully serving as a transatlantic hub for flights from Europe, is already losing these customers to UK bases. Our connectivity with the UK, once among the busiest routes in the world, is suffering because of restrictions within the common travel area, CTA, all on this side of the Irish Sea.
We need to plan urgently for the implementation of the EU digital Covid certificate, including allowing antigen testing for both inbound and outbound travel. There needs to be immediate engagement with private providers who have the experience to deliver the digital Covid-19 certificate to the travelling public.
Mr. Barry O'Brien:
Gabhaim buíochas leis an gCathaoirleach as an gcuireadh. Is mór againn é. Táimid anseo chun réiteach teicneolaíochta agus tástála a mholadh don choiste. I thank the Chairman for the privilege and opportunity to address him and his fellow committee members here today. I wish to convey ten points.
In conjunction with the vaccination programmes and other precautions, we want to help the Irish Government and the Irish people to eradicate the Covid-19 contagion as quickly as possible. This can be achieved through an integrated technology and testing solution based on a combination of practical experience and technological expertise. This system involves a digital platform and a multilayered testing programme which we combine. It has been proven to work in pilot events and can be customised to suit any event, flight or form of travel. All flights, ferry sailings and train journeys should be treated as mini-events and the same basic principles apply to all those activities. This can all be achieved at an economical price in terms of time, effort and money. It can also help to reboot the Irish economy and save the State a significant amount of money both now and in the future. We would like the Irish Government and agencies of the State to avail of this great technological opportunity and to engage with us immediately. Early and full engagement will yield the best results and the most savings.
The findings of ongoing mass testing and reporting are key to controlling the spread of this virus. All such data will be retained in a secure Irish GDPR-compliant cloud platform, but it can be shared with the Irish public health authorities, as appropriate and agreed. This technology affords operational connectivity and compatibility with the EU digital Covid certificate and other international platforms which are deemed appropriate. This solution is absolutely no substitute for social responsibility. Rapid test results and their results are not a licence for personal misbehaviour. Rapid tests are additional tools for informing the further containment and curtailment of infection. This tech and test solution is already activated and ready to go. The software is already fully developed and ready to help schools, businesses, sport and society to get moving again as quickly and safely as possible. Our strategy, processes and technology are all laid out in the submission which has been circulated to members and a brief explanatory video has also been circulated, which helps to explain the process in six simple steps. It is my privilege to head up a team of dedicated professionals. I am delighted to be joined by two members of that team, our pharmaceutical expert, Chris O'Grady and our technology expert, Simon Osman. I ask Mr. O'Grady to say a word also.
Mr. Chris O'Grady:
I am a registered pharmacist and a director of Duelchem Limited. I apologise because my Gaeilge is not as polished as Mr. O'Brien's. Duelchem is an Irish pharmaceutical retail and wholesale company based in County Kilkenny, which was set up in 2008. We have been supplying the Irish healthcare sector with pharmaceutical products for more than a decade. We have a strong working relationship with the HSE, collaborating on multiple projects, with a view to expanding this relationship.
As a pharmaceutical wholesaler, we hold a wholesale distribution authorisation licence which is regulated by the Health Products Regulatory Authority, HPRA. This HPRA regulation obligates us to verify the integrity of our suppliers and the products we distribute and to register with the Irish Medicines Verification Organisation, IMVO. Our regulatory affairs team ensures we are prepared for and comply with legislative changes such as the falsified medicines directive, the recent medicinal devices regulation and the forthcoming May 2022 in vitro diagnostic medical devices regulation.
In response to the pandemic, Duelchem set up reassurance.ie, which operates a number of testing centres to help to identify and ultimately reduce the number of Covid-19 cases. We offer both antigen and PCR tests and publish results, if required, on reporting applications such as healthpassportworldwide.com.
Symptoms have been, to date, the main trigger for self-isolation and Covid-19 testing.
The success of the vaccine programme - the rate of vaccination is estimated to be approximately 50% - does, however, increase the chances of people getting Covid-19 asymptomatically. The absence of symptoms increases the likelihood of Covid-19 spreading within the community because the triggers that we know for self-isolation and testing, such as temperature, loss of taste, flu-like symptoms, etc., are not as prevalent.
Currently, when an individual develops symptoms, he or she self-isolates and contacts his or her GP or the HSE to arrange a PCR test, but 51% to 70% of transmission of Covid-19 happens when no symptoms are present, either pre-symptomatic or asymptomatic. The symptoms usually come from the body's immune response and, therefore, by the time people develop symptoms, they are at their peak viral load or possibly even already past it. By the time they receive the PCR test result in 48 hours to 72 hours, assuming they were symptomatic when they got the test done, they are possibly no longer even transmitting the virus and are no longer infectious or contagious. While the PCR captures the definitive result and initiates contact tracing, antigen tests have a significant role to play in stopping the spread of the virus. The solution we propose today is the use of an antigen self-test in triplicate, with the digital platform to underpin the testing programme. Mr. Osman, our technology expert, will now briefly illustrate the integrated solution.
Mr. Simon Osman:
I am also honoured to be here today to take part in this meeting and represent the technology industry. My background is building technology companies, specifically in the software space, and building applications and infrastructure businesses. More than 12 months ago now, we formed tested.me. The purpose of the company was built on the desire to help companies and individuals work through and recover from the challenges of the pandemic and beyond. We realise that the need for an individual to be able to present a trusted health status using a mobile phone application would be hugely important, alongside a reporting solution and a health information platform. Due to the nature of the information needed, we felt that the mobile application needed to include ID verification in order to create trust, so you go through this process when you download our app. We also give individuals a sense of choice and ownership, so in our app you can see share history, you can choose the level of detail that you want to share, and you can also delete information.
Importantly, the third principle was to make sure that our system was interoperable. As we have gone through the last year, we have found that this aspect is extremely important in terms of building a compliant digital platform. This means that we understand that it is necessary to be able to connect with health platforms, labs, other patient applications, e-commerce systems and booking systems to create that end-to-end solution.
Version 1 of our solution went live in August of last year, with a focus on helping workplaces specifically. Over time, we have developed the product to meet other needs such as travel and the events space. We have had approximately 300,000 active connections on our platform and thousands of test results uploaded daily. The active users are across many countries and we are very proud of the work we have done in schools, workplaces and hospitality. We are now in discussions regarding supporting the travel area specifically, working with the island of Santorini in Greece and also reopening some major events this summer. We also achieved a successful pilot within a main airport in the UK.
Our journey has been an extremely interesting one. I am sure everyone on this call today has experienced an interesting 12 months with the challenges that we faced. As a company we have been called in by the UK Government into many steering committees in terms of the Covid response. We are part of the Digital Healthcare Council in the UK. I have also presented to the Conservative Science & Technology Forum regarding digital identification and digital health passes. We have been working with the NHS in terms of the app and integration. We are HIQA compliant as a company. We are working towards our ISO 27001 certification. We are Cyber Essentials Plus certified, and we also have our own information security management system.
At a global level, we also work within the global health pass and we also sit on the Vaccination Credential Initiative group, which is important in terms of understanding the global standards and the protocols that need to be in place to create this borderless environment again in terms of travel and get society moving. It has been an absolute pleasure to introduce myself. I would like to hand back to the Chairman now for the question and answer session.
I thank Mr. Osman. Dr. Mina will join us at 1.30 p.m. What I propose is two rounds of questions with the current witnesses remaining for the full session. That way we will get best value. Each member will have two opportunities to speak.
I thank the witnesses for their presentations and for the time they spent preparing them. I will get straight into the questions. In terms of scalability, how quickly could Duelchem scale up to service the Irish aviation sector and airports? Is it the technology piece that they do, or do they also do the testing piece? Do they work with partners regarding that?
