Quality of production is an essential ingredient for market success of lateral flow tests
You might be surprised just how on-site diagnostics could help your business.
Forsite achieves ISO9001 accreditation
Forsite Diagnostics is delighted to announce achievement of ISO9001:2008 accreditation. The award was made by Lloyds register Quality Assurance following a rigorous audit of Forsite’s diagnostic manufacturing operation in late 2009.
Added on Thursday January 07, 2010.
Being granted approval of ISO9001:2008 status marks another important step in the development of Forsite as a high quality manufacturing business.
‘Having this formal recognition of quality standards throughout the business is a real boost for Forsite’, says Chris Danks, Forsite’s chief executive. ‘We can move into 2010 with increased confidence in our ability to address new and challenging markets. This is good news for our customers also who rely on the quality of our work for successful products.’
The quality of manufacture of rapid immunoassays has a very real impact on end-user performance, and therefore on the decisions made by the user. ‘Forsite’s business model is focused on delivering products of the highest quality. We achieve this by understanding customer needs and developing then manufacturing assays to meet these requirements’, continues Chris. ‘During projects we welcome quality inspections from customers because there is no substitute for face to face agreement over specific quality standards to be met.’
Helen Roper, quality manager at Forsite, is delighted with the award of ISO9001. ‘Achieving approval is a real team effort and for a young company like Forsite to make the grade it demonstrates a firm commitment to success.’
First pen-side test for BVD launched
A new pen-side diagnostic for the serious cattle disease Bovine Viral Diarrhoea (BVD) has been launched by Forsite’s parent company, Safeguard Diagnostics.
Added on Monday November 16, 2009.
The rapid test can be carried out in a few minutes giving a visual result which allows vets to make informed decisions about management of symptomatic cattle. Safeguard have launched the test following extensive validation trials with XL Vets in the UK, and plan to introduce the test to Europe and North America next year.
BVD has a major impact on cattle health, resulting in loss of milk yields, general sickness and in severe cases, death. Cattle can be persistently infective without showing symptoms, making it difficult to eradicate from infected herds. Current methods of diagnosis involve laboratory testing which can take several days. Safeguard’s new test uses the lateral flow diagnostic principles found in home pregnancy tests, and gives clear results in under 10 minutes.
The new assay has been developed by Forsite Diagnostics, and is manufactured by the company for Safeguard in its state-of-the-art automated manufacturing facility. David Danson, Safeguard’s European Chief Operating Office, comments that, ‘This new test for BVD is a real improvement over existing methods of diagnosis. The diagnostic performance of the rapid test is excellent – specificity is 99.06% and sensitivity is 100% - meaning vets can have full confidence in the assay.’
The Safeguard BVD Screening Test is available now, and enquiries can be made to support@sgbio.com.
Resisting the rise of the malaria parasite
Improving the effectiveness of anti-malarial drugs used in Africa is the aim of a new international project funded by the European Union.
Added on Tuesday September 15, 2009.
The MALACTRES project will develop low-cost, point of care tests for identifying drug-resistant parasites in malaria patients. Using knowledge from the test results, doctors will be able to prescribe combinations of drugs designed to overcome resistance in the parasites, therefore making treatments far more effective and improving the health of individuals and the population overall.
The 5-year MALACTRES project is led by Dr Henk Schallig (Royal Tropical Institute, Amsterdam, The Netherlands) and brings together partners from Belgium, United Kingdom, Tanzania, Nigeria and Burkina Faso. ‘Collectively, the project partners have experience in genetic analysis, malaria epidemiology, diagnostic test development and in carrying out clinical field trials. Early progress in the project has been excellent’, says Dr Schallig.
Success in the project will have real advantages for communities and individuals suffering from malaria. Firstly, the diagnostic tests being developed will allow screening at a population level to determine the likely level of resistance to drugs among malaria-infected patients. Secondly, drug therapies can be more-closely targeted to the needs of an individual based on the results of the resistance-screening tests.
During the project, blood samples from several hundred malaria patients in Tanzania, Nigeria and Burkina Faso will be sent to Europe for analysis of the parasites’ DNA. ‘We will be looking for genetic markers which indicate resistance to drugs which are given to patients as part of the artemisinin-based combination therapy’, continues Dr Schallig. Once we have identified more of these genetic markers, we will develop simple detection tests which can be used by clinical staff at the point of care.’
‘An important part of the project is the training and capacity building for our partners in Africa. During the project several staff will spend time in the European laboratories developing skills to take back to their own clinics and laboratories. The active participation of colleagues from Tanzania, Nigeria and Burkina Faso means this project has an excellent opportunity to make a real difference to the health of thousands of people who carry the burden of malaria’, concludes Dr Schallig.
Ends
Notes for editors
1. Malaria is by far the world’s most important tropical parasitic disease. Aproximately 300 million people become ill each year. Malaria is due to infection with the Plasmodium parasite, a small single cell organism. The disease kills an estimated two - three million people per year, mainly young children in developing countries. Approximately 1 child dies every 30 seconds due to malaria. Other important risk groups are pregnant women and non-immune travellers. The parasite is transmitted from man to man occurs via the bite of infected blood-feeding female mosquitoes (Anopheles). Inside the human body, the malaria parasites multiply extremely rapidly in the liver. At a certain time point, they leave this organ and subsequently infect red blood cells (erythrocytes). A next wave of Plasmodium replication takes place in the erythrocytes, then the red blood cell bursts, followed by infection of new red blood cells by the parasites. Malaria begins as a flu-like illness 8 - 30 days after infection. Symptoms include fever, with or without other symptoms like headache, pain in the muscles, vomiting, diarrhoea and cough. Typical cycles of fever with shaking chills and drenching sweats may develop. Destruction of the erythrocytes leads to severe anaemia. Death may be due to infected red blood cells blocking blood vessels in the brain (cerebral malaria) or damage to other vital organs (e.g. liver and kidneys). (brief description of disease and its effects in Africa, 100 words or so)
2. The most widely used treatment for malaria is now artemisinin-based combination therapies, in which several drugs are administered together in order to overcome resistance in the parasite. However, the effectiveness of these treatments is being broken down by the parasite. In order to be effective, the presence of resistance in the parasite needs to be known so that the precise combination of drugs can be altered accordingly.
