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Misdiagnosed Type 1 diabetes patients could be freed from the need to take insulin after a new test is rolled out. Scotland will become the first country to offer the C-peptide blood test to all patients who have had a Type 1 diagnosis for at least three years. The test shows how much insulin a patient's body is producing itself. A pilot by NHS Lothian allowed some people who had been taking insulin to stop or reduce the treatment. The test will be available from 1 November. C-peptide testing, which has been used as part of diagnosis for some patients for many years, can help distinguish whether a patient has Type 1 or Type 2 diabetes. C-peptide is made in the body at the same time as insulin. By testing levels of C-peptide, doctors can work out how much insulin a diabetes patient is making themselves. If C-peptide is present in significant amounts, it might indicate that the person does not have Type 1 diabetes at all, and consequently may not need daily insulin injections. The tests will be offered at hospital diabetes centres. Public Health Minister Maree Todd said that tackling diabetes was a priority for the Scottish government and that she wanted everyone living with diabetes to access safe, effective healthcare, treatment and support. She said: "Type 1 diabetes is a significant health challenge right across the world." Read full story Source: BBC News, 31 October 2021

Deborah Birx, who was the White House coronavirus response coordinator under President Donald Trump, has told a congressional inquiry that at least 129 000 lives could have been saved if his administration had provided adequate testing and properly communicated the gravity of the situation to the public. But the election year “just took people’s time away and distracted them from the pandemic,” she told the House Select Subcommittee on the Coronavirus Crisis. “I felt like the White House had gotten somewhat complacent through the campaign season.” Asked if Trump did everything he should have to counter the pandemic, she said, “No. And I’ve said that to the White House. I believe I was very clear to the president in specifics of what I needed him to do.” “If we had fully implemented the mask mandates, the reduction in indoor dining, the getting friends and family to understand the risk of gathering in private homes, and we had increased testing, then we probably could have decreased fatalities by 30-40%.” That would amount to at least 129 000 preventable covid deaths over the course of the Trump presidency, which saw roughly 429 000 reported deaths attributed to the coronavirus." Read full story Source: BMJ, 28 October 2021

The laboratory at the centre of the Covid testing fiasco returned just four positive results out of more than 2,400 tests sent to it from one city, the Guardian has learned, raising questions about why it was not discovered sooner. The positivity rate of just 0.2% from Sheffield tests sent to the Wolverhampton lab run by Immensa contrasts sharply with the national rate of about 5-8% at the time of the scandal. Data released under freedom of information laws by Sheffield city council showed there were four positive results, 2,391 negative and 13 void results processed by the lab from 1 September until it was suspended in mid-October. The disclosure also shows the scandal covers local authorities as far away from Wolverhampton as Yorkshire, with the UK Health Security Agency refusing to disclose which areas are affected beyond saying they are mostly in south-west England. One expert suggested there should have been about 200 positive results based on prevalence figures from the time. Kit Yates, a senior lecturer in mathematics at Bath University, said the country needed to see a full list of all the walk-in/drive in centres that were affected. “It’s all well and good notifying those people who were tested, but because of the nature of this communicable disease, this scandal now reaches well beyond those people,” he said. “The public deserve to know if their area was affected.” Read full story Source: The Guardian, 27 October 2021

The private laboratory that is under investigation for potentially issuing more than 40,000 false negative Covid tests was not fully accredited to perform the work, contrary to assurances made by health officials. The UK’s independent accreditation service, Ukas, told the Guardian on Monday that neither Immensa Health Clinics Ltd nor its sister company, Dante Labs, had ever been accredited by the service, and that it had informed the Department of Health that statements suggesting otherwise were incorrect. The UK Health Security Agency announced on Friday that it was suspending operations at Immensa’s laboratory in Wolverhampton pending an investigation into concerns that at least 43,000 people with coronavirus had been wrongly told their swabs tested negative for the virus. Because many of the individuals would have believed the typically more accurate PCR tests performed by Immensa over simpler lateral flow tests, there is a substantial risk they unwittingly spread the virus on to thousands more people. Read more Source: The Guardian, 18 October 2021

