Department of Health rebrands 'professional use' kit as a self-test

Department of Health rebrands 'professional use' kit as a self-test

01/12/2021

Department of Health puts NHS branding on rapid Covid tests in ‘bizarre’ loophole so it can get around manufacturer instructions and tell people to swab themselves – even though they miss HALF of cases when used as DIY swabs

  • EXCLUSIVE: Innova coronavirus test put into NHS packaging for ‘flexible use’
  • Manufacturer instructions say it is for professional use on people with symptoms
  • But Department of Health is giving it to people without symptoms to self-test
  • Experts said rebrand was ‘unusual’ and wouldn’t be needed for a quality product 
  • Scientists warn the self-test kit isn’t fit for purpose and its use should be stopped

The Department of Health is repackaging controversial rapid coronavirus tests as NHS self-tests in what critics claim is a ‘bizarre’ move to get around manufacturer instructions which say they are for professional use.

UK officials announced on Sunday that they will roll out 15-minute lateral flow swab tests to all councils and schools in Britain in a bid to get on top of Covid transmitting between people without symptoms.

But one of the main tests being used only detected 41 per cent of Covid cases in a trial in Liverpool where people swabbed themselves, and the manufacturer insists they are only ‘intended for use by trained clinical laboratory personnel’.

MailOnline can now reveal that the kits are being bought and repackaged as a self-test by the Government. Ministers have spent more than £825million buying the lateral flow tests from American firm Innova.

Innova says that a medic should use the test on someone with Covid-19 symptoms within five days of those symptoms starting, but the Department of Health is rolling them out for the public to test themselves when they don’t have any symptoms at all.

This is despite Public Health England’s own study finding the tests are at least 20 per cent less accurate when people do them themselves, and top scientists urging the Government to stop using them, warning they are unfit for purpose as self-tests.

In order to override the original instructions, the Department of Health has listed itself as the manufacturer – despite the fact it plays no part in making the device – so it could have ‘flexible’ use of the test with the blessing of the regulator, the MHRA.

Scientists described the move as ‘bizarre’ and warn that the use of low quality rapid testing will potentially give tens of thousands of people a false sense of security by wrongly telling them they are negative when they actually have coronavirus. 

Testing experts including Professor Jon Deeks, from the University of Birmingham, have repeated called for the Government to stop using the Innova test – Professor Deeks said today that officials are suggesting to people the test is better than it is.

Coronavirus self-testing is being rolled out across the UK to try and pick up on people who are spreading the virus without knowing about it because they’ve got no symptoms (Pictured: A university student swabs his own throat in Hull)

Innova’s usage instructions say the company’s test is supposed to be used on people with symptoms and is ‘intended for use by trained clinical laboratory personnel’

Innova’s test is being used at care homes already (pictured: a box of the tests at King Charles Court Care Home in Falmouth) and is part of the mass rapid testing roll-out extended to all councils in England

The Department of Health announced in December that it had got approval for a ‘NHS Test & Trace Covid-19 self-test device’, for which it is listed as the legal manufacturer.

However, the actual maker of the test is a Chinese company called Biotime which makes it for Innova Medical Group in Pasadena, California, which then sells it on to the British Government, officials confirmed.  

By buying the Innova tests and repackaging them in NHS branding, the Department of Health has become the legal manufacturer and can set its own usage instructions. 

SCIENTISTS URGE GOVERNMENT TO STOP USING INNOVA TEST

Scientists have accused the Government of misleading the public over the accuracy of Innova’s rapid test and called for its use to be stopped.

Professor Jon Deeks, Dr Angela Raffle and Dr Mike Gill – from the University of Birmingham, the University of Bristol and a former regional director of public health, respectively – said in a letter published at the weekend: ‘The Innova lateral flow test is not fit for many of the purposes being proposed by the government. 

‘In the Liverpool pilot, the test missed infection in 60 per cent of people, and of greatest concern missed it in 30 per cent of those with very high viral loads who are at highest risk of spreading the virus to others. 

‘An erroneous test result may lead to people taking the wrong actions and putting themselves and others at risk of infection. This may increase and not reduce disease spread, illness and death.’

They said the limitations of the test were not being made clear by the Department of Health and that it was being made out to be more accurate than it is, in some places being compared to the significantly more reliable PCR tests.

Lateral flow tests do have some benefits, they argued, but the way this was being used risked too many people getting false negative results or not reporting results when they were positive.

Professor Deeks told Sky News today: ‘Government messaging on this hasn’t been explaining this to people and it’s a bit difficult. Most of us have never done a diagnostic test in our lives ourselves, and we would expect a positive to mean “yes” and a negative to mean “no”.

‘But here a positive means “probably” and a negative means “we really can’t tell”. So it’s a difficult message to get out to people, and I don’t think it’s been done at all well.’

