News
Brace yourself: New UK medical device regulations set to sweep self-test kit ranges off the market!
Monday 24th July 2023
SELFCHECK
With new UK medical device regulations just around the corner, it is now more important than ever that multiple retailers consider the impact on self-testing kits, and take action to ensure continuity of supply. Until the UK left the EU following Brexit, the regulations applying to professional laboratory tests and self test kits, were the EU regulations, known as the In Vitro Diagnostic Directive 98/79 EC (IVDD). These EU regulations were updated in 2017, with a 5 year transition period, as reform was greatly needed to protect patient safety by improving the quality, safety and reliability of medical tests and to properly regulate new products. These new regulations are the EU Regulation for In Vitro Diagnostic Medical Devices 2017/746 (IVDR). The…
Own-label opportunities for self-test kits
Thursday 1st June 2023
SELFCHECK
If you are considering launching your own brand of self-test kits in the UK, check here for further information on self-test own-label opportunities
Position statement on self-test kits
Thursday 25th May 2023
SELFCHECK
With reference to the position statement published by the RCGP on non-symptomatic self-tests this week, our response can be found here
New Pregnancy Test from SELFCHECK
Tuesday 21st March 2023
SELFCHECK
Clearblue and First Response are the market leaders, and household names when it comes to branded pregnancy tests in the UK, offering consumers reliable results, and a brand they can trust. Ultra-low cost pregnancy test alternatives are also available in discount stores and supermarkets. All the pregnancy tests meet the necessary regulatory requirements and are simple to use. So why has SELFCHECK decided to enter the pregnancy testing market with a mid-range priced product? SELFCHECK has been providing a wide range of health-screening blood and urine tests for over a decade, and are known for their exceptional customer service. The SELFCHECK range, including their new urine pregnancy test, is assembled at their laboratories based at the OpTIC Technology Centre in North Wales,…
Hay fever or a cold? How can you tell?
Thursday 16th March 2023
Pollen is released from different plants at different times of the year. Knowing when your symptoms occur can help you identify the likely trigger. Hay fever is the most common seasonal sensitivity. Hay fever symptoms can be experienced all year and may be confused with a cold. They can also trigger more severe conditions such as asthma, cough, wheezing and shortness of breath. Other allergy symptoms may include; frequent bouts of sneezing runny, itchy or blocked nose watery, itchy red or sore eyes itchy sore throat and tongue headache and loss of concentration Pollen may be from trees, grasses and weeds with increase in symptoms coinciding with the flowering of these plants. Trees can cause symptoms during spring, grasses in the…
Should your patient self-test?
Friday 18th November 2022
Dr John Rees
Although self-test kits can provide information about a patient's health, a test result by itself is not a diagnosis. Responsible self-test manufacturers should tell their customers that if they are concerned about their symptoms to speak with their doctor or pharmacist - and not buy a test kit. Medical tests are usually only requested by doctors after first taking into account their patient's symptoms and clinical history, rather than testing first, and then working out how this relates to symptoms. Doctors are rightly concerned that the wide-spread use of self-testing kits could increase the burden on already overstretched NHS services. Although currently, there is no evidence that this is happening. Similar concerns were expressed by doctors almost 50 years ago, when…
Why self-test kit suppliers must provide access to professional customer support
Friday 23rd September 2022
Dr John Rees
In an ideal world, medical self-test kits would be provided to patients by their doctor or a pharmacist, who would also be in a position to provide advice about how to use the test and interpret the results. However, difficulties getting GP appointments, time constraints during consultations, the funding system for NHS diagnostics in primary care, and subsequent delayed referral for laboratory tests, means that this is unworkable. Current medical device regulations stipulate that manufacturers of self-test kits must perform user trials with laypersons to show that the majority of people can perform the test and interpret their results correctly. Nevertheless, it is inevitable that a small, but important, proportion of users will, despite their simplicity, misinterpret the instructions, or will…
Tighter regulation for self-test kit distributors
Friday 5th August 2022
J R BIomedical Ltd
All self-test medical devices are strictly regulated in the UK, and EU. Following brexit, since January 2021, all tests sold in the UK have to be registered with MHRA. Further, new regulations will also come into force on the 1st July 2023 and are likely to mirror those of the In Vitro Diagnostic Regulations (IVDR) currently in force within the EU. Stricter legal requirements for distributors of self-test kits One of the key changes of the new IVDR is that for the first time, responsibilities will be imposed on the distributor, as well as the manufacturer. For instance, it will be mandatory for distributors to have credible evidence of full traceability of products, suitable storage facilities and compliance with the IVDR standards, such…
Iron deficiency anaemia - do you know the symptoms?
