Expert panel for first time achieve consensus on standards and prerequisites for high quality diagnostics
An expert panel led by YorkTest.com which includes The British InVitro Diagnostic Association has, for the first time achieved a consensus on the standards, indication fields and prerequisites to ensure high quality diagnostics. The consensus, which outlines the criteria to help people distinguish “good” diagnostics with evidence for health benefits, was launched today.
Recent reports have shown that provision for allergy testing across the UK is inadequate(1) and that allergies and food intolerances are growing. For example; over 12 million Brits claim to be food intolerant - but less than a quarter of those have had it medically diagnosed properly(2).
Diagnosing allergies or food intolerances can be a lengthy and haphazard process. Regulation of self-tests/diagnostic testing services in the UK is poor and there is massive confusion about which tests are worthwhile.
The expert panel focused primarily on diagnostics for food allergies and intolerances which are often criticized for being misleading, unreliable and have no scientific basis. Although no diagnostic is 100% accurate the criteria aims to regulate those with no scientific evidence and protect and support the consumer. The expert panel concluded that a “good” diagnostic must:
1. Must be reliable and achieve suitable technical performance.
2. Must be proven in clinical trials.
3. Must be accurate and have a 'gold standard reference point'. If no ‘gold standard reference point’ exists then studies on clinical efficacy must be presented.
4. Must provide evidence for suitable sample/transport robustness studies.
5. Must provide consumer data to show that the test works in practice, and can be interpreted correctly.
6. Must have a CE mark / ensure that the test that was used to provide the service has got a CE mark.
7. Must be carried out exactly according to the Manufacturer’s instructions (any deviation must be shown to be valid by separate data).
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(1) House of Lords report, 2007
(2) Food intolerance survey, UK, 1500 people, September 2007
Doris-Ann Williams Director General at BIVDA believes that the criterion sums up the key elements of a diagnostic – that it should be convenient, accurate and reliable. “I am very pleased with the criteria and this is a very welcome first step towards regulating diagnostic testing services and ensuring consumers really are getting positive and proven benefits”.
Dr Hilary Jones said; “It is absolutely essential that diagnostics including food intolerance tests are meaningful and can be interpreted and acted upon accurately. The YorkTest foodSCAN test for food intolerance meets the specific requirements of the new criteria and in recent clinical research showed positive health benefits to 3 out of 4 people who took the test”.
-ENDS-
Notes to Editors:
For a full breakdown of the Food Intolerance Survey 2007 and more information on the clinical research in Nutrition and Food Science and Headache Care
Case studies
Media interviews with Dr Hilary Jones, BIVDA and YorkTest
· YorkTest can be purchased on www.yorktest.com or by phoning 0800 074 6185
· The YorkTest 113 FoodSCAN tests for intolerances against 113 different foods.
· The cost of the 113 FoodSCAN is £250.
· The YorkTest FoodSCAN involves a small sample of blood taken from home which is sent to YorkTest for analysis. Within two weeks the results come back the recommendation about which foods (if any) were to be eliminated from the diet.
· With nutritional support as part of the package, you are professionally helped to adapt to an elimiation diet based on the foods which she tested positive for and subsequently her symptoms relented.
· Over three out of four people have been proven to get better from their symptoms when using a 113 FoodSCAN.
Please contact Lyndsey Gordon on 020 7309 1098 / lyndsey.gordon@uk.ogilvypr.com
OR Rachael King on 020 7309 1000 / Rachael.king@uk.ogilvypr.com