Dr. Power has a very interesting perspective on the issue, given her background. I am very interested in hearing about her experience. I have a similar question to her in terms of scalability. She outlined the operation she has. If the Government was to say that we are moving to antigen testing in the near future, prior to departure and post arrival, would her firm be in a position to get involved or what sort of scale needs to happen in the meantime?
This question is for Dr. Power as well. There seems to be significant resistance to antigen testing. I want to hear Dr. Power’s perspective on and experience of that. Where does she think it is coming from? Could she speak to the point of affordability and convenience and also the aspect which has arisen in terms of public health? Is there a risk associated with antigen testing, particularly serial antigen testing? Professor Mark Ferguson raised this as a prospect and real opportunity with us on 5 May and the committee raised it with the Government. Could Dr. Power speak to the strength of antigen testing in terms of how it compares with PCR testing?
Mr. Chris O'Grady:
Duelchem is more than equipped to deal with the scalability required for the aviation sector. Our supplier has a lead time of landing product in Ireland for distribution that ranges between seven and 14 days. Our supplier can turn 8 million units in our direction which, hypothetically, is enough to supply each member of the population with two tests a week so scalability is not a concern.
I will hand over to Mr. Osman to speak about the application. We are on the technology side.
Mr. Simon Osman:
There are two things that come to mind immediately in terms of the scalability of the technology. In terms of distribution, our front end application – our mobile application, is available in the App Store and in Google Play, so for android and Apple users it is available right now globally. In the context of scale, it is easy to distribute to the public.
I try not to use too much technological jargon, but the back end of the system, the compute, is managed in the AWS data centre within the Dublin region, so we are already situated within Ireland in terms of data and our systems are all very scaleable platforms.
We work with the likes of Salesforce etc, which is one of the big global players. In terms of scalability and the technology, it is extremely scalable from that perspective. We have done various performance tests up to the millions.
Dr. Niamh Power:
On scalability, all private providers of antigen and PCR testing for travel will need to be brought on board. Looking back at levels of travel from 2019, which would have been the last normal year, approximately 25 million passengers went through Dublin Airport alone. All hands on deck are needed for this.
I understand the idea of self-testing would of course make things much more scalable and convenient. As far as I am aware, however, the European Commission has stated self-testing will not be allowed for the EU digital green certificate. That needs to be worked on. From my own experience of self-testing, our company supervised a self-testing event of 300 airline pilots who are generally clever and well able to follow instructions. There are definitely some issues there with practice. In UK schools, for example, the kids self-test at school three times and then they are allowed to do so at home. There is definitely a learning curve regarding swabbing and the actual processing of the tests. While it is a learning curve, it can be overcome. The European Commission would have to get on board with that.
Regarding resistance to antigen testing, as a medical doctor and having been involved in providing antigen testing for travel, I do not understand why there is such resistance. I do not see any evidence for it. I would like to see the evidence if it exists. Several arguments have been made, one of which is antigen testing will encourage poor behaviour. In fact, the Covid-SMART project in Liverpool in the UK did not support that argument. It is back to the argument of seat belts and condoms that we have had, namely, applying a public health tool will not necessarily encourage poor behaviour.
From the aviation context, the poor behaviour argument is moot. We have very well controlled environment both at airports and in aircraft. Poor behaviour and non-compliance with regulations will not be tolerated. Those passengers will just not be carried. From the behavioural aspect, I do not think that is an issue for travel.
On the sensitivity argument and the public health risk, sensitivity can be improved by proper sampling techniques and use of the testing. For the moment, this will mean that it should be monitored testing as per the EU guidelines. There is a definite role for self-testing for screening purposes for schools, colleges, other forms of transport, workplaces, residential care homes etc. Thousands of leaving certificate students will start their exams today. Many of them will be told, unfortunately, that they cannot sit their exams because they have been designated a close contact. Had we been organised to facilitate those students, they could have taken a rapid antigen test just before going into the exam and then be able to do it. There are many opportunities that we have missed to roll out antigen testing for the good of society.
On sensitivity regarding travel, it has been shown in studies that an antigen test 24 hours before a flight is as good as a PCR test only two hours before. That is a very simple fix. One just requests an antigen test 24 hours before. Professor Mina will have more statistics on this. His studies will show that the real issue with sensitivity is the period of time before a person becomes positive on an antigen test when they are already positive on a PCR test. That is just an eight-hour to 24-hour window. Even a 48-hour antigen test would be as good as a 72-hour PCR test. These can all be overcome and should not be a reason why we should discount antigen testing for travel.
I thank the guests for their continued engagement with the committee. I had the opportunity to meet with Dr. Niamh Power when she visited as part of the Irish Air Line Pilots Association, IALPA, delegation recently.
We are united as a committee at this stage in recognising the importance of antigen testing in terms of getting the free movement of people. Everything the witnesses have provided us with is helpful. My big question concerned capacity and scale but that has already been addressed. My other question is to understand what other countries are doing. Have the witnesses any individual experience of the use of antigen testing, particularly the aviation sector, in other areas with which they are familiar through contacts or experience?
Mr. Simon Osman:
One example is the Bristol Airport project where we worked with a lab. We also worked on the flow of the individual turning up to the flight and getting on it. There was a lateral flow test taken on the morning of the journey to make that happen. Lateral flow testing was part of the process. At the point of go-live for this project on the route to Amsterdam, due to another lockdown, it was cancelled from moving into a full productive environment. The process had been approved at that point. We will be talking with them again in the next few days in terms of where we are with the status of that. There was a moment where there was an agreement that the lateral flow test option was a good one.
The challenge we have with airline travel is the moving target around the guidelines and each country's different regulations. The UK is running a traffic light system, which does not necessarily twin with the system at the other end. It is that common set of guidelines that are now working their way through measures like the good health pass initiative. The ability to interoperate with other platforms will become important.
In the UK, lateral flow has got wide adoption in a number of sectors. We are seeing it in schools. Individuals are now testing twice, maybe three times, a week depending on what setting they are going into. We are seeing it used across the whole sector. We have been working with UEFA and other large organisations around lateral flow testing as part of the solution. As we see the vaccination percentage get to a good number, we will see lateral flow tests filling the space and becoming the day-to-day mitigation and management solution of transmissibility.
We have seen lateral flow testing in most of our proof of concepts that we have been running. It is part of the process. It is important to recognise it is different kind of solution or different products for different use cases. To force things against each other into the same place is where there are clashes. There is a use case for both products.
In terms of the public health solution, we believe the correct model is to look at lateral flow testing on a public health level. In terms of science and accuracy, then one can move to PCR, for example, on a positive test. I am a technologist - I want to make that clear - but that is my experience of what we are seeing in terms of data, the best way to mitigate risk and get things moving again in a safe and secure way.
Dr. Niamh Power:
We are operating out of Dublin and Cork and do not have any experience of airports abroad. As Mr. Osman said, there is a massive difficulty in terms of moving targets, with some countries, such as the Netherlands, changing position overnight. The big advantage antigen testing gives is that we can quickly adapt to those moving targets. For instance, when the Netherlands introduced the requirement for a test four hours before a flight into the country, we were able to accommodate that. People who had turned up at the airport without a test, the wrong test or an out-of-date test were able to come to us, have their antigen test and be back at check-in 20 minutes later with their certificates. That simply cannot happen with PCR testing, whereas the scalability and flexibility are definitely there with antigen testing.
The difficulty I would worry about is that even though antigen testing is very rapid and adaptable, how will it be integrated in terms of uploading the digital green certificate? The concern is that there will be a delay. Will somebody else have to validate the test or will centres be able to validate and upload directly? The beauty of antigen testing is its speed and adaptability. If a centre is deemed eligible by the HSE or the Department of Health to be part of the digital green certificate system, then we should be able to upload directly. If we have to go through a validation process after the tests, it really takes from the beauty, speed and flexibility of antigen testing.