Monday 1st November 2021
SELFCheck
Iron deficiency anaemia is a common, major, and global public health problem. Women of childbearing age and pregnant women are at particular risk. Common symptoms of iron deficiency can include headaches, tiredness, lack of energy, palpitations, and hair loss. Measurement of specific biomarkers in the blood, such as ferritin, are a simple and more reliable indicator of iron deficiency anaemia compared to a full blood count. Knowing that you have a low iron level can help you seek advice from your pharmacist and doctor to help you reduce the risks of long-term diseases associated with iron deficiency anaemia. The SELFCheck Iron Level Test is a quick, 10 minute, reliable immunodiagnostic test for the assessment of your ferritin level from a finger prick…
Patients seek out self testing kits as blood tube shortage worsens
Monday 13th September 2021
SELFCheck
The COVID-19 pandemic has driven global shortages of blood test tubes which has already impacted the NHS and is likely to get worse before it gets better. Some doctors are facing difficult choices as to who to offer blood tests to and who will have to wait. According to the British Medical Journal, most of the blood tubes used by the NHS are manufactured by Becton Dickinson (BD) but supply chain issues for raw materials as well as an increased demand for blood tests are fuelling the problem. Whilst patients are being refused blood tests for common health conditions, companies who manufacture 'instant' self testing kits that are used at home, such as SELFCheck, are seeing a corresponding increase in demand. In…
Hello Simply Supplements!
Wednesday 1st September 2021
SELFCheck
We are pleased to welcome Simply Supplements as the latest retailer of our SELFCheck range of medical self test kits. Established over a decade ago, Simply Supplements has grown to become an industry leader supplying customers all around the world with premium quality food supplements and health products. Helping to provide customers with good quality products and value for money as well as genuine customer care, Simply Supplements make healthy living simpler! Order SELFCheck online now Simply Supplements
Is it really hay fever?
Wednesday 9th June 2021
Dr John Rees
It's that time of the year again when, for most of the UK, pollen levels are off the scale and many of us reach for the antihistamines and steroid spray hay fever remedies, but for the majority of people allergies cause symptoms all year round. But is it hay fever or perhaps a common cold? Both have similar symptoms but are treated in different ways - so, can a new 10 minute allergy test help tell the difference? What are allergens? It sounds obvious but allergens are the things that trigger allergies. Allergens are in the main highly water soluble proteins, usually with molecular weights between 10 to 100kDa. Allergens are found in diverse biological materials from moulds, plants, animals including insects…
Fact checking self test myths
Wednesday 2nd June 2021
Dr John Rees
Are self test kits regulated in the UK? What about false positive and negative results? FACT or MYTH? Traditional established healthcare pathways are best This is TRUE. Discussing your health concerns with your doctor is best. Nevertheless, self test kits are easily accessible, easy to use, give reliable results and can help prompt you to have that conversation with your doctor about your health concerns when you may otherwise might not have. Self test kits are not regulated in the UK FALSE. In the UK, self test kits are more tightly regulated than tests used in hospital laboratories. Self tests are difficult to use This is FALSE. All self tests legally available in the UK have to undergo user trials with laypersons to show that the majority…
Can self test kits be easily used by laypersons?
