News

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…

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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…

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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…

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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…

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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

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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? Dr Rees has a PhD in Allergy from St Bartholomew's Hospital Medical School, University of London and a member of the British Society for Allergy & Clinical Immunology and the British Society for Immunology. What are allergens? It sounds obvious but allergens are the things…

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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? Dr John Rees fact checks the myths around self testing kits. Dr Rees has a PhD from St Bartholomew's Hospital, University of London and is a Eurostars technical expert, with over 30 years experience in the development of laboratory and point of care medical diagnostics. 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…

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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…

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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…

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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…

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