Dr. Niamh Power:
It depends very much on the provider. The tests can be purchased for somewhere between €50 and €60. Some providers are more expensive than others. At the moment, travel is very low-volume. Our centre is open from 3 a.m. to 5 p.m. and we facilitate our regular customers coming in or going out late. In order to be able to cover all those hours, there is a staffing cost. When we get to a stage of high numbers travelling, that cost will possibly come down because we will not have to staff centres that are not being used. At the moment, to be able to deliver the flexibility we want to deliver, we have to be open for those hours.
I am caught on time. I will let Deputy Lowry in because he asked for the witnesses to come before the committee. I am conscious that Professor Mina is joining us at 1.30 p.m. The Deputy has four minutes.
I welcome our guests and thank them for their competent, professional and informative presentation and for sharing their expertise and experience. I emphasise their experience and expertise because I have raised the issue of the use of antigen tests on several occasions in Dáil Éireann. Having raised it with the Taoiseach, the Tánaiste and several Ministers, I came to the conclusion that the political establishment is in favour of the use of antigen testing. In the most recent exchange I had with the Tánaiste, he referred to differing opinions between scientists and public health doctors regarding its use. He also referred to the report by Professor Mark Ferguson, the Government's chief scientific adviser, and indicated that the Government has now formally endorsed his report. In that report, Professor Ferguson sees a very prominent position for antigen testing in our battle against Covid.
I want to raise an issue that has been brought to my attention by members of the public. I firmly believe in the use of antigen testing. It is my understanding that many of the large sporting organisations in this country, including the GAA, IRFU and the soccer authorities, had moved to the stage where they were prepared to go with antigen testing. It is a misnomer to say that the Government is opening up sporting, cultural and entertainment events. That is simply not factual. The numbers allowed into venues under the new protocols are so low as to be meaningless. It really is nonsensical. The administrators of the national organisations had no option other than to go along with the proposals. However, I am very much aware that they are privately very critical of the arrangements. Compliance with these new regulations is massively time-consuming and cumbersome and there is a huge workload involved for very little gain. For the number of people allowed into the venues, the workload is extremely high. We have a situation now where voluntary organisations are giving out a sparse allocation of tickets and that will become a nightmare for officials.
I find it difficult to understand the resistance to antigen testing by the CMO and the National Public Health Emergency Team. It is very baffling and defies all logic. I must say, and I am doing so publicly, that the stubborn obstruction to its use must be questioned. We need to invite the CMO and his team to come before this Oireachtas committee. They must be given the opportunity, in public, to explain their rationale in this matter, justify their decision to disagree with the scientific evidence and explain the reasons they are not accepting Government advice and ignoring the advice of the European Commission. As an island nation, we depend on aviation for connectivity. We have to ask why antigen testing is being deliberately excluded as part of our weaponry in the battle to detect and control the spread of Covid. As far as I am concerned, we, as a committee, have an obligation to demand an answer to that question. I request that the CMO and his officials be brought before us at a very early stage.
It is probably a more attractive view but I will turn the camera around.
Mr. Osman mentioned the sequence of exchanges he has had with the NHS and numerous other agencies in the UK. Have Mr O'Brien and his team had a similar experience here? Has the HSE or any Irish agency reached out to his company for a presentation or information?
Will one of the witnesses address the comparative costs of PCR and antigen testing? We are all very aware that Ireland depends on people being able to travel in and out of the country. The aviation sector depends on that capability. We know there are families who will want to go on holiday as soon as the restrictions are lifted, but they will have to look at the costs of testing. For a family of four, comprising two adults and two children over seven years of age, the cost of PCR testing is absolutely enormous. Antigen testing is much more favourably costed. I ask one of the witnesses to address the cost factor.
For the Deputy's information, we there is an open invitation to the CMO, Dr. Holohan, to come before the committee. It is something we will be taking up again this week. In the context of the discourse around this issue, we need him to come before the committee. It is important to put the facts out there, which is all we want to do.
I will go to Mr. O'Brien first to respond to Deputy Lowry's points.
Mr. Barry O'Brien:
I will deal with the question on costs. Obviously, this is an issue that is very commercially sensitive and subject to negotiations. I can tell the committee that the cost of the construction of the technology has been largely funded outside Ireland. We have a unique opportunity now to bring that technology here. As I said, a lot of the cost of its construction has been incurred elsewhere.
However, there is a cost in maintaining it, maintaining the infrastructure and support that is necessary and customising the application to suit the individual event or flight - the aviation, train or ferry journey, or whatever it is. That can all be done through consultation but Ireland has avoided the heavy investment in the technology because it has been done by others elsewhere.
Second, the critical issue with cost is the volume of the order. The bigger the order and the number that is required, the lower the price will be. There is the issue of available stocks of the approved products, and all of that can be ascertained. As was indicated by Mr. O'Grady, we can access up to 8 million of these tests per week, if needs be, and the cost of that would be greatly reduced by a substantial order. There is then the issue of the timeframe which has to be met and supply chains.
There is also the distribution issue. For example, does the customer want an entity in the private sector, such as Dr. Power’s company or Mr. O'Grady’s company, to distribute it or does the customer want to use a commercial entity that will actually be required to distribute it, or perhaps use the organisation that is involved? I give the example of the GAA in particular. My goodness, there is no better organisation given it is organised on a county and parish basis and can have a prearranged system for distribution of these tests. We can add to that the fact most people nowadays have a smartphone, and the linkage that can be done between the technology and the test is fantastic and can be scaled up immediately.
We try to minimise the manpower that will be required with the technology, and Dr. Power and Mr. O’Grady indicated that trying to keep a clinic open on a day-to-day basis will result in manpower costs, but there are-----
Mr. Simon Osman:
I agree with most of what Mr. O'Brien said in terms of the technology. It is adaptable and customisable but there is time and effort involved. As someone who develops software, time is always our biggest battle. It is not a matter of throwing teams and teams of developers at it because it gets inefficient at a certain scale. Regarding the ability to build platforms and technology, there is an element of that, and the more developers there are, the more that can be done. Equally, however, with a solution that needs to be pulled together and that is compliant between the science, the medical and the technology to develop it, there are lots of points where there are what I would call interfaces, which need to be thought through. From our perspective, that is our advantage. We started developing 13 or 14 months ago, when we saw where this was heading.
In terms of the experience with the NHS, from our perspective, we are interoperating with the NHS as a private company. We are not building the app and, frankly, we have some views about how that application is being put together at the moment. I can only really talk about the cost and, again, I concur with Mr. O'Brien that it depends on frequency and the number of users. That tells people what scale their platform needs to look at from a computing point of view, and then there are all the data sensitivity aspects, storage and making sure that it runs. Then, there is the verification piece. To create digital ID, there is a cross between the individual and the-----
In Ireland, we are very fond of our sport and a lot of people miss being able to engage with sport. The recent measures brought out by the Government create a huge problem for the administrators in voluntary organisations. The question arises as to who gets admitted and who is left outside. Are we saying that people who are fully vaccinated are not entitled to go to a GAA match? Because we are not using antigen, the current system is farcical in my view and it is going to cause friction, rancour, dissension and division within voluntary organisations. It will put officers and officials in an invidious position. The current limitation on attendance means the numbers are paltry and it is especially galling when we know there is an alternative in rapid antigen testing, as outlined to us today.
On a question to Mr. O'Grady, has his company the capability to deal with, for example, 2,000 to 3,000 people attending a local GAA match? How would that process work?