Thursday 11th March 2021
Dr John Rees
SUMMARY Out of 5,313 SELFCheck blood test users, 99.4% did not report any issues using their self test kit. A minority of users (0.58%) reported issues mostly concerning the use of an automatic lancet or collecting the blood drop. Some users were unaware that the reason for test failure was inadequate technique or unknowingly misinterpreting the instructions for use. The high level of usability was attributed to the clinical grade quality of components, clear instructions, and access to professional customer support. INTRODUCTION Self test kits such as SELFCheck, which require a finger prick blood sample, have become increasingly available to help diagnose a range of medical conditions. In the UK, self test kits are strictly regulated in the same way as hospital laboratory…
Well launches SELFCheck self-testing kits
Monday 1st February 2021
SELFCheck
We are pleased to welcome Well pharmacy as the latest retail chain selling SELFCheck self-test kits in the United Kingdom. Well, formerly known as The Co-operative Pharmacy, is the largest independent pharmacy business and the third largest overall pharmacy chain after Boots UK and Lloyds Pharmacy with 760 stores. It is also the largest pharmacy chain in Wales and has an online store www.well.co.uk. As well as making sure patients get their NHS prescriptions quickly and easily, their expert pharmacists are on hand to provide patients with advice and support for their health needs. The SELFCheck range includes simple, reliable and fast home test kits including tests for bowel cancer (FIT), female chlamydia, coeliac disease (gluten sensitivity), urine infections and a drugs…
Medical self tests are strictly regulated in the UK
Thursday 10th December 2020
Self-test kits can help prompt you to speak with your doctor sooner than you might have. The UK regulations ensure that you can trust that your self-test; has been independently evaluated and approved by the regulatorsuses the same scientific principles as those used in hospital laboratoriesis safe, giving reliable results and follow up informationhas been designed and evaluated to be easy to use by most peoplethat the proportion of false positive and false negative results is acceptable to doctors and equivalent to hospital lab testscomponents are high quality and fit for purpose eg. lancets and pipettes are the same as those used in hospitalswas developed and manufactured in laboratories certified to international standards for medical devices (ISO13485:2016) Always check that your self-test kit…
SELFCheck joins Welsh Government Trade Mission in Dusseldorf
Friday 13th November 2020
JR Biomedical Ltd
The SELFCheck range of self-testing kits will be presented at the world's largest trade fair for medical devices next week - MEDICA 2020. JR Biomedical, who assemble the rapid self test devices at their ISO13485 certified laboratories, will be part of the Welsh Government trade mission alongside 12 other Welsh companies showcasing a range of products and services including cutting edge medical technology, diagnostic testing and single use medical equipment. MEDICA will be a little different this year, usually in Dusseldorf, Germany, the exhibition will be solely online due to the ongoing coronavirus restrictions. The SELFCheck range is currently supplied through retail pharmacy chains in the UK including Lloyds Pharmacy, Superdrug and Well Pharmacy. As well as lateral flow rapid tests for consumer use,…
Self testing - on the verge of a new normal
Wednesday 21st October 2020
JR Biomedical Ltd
As we enter the second wave of COVID-19 in the UK, increased pressures will once again be placed on NHS health screening programmes as well as primary and secondary care. Providing that the safety and reliability of self tests can be guaranteed, could greater access to medical self testing kits contribute to a 'new normal' in healthcare? The advantages of self testing are clear; results at home within minutes with appropriate follow-up advice, empowering individuals to make proactive decisions for their health. Self test kits also provide an additional route towards traditional NHS pathways for patients who may be too embarrassed to speak with their doctor in the first place or are unable to arrange an appointment due to work…
SELFCheck Pharmacy Training Guide 2020
Tuesday 20th October 2020
Our guide for pharmacists on how to help your patients get the most from their SELFCheck tests is now available to download here. Further information is available for each specific product located on the 'Products' tab in the main menu. If you have any specific questions about SELFCheck and UK pharmacy please contact us.
