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.”

HIV Self test kit photo.jpg

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.

New Advance In Wearables


A new soft, flexible microfluidic device sticks on forearm or back skin to measure sweat and show how the body is responding to exercise. The small, simple, low cost device analyses key biomarkers to help a person decide quickly if any adjustments, such as drinking more water or replenishing electrolytes, is needed, or if something is medically wrong.

It is designed for one-time use of a few hours and features a number of innovations including:

• The ability to capture, store and analyse sweat in situ and in real time
• Can quantitatively determine biomarker levels using colorimetric analysis
• A power source is not required to display the results; instead, a smartphone camera and app are used to read the biomarker change


The device’s sensitivity even enables it to pick up the biomarker for cystic fibrosis and it is hoped that in future it may be used more broadly for disease diagnosis.

Study leader John A. Rogers, professor of materials science and engineering, discussed the device: “The intimate skin interface created by this wearable, skin-like microfluidic system enables new measurement capabilities not possible with the kinds of absorbent pads and sponges currently used in sweat collection.”

The team have studied the efficacy of the device in two groups of cyclists and found it to be both accurate compared to conventional lab analysis and durable in unpredictable environmental conditions. Their findings were published on 23rd November in Science Translational Medicine.

New Test Launched in European HIV Testing Week


In its fourth year, and the second time hepatitis testing has been included, European HIV Testing Week is currently in action. Starting on 18th November, and finishing a week later, testing week is spanning the length and breadth of the continent with partners participating from over 50 European countries.

Prior to this, the world’s fastest HIV self-test kit went on sale last week in order to relieve pressure on overcrowded sexual health clinics.

bioLytical Laboratories, renowned for their production of rapid infectious disease tests, has developed the INSTI HIV Self Test, following research revealing that over 103,000 people are living with HIV in the UK and an estimated 18,100 remain unaware of their positive status.


It was reported recently that funding cuts have resulted in clinic closures across the country meaning the pressure is on for remaining clinics. Failure to fund routine testing in GP surgeries is leading to late diagnosis when early treatment of the disease is highly beneficial.

With one prick to a finger and a droplet of blood, the INSTI HIV Self Test provides immediate results and is over 99% accurate. Other home testing kits can take up to 20 minutes to produce a result, and in some cases laboratory test results can take several days or weeks.

The INSTI HIV Self Test kit also includes a resource card on where to seek help or for those who have general questions on HIV screening.

The test is available now online at and costs €29.95 (£25.95) per kit.

WHO expresses interest in new Zika test

Scientists in Singapore have developed a kit that can test for the Dengue, Chikungunya and Zika viruses all at the same time in just two hours.

The three mosquito-borne viruses cause similar symptoms such as rashes and joint pain. Symptoms for the Zika virus are generally mild and go away within a week, causing the disease to be misdiagnosed.

The kit is ready for use and only costs a few dollars to produce. Dr Masafumi Inoue, a senior research scientist at the Agency for Science, Technology & Research’s Experimental Therapeutics Centre confirmed that the World Health Organisation (WHO) has expressed interest.

Zika Testing Kit.jpg

Dr Masafumi Inoue is currently compiling clinical data for the health authority before sending the kit over for testing. If the testing is successful, the WHO may use the kit to test for the viruses.

As it is extremely important to quickly distinguish between the three major mosquito-borne viruses, the kit could prove incredibly useful in ensuring patients receive the required treatment and care without delay.

All that is required from the patient is a blood or urine sample. The genetic material of the virus is then extracted to find out what the virus is. The detection process takes two hours, reducing the time by threefold if each of the viruses were to be tested for individually.

The idea to develop the kit came about six months ago when Brazil had been hit badly by a large number of Zika cases.

Big push for 23andMe at NACDS


“This is a story about why you became … who you are,” a friendly woman’s voice says in the new TV ads for 23andMe genetic tests, explaining further that results offer “unique insights into your health, traits and ancestry”. It was rather surprising to hear my 16 year-old son say that he might want to try it someday.

In addition to learning where his great great great great grandfather came from, which is interesting to him now, some day my son will be able to learn about his genetic traits in the same way as his caffeine consumption, deep sleep, lactose intolerance, muscle composition and saturated fat and weight. But more importantly, many many many years from now, when he wants to be a father, he will know if he carries genes linked to conditions like cystic fibrosis, sickle cell anaemia and hereditary hearing loss (probably not the same condition as the selective hearing loss that happens when it’s time to take out the trash).

