Oireachtas Joint and Select Committees

Wednesday, 12 May 2021

Joint Oireachtas Committee on Transport, Tourism and Sport

Covid-19 Testing and Air Travel: Nuevo Ireland

Photo of Kieran O'DonnellKieran O'Donnell (Limerick City, Fine Gael)
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The purpose of the second part of our meeting is to discuss Covid testing and air travel. On behalf of the committee I welcome Dr. Damien Kenny, director; Mr. Roberto Spano, chief executive; and Mr. Niall Lord, Nuevo Ireland. They are very welcome. I thank them for agreeing to participate in this meeting at such short notice. I apologise for the delay in starting. Our previous session with Mr. Bassato from Rome airport ran a little over time.

Witnesses are reminded of the long-standing parliamentary practice that they should not criticise or make charges against any person 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. Therefore, if their statements are potentially defamatory with regard to an identifiable person or entity, they will be directed to discontinue their remarks. It is imperative that they comply with any such direction.

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 wish to remind members of the constitutional requirement that they must be physically present within the confines of the place Parliament has chosen to sit, namely, Leinster House or the Convention Centre Dublin, to participate in public meetings. Unfortunately, I will not be able to permit a member to participate where he or she is not adhering to the constitutional requirement. Therefore, any member who attempts to participate from outside the precincts will be asked to leave the meeting. In this regard I am asking members partaking via MS Teams to confirm they are on the grounds of the Leinster House campus prior to making a contribution.

I call Dr. Kenny to make his opening statement.

Dr. Damien Kenny:

I am grateful to the committee for allowing us to present today. I know all the members are very busy. As widespread vaccination facilitates emergence from the restrictions imposed by the Covid pandemic, most will agree that some form of testing is essential. However, the debate on testing seems to have focused on which testing system is best, rather than on which is most appropriate for the given circumstances. Nuevo Ireland is a biosecurity firm and we are presenting our mobile, real-time PCR testing system. We believe this can contribute to facilitating a safe return to international travel, which we all understand is essential moving forward. The system has been approved by the US Food and Drug Administration, FDA, and Health Canada. It is CE-marked and has been validated across two separate laboratories testing four different lab-based systems, with an extraordinarily high sensitivity and specificity of approximately 99%.

The system consists of four main components. The first is the M1 sample prep cartridge, which allows purification of the raw sample, usually a nasopharyngeal aspirate. Then there are the go-strips, which the committee will have seen in the presentation we sent. These contain the agents to process the purified sample and allow amplification of the ribonucleic acid, RNA. The Franklin thermocycler then rapidly heats and cools the RNA to allow significant and exponential amplification of any RNA that may be present in the sample. This a mobile, battery-operated system that is carried around in a suitcase and weighs approximately 2 kg. The Biomeme software allows quantitative and qualitative interpretation of the results, which are usually available within 60 to 70 minutes of the test sample being processed.

We have begun to test in Ireland. We wish to emphasise that this is an accurate, convenient, rapid and gold standard PCR system. We acknowledge that this testing takes place outside the classical laboratory setting but we should all recognise that there are multiple examples of how in vitrodiagnostics have successfully moved outside a laboratory setting over the past number of years, including with urine testing, breath testing, blood testing and now even diagnostic ultrasounds. We are talking about providing this gold standard opportunity to evaluate for SARS-CoV-2 as a screening tool. That is where its significant strength lies. The types of assays we use, and the fact we are testing for not only the spike protein but another target on the SARS-CoV-2 virus RNA, have facilitated us picking up all known variants to date. Multiple other studies are going on to continue that work based on evolving variants. One of the things we feel is essential, particularly from a travel and transport perspective, is not only that we are accurate but that we are accurate across evolving variants of SARS-CoV-2. As we have seen in the past, different variants coming into our country can lead to a significant spike in infection rates and clinical outcomes.

I do not have much more to say about the system. I would be very happy to take questions, unless Mr. Lord would like to provide any other information.

Mr. Niall Lord:

We want people to understand where we see value in this system across transport. We have had a lot of interest from airlines, be that from airline crews or handlers within the airline industry. Members will agree that when travel starts to reopen, our air crews and so on will effectively be front-line staff, especially if travelling on multiple flights across different countries. The testing for that is too slow at the moment with a 24-hour turnaround on PCR tests. Staffing will present its own problems for airlines. This is a solution that can be taken up from within the airline industry.