David Hart (Santo) Ltd to supply independent pharmacists with SELFCheck
Thursday 17th September 2020
It is not often practical for independent pharmacists to order SELFCheck products by the case and are missing out on the increasing demand for self test kits in the UK. To address these issues, independent pharmacists can now order smaller quantities of SELFCheck self test kits from David Hart (Santo) Ltd. SELFCheck is a range of simple to use home tests that meet the UK medical device regulations (IVDD 98/79EC) and are assembled at ISO13485 and ISO9001 certified laboratories based at Glyndwr University, OpTIC Technology Centre in North Wales. The current range of SELFCheck self test kits includes; allergy (immunoglobulin E)diabetes (blood glucose)FIT bowel cancer screeningcholesterolfemale chlamydiacoeliac disease (gluten sensitivity)menopause (FSH)drug testingpregnancy blood testprostate (PSA)stomach ulcer (H pylori)thyroid (TSH)urine infection (leucocytes, nitrite, protein) All…
Do you have an allergy?
Wednesday 5th August 2020
Dr John Rees
The UK has one of the highest rates of allergies in the entire world. Allergies can range in severity from mild hay fever symptoms for a few days during the summer to life threatening allergic reactions. There have been many reasons proposed for why we have such a high rate of allergies in the UK with around 40% reporting allergy related symptoms. Allergies are often the triggers for asthma, eczema and symptoms of hay fever as well as life threatening anaphylactic reactions to foods and drugs. Whether we get allergies depends mostly on our genes. If both your parents have an allergy then the risk of you having allergies too can be as high as 80%. These genetic risks together with…
Using a SELFCheck Blood Test is Easy
Thursday 2nd July 2020
JR Biomedical Ltd
All SELFCheck self test kits are manufactured and assembled according to a stringent medical quality system (ISO13485) and have been independently evaluated by scientific and clinical experts to check that the tests are easy to use and give reliable results by anyone at home. Even if you are a healthcare professional, and are familiar with using point of care blood tests, it is essential that you read the instructions provided with the test as medical tests from one manufacturer to another often vary in the way they are to be used. Providing you follow the instructions as written you should find that the test is easy to use and gives you a result in minutes. The video below shows one of our colleagues…
Reasons for 'invalid' self test results
Wednesday 24th June 2020
SELFCheck
Invalid test results are extremely rare and almost always due to the instructions not being followed as written. The photo here shows a test cassette where not enough blood has been added and an invalid result. It is a legal requirement in the UK and EU that all self test kits undergo user trials with lay persons as part of the independent scientific and clinical checks to show that most people find the instructions easy to follow and can interpret the results correctly. Only if the results of these trials are positive is a self test kit allowed to be sold to the general public (IVD Directive 98/79EC). All batches of SELFCheck self test kits are manufactured and assembled in ISO13485 certified…
COVID-19 (SARS-CoV-2) Nucleocapsid (N) protein significance in serology diagnosis used in COVID-19 (SARS-CoV-2) ELISA
Thursday 11th June 2020
Demeditec GmbH
The COVID-19 (SARS-CoV-2) ELISA uses the SARS-CoV-2 nucleocapsid protein (N protein) as antigen for the detection of antibodies to SARS-CoV-2. The N protein is a structural component of the helical nucleocapsid and plays an important role in viral pathogenesis, replication and RNA packaging. Furthermore, this protein is more conserved than other proteins of the virus, such as spike and membrane glycoproteins [1-3]. It is well known that S1 (part of the spike protein) and N proteins are the dominant antigens of SARS-CoV and SARS-CoV-2 that elicit IgG, IgM and IgA antibodies, and antibody response against N protein is usually stronger [4]. Studies have demonstrated for SARS-CoV that among all coronavirus proteins, the N protein is the most abundant throughout infection…
A new type of pregnancy test
Tuesday 21st April 2020
SELFCheck
You think you're pregnant. You rush out to the supermarket, hand over ten quid for a well known branded pregnancy test, get home, read the instructions and realise that to get a reliable result you have to wait until tomorrow morning as the test requires an early morning urine sample. Some good news. Leading consumer self test brand SELFCheck have now launched a 5 minute, finger-prick blood spot pregnancy test that you can use as soon as you get home. Blood tests can be more reliable than urine tests for showing that you are pregnant and, for this reason, are sometimes used in hospital labs to confirm a urine pregnancy test. Unlike urine pregnancy tests, you can use a blood test at any…
Coronavirus rapid tests - a warning
Thursday 19th March 2020