Around 43,000 people in England may have been wrongly told their Covid-19 test was negative because of errors at a lab. Testing at the Wolverhampton laboratory has been suspended following an investigation by NHS Test and Trace. It is now contacting those affected, mainly in the south west region, to ask them to take another Covid test. Concerns were raised when people had positive lateral flow tests but negative PCR results from the lab. Read full story Source: BBC News, 15 October 2021

The lateral flow devices used in the community testing pilot in Liverpool only picked up half the COVID-19 cases detected by polymerase chain reaction (PCR) tests and missed 3 out of 10 cases with higher viral loads, according to the government’s own policy paper. Given the low sensitivity of the Innova lateral flow devices when used in the field, experts are questioning how they can be used to allow care home residents to have contact with relatives over Christmas safely or for students to know for certain that they are not infected before returning home. The information can only be found by looking in annex B of the document, Community testing: a guide for local delivery, which was published on 30 November. This is the first publicly available information about the field evaluation of the Innova tests in Liverpool which has been criticised for its lack of transparency, accuracy of the tests used, and costs and potential harms. Read full story Source: BMJ, 4 December 2020

Trusts are carrying out harm reviews after a ‘contamination issue’ affecting hundreds of samples resulted in some staff and patients being wrongly told they had coronavirus, HSJ can reveal. The error happened in mid-October and involved swabs from five trusts in the South East region, which were being processed by the NHS-run Berkshire and Surrey Pathology Services. HSJ understands it is thought that around 100 people across several trusts were given false positive results, and subsequently tested negative. The trusts involved are the Royal Surrey Foundation Trust, Frimley Health Foundation Trust, Royal Berkshire Foundation Trust, Ashford and St Peter’s Hospitals Foundation Trust and Berkshire Healthcare Foundation Trust. Frimley has completed a clinical review and found no harm had been caused, while Royal Berkshire, Ashford and St Peter’s and the Royal Surrey have reviews ongoing. The position for Berkshire Healthcare, a mental health trust, is not known. Read full story (paywalled) Source: HSJ, 2 December 2020

Health inspectors in England have been moving between care homes with high levels of COVID-19 infection without being tested, raising fears they have put more residents at risk of catching the virus, leaks to the Guardian have revealed. In recent weeks all care home inspections carried out in the north of England have been of infected homes, including a facility where 38 of the 41 people receiving care and 30 staff – almost half of the workers – had tested positive, internal documents from the Care Quality Commission (CQC) show. Over the last two months inspectors have been checking infection control procedures and care standards in up to 600 care homes, many of which were dealing with outbreaks of COVID-19, but the Department of Health and Social Care (DHSC) has yet to provide testing. The CQC said on Friday it was expecting to start testing inspectors “in the coming weeks”. Weekly Covid deaths in care homes have been rising. In the week to 20 November, 398 people were notified to the CQC as having died from Covid, up from 138 a month earlier. The death toll remains lower than at the peak of the pandemic, when more than 2,500 people were dying a week in late April. The situation has sparked “very real anxieties about contracting the disease” and spreading it between infected homes, the leaked memos reveal. One inspector described work to his managers as like “going into the eye of the storm”. Read full story Source: The Guardian, 27 November 2020

NHS Test and Trace chief Baroness Dido Harding will be interviewed by HSJ editor Alastair McLellan at 9am tomorrow as part of HSJ’s virtual provider summit. HSJ’s subscribers working in the NHS or a non-profit organisation can register to attend the summit here. Other speakers will include new Health Education England chief executive Navina Evans and King’s Fund chief executive Richard Murray. The subjects due to be covered include how the NHS will tackle the drive to recover routine care, the service’s workforce challenges and how forthcoming legislation may impact the governance of the service. Full details of the programme can be seen here.