He added: ‘This weekend the Business Minister was quoted as saying “This will make workplaces completely safe”. It’s not the right way to tell people about this.’

‘I think there’s an anxiety that, if we tell people the truth as to how bad this test is, people won’t bother getting it. But we have to do the truth – we can’t tell people that the test is better than it is.’

The researchers urged in their letter: ‘Stop further rollout of rapid asymptomatic testing using the Innova LFD, including its use in care homes, schools, communities and self-testing by untrained people at home.’ 

A similar, but not identical comment, is available on the British Medical Journal blog.

Experts say this is so they could more easily get approval from the MHRA to use the test – designed to be used by trained lab staff – as a self-test.

‘It’s very clear to me that we’re not using them as directed by the manufacturer,’ Dr Al Edwards, a pharmacy researcher at the University of Reading told MailOnline.

‘It’s quite a normal thing to add steps that aren’t recommended by the manufacturer but there is a big difference here – that decision is usually taken by a lab, you don’t just ask people randomly to do something.’ 

Although Innova claims the test is 95 per cent accurate in lab conditions, an evaluation by Oxford University and Public Health England found it only detected 58 per cent of positive cases when people tested themselves in a study, compared to 79 per cent when they were done professionally.

And in a real-world pilot it performed even worse. When members of the public in Liverpool swabbed themselves and trained Army personnel tested the samples, the tests only detected 41 per cent of positive cases that were identified by better lab-based PCR tests.

In a report on that trial, officials admitted they weren’t using the test for what it was designed for, writing: ‘Some of the use envisaged by community testing may be outside the manufacturer’s instruction for use’.

The Department of Health is pushing ahead with self-testing despite concerns from scientists that the Innova kit– the SARS-Cov-2 Antigen Rapid Qualitative Test – isn’t accurate enough.

To do this it has listed itself as the manufacturer of the test by repackaging the kit with NHS branding and called it a ‘self-test’, making it legally responsible for the way the test is used. 

Department of Health sources confirmed to MailOnline that the NHS test is the Innova test and said it had rebranded it ‘in order to gain approval from the MHRA for the most flexible use of the device at pace’.

The MHRA gave emergency approval for the self-test on the condition that people will only be allowed to act on a positive result, and a negative should not be used to ‘enable’ them to relax rules.

But in MHRA emails seen by MailOnline, one official at the regulator admitted: ‘The messaging and specific actions due to a result fall within the remit of the legal manufacturer not MHRA.’

In this case the legal manufacturer is the Department of Health, which means Matt Hancock’s department now has de facto approval to do whatever it likes with the test.

‘For a health department to become the manufacturer is quite a bizarre thing to do,’ Professor Jon Deeks told MailOnline.

‘I imagine it will have happened before but it doesn’t seem normal.’

A sales rep at a testing company in the UK, who did not want to be named, told MailOnline the move was ‘very, very unusual’ and there should be ‘no reason’ for it if the test was of a high quality.

He said: ‘It couldn’t be clearer in the Innova instructions that the test is for people showing symptoms, within the first five days, and it’s for trained clinicians.

‘It’s obviously not designed for self-testing or asymptomatic donors.’

He said that using a test against manufacturer instructions was ‘off-label’ and could lead to difficulties getting approval or legal complications if something goes wrong.

The Department of Health announced on Sunday that asymptomatic rapid coronavirus testing would be rolled out to all councils in England.

It had already been available in some local authorities but will now be possible in all areas, although it will be for councils to set up the systems themselves.

107 areas had already started testing, with 131 signed up. The programme was expanded to all 317 local authorities. 

In addition to regular testing in care homes and the NHS, rapid tests will be offered to secondary school and college staff and pupils, and staff at primary schools.

Some councils will offer asymptomatic testing to any residents who want it.

The tests, which produce results in just 15 minutes, use a nasal or throat swab to detect coronavirus.

Officials have said that only positive results should change someone’s behaviour, and anyone who tests positive should get a proper PCR swab test and self-isolate.

However, people getting negative results will be allowed to continue to go to work and school and potentially to visit care homes.

Health Secretary Matt Hancock said: ‘With roughly a third of people who have coronavirus not showing symptoms, targeted asymptomatic testing and subsequent isolation is highly effective in breaking chains of transmission.

‘ Rapid, regular testing is led by local authorities who design programmes based on their in-depth knowledge of the local populations, so testing can have the greatest impact.

‘We are now expanding this offer to every local authority across the country, and asking testing to be targeted on workers who cannot work from home during this national lockdown, while asking employers to work with us to scale up workforce testing.’

‘Lateral flow tests have already been hugely successful in finding positive cases quickly – and every positive case found is helping to stop the spread – so I encourage employers and workers to take this offer up. We must all do all we can to stop the spread of COVID, right now.’ 

