HIV / AIDS home test kits seized over potential false results

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has seized 114 Hightop HIV/AIDS Home Test Kits, which could be potentially misleading in providing false results. The agency has advised that anyone who has used the kit should seek a further HIV test at a local sexual health clinic or through a GP.

A statement issued by the MHRA stated: “All UK based stock of Hightop HIV/AIDS Home Test Kit have been seized by MHRA and all sales of the product into the UK market have been stopped by the manufacturer”

The statement continued: “The HIV kits, manufactured by Qingdao Hightop Biotech Co Ltd, do not have a valid CE mark which means the product has not met a number of regulatory requirements concerning test performance, labelling and instructions for use.”

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Self-testing kits for HIV became legal in the UK from 6 April 2014, but buyers have always been warned to carefully check the CE mark before purchasing any kit. Self-test kit users who purchase kits online or from the high street should know what they are buying is safe and reliable. MHRA is currently investigating the issue with experts at Public Health England.

John Wilkinson, MHRA’s director of devices commented: “If you are concerned you may have used an unreliable test kit, speak to your GP, sexual health clinic, pharmacist or other healthcare professional”. He further added: “Make sure the kit has a CE mark and clearly states that it is intended for home self-testing. Don’t use a test kit if it’s damaged or the seal is broken.”

MHRA strongly suggests consumers should only buy a self-test kit from a reputable source, such as an online pharmacy registered with the MHRA. In the UK, online pharmacies must be registered with the MHRA and display the European common logo on every page of their website. While home self-test kits for HIV and STIs have many benefits, including letting people test in their own space and on their own terms, there’s equal concern surrounding their use.

According to recent surveys there are more than 100,000 people living with HIV in the UK and around a quarter of them don’t know they’re HIV positive.

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Smartphone app may help older adults manage serious mental illness and chronic health conditions

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The use of new technologies in geriatric psychiatry shows promise for advancing personalised medicine and improving patient care. A new study in The American Journal of Geriatric Psychiatry describes the successful adaptation of an integrated medical and psychiatric self-management intervention to a smartphone application for middle-aged and older adults with serious mental illness.

Care of middle-aged and older patients with serious mental illness can be difficult. Often these patients suffer from other medical conditions and are at increased risk of premature death. In order to help patients cope with their illness, researchers from Dartmouth developed a smartphone-based intervention using adaptive systems engineering framework and principles of user-centred design.BJHC_elderlylady_mobile_mini_0_8

“The use of mobile health interventions by adults with serious mental illness is a promising approach that has been shown to be highly feasible and acceptable,” explained lead investigator Karen L. Fortuna, PhD, of the Dartmouth Centers for Health and Aging and the Geisel School of Medicine at Dartmouth.

They found that even patients with limited technical abilities could use this app successfully. The app and intervention protocol were developed using commercially available products from Wellframe.

Following multiple design iterations, investigators tested the app’s usability and found Ten participants with serious mental illness and other chronic health conditions reported a high level of usability and satisfaction with the smartphone application.

The app takes patients through 10 sessions over a period of around three months, covering topics such as stress vulnerability and illness, medication adherence and strategies, and substance and medication abuse. Physicians can remotely monitor app use, and intervene when problems are detected, facilitating telemedicine for less accessible populations.

This study is part of a special issue of The American Journal of Geriatric Psychiatry that captures an important moment in the evolving relationship between technology and the clinical care of

 

Vitamin B3 could prevent miscarriages and birth defects

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An extra dose of vitamin B3 might help prevent certain kinds of complex birth defects, according to a new study. It is thought the vitamin can help compensate for defects in the body’s ability to make a molecule, nicotinamide adenine dinucleotide (NAD), which researchers have now linked for the first time to healthy fetal development in humans.

Every year 7.9 million babies are born with a birth defect worldwide. The discovery suggests the possibility that boosting levels of B3 in pregnant women’s diets might help lower overall rates of birth defects.