Matt Hancock has called for British people to routinely get tested for the flu, saying covid diagnostic capacity should be kept and used for “everything” once the pandemic dies down. Speaking at the Commons health and social care committee this morning, the health and social care secretary said the nation “must hold on to” the mass diagnostic capacity it has created for coronavirus. Going further, he called for a change in culture to one of “if in doubt, you get a test”, and for a long-term expansion of diagnostics. Mr Hancock said: “Why in Britain do we think it’s acceptable to solider on when you have flu symptoms or a runny nose, and go in [to work] and make everyone ill? “If you have flu-like symptoms you should have a test for it and find out what is wrong with you and stay at home. We are peculiar outliers in soldiering on and going to work and that… culture, that should change.” Read full story (paywalled) Source: HSJ, 24 November 2020

The NHS will rollout twice-weekly asymptomatic testing for all patient-facing staff by the end of next week, according to a letter from NHS medical director Stephen Powis. Government said only last week that universal asymptomatic staff testing would start in December, but government has now agreed it will bring this forward to this week for a first tranche of 34 trusts; and all others next week. The tests at 34 trusts this week will cover “over 250,000 staff,” Professor Powis said. He set out plans for the new testing regime in a letter to Commons health and social care committee chair Jeremy Hunt who has been pressing the government for routine staff testing since the summer. “Staff will be asked to test themselves at home twice a week with results available before coming into work,” Professor Powis said. The new testing regime can start following “further scientific validation of the lateral flow testing modality last week, and confirmation over the weekend from Test and Trace that they can now supply the NHS with sufficient test kits”. Read full story Source: HSJ, 9 November 2020

A mass testing pilot of the government's "operation moonshot" has begun in Liverpool. The pilot scheme will see half a million people offered tests, including a new form of rapid testing, even if they do not have symptoms, as Botis Johnson banks on technological advances to steer the nation out of a second wave of COVID-19. Around 2,000 members of the military are helping NHS staff to administer a combination of swab tests and new lateral flow tests which give results within an hour without the need of a lab. Loop Mediated Isothermal Amplification (LAMP) tests, which can give results in as little as 20 minutes are being trialled for hospital and care home staff. But it comes as the Guardian reported that some of the technology at the heart of the scheme missed more than 50% of positive coronavirus cases in a Greater Manchester pilot. The OptiGene LAMP test identified only 46.7% of infections during a trial in Manchester and Salford last month, according to a letter from Greater Manchester's mass testing group seen by the newspaper. The Department of Health and Social Care (DHSC) said that it was "incorrect" to suggest the rapid test has a low sensitivity, adding that it had been validated in another recent pilot. Read full story Source: Sky News, 6 November 2020

People in Liverpool will be offered regular COVID-19 tests under the first trial of whole city testing in England. Everyone living or working in the city will be offered tests, whether or not they have symptoms, with follow-up tests every two weeks or so. Some will get new tests giving results within an hour which, if successful, could be rolled out to "millions" by Christmas, the government says. Liverpool has one of the highest rates of coronavirus deaths in England. The latest figures show the city recorded 1,754 cases in the week up to 30 October. The average area in England had 153. The pilot aims to limit spread of the virus by identifying as many infected people as possible, and taking action to break chains of transmission. It is thought around four-fifths of people who are infected with coronavirus show no symptoms. Read full story Source: BBC News, 3 November 2020

A total of 338 patients with a diagnosis of COVID-19 were discharged from Scottish hospitals into care homes in the three months from March this year, says a report from Public Health Scotland. The discharges were necessary to free up space in hospitals for COVID-19 patients but some care home owners have claimed that it introduced the virus into their premises, causing almost 2000 deaths across Scotland.2 Public Health Scotland says that most of the 3599 discharges that took place in the busiest month of March were among people who had never been tested. Of the 650 who were tested, 78 were positive, but the discharges still went ahead. Scotland has been found to have the highest rate of COVID-19 related deaths in care homes of any part of the UK. Read full story Source: BMJ, 29 October 2020