Some manufacturers are selling products for the diagnosis of COVID-19 infection in community settings, such as pharmacies and online. The current view by Public Health England (PHE) is that use of these products is NOT advised: some of these products look for virus while others look for the body's immune response to the virus. Such tests are very rapid and can work on a range of specimens including serum, plasma or finger-prick whole bloodthere is little information on the accuracy of the tests, or on how a patient's antibody response develops or changes during the course of a COVID-19 infection. It is not known whether either a positive or negative result is reliableat the very early stages of infection there is a…
New Thyroid Health Test
Thursday 21st November 2019
Symptoms of an under active thyroid gland are quite general and can easily be dismissed. According to the NHS, symptoms of an underactive thyroid are often similar to those of other conditions, and they usually develop slowly, that they may not be noticed for years. The only accurate way of finding out whether you have a thyroid problem is to have a thyroid function test, where a sample of blood is tested to measure your hormone levels. Thyroid disorders are one of the most common disorders in the world, and are more common in women. The patient support group Thyroid UK, state that hypothyroidism is mostly seen in women between the ages of 40 - 50 and is ten times more…
Self test kits and early diagnosis
Monday 7th October 2019
JR Biomedical Ltd
SELFCheck is a range of easy to use medical health screening self test kits that you can buy from your pharmacy and use in private at home. SELFCheck tests give you a result within minutes without the need to send your sample in the post and waiting days for results. As you do the test yourself you also avoid paying expensive laboratory fees. SELFCheck test kits are available to check for different medical conditions, some require a finger prick blood drop such as the gluten sensitivity test for coeliac disease or stomach ulcer test whilst other tests require a swab, urine or stool sample. Step-by-step, easy to follow instructions are provided together with information on what your test result means so…
How to use SELFCheck finger pricker lancets
Monday 23rd September 2019
JR Biomedical Ltd
One of the main issues surrounding self test kits has always been the need for a small blood sample. This is usually taken from the finger tip and in most cases only a drop or two of blood is required. The procedure is quite simple using 'automatic' lancets (finger prickers) that are routinely used in hospitals and clinics. The lancets provided with SELFCheck kits have been specifically chosen to be easy to use and provide sufficient blood for the tests. Although the lancets are not difficult to use, it is important to read and understand the instructions before touching the lancet to avoid inadvertently triggering the device. Once the lancet is triggered, a needle is fired, punctures the finger tip and…
Superdrug launches SELFCheck self test kits online
Wednesday 18th September 2019
We are pleased to welcome Superdrug as one of our latest retailers supplying SELFCheck self test kits online in the UK. SELFCheck self test kits allow anybody to check whether they have markers in their blood or urine for common health conditions such as gluten sensitivity (coeliac disease), colon polyps and stomach ulcers. The SELFCheck tests take around 5 to 10 minutes to complete and you get a result there and then in the privacy of your own home - avoiding the need to send your blood sample away, waiting days or weeks for results and sometimes expensive lab fees. But perhaps one of the key benefits of the SELFCheck brand is that consumers can be confident that the tests give results…
SELFCheck customer helpline
Friday 21st June 2019
JR Biomedical Ltd.
Medical self test kits have been helping ordinary people to get a quick diagnosis or monitor their health for decades. Diagnostic technology is evolving, moving out from the hospital laboratory, to the hospital ward, into GP practices and the patient's own home. Self test kits are easily accessed through pharmacies, supermarkets and online stores but not all retailers and distributors have the necessary scientific and technical background to answer all the questions that your customers may have. So, with a background in developing and manufacturing medical diagnostics, as well as an independently audited ISO9001 Quality Management System demonstrating our commitment to customer service, we are pleased to provide you with the support you may require to help you give the best customer…
Pharmacy SELFCheck Starter Pack
Monday 17th June 2019
JR Biomedical Ltd
If you are an independent pharmacist or own an online pharmacy you may have considered offering self test kits and we would like to make things as easy as possible for you to get started. Product descriptionsHigh resolution images for your web siteRegulatory guidance You can now order the SELFCheck Starter Pack securely online from our B2B trade website and pay with credit card, debit card or Paypal. Order Now This website is strictly for trade orders only. Each starter pack contains 3 each of the 10 SELFCheck tests (30 packs in total). You will need to register on the site for a trade account to view pricing and place orders. For a full trade price list of the range please contact us.