Researchers from the Victor Chang Institute in Sydney called it ‘a double breakthrough’ as they found both a cause and a preventative solution. The researchers analysed the DNA of four families where the mothers had suffered multiple miscarriages or their babies were born with multiple birth defects, such as heart, kidney, vertebrae and cleft palate problems.

They found mutations in two genes that caused the child to be deficient in a vital molecule known as Nicotinamide adenine dinucleotide (NAD), which allows cells to generate energy and organs to develop normally. Lead researcher Prof Sally Dunwoodie replicated these mutations in mice and found they could be corrected if the pregnant mother took niacin (vitamin B3).

“You can boost your levels of NAD and completely prevent the miscarriages and birth defects. It bypasses the genetic problem,” she said. “It’s rare that you find a cause and a prevention in the same study. And the prevention is so simple, it’s a vitamin,” she said.

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Back In 2005, Dunwoodie’s team dealt with a particularly severe case, a baby who had major defects in the heart, backbone, and ribs; the rib problems being so bad that the child’s lungs couldn’t fully inflate. The team found that the family carried a mutation in a gene related to the production of NAD, a molecule crucial for energy storage and DNA synthesis in cells. Both parents carried a mutation in one of their copies of the gene, and the affected baby had inherited two defective copies.

No one had reported any role for NAD in heart or bone development, Dunwoodie says. “We didn’t know what to do with it.”

To confirm the role of the mutations in organ and bone development, the researchers knocked out the two genes in mice to see whether similar birth defects appeared. At first all the pups were normal. But then the researchers realised that standard mouse chow is rich in niacin and that cells can use either niacin or nicotinamide—both known together as vitamin B3—to make NAD by an alternate pathway.

The work opens a potentially exciting new area of research for developmental biologists: Trying to understand how cell metabolism affects development

 

 

App “as effective as the contraceptive pill”

A revolutionary form of contraception, especially available over-the-counter, has been long awaited. This year alone we have seen trials in male contraceptive injections and demands for numerous OTC contraceptive pills. Drastic change and action have long been in high demand.

What started out as a hobby project for Elina Berglund Scherwitzl has now become approved as the world’s first contraceptive app. The nuclear physicist, who had been working on the team that discovered the Higgs boson, felt finished with hormonal contraceptives and their physical and mental pitfalls, but was not yet ready to have a baby.

With a wealth of data skills, Elina was determined to find an alternative form of contraception. “Like many women I had tried many different contraception options since my teenage years and hadn’t really found a solution that fit me,” she explained. “It was in my quest for an effective natural alternative that I discovered that you can see when you’re fertile by your temperature, and for me that was really a revelation.”

Using complex mathematics and data analysis, Elina began developing an algorithm designed to be so accurate that it could identify exactly when in her cycle she would ovulate. This then enabled planning for when she would need to use protection, to a much higher degree of certainty than natural planning methods, which many women with timely periods are able to use.

These results proved to be so accurate that, together with her husband, fellow physicist, Raoul Scherwitzl, Elina set about founding her own business, Natural Cycles.

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Natural Cycles is an app designed to help women around the world with their fertility and contraception needs, allowing them to collect their own temperature datasets and closely monitor their cycle trends in the process.

Launched in 2014, the app now has some 300,000 users, who pay a monthly or annual fee for the service. Following several medical trials, the app became the first tech-based device on the planet to be formally certified for use as contraception, in February this year. It gained approval for use across the EU after getting the green light from the German inspection and certification organisation Tuv Sud.

The start-up now markets itself as being “as effective as the pill” following one of the largest clinical studies in contraception involving more than 4,000 women, published in the peer-reviewed European Journal of Contraception and Reproductive Health Care.

The researchers, which included the co-founding couple, found that 7% of women who used the app in a “typical” way (allowing for some human error) got pregnant, compared to 9% taking the pill and less than 1% using IUD coils. “Just like the pill we need some effort from the user on a daily basis. But we really hope to be the default alternative if you don’t want to use hormonal contraception or IUDs,” Elina commented.