Almost half of hospital patients have been discharged without receiving the results of their coronavirus test – including some patients who were sent to care homes, new research from Healthwatch and British Cross has revealed. Independent national patient body Healthwatch England said it had learned many patients were discharged from hospitals between March and August this year without proper assessments with many vulnerable people sent home without medication, equipment or the care they needed. At the start of the pandemic thousands of patients were discharged to care homes as NHS England instructed hospitals to free up 15,000 beds ahead of the first wave of coronavirus. Approximately 25,000 patients were sent to care homes with some not tested, sparking fears this helped seed care homes with the virus. There have been around 16,000 care home deaths linked to COVID-19. According to a survey of almost 600 discharged patients and interviews with 60 NHS staff, Healthwatch England said it had found serious flaws with the way hospitals had followed NHS England’s instructions. Read full story Source: The Independent, 24 October 2020

There is growing distrust for the NHS and government in communities that are of fundamental importance to the national effort to counter covid, according to research by NHSX. People in so-called “hard to reach” communities are faced with stigma and racism due to the covid pandemic but have dwindling trust in the health service, the research found. They are worried about how their personal data will be used by the NHS and other state bodies. They are particularly concerned that their details will be passed on to the police or immigration services. Read full story (paywalled) Source: HSJ, 20 October 2020

More than 200 people who went through hotel quarantine in Victoria, Australia, must be screened for HIV amid fears of cross-contamination from incorrect usage of blood glucose test devices. Several such devices were used on multiple people in quarantine between 29 March and 20 August, necessitating screenings for blood-borne diseases such as hepatitis B and C and HIV. These monitors, which take a small sample of blood from a fingertip, are intended for repeated use by only one person. While the needle is changed between usages, microscopic traces of blood can remain within the body of the machine, creating a low clinical risk of cross-contamination and infection. Safer Care Victoria, the state’s healthcare quality and safety agency, has assured the public there is no risk of COVID-19 spread as the disease is not transmitted by blood. These devices have since been taken out of circulation. In a statement, a spokesman for the agency said they have identified 243 people who had been tested by one of the shared machines during the timeframe in question, and will be contacted for screening. Everyone “who had conditions or episodes that may have required the test will also be contacted as a precaution”. The Victorian premier, Daniel Andrews, labelled the incident a “clinical error that was made some time ago”. “Safer Care Victoria have made some announcements in relation to a clinical error that was made some time ago, very low risk, but you can’t take any risks with these things. You have to follow them up properly and that’s exactly what has happened,” he said at a press conference on Tuesday. Read full story Source: The Guardian, 20 October 2020

Ministers have denied care home inspectors access to weekly testing for coronavirus – despite fears they could contribute to the spread of COVID-19 as cases rise across the country, The Independent can reveal. The Care Quality Commission (CQC) was told by the Department of Health and Social Care last month it could not have access to regular testing for inspection teams as the watchdog prepares for 500 inspections of care homes during the next six weeks. Officials said the teams, who are assessing care conditions for the vulnerable and elderly, did not get close enough to people to present a risk. During the first wave of the virus, after Public Health England initially said there was no risk to care homes, an estimated 16,000 residents died from the virus. At the height of the crisis up to 25,000 NHS patients were discharged to care homes by the NHS, with many not having been tested for the virus. Labour MP Barbara Keeley said: “The refusal of the Department of Health and Social Care to treat CQC inspectors in the same way as other staff going into care homes puts lives at risk.” Read full story Source: The Independent, 20 October 2020

Leaking vials and suspected contamination were identified in a batch of more than 500,000 test tubes produced for the NHS Covid test and trace operation over the summer, whistleblowers have said. The test tubes were provided by a small UK-based company, Life Science Group (LSG), which produces materials for the diagnostics industry. According to the whistleblowers, there have been repeated problems with test tubes filled by LSG leaking. Stocks of some 600,000 test tubes were inspected in August as a result, and records seen by the Guardian describe the discovery of what looked like hair and blood contamination. It is understood firms in the supply chain concluded that the contamination was not hair or blood, following inspections. However, records seen by the Guardian suggested at least one bag of LSG test tubes thought to be contaminated “cannot now be found”. The whistleblowers said that rather than rejecting the entire potentially compromised batch, as would be normal safety protocol with NHS supplies, only part of the batch with visible problems was removed from use. They said they had blown the whistle because they were concerned for public safety. Read full story Source: The Guardian, 16 October 2020