Mr. Chris O'Grady:
I agree 100% with the Deputy. I will talk him through how it would work. If people were to engage with this version of a solution that I will outline, I do not see any reason we could not approach upcoming events like all-Ireland hurling and football finals in August with the expectation of having full stadia. I will give a brief outline of what I am proposing and how it will cater for different organisations, which will have different preferences on the exact details. I will just give a flavour of how it would work.
Individuals would buy a ticket online. They would be instructed to download the relevant app in order to retrieve their purchase ticket. As part of the app download, they would be required to populate in their details. The individual would then be furnished with a self-test pack containing three packs. The app would display a demonstration video which would illustrate technique. The app would also instruct on how to interpret the results and how to upload a verification photo of the result window. As the application is web-based, whatever event co-ordinator is controlling it, be it the GAA, IRFU, FAI or otherwise, would have immediate access to the results and the verification photos in real time. The app would notify or remind the individual three days before the event to perform the first test of the three-pack, to interpret and declare the result in the app and to upload the verification photo. Then, assuming that first test was negative, on the day of the event, the app would notify and remind that individual to perform the second test of the triple-pack, to interpret and declare the result and to upload the verification photo. Assuming that second test is negative, the app would assign a green tick health status. The green tick health status in the app would grant the individual access to the event. The app would then notify or remind the individual five days after the event to perform the third and final test, interpret and declare the result and upload the verification folder.
Obviously, if there is a positive result at any of these stages, that has to be dealt with. For example, if there was a positive result at the first test, which is three days beforehand, this would allow the individual sufficient time to go and get a PCR test, which could confirm or overturn that positive antigen result. If the positive result is confirmed, the individual would be refunded the cost of the ticket in the same way it was purchased. If the positive result is overturned by the PCR test, the results can be uploaded into the app to supersede the antigen test result and grant access to the event. The positive result for the second test, which is on the day of the event, would mean an automatic refund for the individual because there would not be time to go and get a confirmatory test. This is the benefit of having it in triplicate.
If this, or a form of it, was embraced, the number of people in the stadium is irrelevant. If the system is implemented, it works for 500, 5,000 or 100,000. It is the same process. It is just about filtering out contagious people at earlier stages in order to not bring them into the main group.
Mr. Barry O'Brien:
We have written to all appropriate State Departments and agencies. To answer Deputy Lowry's question, apart from getting an acknowledgement of receipt, there has been no approach to us by any Department or agency. Having also discussed this with the sporting organisations, it appears to us that, while they are all very favourably disposed, they do not want to engage in the testing as such. Somebody else has to do the testing but they are favourably disposed to the technology. They also want to deal with the issue of cost. There appears to be a fear in the public sector that the Department of Health's policy is against antigen testing. Consequently, nobody is pursuing these discussions with us or with others. That seems to be the fear.
On the cost, if one is talking about the volumes I have mentioned and getting Croke Park filled as quickly as possible, the cost of these tests drops dramatically to a fraction of what was indicated earlier by Dr. Power and others.
We need to move on to other members but Mr. O'Brien has highlighted an issue the committee is going to take up with the Chief Medical Officer. I will now call on Deputy Ó Murchú, who has four minutes. Once Dr. Mina joins us, I will allow him to speak and we will then roll on with the questioners.
A lot of what I was going to say has already been said. Professor Mark Ferguson came before the committee and gave us his report. We saw this as a possible solution, in combination with the digital green certificate. I accept what is being said with regard to event systems. Dr. Power talked about dealing with the sensitivity difficulties with PCR testing and about testing twice over a 48-hour period. She was obviously talking about something carried out by professionals rather than self-testing. How does she see that working?
Another fear I have relates to the digital green certificate. I believe I already know the answer but have any testing companies been contacted by the State, which has responsibility for putting together a paper version of this certificate or an app? I have a secondary question, which is probably appropriate for Mr. Osman. What he operates could probably form a template for a digital green certificate app, as it is not a vastly different idea. My fear is that, as often happens with Government, there will be a long drawn out procurement process and that the app will not be ready for delivery when it is needed. Perhaps Dr. Power will answer first.
Dr. Niamh Power:
On testing for travel, I did not suggest that we should test twice but that, in order to mitigate the risks arising from the period of time before a person would test positive on an antigen test but in which they would test positive on a PCR test, in other words, the early stage of infection, rather than insisting on a PCR test within 72 hours before a flight, which is now pretty standard in Europe and across the world, we could mitigate the risks by requiring the test to be taken within the 48 hours, or even 24 hours, before a flight. That would solve that issue.
There certainly has not been any contact with private companies. V1 Medical has not been contacted. I spoke to the founder and owner of one of the longest-standing travel medicine clinics in Ireland and this clinic had not been contacted. I have also spoken to someone involved with a company which, although a newer entrant to the market, is one of the larger testing companies providing testing at the airports and this company has also not been contacted.
To quickly go back to Deputy Lowry's last question, V1 Medical was in consultation with one of the major Irish sporting bodies about a test event it was hoping to run in May. This body contacted ourselves and some other test providers. We went through the logistics and set up a digital platform. This was presented to Government but permission was denied. The next event in that sporting series is now to go ahead with no testing and very limited numbers, as Deputy Lowry mentioned.
On the issue of cost, to put it simply, regardless of overheads, manpower and so on, in the last week I was quoted between €95 and €180 for the processing of a PCR test while I can buy a rapid antigen test for less than €5. That is the cost issue we are facing if we really want to push PCR testing as opposed to antigen testing.
The question relates to the green digital certificate. I assume Mr. Osman has a general indication of the information this will provide and so on. He has already talked about the safety and security of the information held on his own app. I assume he would almost have a template app for this certificate. On the wider issue, my fear is that procurement processes and so on could hold up this measure and that the State will not produce what is needed to be ready to go on 19 July.
Mr. Simon Osman:
From my perspective, we are a private company so we can move quickly and be extremely flexible from a commercial perspective. I do not see that holding things up. We built the technology in a customisable way. The rules engine around how it is built is very flexible. It is built for multiple jurisdictions and regions. We could meet some fairly short timelines. From a commercial and legal perspective, it is a private organisation so matters will not be held up by a difficult third-party shareholder.
I thank everybody. I am relatively new to the committee so I did not have the benefit of meeting Professor Mark Ferguson and others who have spoken to the committee at an earlier stage. I thank Mr. O'Grady in particular for explaining the three-phase testing process and so on. One of my questions relating to that is what is there to compel people to do a third test? One obviously needs to do the first and second tests because, if one does not, one will not get a ticket to the event. Having gone to the event and enjoyed it, how can people be compelled to take a third test and to upload the results? People may find out from the last test that they are positive but decide not to tell anybody. Is there anything in the system to address that?
Mr. Chris O'Grady:
The value of the third test, which may not accrue from the others, is that one has the benefit of being able to analyse data post event. This is not something we get from tests carried out prior to an event. The way to obligate people to take this test is, if they buy tickets on the website of the FAI, the GAA or the IRFU, the third test would be the final step of the transaction and would fulfil the requirements of the application. An unfulfilled transaction would disqualify people from purchasing further tickets.
It would be made known to people at the time that the obligation involves a three-step phase. With regard to the value got from the third test, where there is a case relating to an event an asymptomatic attendee would be referred for a PCR test but that would result in earlier isolation, earlier contact tracing and reduced community transmission. It would also reassure the attendee. People are socially responsible and want to know they have not contributed to the problem. They want to know they are clear before they engage with colleagues or family members. They get reassurance some days after the event that they are fine. The event co-ordinator verifies that the event it has run has had no Covid impact. If somebody says there was an outbreak in a certain geographical area, there will be data after the event to show the outbreak was not related to it and could be coincidental. If there are positive results after an event, there is the application to notify anybody who may be affected. The event co-ordinator can notify, through the application, and make people aware that there was a case and that they could be close contacts and should get a HSE confirmatory test. It is just another safety net to catch a case after the event.
On the argument as to the reliability of self-testing, is there a way to ensure an irresponsible person will not go to an event using someone else's test result? Is there a way to check? Will tests be numbered 1, 2 and 3 or have a code that will identify the individual tested? I am trying to work this out. Self-testing is much easier administratively than other forms of testing in that people are not being asked to turn up at a venue and book a time slot. How foolproof is self-testing? I am not Dr. Tony Holohan but I am trying to pre-empt the reasons we are getting such a negative kickback against antigen testing. Can we make it foolproof? Can there be photographic identification? How can it be confirmed that an individual has not got someone else to do his or her test?
Mr. Chris O'Grady:
I will let Mr. Osman give detail of the verification of the tests and how to ensure the results cannot be manipulated. I believe the pushback against the antigen tests is related to the spin about their accuracy by comparison with PCR tests. Regarding the spin about antigen tests being only 60% as accurate as PCR tests, which I have read along with every member of the committee, the detail, while it might be available, is misinterpreted. It is being found that an antigen test and a PCR test cannot be compared. They are two different technologies looking for two different things. The antigen test is looking for protein of the virus whereas the PCR test is looking for the RNA of the virus. The analogy, which ironically is Professor Mina's, is that the PCR test looking for the RNA of the virus is like a detective looking for DNA at a crime scene. More often than not, the crime is over. A PCR test will continue to detect RNA of the virus after people have been infectious and contagious whereas the antigen test will be positive only when the viral load is high and, therefore, when somebody is transmitting the virus. While research shows 71 out of 1,000 people tested positive using PCR whereas only 43 in the same group tested positive using an antigen test – I apologise because the figures are not dead on – that is not to say the antigen test is 40% less accurate; it is to say that the antigen test is testing for contagiousness and for whether the individual's viral load is high enough to mean he or she is transmitting the disease and infecting people. The PCR test, while it has no problem detecting, is actually detecting pre-infectiousness and post-infectiousness. It is not that the antigen test is less accurate but that it is looking for something different. What I have described is the origin of the inaccurate spin.
There is a witness trying to contribute. We are very conscious of time. We have to be out of here by 2.30 p.m. Quite a few members are seeking to participate. The Senator can conclude his questions now if he wishes to do so but I would like Dr. Mina to make his presentation now.
I welcome Dr. Mina to our session. I thank him for taking the time to join us so early in the morning in Boston. He is well known in Ireland in that he has contributed very much to the antigen–PCR debate. Our committee is discussing this. I am aware that Dr. Mina has interacted with Professor Ferguson on his contribution here. What we really want is Dr. Mina's overview on the difference between antigen testing and PCR testing and what he regards to be the role of antigen testing in aviation and, more widely, in the fight against the Covid virus. We will give him five minutes to give us his overview. I thank him for joining us.
I am obliged to read a note on parliamentary privilege. Witnesses are reminded of the long-standing parliamentary practice to the effect that they should not comment on, criticise or make charges against a person or entity by name or in such a way as to make the person or the entity identifiable, or to otherwise engage in speech that might be regarded as damaging to the good name to the person or entity. If the witnesses' statements are potentially defamatory in relation to an identified person or entity, they will be directed to discontinue their remarks. It is imperative that they comply with any such direction.
For witnesses attending the meeting remotely outside of the Leinster House campus, there are some limitations to parliamentary privilege and, as such, they may not benefit from the same level of immunity from legal proceedings as if they were physically present. Witnesses participating in this committee session from a jurisdiction outside the State are advised that they should also be mindful of how their domestic law might apply to the evidence they give.
I thank Dr. Mina for his forbearance. We look forward to his overview.
Dr. Michael Mina:
I have spent the last year or so studying or developing the science on rapid testing, particularly rapid antigen testing. At the beginning of the pandemic, people had not asked how to use testing to really limit spread. That has led to a lot of confusion. I have seen it. There is a lot of confusion in Ireland but it is not just in Ireland; it is also in the United States and every other country. I have been advising governments across the world on this issue.
The biggest issue that I can see people are continuing to have regarding antigen tests concerns the questions of whether they are accurate and how to understand the likes of the Cochrane review, which showed a sensitivity rate in the order of 50%. That needs to be placed in the context of the goal of testing. This is where the biggest questions have arisen. Testing is almost always used in the context of medical practice. That is how we have devised all the metrics we use to evaluate a test but, in the middle of a pandemic, the question of how to use a test is much more about how well the test is limiting the spread and detecting people who are actually infectious. If that is our question, the sensitivity metrics of the rapid antigen tests change dramatically. We have published on this in Science, The New England Journal of Medicineand many more of the world's top medical journals. All of the conclusions are essentially the same in that where there is an attempt to limit spread, the speed at which a result comes back is much more critical than getting every ounce of sensitivity to detect the RNA of the virus.
That is because the PCR can detect down to 100 or 1,000 copies, but people do not spread when they are at 100 or 1,000 copies of this virus. People spread when they are at a million, billion or even a trillion copies of this virus. If the question is whether we can detect a billion copies of the virus, these tests do it very well, down to about 100,000. That is sufficient to detect anyone likely to be infectious.
The other downfall, if we compare these tests to PCR, is speed. What we have to do when evaluating the sensitivity of a comparator test, like a PCR test, and which is not currently done because we do not even have the metrics to do it, is to question the effective sensitivity of the PCR. A test taken two days before flying, for example, is a much poorer performing test than a rapid antigen test taken an hour before flying. People are often worried about missing the first day after somebody is exposed, for example, and whether the antigen test would pick it up, but testing two days before flying means giving an inferior test for that flight versus a rapid antigen test one hour before the flight. That is because if the real concern is transmission on the flight, or thereafter, we want to be able to test as close to the event as possible. That will always be the better solution.
We have shown this innumerable times now, mathematically, and it is really not a question anymore of the mathematics or science. It is now a question of how to create new language. That is really what the world is confronting with testing in this pandemic. We have never had the language before even to describe a test whose primary mode or purpose of use is the obstruction of transmission. It is a very different set of metrics and uses compared with what we normally see.
False positives have also been a major concern for many people. However, with many of the newer rapid tests and some of the older ones, such as Nova and Abbott, both of which we evaluated, for example, we are seeing about one in 10,000 false positives. It is very small number of false positives. If a test is positive, the nice thing is a second rapid test, or even a second rapid molecular RNA test, can confirm right then. The rapid tests can be used for their greatest ability, which is that they are fast, so it does not mean a ten-day purgatory from a false positive. It means a 20-minute purgatory and then the test is confirmed. Again, those instances are rare if the right tests are chosen and selected.
I could go into as much detail as anyone wants, but I really want the take-home message to be that these tests are very accurate if you are concerned about limiting transmission. If you are trying to diagnose somebody who has symptoms because of Covid, use a PCR test. However, if the goal is trying to use a test as a way to limit spread, then use a rapid test, whether it is an antigen or rapid molecular test, both of which will be available in future. Speed is much more important if your goal is to limit spread, especially on something like an aeroplane or at an event etc. I will stop there but am very happy to take questions.
I thank the Chairman for letting me back in. This has been a really useful meeting so far in getting the difference between PCR and antigen testing properly explained. As we talked about during the early stages of the pandemic, the perfect is the enemy of the good and speed is very important in the diagnosis of people who are infectious. Certainly, I have a much better impression of what antigen testing can do now versus PCR. It is incumbent on us as a committee to bring in the Chief Medical Officer, CMO, as soon as we can, to have a conversation with him about what we have heard today.