Repackaging the product could get around this but it was likely just a PR exercise, he said.

‘The MHRA seem to be like the whipping boy in this because they’ve become the go-to regulator,’ he added.

‘”We’re only doing this because the regulator approved it” – that’s the DHSC fall-back.

‘Somebody within the MHRA would look at the Innova information and the instructions and say “wait a minute, the DHSC [Department of Health and Social Care] are not using it this way”, but the DHSC in this case said we’re doing it anyway. It’s a really blatant steamroller.’

A spokesperson for the MHRA said: ‘The MHRA followed a robust assessment procedure when considering the application for exceptional use of the NHS Test and Trace Covid-19 self-test devices. DHSC is the legal manufacturer of this test. 

‘NHS Test and Trace have demonstrated through lay user studies that members of the public have been able to use the self-test device successfully. 

‘The self-test device contains all the components needed to conduct a test, including instructions for use which are specific to it being a lay user self-test. A video demonstrating how to use the self-test device is also available.’ 

On why the Department of Health is pressing ahead with Innova’s test instead of buying one designed to be a self-test, experts said it was a matter of convenience.

Public Health England has already approved the test for use, seen how it works in studies and the Government has bought at least £825million worth of them since September.

’They’ve bought it,’ Professor Deeks said. ‘It’s all sitting in a warehouse somewhere.’

A spokesperson for the Department of Health and Social Care said: ‘With up to a third of individuals with Covid-19 not displaying symptoms, broadening asymptomatic testing is essential.

‘Lateral flow tests used by the UK government go through a rigorous evaluation by the country’s leading scientists which means they are accurate, reliable and successfully identify those with Covid-19 who could pass on the virus without realising.

‘In order to roll out the test as quickly and safely as possible, DHSC became the legal manufacturer of the Innova lateral flow full self-test. This allowed for a faster evaluation which ensured the test had robust usability with high specificity and sensitivity.’

Experts are concerned that officials won’t make it clear to people that the tests are not accurate enough for a negative result to be treated as a coronavirus all-clear.

If a test can only detect 40 per cent of people who have coronavirus, six out of every 10 infected people who take the test will get an incorrectly negative result.

This could lead to people who get negative results being more lax about social distancing rules and potentially spreading the virus further.

Professor Deeks said: ‘The MHRA were very clear that they were emphasising that it’s a limited approval, specifically not to be used for enabling, so allowing people to use a negative result to, for example, visit care homes.

‘The Department of Health doesn’t say that very clearly. It says it’s only being used to find cases. It’s a matter of semantics and it’s open to misinterpretation.

‘Part of the issue is that we’re very concerned that the negative test results will lead to people getting a false sense of reassurance and changing their behaviour in a way that increases the spread of the disease.’

Professor Deeks criticised the tests after an earlier study at the university where he works in Birmingham, where students tested themselves with the Innova devices.

The study estimated that the swabs picked up a shockingly low three per cent of true positives in a group of 7,189 people.

Students were given the rapid tests as part of a nationwide drive to help young people get home to their families for the Christmas holidays.

To check how well the tests were working, experts at the university retested some of the students using a PCR machine, which is the proper test used by the Government.

Retesting around one in 10 of the students in the trial (710 out of 7,189), they found that six of them had wrongly been given negative results when they were actually infected.

Multiplying this by 10 to take the whole group size into account suggested as many as 60 cases may have been missed, said Professor Deeks.

So the two genuine positives that were detected represented only three per cent of the estimated 62 positive results that would have been found with a better test.

Scientists in the UK are divided over the Government’s decision to roll out rapid testing more widely.

Some say the tests have value because they can detect cases among people who otherwise wouldn’t get a swab because they don’t have symptoms.

But others are concerned people will be falsely reassured by their negative results.

Dr Angela Raffle, a public health lecturer at the University of Bristol, said: ‘Further rollout of lateral flow testing is very worrying.

‘Any benefit from finding symptomless cases will be outweighed by the many more infectious cases that are missed by these tests.

Already outbreaks are known to have occurred because people have been falsely reassured by a negative lateral flow result, leading them to attend work whilst having symptoms.

‘The test manufacturers only recommend the Innova lateral flow test for use by qualified medical practitioners and in people with symptoms, yet the Department of Health and Social Care is pushing ahead with use in symptomless people, with the test performed by untrained staff or as a self test.’

But Professor Jose Vazquez-Boland, an infectious disease expert at the University of Edinburgh, argued: ‘We must be clear that the only way to control the coronavirus and attempt its eradication is to immediately identify asymptomatics, as close as possible to “real-time”, to rapidly isolate them and progressively reduce the prevalence and spread of the virus across the population.