The introduction of weekly covid tests for NHS staff in ‘high risk areas’ will mean other groups missing out or waiting longer, well-placed sources have told HSJ. There is also understood to be a standoff between NHS England and Test and Trace over the regular testing of asymptomatic staff, which was announced for the North of England on Monday. NHS trust labs don’t have enough capacity to test all their staff; and there is not enough spare in “pillar two” commercial labs to carry out hundreds of thousands of additional tests. National bodies are said to be in disagreement over who should do it. NHSE believes they should be provided by T&T, and T&T says NHS labs should expand their capacity to carry them out themselves, HSJ has been told. A senior source involved in the testing programme said there would have to be “trade-offs” for T&T to meet the new NHS demand, with supply having to be cut for others who want tests — mostly the general population, or care home staff. At present the NHS has agreed to carry out 100,000 daily tests by the end of the month, as part of the T&T’s overall 500,000 target. It has been encouraged to do more by T&T, but any expansions may face shortages of equipment and supplies such as reagents, as well as staff and space. Read full story (paywalled) Source: HSJ, 13 October 2020

Senior doctors specialising in infectious diseases have written an open letter expressing "concern" about the rapid increase in COVID-19 cases in Northern Ireland. The letter is signed by 13 medics from hospitals across Northern Ireland. It calls for the public to stick to government guidance on reducing social interactions and also warns against "stigmatising people and areas with high levels of infection." The letter reads: "We need to support people who test positive. This pandemic requires us to work together to bring it under control urgently. We need to reduce the potential for transmission to protect our health service, and we need to fix our test and trace system to try and gain better control of this virus in our community." On Monday, 616 new cases of COVID-19 were identified in Northern Ireland, bringing the total during the pandemic to 14,690. The number of deaths recorded by the Department of Health remains at 584. Among those who have signed the letter are Dr Claire Donnelly, a consultant physician who specialises in infectious diseases; consultant virologist Dr Conall McCaughey and consultant paediatrician Dr Sharon Christie. Entitled an "appeal to people to adhere to Covid public health guidance", the letter lays bare the stark reality of the infections rates. The letter adds: "Worryingly the number of cases is increasing rapidly in many areas over the last week, indicating that we have widespread community transmission in many parts of Northern Ireland." Read full story Source: BBC News, 6 October 2020

A technical glitch that meant nearly 16,000 cases of coronavirus went unreported has delayed efforts to trace contacts of people who tested positive. Public Health England (PHE) said 15,841 cases between 25 September and 2 October were left out of the UK daily case figures. They were then added in to reach Saturday's figure of 12,872 new cases and Sunday's 22,961 figure. PHE said all those who tested positive had been informed. But it means others in close contact with them were not. The issue has been resolved, PHE said, with outstanding cases passed on to tracers by 01:00 BST on Saturday. The technical issue also means that the daily case totals reported on the government's coronavirus dashboard over the past week have been lower than the true number. Read full story Source: BBC News, 5 October 2020

The stress and anxiety caused to patients by "poor communication" from NHS bodies in England during the covid pandemic has been criticised by MPs. While recognising the huge burden placed on the NHS, their report said cancelled treatments and surgery had left some "in limbo" and others "too scared" to seek medical help. The report also questioned why weekly testing of NHS staff had not yet begun. And it called for their mental and physical wellbeing to be supported. Jeremy Hunt, who chairs the Health and Social Care Committee, which compiled the report, praised the "heroic contribution" made by front-line NHS staff during the pandemic, which had saved many lives. But he said the pandemic had "massively impacted normal NHS services" and this situation could have been improved with clearer communication to patients and better infection control measures in hospitals. The report, based on evidence from doctors, nurses, patient groups and NHS leaders, said the case for routine testing for all NHS staff in all parts of the country was "compelling" and it should be introduced as soon as possible before winter to help reduce the spread of the virus. The government and NHS England told the committee they wanted to bring in routine testing of staff but any plans depended on the capacity available. Read full story Source: BBC News, 1 October 2020