We are also looking at a pooling scenario whereby we could do one PCR test for pods or families. Instead of a family having to pay for four or five PCR tests, the tests could be pooled and we could give them one result. If there were a positive detection, the family would then need separate PCR tests. There are various capabilities in this system that will allow travel really to open up.

Dr. Damien Kenny:

If I can come back in there, one of the things about which there may have been concerns is performing an in vitrodiagnostic outside a standard laboratory setting. We are not talking about selling this or providing it for the person on the street. We are talking about performing testing outside a standard laboratory setting but in a controlled environment using fully-trained personnel. As I alluded to, there are multiple examples of in vitrodiagnostics having moved beyond the lab. The concept of point-of-care molecular testing is really going to be vital for the healthcare system moving forward. With antibiotic resistance, there are a number of accounts of where lab-based in vitrodiagnostics are accurate but slow and cumbersome. We need something that is rapid and mobile to provide rapid diagnostic testing to be able to identify persons who are asymptomatic but carrying virus.

Photo of Darren O'RourkeDarren O'Rourke (Meath East, Sinn Fein)
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I thank the representatives from Nuevo for the presentation. My background is in diagnostics so I am interested. I agree with Dr. Kenny that we have seen lots of technological developments in recent decades. Hopefully, this is another example of such a development. However, there is always the question of quality, and we have seen some comment on that in the media in recent days. Will Dr. Kenny provide reassurance on the type of quality this system can deliver?

I have a specific question. Some people talk about rapid PCR testing and what they really mean is small batches involving quick turnaround times. We are talking about something different here, a new technology. How many samples can be processed in a run? I am thinking about throughput. With specific reference to use in the aviation context, we heard from Professor Mark Ferguson last week and he talked about serial testing over a period of up to ten days with kits people bring home. We have just heard from representatives from Rome Airport, who talked about a single pre-departure and a single post-arrival test, for which this system might be appropriate. Does Dr. Kenny see that as a possibility? Mr. Lord mentioned aviation workers and stated that is a potential use here. Does Dr. Kenny agree? Does he have a perspective on what role this technology and the Nuevo system could play for the travelling public?

Dr. Damien Kenny:

I thank the Deputy. The first question on how many samples per run is a little easier. One thermocycler can do nine samples in a run, which takes approximately 60 minutes. Again, if we are to bring pooling into that, the system has been validated for three samples in a pool, so one could have three separate samples which would increase that potentially to 27, depending on whether one looked at pods or not. We are looking at internal validation now for five and ten and maybe moving up to as much as 25. As it stands, with our validation of three pooled samples in one of the assays, and we can run nine on an hourly basis, we have opportunity to extend that while of course ensuring the data are valid. Depending on how many machines one has, it can be extended if one is running two or three machines simultaneously.

On serial testing and kit testing, I do not think it is my place to get into a debate on what is the best testing system for aviation. One must choose the appropriate testing strategy for the service one is trying to provide. If there is a person who is symptomatic, some of the cheaper antigen testing is fairly reasonable but if one is embarking on screening to evaluate asymptomatic patients and detect sub-clinical virus in patients before they become clinical but could still spread that virus, particularly in the context of variants as travel opens up, then this is where our system really provides a lot of benefit. Travel is based on convenience, particularly for people who travel a lot and travel for business. There are different forms of travel; people will travel for recreation but also for more business-related matters. As a result, particularly for those who are travelling regularly or travelling for business-related matters and who may be moving through a number of different jurisdictions, having a system whereby we can detect the virus and determine that they do not have it present, then a single test at that stage should be adequate. On antigen testing in other settings, as has been alluded to elsewhere and in the Ferguson report, testing twice a week may be necessary in some environments, including factories, etc. I believe testing once in a travel period should be adequate in the context of the real-time PCR because of the sensitivity of the test and the accuracy it provides.

Photo of Timmy DooleyTimmy Dooley (Fianna Fail)
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Dr. Kenny has given us some very good food for thought. As he knows, our biggest concern is getting the aviation sector back in motion again. It is really about providing something to our public health professionals, who seem to have rather undue influence on the Department of Transport because we are not seeing anything coming forward from the Department by way of a plan to get aviation back moving again.

There are a couple of questions that arise. Has Nuevo carried out any sort of comparison between its on-site PCR versus lab-based PCR? Have there been any tests done in parallel to see the accuracy of one against the other? That is my first question.

