As we head into a new phase of the COVID-19 pandemic, there are still many questions unanswered.
Following Government hints, new guidance from the HFEA, the European Society of Human Reproduction and Embryology and the Association of Reproductive and Clinical Scientists and British Fertility Society, there is understandable relief for fertility professionals and patients that we can gradually begin to restart treatments. Alongside triaging, distancing at work, personal protective equipment (PPE) and other measures as part of a comprehensive risk assessment, there is still a need for testing.
Despite calls from the outset to 'test, test, test' from many experts (particularly the World Health Organisation), we now learn that the UK, despite being one of the world's most advanced and developed nations, has struggled to make it into the 'top 40 nations', when measuring the number of tests per million population.
In case it's not entirely clear, there are two types of test: firstly, the antibody test, which reveals whether a patient has already been infected with the disease and may - though this is not yet certain - be immune. In the absence of a vaccine and safe, effective, accessible therapies, a reliable antibody test will help us to understand the epidemiology of this disease and discover whether we have achieved a level of potential 'herd immunity'.
Secondly, the PCR, (also known as the diagnostic or antigen) test, uncovers whether you are infected with SARS-CoV-2 – the virus that causes COVID-19. In both cases, as in most areas of diagnostics, a bad test is worse than no test at all, but this is true particularly for the PCR test, as false negatives (the test failing to correctly identify infected people) can lead to infectious individuals further spreading the disease. Combined, these tests could prove a vital 'back to work/treatment' strategy for clinic staff and patients alike.
There has been much talk about this so-called immunity passport in the press. It is widely believed that, with a combination of accurate, reliable antibody and PCR testing, individuals can be effectively triaged into work or treatment at low risk, carefully monitored and routinely tested or sent home to self-isolate and recover. Either test alone may not provide the most comprehensive picture.
As those countries worst affected begin to come out of lockdown and we await a second wave of infection, the PCR test remains key. PCR is a routine test that allows small amounts of DNA to be replicated in sufficient quantity to analyse. Unfortunately, coronaviruses contain RNA, not DNA, and this is harder to work with, more dangerous and unstable. That's why it is understandable that the UK initially tried to restrict the testing to Public Health England (PHE) labs, who routinely do this type of work. Surely, therefore, they are the only labs who can do this work properly?
Not necessarily. While no one should dismiss the great work PHE has already done in trying to tackle the coronavirus crisis, there has been a problem from the outset. Right from the beginning, PHE alone never had the required capacity to test all suspected patients, healthcare and care workers; let alone large swathes of the population, in order to isolate infected individuals and reduce disease transmission.
The frustrating thing is that there is, and always has been, a solution.
A UK network of private accredited medical laboratories already exists; many labs already offering genetic tests for NHS and private patients. Despite repeated offers to assist, sadly, many have been overlooked. Apart from some notable exceptions like the Francis Crick Institute, the real success stories outside of PHE are the growing number of laboratories who have joined the COVID-19 testing volunteer network, which, independent of the Government's effort, has steadfastly provided free tests to GPs, care homes and other key workers for many weeks now.
On 2 April, Sir Paul Nurse, head of the Crick, indicated that labs like his, not usually involved in viral testing (but nonetheless highly professional and with sufficient expertise to perform diagnostic testing) could work alongside the NHS/PHE effort to set up a network of fully functional labs locally. He even evoked the spirit of Dunkirk; small but functional and available boats ready to assist a mammoth effort in our country's hour of need.
Despite this inspirational and very public 'call to arms', many offers to help have gone unheard. Indeed, our ISO 15189-accredited laboratory (normally providing genetic tests to clinics to help fertility patients have a better chance of having healthy children) registered early with the various Government agencies involved in tackling the COVID-19 crisis, offering both equipment and staff. From day one, we have always been willing to help with testing and believed that a risk-managed approach to mass testing should always include a network of high quality (ideally accredited) laboratories to provide local testing in case of the catastrophic failure at a so-called 'mega lab'.
Without official recognition or support, however, we have faced significant challenges of reagent and equipment shortage or national requisitioning and have had to 'go it alone'. At many stages we have even reached out to IVF clinics to source equipment and have been genuinely moved by their willingness to work together to solve problems – the Dunkirk spirit in action!
We are now in a strong position to provide PCR (and antibody) testing to clinics and their patients and to help the wider community, as we gradually come out of lockdown and are braced for second and subsequent waves of infection. We further hope that this huge effort, investment and risk is worth it in the longer term, as we try to better understand the impact of viral infection generally (and SARS-CoV-2 specifically) on fertility and pregnancy, as this is still not well understood.
As we all try to find our 'new normal', we need to continue to be flexible, dynamic and supportive in our collective efforts to help patients. Despite the Government's assurance that we now have national capacity of 100,000 PCR tests per day with a new 'target' set of 200,000 tests per day by the end of May, we urge fertility clinic staff especially to ensure that they truly have free and easy access to these tests – especially if asymptomatic.
Many may have heard about the key worker testing website crashing on day one, the long queues at drive-through test centres only to have a self-administered swab kit launched through the hastily opened car window, testing kits being sent out with no return address and there are, no doubt, many other such troubling stories.
What the Government and PHE have finally achieved is incredible, but the new challenge may not be testing capacity intrinsically, but easy access to high-quality tests, timely reporting and focused customer support for asymptomatic individuals. This is where smaller, private laboratories may show their true worth. It's time we considered them. To use the Dunkirk metaphor - let's launch those boats! With daily declining fatality rates and the peak of infections behind us, the battle may be over for now. But the war is certainly not yet won.