My last question, for whoever is most qualified to answer it, is, in the context of the vaccine roll-out, and it is fantastic it is being rolled out as quickly as it can be, the EU digital green certificate, the vaccine bonus and so many of the population being fully vaccinated, do we still need antigen or PCR testing for people once we know they have been vaccinated? More than half the adult population is now vaccinated with at least one dose. In three or four weeks that will be two doses. I am not trying to take away anybody's commercial opportunity, but it is hoped in the fullness of time we will not need to do antigen testing at all. Are any of the witnesses, possibly Dr. Power who is a medical doctor, able to tell us whether we need to do antigen testing at all once we have all been vaccinated? Will we still need to do it?
I will not put the professionals on the spot, but I will ask Professor Mina, who is the authority as everyone knows. Will he address that point? When the population is fully vaccinated, will there be a requirement for antigen and PCR testing in terms of travel?
Dr. Michael Mina:
We have now seen plenty of people who are vaccinated but carry the virus. Again, I am pretty confident at this time, with the variants circulating today, that the vaccines will prevent disease, especially severe disease. However, we have also seen a lot of data that show distributions of the viral loads are actually not that different between vaccinated and unvaccinated people. We know vaccinated people are likely to be transmitting less because we are starting to see herd effects, meaning when adults are vaccinated we see fewer cases in children. That is a major win.
We need to be very cognisant that we continue monitoring the situation. In my family, for example, which is not an example I usually give but shows how I am thinking, my wife is pregnant and currently has a single dose of vaccine. I will not go into the details of why that is. Even when people who are vaccinated come to our house, we ask them to take a rapid antigen test. That is because we know that people can carry the virus asymptomatically when they are vaccinated, especially things like the Delta variant and the inevitable next variants that will come around.
We just have to very cautious and keep watching the data as they flow in but, at the moment, for travel on an enclosed plane, having pretty tight restrictions is still a good thing. Whether these restrictions are testing everyone before they got on even if they are vaccinated or continuing to use masks, the question of whether they should be used is not a bad question to be asking right now.
I thank Dr. Mina for being here and wish his mother a very happy birthday today. I will not delay the meeting. Dr. Mina has given a very impressive presentation, as have our other witnesses. The Chief Medical Officer, Dr. Tony Holohan, has consistently warned of the drawbacks of antigen testing. He has referred to the test as being 50% accurate. Does Dr. Mina agree with that sentiment?
Dr. Michael Mina:
Not at all. It is just an inaccurate assessment. If the goal, again, is to limit and block transmission and track transmissible people, the mathematics is very simple. I will give an example that everyone can understand. A person is positive on a PCR for about 30 days. We know the isolation window proposed by the Centers for Disease Control and Prevention, CDC, is only ten days. The WHO has seen that a ten-day isolation window is appropriate. That means ten days is the maximum infectious period, but with a PCR positive test it is 30. Doing the simple division of ten days of transmissibility divided by 30 days of being PCR positive, means that only around 30% to 40% sensitivity should be expected of a transmission-indicating test when comparing it against PCR. A 50% accuracy rate is actually a good value when comparing a test with PCR. If that test is only supposed to detect infectiousness, the accuracy rate should only be somewhere between 20% and 50%, taking variants into account. It should not be more than 50% sensitive. The other 50% that is being missed are almost always people who are post-infectious in those 20 days after the isolation period.
We have been discussing the European green certificate, antigen testing and returning to sporting events. Dr. Mina is based in the city of Boston. On 29 May the Governor of Massachusetts ended all restrictions and the Red Sox are back playing in Fenway Park. Would Dr. Mina be confident antigen testing can play a significant role in people attending sporting events?
Dr. Michael Mina:
I certainly would. We have plenty of data showing that antigen testing will detect it. If everyone walking into a sporting event uses an antigen test in the hour or two before that event, it will cut down on the absolute risk of transmission after the event by 90% to 95%. If we are already starting at a rather low risk, it really cuts down the overall risk. Importantly, it would then be possible to have very quick access to be able to then trace the outbreaks if antigen test programmes are set up. The benefits compound on each other.
Dr. Michael Mina:
Yes, I think so. I would caution not to regard the United States as the gold standard here. We have done a pretty terrible job in this country. However, we can look at airlines. United Airlines and Abbott are now collaborating on a rapid testing programme. For example, testing to fly back into the country is now being used as a tool. It is a very powerful tool.
Let us take a step back. Covid is an information problem. We would not have transmission if we knew who was infectious when they were infectious. These tests give us eyes. They give us the ability to see infectious virus. It is not some other big scary type of test. It is just an information game, evaluating somebody using rapid test.
I thank all the witnesses for appearing before the committee. The questions I had have already been asked and answered very effectively. I am at a loss as to why the committee is still making this argument. Such an effective job was done to diminish the efficacy of antigen testing early on in this pandemic. Many people have done good work to push back on that. I believe that our session with Professor Mark Ferguson once and for all ended any residual arguments about the efficacy of antigen testing. Today has been very useful because it shows how sector-ready the industry is to provide this. There are no barriers to implementing this effectively in aviation, at sporting events or at events in general, bar this blockage.
I acknowledge the work the Chairman is doing to ensure this stays on the agenda, but the arguments are increasingly stronger. We certainly need the Chief Medical Officer, CMO, to appear before the committee to answer what has been proposed. For me, it is unanswerable at this stage. This committee continues to present quality witnesses supporting why antigen testing is useful and there is nothing more I can add beyond that. I thank the witnesses and reiterate that we need to get the CMO to appear before the committee.
We will invite Dr. Tony Holohan, the CMO, to our committee. I ask him here publicly to engage with our committee and put his arguments on antigen testing. The purpose of the committee is to get to the facts. The missing piece of the jigsaw at this stage is that we need the CMO to appear before the committee to give his views on antigen testing. I ask for that to happen very shortly.
I wish Dr. Mina well with his soon-to-be-born child. Would it be fair to say that he believes that speed trumps perfection? One of our fellow Irishmen, Dr. Ryan in the WHO, has always made that point. Dr. Holohan's point that antigen testing is only 50% accurate has gone into the lexicon. Dr. Mina has dealt with that very well today.
In layman's terms, my understanding is that Covid has a 14-day cycle. For the first couple of days someone is not that infectious. There is a peak period in between when the person is highly infectious and in the following days towards the latter end, they are not as infectious. PCR testing will probably detect the Covid infection throughout that period. Antigen testing will pick it up when it is at its most infectious. Therefore, Dr. Mina's thesis is that with antigen testing if it is 50% accurate that means it is picking up the cohort who are most infectious and it is much faster. His basic point is that an antigen test taken pre-departure is far more effective than a PCR test taken 72 hours prior to arrival.
Dr. Mina had a very interesting exchange with Professor Phillip Nolan who spoke about snake oil regarding antigen testing. Obviously, we saw the discourse they had on social media. I ask Dr. Mina to dispel that notion about it being snake oil. Does he regard antigen testing as complementary to PCR testing? Does he see it as standing alone? Does he believe it is more effective than PCR testing? What role can it play as we move into a world increasingly vaccinated against Covid? What practical things can we do in Ireland to get PCR testing to play a vital role in the fight against Covid? If we do not have antigen testing, are we putting the population at greater risk of catching the infection than by having antigen testing?
Dr. Michael Mina:
One very important point is rarely brought up. This gets to the question of why speed is so crucial. For example, PCR tests are used three days before a flight. When the virus grows in somebody's body everyone will be undetectable for the first couple of days after exposure. Once they become detectable on either test, usually the PCR is first, the virus will grow from barely anything to 1 million or 1 billion copies within a day. It grows very fast and that is the nature of exponential growth which is the only way viruses grow inside the body.