‘Mass regular [coronavirus] screening must be rolled out without further delay, across the whole UK in a coordinated effort, to focus interventions only on asymptomatic transmitters and avoid the ill effects of indiscriminate restriction measures in society and the economy.’  

A spokesperson for Innova told MailOnline: ‘DHSC is branding the test as they are working towards more flexible use of the test and we are happy to support the UK in all manners to which the test is appropriate for use.

‘The instructions for use were originally written around symptomatic patients as that is how the test was firstly deployed. 

‘Since then, we are constantly evolving and finding the test to have greater than 85 per cent sensitivity in people with infectious viral loads, regardless of symptoms, when used correctly.

‘On the self-testing, we at Innova are highly focused on helping people use the test correctly from an operational support perspective. 

‘The test performs extremely well when used correctly. Thusly, Innova is preparing to launch simple instructional videos to assist in self-testing operations. We are also going to launch a self-guided artificial intelligence application to guide people on proper use while performing the test.’

The company added: ‘The Liverpool data is not necessarily the most accurate representation. There is forthcoming information which will place the Liverpool pilot into better context. 

‘On the symptomatic versus asymptomatic we are highly confident that the Innova test performs extremely well for capturing infectious people, especially when used as antigen tests should be used, in several times per week applications where it catches the infected person as their viral load increased and they become infectious to others.’

HOW LATERAL FLOW TESTS ARE ONLY TRUSTWORTHY WHEN ADMINISTERED BY TRAINED STAFF

Lateral flow tests are only accurate at diagnosing coronavirus when administered by trained professionals, studies have repeatedly shown. 

The tests, which give results in as little as 15 minutes, use swabs of the nose or throat. Samples are then mixed in a testing liquid and put into a plastic cassette which can detect the presence or absence of coronavirus and then produce an image of a line, the same way as a pregnancy test, to indicate whether it is positive or negative.

The Department of Health and NHS are instructing people to use the tests on themselves, despite manufacturers of some kits saying they shouldn’t be used as DIY swabs.

Both the swabbing procedure and the use of the test cassette can easily be done wrong and affect the accuracy of the test. 

If the swab isn’t done for long enough, or deep enough into the nose or throat, it may not pick up fragments of virus. Medical professionals are also able to use nasopharyngeal swabs, which go right to the back of the nostril, whereas this is not advised for people who test themselves.

And if the sample isn’t properly inserted into the cassette the result might be wrong, or people may misread the display when it produces a result. 

SELF-TESTING CUT ACCURACY FROM 79% TO 58%

A University of Oxford and Public Health England evaluation of the Innova lateral flow test, which is being widely used in the UK, found its sensitivity – the proportion of positive cases it detected – fell from 79 per cent to 58 per cent when it was used by untrained members of the public instead of lab experts. 

Based on this evaluation, officials pushed ahead and used it for a real-world self-testing trial.

PILOT IN LIVERPOOL FOUND FEWER THAN HALF OF POSITIVES

When the same Innova test was trialled on members of the public in Liverpool – with people taking their own swabs and trained military staff operating the tests – the swabs picked up just 41 per cent of positive cases.

In the study the rapid tests detected 891 positive results, compared to lab-based PCR swabs that found 2,829 positives in the same group. This means 1,938 people got a wrong negative result from the rapid test.

The study didn’t compare this to professionally done rapid tests, but the manufacturer Innova claims its test is 95 per cent sensitive in lab conditions. 

…BUT TESTING DONE BY MEDICS IN SLOVAKIA ‘REDUCED INFECTIONS’ 

Despite rapid lateral flow tests getting bad press, officials in Slovakia used them on 5.2million people – almost the entire population of 5.5m – in a trial that a study later estimated to have cut the country’s infection rate by 60 per cent.

The tests used were between 70 and 90 per cent accurate and all the swabs and evaluations were carried out by trained medical workers. They used deep nasopharyngeal swabs, that go to the back of the nose, whereas self-testing generally relies on a swab of only the nostril.

London School of Hygiene & Tropical Medicine researchers said that the scheme successfully weeded out coronavirus cases that wouldn’t have been found otherwise, slashing the number of cases by over half in a week during a lockdown. 

HOW RAPID TESTS ARE DIFFERENT TO LAB-BASED PCR SWABS 

Lateral flow tests are an alternative to the gold standard PCR test – known scientifically as polymerase chain reaction testing – which is more expensive and more labour-intensive but more accurate.

PCR tests also use a swab but this is then processed using high-tech laboratory equipment to analyse the genetic sequence of the sample to see if any of it matches the genes of coronavirus.

This is a much more long-winded and expensive process, involving multiple types of trained staff, and the analysis process can take hours, with the whole process from swab to someone receiving their result taking days.

It is significantly more accurate, however. In ideal conditions the tests are almost 100 per cent accurate at spotting the virus, although this may be more like 70 per cent in the real world. 

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