New images for SELFCheck packaging
Friday 7th June 2019
SELFCheck
We are pleased to provide hi-res images of the SELFCheck self test packaging for our retailers to use online. Each product JPG file is 300dpi measuring approximately 2000x1860px and are available to download now from our Dropbox If you have any problems downloading the files or any questions please contact us.
Key information for UK retailers of self test kits
Saturday 1st June 2019
Self tests are a class of medical devices that are tightly regulated in the UK, having to comply with the EU In Vitro Diagnostics Directive/Regulations (IVDD/98/79/EC) just like medical diagnostics used in hospital laboratories. Self test diagnostics such as blood glucose meters and pregnancy tests have been available for decades, allowing individuals to take more control over their health. Similar technology is now finding its way into tests for different diseases such as coeliac disease, bowel cancer and STIs. Used correctly and with good advice before and after purchase, self test kits can provide an accessible, low cost and reliable way to help identify a specific health issue. Whether the outcome of a self test is a positive or negative result, individuals can…
New medical device regulations. Time is running out for distributors
Wednesday 29th May 2019
JR Biomedical Ltd.
The new European Regulation on IVD's (diagnostic tests) EU-MDR/2017/746 came into force 25th May 2017 with a 5 year transition period. This means that all laboratory and self test diagnostic tests sold in the UK will have to be compliant with these regulations by May 2022. These new obligations may impact current supply and distribution agreements. An important point related to the distribution chain for medical device manufacturers means that each economic operator (manufacturer, importer, and distributor) must verify that a previous economic operator has complied with the EU MDR requirements. Thus, importers and distributors must ensure independently that, prior to placing a medical device on the market, the manufacturer, importer and the device itself meet the stipulated EU MDR…
The importance of knowing your PSA levels
Tuesday 28th May 2019
Professor Christopher Eden, The Royal Surrey County Hospital, Guildford
Thirty-five years following the discovery of prostate specific antigen or PSA (a molecule in the blood) we now have scientific evidence of the highest quality (a randomized controlled trial) that screening men for prostate cancer using PSA saves lives. PSA has come in for a lot of criticism, as it is not completely sensitive or specific for detecting prostate cancer. It is elevated by a number of non-cancerous conditions (increased age, increased size of prostate, urinary infection, urinary obstruction, prostate trauma and ejaculation) as well as being normal in a fifth of men with prostate cancer. However, urologists know this and never diagnose prostate cancer on the basis of a raised PSA level alone. We use it to identify men in…
Bowel cancer
Tuesday 28th May 2019
Patrick Kirby, Medical Scientist
Bowel cancer is the UK's second biggest cancer killer and the fourth most common cancer. Just under 16,000 (15,708) people die each year in the UK - that's a life every 32 minutes. Over 40,000 (40,695) people are diagnosed with bowel cancer each year - that's one every 13 minutesOne in 14 men and one in 19 women have a lifetime risk of developing bowel cancerOver 93% of people diagnosed with bowel cancer at an early stage survive for at least five years compared to less than 7% of those diagnosed at a late stageFive-year survival rates for bowel cancer have doubled over the last 40 yearsMore than 8 in 10 cases of bowel cancer occur in people aged 60 or…
A case for home testing
Tuesday 28th May 2019
Patrick Kirby, Medical Scientist
I have recently read several articles about home testing and, in an ideal world home screening tests would not be necessary but early diagnosis and prompt medical intervention is always beneficial, and figures announced by Diabetes UK indicate that there may be one million undiagnosed Type II diabetics in the UK, which the current NHS systems are just not picking up. So, how do you identify early signs of an abnormality? You implement a screening programme aimed at "high risk groups". At least the Government has introduced national bowel cancer screening for people in England & Wales between 60 and 69 (to be extended to age 74). But in 2017 nearly 1,800 people under 60 died from bowel cancer…