23andMe NACDS

Currently available through e-commerce, 23andMe is ready for retail and was promoted with a dominant display at last week’s Total Store Expo, held by the National Association of Chain Drug Stores, in Boston.

Personalised medicine is bring developed to give patients the best possible treatment outcomes in a clinical setting – but 23andMe in CVS or Walgreens is bringing DNA testing to the masses, intriguing even a 16 year old…

Prince Harry gets pricked publicly; Faster OTC HIV test approved

Last Thursday, people all over the world watched the UK’s Prince Harry get his finger pricked when he streamed his HIV test, conducted in a clinic, live on Facebook.


People who prefer a less public test will benefit from bioLytical Laboratories’ new INSTI HIV Self Test, which was approved last week by the EU and will be available in retail and e-commerce sites by the fourth quarter of this year. According to bioLytical, INSTI is the world’s fastest HIV Self Test, providing instant results with just one drop of blood. The at-home test reportedly yields greater than 99% accuracy.

Getting tested for HIV is the first step in taking control of one’s health and preventing transmission to others, and it is a step that can be the hardest to take, according to healthcare professionals. “It’s amazing how quick it is,” said Harry about his bioLytical HIV test (negative), performed at the Burrell Street Sexual Health Centre in South London. “Once you get people through the door, that’s the hardest bit out of the way.”

“Accessibility, inconvenience, anxiety, lack of awareness, stigma and discrimination are some of the reasons why a person may hesitate to take an HIV test,” noted Rick Galli, Chief Technical Officer of bioLytical Laboratories, “and this is exactly why we commend Prince Harry’s efforts towards the cause.”

OTCs in Action also commends bioLytical Laboratories for its efforts to improve HIV testing in public and private. 

OTCs in Action Episode 38: Owning the ailment with “Prodices”


This week, “Prodices” – hybrids of products and services – are OTCs in Action. All OTC brands have a web page, many tweet and post on social media, and a few offer apps to help manage self-treatment. Brands that include diagnostic tools, OTC therapy and condition monitoring are Prodices, according to Sorento Healthcare’s Susan Josi, Nicholas Hall’s Network Partner in India. She shares her exciting perspective in this month’s edition of Nicholas Hall’s OTC INSIGHT Asia-Pacific:

At a time when technologies are converging and boundaries are blurring, the once clear divide between product and service is becoming hazier. So how do we create consumer-centric solutions in the context of the brands we handle and the ailments they treat? The answer is to take the best of both worlds – the advantages without the disadvantages. Welcome to the age of “Prodices”, a term coined by pharmacist and author Jordi Bernal Fiego to describe hybrids of products and services, which seamlessly integrate the original advantages and features of each and offer a solid value proposition for the consumer.” The concept of Prodices is still in its infancy but some healthcare companies have already implemented these types of services in basic ways.

The following are some examples of Prodices currently available to consumers:

  • iCan (Piramal Enterprises). In India, Piramal launched the i-canhelp webpage to support its pregnancy test brand, Elevit (Bayer)
  • In S Korea, Bayer updated the website for its pregnancy multivitamin to include an ovulation calendar to help with conception
  • Benza (Takeda). Takeda operates an online pollen forecast to support cough, cold & allergy brand Benza in Japan
  • Calpol (J&J). In the UK, J&J developed a smartphone app for children’s systemic analgesic Calpol, which includes features such as a temperature tracker and symptom checker

Owning the ailment

A more futuristic prospect is available to create a Prodice model for brands to straddle the continuum of care from diagnosis to treatment adherence and monitoring, to ensure that health outcomes are positive. The key to developing this model is to map the consumer’s journey more intimately in a bid to understand the various interventions needed to help them get a more positive outcome while managing their condition. These interventions can be varied and, in many cases, cannot be addressed by one company alone. Therefore co-creation through collaborations or acquisitions will be the order of the day.

It is evident that the most enterprising healthcare companies of today are preparing to embrace a distinctly different future in this domain. These early movers are attempting to secure their innovation and organisational efforts around the concept of “owning the ailment” – as opposed to merely “treating it” – with products, services and solutions across the entire continuum of care.