I bring that up because if somebody uses a PCR test two or three days before a flight and they get a negative result, by the time they walk onto that flight they could literally be at their peak of infection. They could actually have 1 billion or 1 trillion viral particles in their nose, completely undetected, because they got a test before they were detectable. The point is that the virus grows extremely quickly in the body. This is why we get super-spreaders. Someone at the peak of infectivity could actually be showing their negative PCR test from a swab taken two or three days earlier and walk onto a plane or into an event as a super spreader. An antigen test right there would detect those people without any problem. Those are the most important people to detect and have them rapidly removed from circulation. That is essential.
We then need to ask what is happening with vaccines. We saw what happened with the New York Yankees players and staff recently, and now we see the CDC back-pedalling. For about a year, I have tried to warn the CDC about this. If we start to relax our safeguards because the population is getting vaccinated, PCR testing is so sensitive that if somebody gets exposed, we are very likely to start picking up really low fragments of RNA.
When the viral load is that low, especially in a vaccinated person, it is often the case that the person will not be transmitting. Some people who have been vaccinated can transmit, and they will be protected on both tests. We do not want to quarantine people who are no longer transmissible; that is a net negative for public health, and PCR would cause that.
Antigen tests, because of their speed, which I explained, are safer and better when our goal is simply to limit transmission, especially in an acute event such as a flight, and also because they are much more accessible. They can be used on a more ongoing basis, if needed, over a longer period. It is much easier to do that than it is with PCR. Unfortunately, PCR, out the gate with this pandemic, was deemed to be the gold standard. As a public health test, however, it has few, if any, of the qualities we want in such a test. Rapid antigen testing, on the other hand, features speed, frequency of testing and many other qualities we would seek in a test that has a purpose of limiting transmission.
Antigen testing could be introduced in Ireland for air travel and sporting and cultural events. Dr. Mina has published academic papers on this area. Has he carried out empirical work to show what it would do to reduce the rate of transmission among the general population in Ireland? This feeds in to public health.
Dr. Michael Mina:
If antigen tests were widely available and people had access to them, and in particular if a government used these tests and devised a programme around them whereby they would be used two hours before an event, or twice a week if children were going back to school, or whatever it might be, these tests could keep down spread to a minimum. An epidemiological term that most people will have heard by this point is the R nought, or reproductive, number of the virus. If that can be kept below 1, outbreaks will not take off. Some people have thought that in order for a test programme to be effective, it needs to stop 100% of transmission, but that is a poor way to examine a population effect. All we have to do to prevent outbreaks from occurring in a population at large is to ensure that for every ten people who are infected, nine others will go on to be infected from those people, instead of 13. If the ratio can be kept below 1, outbreaks cannot take off. That is the basic principle of controlling outbreaks in epidemiology-----
I thank our guests. Their contributions are very important, not least in terms of how they compared PCR and antigen testing and how they spoke about the way we use tests and how tests can be plugged into a strategy. Would antigen testing be used pre departure and post arrival? Would it be self-administered or carried out through a laboratory on site at, say, an airport? Will our guests comment on the cost and affordability and the implications that might have for international travel? Could antigen testing allow us to forgo having to quarantine at home, which is in place in Ireland at the moment?
Dr. Niamh Power:
The closer to departure that an antigen test can be taken, the more helpful it will be. There are all kinds of logistical issues with allowing people to be tested in time for their flights, so there probably has to be some compromise in that regard. Perhaps 24 hours would be good.
Regarding the point-of-care tests, neither rapid antigen tests nor rapid PCR tests are allowed by Ireland. It has to be a lab-based test. The beauty of these rapid tests is that they do not require a lab, so they can be conducted on site as the person is going onto his or her flight or just beforehand.
As for forgoing quarantine, Professor Mark Ferguson gave a great presentation to this committee a few weeks ago and spoke about some studies that had been carried out in the UK, which are also outlined in the report in his name. The studies found that serial daily antigen testing could replace quarantine and allow people to continue in their everyday life rather than quarantine, whether because they have arrived from another country or because they have been nominated as a close contact. We missed a trick with the leaving certificate, which is beginning today, where thousands of students who are stressed beyond their means might not be allowed to take their exams if they have been named as close contacts.
Dr. Michael Mina:
Quarantine is very destructive. If we quarantine people all the time, it is very difficult. These tests can be used as an alternative. If we were to test whether someone has had exposure or if he or she is just arriving into another country, these tests can be used every day, instead of quarantine. A test used every day will probably be more effective than quarantine, particularly when we start to consider the fact that people in quarantine tend to become non-compliant after a few days. That has to be taken into account, and a test used every day will be a very effective substitute for a quarantine of somebody who is not known to have been infected.
The matter has been put in stark terms. Mr. O'Grady dealt with some of this earlier and Dr. Mina has outlined how antigen testing is a supreme tool for stopping transmission. I had intended to ask a question about optimal times. Dr. Power stated that we will have to be able to facilitate the green digital certificate if we are to go at this. Professor Ferguson spoke about serial testing as a means of bridging the gap between antigen and PCR, and I accept the argument that this could be used to avoid people having to quarantine. I also accept the arguments made about antigen almost being better from the point of view of transmission. Is there a need for any element of serial testing, pre or post arrival, to bridge that gap? Do we need to operate pilot projects as soon as possible in order that we will have our own information as opposed to that freely available from tests carried out in Britain and throughout Europe?
I will put the Deputy's question to Dr. Power first because it relates to her field, aviation. How quickly could a pilot antigen testing scheme be set up, for example, on a moderately busy route from Ireland to the UK?
Dr. Niamh Power:
To conduct a pilot programme, we would first need to decide what we wanted to find out from it. The Department of Health, the HSE or whoever else might wish to tell us that, but as regards the logistics of carrying out tests for a flight, I could do that this afternoon if needs be.
It is that quick. We really can scale it up that quickly.
On Deputy Ó Murchú's point about post-arrival screening, that probably depends on the risk in the country the arrivals are coming from. For a country that has to undergo mandatory hotel quarantine at the moment, such as India, because of variants of concern, then, rather than the Department of Health or whoever deciding we need quarantine, we can replace that with serial testing. For EU countries without a particular risk, I do not see why we should quarantine. The ethos of the digital Covid certificate is that countries of an equal or lesser risk to us should not be subject to quarantine.
Dr. Michael Mina:
Antigen, for sure, because where a PCR test provides a positive result in an asymptomatic person who does not have known exposure, the chances of that positive reflecting an old infection that is no longer infectious are much greater than the chances of it reflecting a currently infectious case. An antigen test will only detect the infectious case so it is superior in that regard.
I think that is the thing. I was using the wrong language when I referred to bridging the gap. That is the narrative we have had and we have got a straight answer today in relation to antigen being superior. We need to have the CMO and possibly Dr. De Gascun in.
My view from the expert advice we have heard today and all the evidence we have heard previously is there is no reason Ireland should not embrace antigen testing. There is overwhelming scientific evidence to show the effectiveness of antigen testing and I suggest we follow up today’s meeting with an invitation to the CMO and his team. This is a serious public interest matter which can no longer be dealt with behind closed doors. We need answers in public. Our public health officers must justify and give the reasons for their opposition to antigen. I want to see our venues and events reopening. That can be done safely with antigen and we can allow people to get back to enjoy their lives. This is one of the tools to do that.
A previous question was asked of Dr. Power and I would ask the same question of Dualchem and Mr. O’Grady. They have had no contact. They have written to all these agencies of the State. We as a committee should write to these agencies to remind them they have a presentation from Dualchem and others and they should start negotiations with them on what they have to offer.
Will Mr. O’Brien and Mr. O’Grady write to the committee giving us copies of the correspondence so we can follow up directly and put this firmly on the agenda? We reiterate our invitation to the CMO, Dr. Holohan, and his colleagues to come before us. We will follow up with them. This matter requires public discussion on a factual basis to justify why antigen testing is not being used. From what we have heard today, it would make an enormous difference.
