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08th Aug 2023

Point of Care Diagnostics: What are the Ethics?

Gabrielle Percival

Investment in the UK’s MedTech scene is flying high, with point of care diagnostics continuing to ride high on the resurgence it gained following the pandemic. As diagnostics move beyond the hospital and lab into our homes and communities in a cause for celebration, there’s also cause for another type of conversation. Namely, prescribing a discussion about the ethical implications of these mind-blowing advancements in diagnostics.

With more self-administered, point of care tests (POCTs) becoming readily available over the counter, is it futuristic or reality that we might soon be able to use MedTech to screen ourselves for life-changing diseases, like cancer? And where do we sit on that from an ethical perspective? 

What is point-of-care testing?

It’s a complex question, so it makes sense to start with the basics. Point of care testing is a type of diagnostics that happens outside of the central laboratory. For instance, pricking a finger to measure blood glucose levels to manage diabetes (over four decades old). Or, providing a urine sample for a pregnancy test – so mainstream now that seeing pregnancy tests on the supermarket shelves one aisle over from the in-store bakery feels ‘normal’. But like the introduction of anything ‘new’, this type of POCT kit was met with a fair amount of opposition during its introduction. 

The first ‘DIY’ pregnancy test

Just over 50 years ago in the 1970s, the first ‘DIY’ point of care diagnostics kit became available to women in the UK to find out if they were expecting. ‘Predictor’ was available to purchase over the counter in most pharmacies, though high-street favourite Boots was notably an exception.

Resistance to change remains commonplace today. Whilst we’re a world more open and accepting of new ideas and technologies, change always stirs a variety of emotions. Though I find it comical that 49 years ago, consumer watchdog Which? told women that ‘clumsy’ users could end up ‘wasting almost £2’ (equivalent of £18.05 now!) on the DIY pregnancy test, it was a radical step for both the feminist movement and MedTech. 

Stacking shelves with point of care diagnostics

Fast forward over half a century, and pharmacy and supermarket shelves are stacked with POCT kits that once seemed ‘futuristic’:

  • Urinalysis for possible urinary tract infections 
  • Screenings for sexually transmitted diseases, like chlamydia 
  • Rapid antigen tests for viral infections, like Covid-19 

None of us want to receive a positive diagnosis for any type of medical condition. But speaking very generally, the conditions detected by the tests above are largely not indicative of a terminal* medical condition. Will they ever be, and should we be able to perform these tests whose results carry such weight ourselves?  

*Exceptions occur 

Accessible point of care testing 

I’m no medical expert. But I am a member of the public who can easily access the results of a recent sexual health screening or genetic test I carried out at home via a text message to my phone. If either scenario returned a positive result, I’m sure I’d feel incredibly sensitive and concerned about the implications. Communicating such results via text or email must’ve been met with resistance when it was first suggested, just like Predictor. But the pros clearly outweighed the cons – over 2.1 million sexual health screens took place in the UK during 2022, and I wonder how many people were informed of a positive result via text. It leads me to wonder: 

  • Where do we draw the line for the types of conditions we can rapidly test and receive results for, in the absence of a medial professional, like a doctor? 
  • How much information is too much information out of a clinical setting? 

But also, who is to deny us access to such diagnostic capabilities when we are free to access a staggering amount of data on ourselves already, from our GP records found on the NHS app to our sleep scores on our wearables? 

At-home testing for HPV 

One self-diagnostic kit now available from some online doctors, pharmacies, and testing services in the UK is for HPV. Women usually attend cervical screenings at their local GP practice to look for high-risk types of HPV (human papillomavirus). Up to 80% of people will get HPV at some point in their lives, with most of us able to fight off the virus on our own. But certain strains are more high-risk and can cause cell changes which can lead to certain types of cancer.

Despite the NHS offering smear tests to all women aged 25-49 every three years, there are still huge barriers to women getting screened. Fear of the unknown, embarrassment, the procedure’s uncomfortable reputation… There are a myriad of reasons why regular screenings aren’t always taken up.

But in 2021, the NHS announced a trial for 31k+ women to take at-home tests for HPV to try and increase the number of screenings for the virus. Research shows that 99% of women are able to self-swab effectively. And if the test returned a positive result, the women were invited for a cervical screening at their GP practice.

Changing attitudes towards diagnostics

The ability to test at home, outside a clinical setting, for a virus that could lead to cancer, feels immense. For all the positives, like… 

  • Encouraging more women to test 
  • Breaking barriers to testing itself 
  • Supporting the early detection of high-risk HPV 

…there’s still weight behind receiving a call, text, or letter to say a recent test returned a positive result. 

It’s important to note that a positive result for HPV does not equal a positive cancer diagnosis. But it shows how far attitudes are changing, with making tests holding potentially significant life-changing results as accessible as possible.

Trends for future POCT kits

So, does the reactive, almost proactive nature, of point-of-care diagnostics which could lead to earlier detection of life-limiting diseases (and in some cases, reduce their impact), outweigh the ethical considerations of taking these tests ourselves? 

We saw the popularity of rapid testing for Covid-19, with over 520 million antigen tests taken in the UK as of December 2022. In the same timeframe, the US had performed around 1.15 billion tests. The world quickly adopted rapid POCTs to prevent the infection spreading.

By rule, the more of us who knew we had the contagious infection adapted our behaviour to limit the spread of infection. And the same rule can be applied to developing POCTs for other infectious diseases, too, from ongoing Avian influenza (bird flu) to outbreaks to Lyme disease (the bacterial infection spread by infected ticks). POCTs to quickly diagnose these conditions at home could help slow outbreaks of diseases that can seriously affect health. 

How significant is the implication of the result if another result is speedier detection and treatment put into place quicker?

Just as whether movies predicted the future of MedTech, I’ll leave this ethical point with you to ponder. 

Let me know your thoughts by getting in touch!

You might also be interested in The UK MedTech Innovation Assembly 2023 which is taking place this November! Click here to find out more about the day-long event which is drawing in MedTech and HealthTech experts to explore investment, cybersecurity, AI, and other technology facets that present both opportunity and challenge to the sector.