In the absence of knowledge about resistance, ineffective drugs can be given as the first line defence. It can take days or weeks to find out if these drugs are working. If the parasites are resistant, second line drugs can be given. Knowledge of the resistance patterns can help clinicians prescribe effective combinations of drugs from the outset.
3. Partners in the MALACTRES project are:
Royal Tropical Institute, Amsterdam, The Netherlands
Wageningen University, The Netherlands
Institute of Tropical Medicine, Antwerp, Belgium
London School of Hygiene and Tropical Medicine, London, UK
Forsite Diagnostics Ltd, York, UK
Kilimanjaro Christian Medical Centre, Tanzania
University of Benin City, Benin, Nigeria
Centre Muraz, Bobo Dialassou, Burkina Faso.
4. The MALACTRES project started in January 2008, and has a 5-year duration. The project budget is 3.8 million Euro (2.7 million Euro provided by the European Union under project number 201889). The full title of the project is: ‘Multi-drug resistance in malaria under combination therapy: assessment of specific markers and development of innovative, rapid and simple diagnostics’.
5. For further information on the project, please visit the website www.malactres.eu, or contact Dr Henk Schallig via malactres@kit.nl.
Blight Check listed by Wyevale Garden Centres
A new and innovative test for blight on potatoes and tomatoes is now available across the country through the Wyevale group of garden centres.
Added on Thursday June 18, 2009.
Blight Check allows vegetable gardeners to detect the blight fungus at the first sign of damage. Agreement over stocking the product was reached in May between Wyevale and Forsite Diagnostics who manufacture the test. All Wyevale garden centres now carry Blight Check.
The strong upsurge in Grow Your Own vegetables has produced a large number of gardeners who are new to growing potatoes and tomatoes – both of which are very susceptible to blight. ‘These new enthusiasts need all the help they can get to recognise and control blight’, says Sophie Gehin, Wyevale’s Gardening Buyer.
Potato and tomato crops are growing strongly now and the threat of blight is real. With the summer off to a wet start in many parts of the country, the risk of blight is increasing. Sophie advises gardeners to keep a close eye out for blackened areas on leaves and stems and to use Blight Check to confirm if it is blight. ‘With blight spreading so quickly through a crop in wet conditions, early detection is important if control measures are to be effective’, says Sophie.
Protecting England's heritage plants
Pocket Diagnostic tests are helping the National Trust as it fights to protect valuable gardens and plant collections on behalf of the nation.
Added on Thursday December 04, 2008.
Managing over 200 historic gardens and the extensive heritage plant collection is a big challenge at any time. But throw in the complication of new biosecurity threats and it gets a lot worse. This is just the situation faced by the National Trust in the UK, who manage some of the nation’s best-loved gardens and plant collections.
The National Trust is taking biosecurity very seriously, and its staff are working with plant health experts from the Government to develop an action plan to protect valuable plants and landscapes. Although the threats from a wide range of damaging pests and diseases are being assessed, it is Phytophthora ramorum this is of most immediate concern. And Pocket Diagnostic tests are helping in this battle.
Co-ordinating the response to the plant pathogen for the National Trust is Ian Wright (pictured), a Garden Adviser for The National Trust in Devon and Cornwall in the south west of England. The first case of Pyhtophthora ramorum in a National Trust garden was seen in 2002 notes Ian, but over time it has spread. ‘With a growing number of gardens affected by Phytophthora ramorum and P. kernoviae (now 17 gardens with over 460 outbreaks) we made a decision not to sit back and wait any longer but to try to react proactively, identifying ways to ensure the safeguarding of our collections, as well as working with others to understand the disease and manage our gardens to lessen any risk.’
With so many gardens to survey, the National Trust recognised that the Government’s Plant Health and Seeds Inspectors could not provide resources for comprehensive monitoring. The decision was taken to train Trust garden staff to identify the symptoms and carry out initial diagnosis. And this is where the Pocket Diagnostic Phytophthora test comes into play. Workshops were held with garden staff in high risk areas of England to train them in using the on-site test. According to Ian, these workshops proved very useful, and use of the Pocket Diagnostic tests has become part of ‘good practice’ for garden staff across the country.
‘The test is simple to use, and gives a rapid heads-up if something is wrong. We can then take action quickly while we wait for results from laboratory tests’, says Ian. The Pocket Diagnostic test detects all species of Phytophthora, and additional laboratory testing is needed to confirm whether the damaging species are present.
Ian predicts that Phytophthora will pose a real threat to the UK’s trees and shrubs for many years. Testing for the disease will go on, but what would be of real help is an on-site test to confirm the diagnosis of P. ramorum and P. kernoviae. If Forsite’s plans are anything to go by, Mr Wright may not have to long to wait for this wish to be fulfilled.
© Forsite Diagnostics 2010
Registered address: Forsite Diagnostics Limited, Quadrant House, 4 Thomas More Square, London, UK, E1W 1YW.
Registered in England & Wales: 05696673