My second question relates to cost. Can the Nuevo representatives indicate to us what the cost might be at a reasonable scale? I am aware that in a controlled environment where only a small number of tests are being carried out the costs will be higher. What would a scaled-up version cost, assuming that flights were back running at 50% or 60% or whatever? Can our guests give us some idea of what the cost of that might be?

Dr. Damien Kenny:

I thank the Senator for the questions. On the validation testing, the system has been validated against four lab-based systems and has shown a specificity and sensitivity of approximately 99% across those testing strategies. The system is being used in the US at the moment, and is being used for testing. I think there have been well over 1 million tests performed to date in the US with this technology. This is without the need for backup laboratory testing because it has been accepted that it is an accurate, adequate stand-alone test for patients for assessing whether or not they have any presence of RNA virus in the context of SARS-CoV-2. On the costs and commercial aspects, I might hand over to my colleague, Mr. Lord, because he probably has better grasp of it.

Mr. Niall Lord:

On the commercial side, with this test obviously come the machines. The way we are trying to price this is on a per-test basis. As with anything, volume will dictate price. To give an example, I am actually out at the airport today where we are carrying out a test of 54 nationals who are heading back. We are running those tests there today and we will have the whole thing turned around in three to three and a half hours. Pricing will, again, come down to volume.

If I were to give a ballpark figure of where we are, it would be in the region of €50 per test, including the equipment, plus or minus 10%.

Photo of Timmy DooleyTimmy Dooley (Fianna Fail)
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When Mr. Lord says "including the equipment", is this a licensing arrangement or is it-----

Mr. Niall Lord:

The model we are working on is that if people are purchasing a certain amount of tests, the equipment will be provided free or charge. Then it becomes a fixed-price test.

Photo of Timmy DooleyTimmy Dooley (Fianna Fail)
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Nuevo Ireland is not offering a service whereby it puts in place the infrastructure at an airport and provides the service to the airport, airline or whatever. It is not a service provider but a technology-----

Mr. Niall Lord:

Not at present but we are working with some of the testing companies who are utilising the technology. There is an opportunity to partner with some current players in the market to provide them with a one hour or hour and a half turnaround for emergency cases or for airline staff, airline crew, etc. It could be rolled out to allow for pooling whereby a family could come up, have a test and be free to travel within an hour and a half. The capabilities of this are kind of endless.

Photo of Timmy DooleyTimmy Dooley (Fianna Fail)
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I will give an example. If we had planes back in the air going through Shannon Airport in the morning and we were back to, say, 300-400 passengers per day, a fraction of what would have been going through, talk me through that scenario. How many personnel would be needed on site to get it done within an hour? Give us an idea of how that might work.

Mr. Niall Lord:

I will give an example of what we are doing today. We are doing 54 people today. We have two machines here. There are nine samples per run. We would have those 54 people turned around in approximately three or three and a half hours with test results. On site today, we have two people operating the machines and doing the samples and one doing administration. To scale that up, if you had double that, you would be able to do 100; treble that, you would be into 200. One operator per machine is needed and possibly an admin person between each two machines.

Photo of Timmy DooleyTimmy Dooley (Fianna Fail)
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So we are talking about €50 and a delay of about three hours. On the availability of the equipment, Mr. Lord said it was in the US. If Ireland was to move in this way as part of the introduction of the digital green cert and in conjunction with everything else that is happening across Europe, and if Mr. Lord was told that aviation would be beginning again by 1 July, how easy would it be for him to lay his hands on this equipment? How quickly could he get it deployed? What is the lead-in time? This feeds into a lot of the work of this committee. We are screaming at the Department of Transport to come forward with a plan, recognising it will not happen with the flick of a switch----

Photo of Kieran O'DonnellKieran O'Donnell (Limerick City, Fine Gael)
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Senator Dooley, I need to allow Mr. Lord to conclude because I have others to come in and we are very caught on time. I will take a quick response from Mr. Lord.

Mr. Niall Lord:

At the moment, we have capability of up to 200 machines per month. There is no limit on assays.

Photo of Timmy DooleyTimmy Dooley (Fianna Fail)
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Could Nuevo Ireland have 200 machines here for 1 June or 10 June?

Mr. Niall Lord:

Yes, potentially.

Photo of Timmy DooleyTimmy Dooley (Fianna Fail)
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Okay. That would do a small fraction of passengers. Will Mr. Lord provide the committee with a bit more detail around that, recognising where we would like to get to in terms of recovery-----

Photo of Kieran O'DonnellKieran O'Donnell (Limerick City, Fine Gael)
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And how it can be done.

Photo of Timmy DooleyTimmy Dooley (Fianna Fail)
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-----lead times, delivery times and all of that?

Photo of Kieran O'DonnellKieran O'Donnell (Limerick City, Fine Gael)
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We can follow up.

Photo of Joe CareyJoe Carey (Clare, Fine Gael)
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I thank the witnesses for the presentation. Over the past couple of weeks there has been some public comment by people in authority on rapid antigen testing, in particular Dr. Tony Holohan. I ask for the witnesses' view on that. What is their stance on what Dr. Holohan said about the validity of these tests? We have heard compelling evidence from authorities in Italy today to state they are very reliable and have helped enormously in getting their aviation industry back on its feet. As the witnesses will be aware, we are trying to do the same in this country, so I would like to get their views on the comments made by Dr. Holohan in recent days.

Dr. Damien Kenny:

I do not want to be drawn into a political debate on this. As a practising clinician, I would say you need to choose the appropriate test for the circumstance. If we are looking at facilitating return to travel, the important thing is to have a good screening test. A screening test needs to ensure a high positive predictive value and a high negative predictive value. The problem with antigen testing, in my opinion, is that if a person is asymptomatic, those values go down significantly as a consequence of the fact that it is not able to detect virus. Even more important as we look to open up our borders is that the transmission of variants across borders can be really detrimental.

Being very specific to travel, if you had a clean slate to design a test that would be a good screening tool for asymptomatic people who want to travel with a high risk of a low volume returning with a high-risk variant, you need gold standard testing for that, and for me that is PCR. We need to look at a testing strategy that complements itself. Antigen has its place, lab-based PCR has its place and I firmly believe that real-time,in vitro, point-of-care mobile diagnostics have a place with SARS-CoV-2, particularly in the context of travel as we want to open up.

Photo of Ruairi Ó MurchúRuairi Ó Murchú (Louth, Sinn Fein)
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Dr. Kenny is making the sale for this in relation to transport, particularly aviation, from the point of view that the danger into the future, until we have everybody vaccinated, booster shots ready and all the rest of it, will come from variants. This is a system that can be deployed. What Senator Dooley has said needs to be done in relation to information on ramp-up capacity. I assume if we have a case of something getting through the gap in relation to a variant, this is a system that could be used in an outbreak setting to catch and contain as quickly as possible. My question is on two things: the applicability, where this can be used and the follow up with that other information, and beyond that, the interaction with Government and NPHET. Nuevo Ireland has its own validation done but it needs validation and acceptance from the public health authorities before it can go where it needs to go in relation to this.

Dr. Damien Kenny:

I agree completely. On the catch and contain point, the system was originally developed in 2013 to look at Ebola breakouts in west Africa because a lab-based system is not available in western Africa. It is a highly contagious pathogen with significant implications for those who catch it. We are looking at a similar scenario here, involving screening a large number of people to pick up a small number who may have something that has a huge implication for all of us. On the validation testing, I do not disagree with what the Deputy has said.

Photo of Kieran O'DonnellKieran O'Donnell (Limerick City, Fine Gael)
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Where are the Irish authorities at in terms of validation?

Dr. Damien Kenny:

We had a call and we did a demonstration for-----

Photo of Kieran O'DonnellKieran O'Donnell (Limerick City, Fine Gael)
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It was with Ms Anne Mannion.

Dr. Damien Kenny:

Yes, with Ms Anne Mannion. It was for the HSE and the chief scientific officer in regard to the system. She is bringing it back to the task force to present it to them, and we are waiting to hear back from them.

Photo of Kieran O'DonnellKieran O'Donnell (Limerick City, Fine Gael)
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Very good. I call Deputy Cathal Crowe. I ask him to be brief as we have to finish shortly.

Photo of Cathal CroweCathal Crowe (Clare, Fianna Fail)
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I have been listening with interest. I want to take a closer look at the efficacy. Does all this speeding up of testing, accelerating of the process, involvement of machines and mechanisation in any way reduce the efficacy?

Dr. Damien Kenny:

No, we do not believe so. With regard to the thermocycler, the process is the same process, and it has just been narrowed down to some extent. In fact, we have a 45-cycle run, which lasts a bit longer than may be necessary because of mandates originally from the FDA, but there is even a possibility to bring down the testing times with a reduced number of cycles. Most certified labs would look at between 30 and 35 cycles as being adequate to be able to rule out whether or not there is amplification of RNA. I do not believe the mobility or the size of the testing strategy has any implication for its accuracy.

Photo of Cathal CroweCathal Crowe (Clare, Fianna Fail)
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I have a question for Mr. Lord. If we were in blank cheque territory and if, overnight, all the airport authorities in Ireland and the Government said this was a great idea and that we would go with it, to what extent can Nuevo step into the Irish aviation sector? What is its upper capacity in terms of roll-out and testing ability? If we were to see recovery of aviation over the coming weeks, how much of a role would it be in a position to play?

Mr. Niall Lord:

With regard to the supply of the equipment, we have been told we can get it up to 200 machines per month every month. The assays are readily available. We are also looking, through Nuevo International, at bringing the manufacturing of the machines to Ireland and for the assays to be made in the UK. There is a bigger opportunity with regard to making Ireland the hub for this type of technology moving forward. In regard to ramping up, again-----

Photo of Kieran O'DonnellKieran O'Donnell (Limerick City, Fine Gael)
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I ask Mr. Lord to be brief.

Mr. Niall Lord:

We are prepared to ramp up but we do not know what sort of take-up this is going to have. As I said, we are at the early stages and we are testing at the moment. I will have to come back to the Deputy on that.

Photo of Cathal CroweCathal Crowe (Clare, Fianna Fail)
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I would appreciate that because it is an essential detail.

Photo of Kieran O'DonnellKieran O'Donnell (Limerick City, Fine Gael)
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I call Deputy Michael Lowry who was instrumental in bringing these witnesses before us.

Photo of Michael LowryMichael Lowry (Tipperary, Independent)
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It might be helpful if Mr. Spano gave an overview of the situation internationally and how he sees it being applicable to Ireland. What struck me about this technology was its use in classrooms and school backgrounds, and I was very impressed with how effective it can be in that setting. It would be important for the witnesses to forward to us the information they have at their disposal and, in particular, to keep in contact with the committee over the next week or two in regard to the feedback from the Health Products Regulatory Authority, HPRA. I know Nuevo has presented to the HPRA, NPHET and the HSE, and the feedback from them is important. Our problem, as a committee, is that we are getting resistance from the medics on any testing. We see testing, including Nuevo’s PCR rapid test, as being complementary to the existing laboratory-based PCR. We are not replacing it; we see it as complementary and supportive in helping us with that. Perhaps Mr. Spano will give us an overview.

Photo of Kieran O'DonnellKieran O'Donnell (Limerick City, Fine Gael)
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Deputy Lowry is looking for an overview of the international scene to assist our understanding.

Mr. Roberto Spano:

I am CEO of Nuevo International’s biosecurity and we provide a biosecurity concept. We are an Irish-based company. As the Deputy explained, we are investing in Ireland and, as Mr. Lord said, we will produce these machines directly in Ireland. As he also said, at the moment we produce 200 a month but, shortly, we will be able to grow that to 1,000 machines a month. We will then be able to help Ireland and to get Ireland open, even in terms of everything around transportation. In Ireland, we are producing disinfection without alcohol for export to the whole world. For example, we are supplying product to Qatar for the world championships. This is an overview of all the investments and production that we are doing in Ireland.

Photo of Kieran O'DonnellKieran O'Donnell (Limerick City, Fine Gael)
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I call Senator Jerry Buttimer.

Photo of Jerry ButtimerJerry Buttimer (Fine Gael)
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The most important point is Deputy Lowry’s point that what we are trying to do is to be complementary in the whole process rather than exclusive. The Deputy is correct on that. I suggest that, rather than asking questions, as a committee, we would look at further investigation of the issue of antigen to support the work that has been done here today.

Photo of Kieran O'DonnellKieran O'Donnell (Limerick City, Fine Gael)
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I thank the witnesses from Nuevo for attending. We ask that they would follow up with correspondence on capacity and where the company is at in respect of validation with the Irish authorities. We are looking for a model that is complementary to both PCR, given that its rapid aspect very much appeals to us, and antigen testing to really get to where aviation can open up in a safe way. Everyone has a role to play in this regard. I thank the witnesses.

The joint committee adjourned at 2.47 p.m. until 2.30 p.m. on Wednesday, 19 May 2021.