While the product is only currently certified in the EU, where its users are concentrated in the UK and the Nordics, it is available worldwide and, despite its earlier controversies, has attracted users in some 160 countries.

Exploragen launches new sleep app

DNA lifestyle company Exploragen last week launched their first iOS app, which is available on Helix.com. The online marketplace of DNA-powered products offers insights on nutrition, fitness, health, ancestry, family and entertainment. The new app, which is named SlumberType, is a lifestyle app providing insights on the genetics of sleep, enabling people to understand the way sleep can be influenced by DNA.

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By analysing four key sleep measurements – Chronotype, Sleep Quality, Sleep Onset Latency and Sleep Duration – the app helps users conclude whether they are a morning or night person, how long it may take them to fall asleep, the duration and quality of their sleep, and how these factors may affect other areas of their lives. SlumberType also features tools and trackers which monitor everyday behaviour that potentially affects sleep.

“Our bodies function at their best when we get the right amount of sleep. SlumberType will allow people to understand how their unique biology, combined with their daily habits and activities, affects their sleep patterns, so they can optimise their lifestyle for better sleep”, said Exploragen co-founder and Head of Science Sara Riordan.

The app was recently launched on 24th July and is available now on Helix.com.

The future of diagnostic wearables?

 

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The University of Tokyo has recently started to develop a new generation of wearable diagnostics. The hypoallergenic electronic sensor wearables are designed to monitor health indicators without being invasive or causing any discomfort.

The electronic sensors are made up of breathable nanoscale meshes that attach directly to the skin to produce accurate and precise readings of heart rate and other health indicators. Japanese scientists believe the new wearables can be worn for up to one week, without causing any irritation. However, if devices are worn over a longer period it is thought they may be deemed unsafe, as they prevent breathability and block airflow causing irritation and inflammation.

“We learned that devices that can be worn for a week or longer for continuous monitoring were needed for practical use in medical and sports applications” says Professor Takao Someya at the University of Tokyo’s Graduate School of Engineering.

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The device can be applied by spraying a small amount of water, which dissolves PVA nanofibres to allow it to stick to the skin. It is designed to fit curvilinear surfaces of skin making it ideal to apply to sweat pores and index fingers.

Scientists are hopeful this is the beginning of a new chapter for wearable diagnostics and hope that it will be possible to measure health indicators without causing stress or discomfort to the user. The device is thought to not only be the future for medical diagnostics, but also have applications for sports technology.

 

 

OTC hearing aids: Awaiting US Senate vote

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Cheaply priced reading glasses have long been available to buy without prescription in supermarkets and pharmacies. While there is an available OTC product for some living with farsightedness, there is still yet to be an approved inexpensive over-the-counter equivalent for those living with mild-to-moderate hearing loss.

Medicare and most private insurance plans in the US do not cover prescription hearing aids, which cost around $2,400 for one device. Owing to this, it is thought that many people with hearing loss go without hearing aids because they cannot afford the devices.

This could be changing soon, as the House of Representatives has passed legislation that would create a new class of hearing aids that could be sold OTC.

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“We get inquiries every day from people who cannot afford hearing aids,” said Nancy Macklin, a spokeswoman for the Hearing Loss Association of America. According to a 2016 study from the National Academies of Sciences, Engineering & Medicine, just 14% of those with hearing loss use a hearing aid.

While there are several types of less expensive non-prescription personal sound amplification devices on the market, the devices are not regulated by any government entity for safety or quality standards and are used to aid people with normal hearing but wish to amplify sound.

Recent advances in technology have made the concept of less-expensive, OTC hearing aids very possible. The potential switch is part of the FDA Reauthorization Act of 2017, which the House passed Wednesday with a voice vote. The bill received widespread bipartisan support, but the Senate has yet to announce a timeline for holding a vote on the bill.

The arrival of OTC hearing aids can’t come soon enough for an ageing population that is continually growing. As Baby Boomers age and Generation X hits middle age, the number of people with mild to moderate hearing loss is increasing rapidly.