When Sarah found herself suffering sudden bouts of breathlessness in May, she took herself to hospital. But after her COVID-19 swab test came back negative, doctors said she was probably anxious, and sent her home. Despite this, Sarah’s symptoms continued to worsen. A week later, she was rushed to hospital in an ambulance. Paramedics told her that based on her clinic observations, she should be in a coma. Then came more surprising news: She had tested positive for coronavirus Sarah’s story – given to a patient safety charity under a pseudonym – is one that resonates with Dr Claudia Paoloni, president of the Hospital Consultants and Specialists Association. She detailed another case in which a patient tested negative twice: once when she was first admitted to hospital and once later in her hospital stay. She finally tested positive on her third test – by which time she was on a ventilator in intensive care. Paolini believes COVID-19 swab tests produce a troublingly high rate of false negative results, and the problem lies in the reliance on a single test. “To use as a one-off test in any capacity to exclude someone from having COVID-19 is a folly.” If you want to exclude someone from having the virus, Paoloni said, you must do multiple tests and collect multiple negative results. “If the test and tracing system is not working, which is the case here, transmission will continue unabated in the community.” The most recent data published by the Office for National Statistics says the test’s sensitivity - which it says can tell us how likely it is to return a false-negative result, may be somewhere between 85% and 98%. Dr Deenan Pillay, Professor of Virology at University College London and member of Independent Sage, a group of scientists providing transparent advice during the crisis, said a significant number of self-administered tests could be coming back negative for people who do in fact have the virus. “The single biggest reason why a swab from someone who has COVID-19 comes up as negative is the quality of the swab that is taken,” Dr Pillay said. “Swabbing your nose and throat in a way that will pick up the virus means really scraping down the side of the wall of the nose or back of the throat to get cells from the lining of the throat. That’s not a pleasant thing to do.” This is of course true for at-home testing, which relies on the patient or a family member to collect the swab. But it could be true at testing centres, too. Tom, a 29-year-old from London whose name has been changed for this story, said there were no medical staff on site when he visited a Covid testing centre in London. The only people he interacted with were staff from a third-party contractor paid to carry out testing. “The man simply handed me a test, read out the instructions to self-administer the test, and asked me to do it myself,” he said. Pillay agrees that testing methods are likely to have an impact on false negative results. “I have seen the documentation given out at testing centres and it is very confusing,” he said. “Centres often expect you to administer the test yourself or get someone else in your car to administer it for you, all of which creates difficulties.” Pillay believes the solution lies in having medically trained staff at testing centres. “The way the system is developed at the moment, outsourced to private companies like Deloitte and Lighthouse Labs, is just woeful,” he said. “The whole system is failing at the moment. And it’s happening just as the numbers of infections are starting to rise,” Dr Pillay said. Read full story Source: Huffpost, 27 September 2020

Tens of thousands of people infected with coronavirus were incorrectly given the all clear by England’s Lighthouse Laboratories, a High Court trial will be told next week. Court documents seen by The Independent show the labs are accused of unfairly selecting software that was shown in a test to produce significant numbers of errors and false negatives, samples that should have been positive or classed as needing to be re-taken. The two companies behind the Lighthouse Labs in England – Medicines Discovery Catapult Ltd and UK Biocentre Ltd – are accused of treating British company, Diagnostics.ai unfairly and giving preferential treatment to Belgian company UgenTec, despite the British firm’s software performing better in the test. The case, first revealed by The Independent in June, also includes a judicial review of the procurement decision against health secretary Matt Hancock – one of the first court hearings over the procurement processes followed by the government since the start of the pandemic. The Independent understands lawyers for Diagnostics.ai will accuse the laboratories of choosing a software solution that went on to produce tens of thousands of incorrect results which will have led to infected people going about their normal lives while at risk of spreading the virus. In June, UgenTec chief executive Steven Verhoeven told The Independent the suggestion its software had made errors was “incorrect”. The Department of Health refused to comment on the legal action but said in June that the UgenTec software had been used for several months and was subject to quality assurance processes, though it did not give any further details. Mr Justice Fraser will hear opening arguments in the case on Monday at the High Court. Read full story Source: The Independent, 25 September 2020