We have reached the point in the committee where we seem to have a view around the need for antigen testing. I concur with everybody who has asked for the CMO and Dr. De Gascun to come in. It is imperative that we conclude with them in that. I support that proposition.
Yes. I will go back to Mr. O’Grady from Dualchem. We face into the GAA championship, a huge social and cultural event for all things Irish. My question relates to putting in place what Mr. O’Grady spoke about. If it was done on the basis that the antigen test had to be monitored, rather than self-administered, could it still work or is it too cumbersome or costly a system for that to happen? How long would it take Mr. O’Grady’s company to get such a system up and running for, say, GAA championship matches? Dr. Mina might then comment on self-administered antigen tests versus professional monitoring of same.
Mr. Chris O'Grady:
On the healthcare professional monitored antigen test, I see there being challenges for an event while I agree it is probably applicable to international travel. Logistically, I do not see how healthcare professional antigen tests will facilitate an event because it realistically cannot be performed on-site on the day of an event at the anticipated volumes. I am going on the assumption we are talking full houses.
Mr. Chris O'Grady:
It would be highly irresponsible to bring infected people to the site on the day of the event for testing and then segregate infected people from others. One is bringing them all to, in GAA terms, Drumcondra to tell them who cannot go. If we utilise an independent testing centre such as we operate and Dr. Power operates, directing people to such a centre for an event could unnecessarily mix an event attendee with a possibly symptomatic individual who is not attending the event.
Would it be fair to say that if the Department of Health, the HSE and Dr. Holohan, Dr. De Gascun and their colleagues moved into this space to regulate antigen testing properly, Mr. O’Grady would not have an issue with that?
Mr. Chris O'Grady:
The only challenges I have would be logistical. If there was a logistical solution to testing 80,000 people on the day of an All-Ireland final, it is the exact same process.
The only reason I would benefit from the self-test relates to the question I was asked earlier about how we ensure people are compliant with the post-event test. It will be a big ask from a compliance point of view for people to get a healthcare professional antigen test a number of days after an event and communicate that result to the event co-ordinator. When they have it in their house, it is already in their possession and they have paid for it. It is just asking them to do the swab, interpret the result and upload the photo. I expect compliance to be significantly better for a post-event self-test than one done through a healthcare professional.
Will Dr. Mina comment on the self-administered as distinct from the monitored antigen test?
We did not discuss it but Professor Ferguson is keen on sustained rapid antigen testing. His model was to have people who have travelled from abroad isolate at home with rapid antigen tests being done every second day. Self-administered antigen tests would cut down on tests considerably compared with monitored tests. How does that feed into public health concerns? What do the Department of Health and HSE need to do to properly regulate antigen testing so that it works as an additional aid to public health in Ireland?
Dr. Michael Mina:
The first question is whether a self-administered test works. The short answer is "Yes". Most of the initial studies that looked at self-administered antigen testing found that the efficacy was a bit lower but that was on the first attempt. The first time people try to tie their shoes, they do not do it well, but they do it just fine the second time. It is not different with an antigen test. It is important to recognise and has been shown here, in Liverpool, and elsewhere, that those early reports that people could not do the test as well was because it was the first time and they were fumbling around trying to figure out what the plastic was. These are so simple that the second time they used the test, the efficacy shot up. We can use that knowledge as a test to say that if people need to use a test, maybe they can use it earlier, perhaps two weeks before a flight or event, or they can have a more sophisticated version.
There is a middle ground between healthcare-observed testing and completely independent at-home testing. We have seen that utilised in the United States. I want to be clear that I have no financial ties to any of the companies that we are talking about. eMed is doing observed testing on computers using call centre workers rather than healthcare workers. It allows it to scale to substantial numbers of observed tests. If people are doing the test for the first time, maybe they can get help through a service such as eMed. It is simple. There are solutions to these issues.
We have discussed using rapid antigen testing over time so that people do not have to quarantine or can self-isolate at home. What structures for the regulation of antigen testing could we have here? That would bring much certainty and confidence to this among the public. What do the witnesses believe should be done for public health in that area?
Dr. Michael Mina:
Serial or ongoing testing is an effective tool to limit spread and stop outbreaks. Instead if in a quarantine period, people can have a test daily or every other day. That would be an effective way to stop outbreaks from spreading. If an outbreak is ongoing in a community, antigen testing can be used across a large swathe of that community. Our evaluations have shown that that would prevent an outbreak. Even if cases start to emerge, it would prevent them from causing an outbreak that needs to be addressed. The ongoing use of testing is an effective tool to limit spread.
Regarding regulation, it is important that we evaluate the different tests. If a Government is going to have a contract with a company, it is important to regulate those tests and understand how they are performing. Some of the tests that we saw in Taiwan and Korea were not performing well. Others have performed exceedingly well. It is important to create a panel with an independent group that is able to evaluate the different tests. It could be done in one day. A test could be taken from a company, with a box of 50 of the tests, and an answer could be provided by the end of the day. It is simple and I am happy to advise on how that could work after the meeting.
Mr. Barry O'Brien:
I thank the Chair and the members of the committee for their attention to detail and their courtesy in listening to everything that we said. I thank Dr. Mina because he has been helpful to everybody here. Speed is of the essence. It is the great benefit of antigen testing. I am here to say to the State that speed of engagement is also important. If we have full, proper engagement quickly, everything can be customised and there can be full attendance at the all-Ireland hurling and football finals in August.
Mr. Chris O'Grady:
Yes. Certain elements are involved. Supply of tests is not a problem. Consideration of the IT application to deal with this is not a problem. The number of people who can attend is irrelevant. Once the process is implemented correctly, whether two people out of 5,000 or 300 people out of 80,000 are positive, it keeps them at home.
Mr. Simon Osman:
Not to remove the momentum, since the conversation is going in a positive way, I will go back to one point that Senator Horkan was making earlier to support Dr. Mina's comment. The technology is moving forward quite rapidly with the ability for smartphone applications to read the test for home use. Much work is going on in the artificial intelligence sector to enable more accuracy and better validation of that test against the individual at home. This is continuing in that direction. Echoing Mr. O'Brien, I thank the committee for allowing us to speak today.
We are over time. This is an important issue. We are not against PCR testing but we see a major role for antigen testing. We have had Professor Mark Ferguson, a Government adviser, attend. We have had the current expert witnesses and Dr. Mina from Harvard, who is a world authority on antigen testing. We now need a public meeting with Dr. Tony Holohan, the Chief Medical Officer, Dr. Cillian de Gascun, and whoever else is required to discuss antigen testing. If the CMO has issues with antigen testing, let us justify them. We have heard here today that antigen and PCR tests are different but that antigen tests have a significant role to play in containing the spread of the virus.
I thank Dr. Power from V1 Medical, Mr. O'Brien, Mr. O'Grady and Mr. Osman from Duelchem, and Dr. Michael Mina from Harvard University who has encapsulated in a medically-underpinned but easy to understand way the difference between antigen and PCR testing. It is the first time it has been explained in a way that I think the ordinary person can understand. Antigen testing has a vital role to play.
We need to get back to operating in a normal world. Antigen testing has a key role to play in that. We look forward to our meeting with the Chief Medical Officer, Dr. Tony Holohan. We have an open invite, in writing, to Dr. Holohan. I am aware that things have been very busy, but the nettle must be grasped in this area now. We need to look at antigen testing. It has a vital role to play.
This meeting is now adjourned. The next meeting of the joint committee will be a private meeting at 4 p.m. on Tuesday, 15 June 2021. I thank everyone for attending. Mr. O'Brien might send on those correspondence documents to us.