To read the full article, visit Nicholas Hall’s OTC INSIGHT web page:

Sorento Healthcare Communications includes CubeX, its Strategic Consulting & Business Intelligence division. If you would like to find out more about CubeX – which has expertise in consumer healthcare and wellness – please write to

OTCs in Action Episode 22: Genetic disorders vs. alcoholic blushes


Although red noses are stereotypically associated with flying reindeer and alcoholics, it’s often a symptom of rosacea, a skin disorder most commonly found in people of Irish and Western European descent. To debunk the blarney, alcohol is a trigger for symptoms but less so than sun exposure, emotional stress, hot weather, wind and heavy exercise. OTCs are in Action this month pioneering the future of personalised self-diagnosis, using DNA to identify genes for rosacea and Bloom Syndrome.In the first case, Google’s 23andMe, the groundbreaking company that is bringing DNA testing to consumers, teamed with researchers at Stanford University to study the data of more than 46,000 23andMe customers who consented to sharing their data for research. The study, available online in The Journal of Investigative Dermatology, found two genetic variants strongly associated with the disease among people of European ancestry. Further, the study uncovered that the genetic variants, or single nucleotide polymorphisms (SNPs), found to be strongly associated with rosacea are in or near the HLA-DRA and BTNL2genes, which are associated with other diseases, including diabetes and coeliac disease.

Additionally, the company went a step further in the self-diagnosis continuum last month, when it was granted authorisation by the FDA to market the Bloom Syndrome carrier status report. Bloom Syndrome is an inherited disorder characterised by short stature, sun-sensitive skin changes, an increased risk of cancer and other health problems. According to the company: “This is an important first step in fulfilling our commitment to return genetic health reports to consumers. This is the first-time the FDA has granted authorisation to market a direct-to-consumer genetic test, and it gives us a regulatory framework for future submissions.

“While this authorisation is for a single carrier status test only; we are committed to returning health information to our US customers who don’t already have this information once more tests have been through this process and we have a more comprehensive product offering.”

Last week, 23andMe announced the creation of a new therapeutics group and appointment of Richard Scheller, PhD, as chief science officer and head of therapeutics to lead it. Dr Scheller retired in December 2014 from a distinguished 14 year career as an executive at Genentech, where he was the executive vice president of research and early development.

When Dr Scheller assumes his post at the beginning of April 2015, he will help build a dedicated research and development team. The therapeutics group aims to use human genetic data as the starting point for identifying new therapies for both common and rare diseases. “I have dedicated my life to research aimed at fulfilling unmet needs for very sick people,” said Dr Scheller. “I believe that human genetics has a very important role to play in finding new treatments for disease. I am excited about the potential for what may be possible through 23andMe’s database. It is unlike any other.”

OTCs in Action Episode 14: OTC Transformers


Two innovators featured in Medical Marketing & Media’s Top 40 Healthcare Transformers are shifting the shape of OTC.

Roche’s Michael Coffey, Consumer experience team lead, is changing the way diabetics feel about treatment of their condition. Roche’s Accu-Chek test kits are OTCs in Action to change the blood glucose testing experience by rewarding diabetics with pleasant surprises, such as aroma candles or popcorn, with their monthly supplies.

“The challenge is understanding where our ability to walk alongside the customer truly is and to break out of the commoditised world we live in,” he says. Along those lines, Coffey believes that it’s important to look beyond healthcare to delight consumers; he finds inspiration in the world of discovery retail (wine clubs, Birchbox beauty products).

“Can we get them excited about testing? Can we get them to share it socially?” he asks. “If we can make that happen, it would open up the door for them to talk about diabetes as part of their lifestyle in a positive way. We approach them as people, not patients.” (MM&M, January 1, 2015)

Gary Kay, President and Co-founder of Cognitive Research Corp, has developed technology that can evaluate whether consumers taking OTCs should be in action – on the road, that is. CRC’s simulation programme evaluates a drug’s effect on driving.

“It is critically important that prescribers and consumers recognise that drugs, even OTC drugs, can impair their ability to drive, whether or not they feel drowsy,” Kay says.

Sometimes the interactions are unexpected. The company recently asked test subjects to drink two glasses of wine a day after they took a standard dose of an OTC cold medication. “While that’s a legal amount of alcohol, we found they were really impaired,” Kay reports. Of course, social pressures have sparked change, too. “It took us a long time to become aware of the risks of alcohol and driving, and now we are realising the effects of medications on driving safety. Consumers are demanding that these studies be conducted.”

To read the full MM&M article: