What's happening with Travel Testing for Covid in the UK

I have been recently cited in the Telegraph and interviewed on BBC R4 regarding my thoughts on the state of travel testing for Covid-19 in this country. From the start I want to say that if we had no need for Covid testing ever again I would be most pleased BUT if we are testing for what is a potentially fatal respiratory virus I want the testing to be executed properly and professionally, with everyone involved held to the same standards.

Prior to 2020 most clinical pathology labs were required, if not by law then by professional ethics, to be UKAS ISO 15189 accredited. Some labs were accredited to ISO 17025 for forensics or genetics work but all labs had a common objective – to deliver a high-quality performance with the correct results supplied in a timely, professional and ethical manner. This was a minimum expectation if you wanted to do any work for the NHS or Private Healthcare. You were expected to have Clinical Directors who were held to the highest professional standards, as well as registered Biomedical Scientists who were expected to do the same when working in the lab. Anybody not adhering to these rules and regulations would be quickly reported and dealt with by either the DHSC, UKAS, the MHRA or a range of professional bodies such as the Institute of Biomedical Science (IBMS).

However, all that appears to have changed now.

When the Covid crisis evolved there were around 100 NHS/PHE ISO 15189 accredited virology labs and around 20 private ones already established in the UK. We all adapted very quickly to provide testing for SARS-CoV-2 and re-applied to UKAS for our legitimate ‘Extension to Scope’ - which many of us have now secured. Many of these labs supported the Government and PHE during 2020 doing what was called ‘Pillar 2 & 4’ testing to help protect local hotspots. Here at CCL, we spent many months looking after around 25 Cambridgeshire based care homes, providing testing weekly for staff and residents. I think we did a very good job.

Then in December 2020 the Government (DHSC) ceased most private contracts for Covid PCR testing and there was a big push to move mass testing over to lateral flow devices, self-administered. The performance of these is a debate for another time. The Government then wanted private labs to solely manage the testing for the travel industry. This was a fair move as they didn’t want the NHS to be burdened with doing travel testing when they really needed to get back to sorting out the nation’s health. The Government also wanted a competitive market to keep prices down.

The so called ‘Fit to Fly’ tests became the initial target as people started to travel abroad and airlines wanted to ensure passengers weren’t infected or at least infectious with the SARS-CoV-2 virus. This started the initial frenzy of new labs and new providers into the market. To control this new market and bring some modicum of quality into the system, tight regulations were put in place by MHRA as to what tests you had to perform and what specification they had to meet. UKAS was asked to provide the accreditation to ISO 15189 standard for all new providers and labs. This all seemed to be being directed by new departments within the DHSC. ?In my opinion, this is when it all got very complicated and out of hand. So new providers (basically sellers of COVID tests), could set up and apply for UKAS accreditation. On UKAS’s website it says that “to date we have received over 500 applications/extension to scope request”. Stage 1 is the application, which is a self-declaration for new providers or labs to confirm the meet minimum standards. Stage 2 is to supply further evidence (gap analysis) and for labs they have four weeks to do this after Stage 1, but again a paper exercise. Stage 3 is full accreditation and involves a lot of paperwork and actual on-site audits by UKAS in some cases. You have six months after completion of stage 2 to achieve this. The inference being that if you do not achieve this, you are (or could be) shut down. However, that’s at least seven months after your application and if I was being cynical, if you don’t get your accreditation you could just take all the money you’ve made in that period, shut down and start up again and the application all over again.

Meanwhile, the established, already accredited labs are having to toe the line at every step, make sure they meet all of their professional requirements, because if they fail, they lose their accreditation (for everything) and all their existing pre-Covid business goes with it.

So, on one side you have highly professional, very experienced and ethical suppliers who are being significantly restrained and hindered because of their pre-existing quality standard, whilst new labs and providers can provide services immediately after application, with very little risk if they are not following all the rules and regulations, they literally have nothing to lose. Which is why it is like the American gold rush out there or the Wild West.

This system is sanctioned by the DHSC because once you have applied and passed stage two you can be listed on the official Government website as a provider and/or lab. These lists direct you to the company websites where you can order tests. The DHSC is quick to say that they do NOT ‘approve’ anyone on the list, but travelers are taking these lists as de-facto approval for the listed suppliers and so they, in my opinion, are very misleading to the general public.

There are rules and regulations in place, but I suspect not everyone is following them. I actually have no idea who is policing them – for example every sample collection kit being used is a medical device under IVDD or IVDR and should be UKCA or CE marked and registered with MHRA. We know this was a big problem for one of the major Lighthouse Lab providers, so what about all these new labs and providers? My problem is not that the correct paperwork has been submitted to say its all OK but what is actually happening in practice? Who is actually checking these thousands of customer complaints which flood Trust Pilot, Facebook and Trip Advisor? I am sure there are three types of provider or lab now working in this marketplace; ones that are fully compliant, ones that want to be fully compliant and ones that have no intention of becoming compliant but will carry on supplying until their time runs out. When it comes to providers websites, what’s to say that some of these that appear on the internet are not just online shops for scammers and data collectors? To order a test you put your personal details into them, your credit or debit card details, home address and then you never get a kit – what’s happened to that data? Even I would not want to order a test online at the moment!

UKAS is an accreditation body - they should not be policing this. They are doing their very best to put some level of quality into the system. DHSC and MHRA should be doing far more to investigate and remove the rogue traders. Some of the advertising practices on the Government lists is dubious to say the least and requires investigation by Trading Standards.

?For the traveler who is uneducated in buying clinical tests, which is probably everyone, how do you tell what’s good and what’s bad. Well rule of thumb – if it seems too good then it probably is. It costs between ￡15 and ￡20 pounds to conduct a good quality PCR test – so I’ll leave it there for you to decide what seems reasonable and what isn’t.

?Look on the review websites and see if they have good or bad reviews or is it a well-known name you can trust. With over 400 providers listed on the Government site for provision of day 2&8 testing it is a gamble.

?Travelers are doing some interesting things as well. I have heard of scenarios where travelers book their 2&8 tests abroad via the internet, get their booking reference number which allows them to board the plane and get back into the country, and then cancel it once back and demand a refund. Who is policing that they have undertaken a test and not brought yet another variant back into the country?

These tests are provided for health of the nation - not a tick box for the travel industry. Getting them correct is important and could significantly affect people’s lives or even lead to more deaths. Some of us are professional ethical suppliers and want to see this cleaned up and soon. It’s a choice between good quality, high quantity and low cost. In reality you can only pick two of these at any one time. What we have now is actually the worst of all worlds. If you buy a test that costs you ￡100 but you don’t get the sample kit, then you’ve lost out on everything. If you buy a cheap test and get the wrong result back, then that could significantly affect people’s lives. If you pay a fortune and get a great service, then that’s not sustainable for most people. The Government needs to work closely with the industry to achieve; high quality testing, quickly processed and reported at high volumes and at a reasonable price. Unfortunately, what has been set up will never achieve this.