SubscribeChange is inevitable - but is invariably for the better. October 2005 saw a key change in the tests available for measuring pancreatic exocrine function, with the withdrawal of the Pancreolauryl Test (PLT) by Pfizer Consumer Healthcare.
The company said that it was unable to resolve various manufacturing and supply issues relating to the capsules used in the test. As Pfizer is the sole British distributor, PLT is no longer available in the UK.
However, there is no need for hospital pharmacists, pathology laboratories or clinicians to be alarmed, as a highly suitable alternative is available: ScheBo Biotech’s Pancreatic Elastase-1 Stool Test (also known as the Faecal Pancreatic Elastase-1 Test, Faecal Elastase Test, or sometimes simply as FE-1).
Indeed, Pfizer recommends this test in a letter it sent to pharmacists notifying them about the withdrawal of PLT. According to independent published research, PLT users could find that the ScheBo Biotech test is even more accurate – and yet much simpler for patients.
Like PLT, the Faecal Pancreatic Elastase Test is a non-invasive procedure used to screen for exocrine insufficiency in patients who are suspected of having pancreatic disease. However, it is much more patient-friendly. With PLT, patients need to collect all of their urine over two separate days (for ten hours per day), with strict restrictions on their diet and medications. In contrast, the FE-1 test doesn’t need these restrictions, and uses a single, formed, random stool sample. It is therefore much simpler and less stressful.
Its superiority over PLT was underlined in a recent independent study in Pancreatology (reference 1), which specifically compared the ScheBo Pancreatic Elastase-1 Stool Test (FE-1) with the Urinary Pancreolauryl Ratio (uPLR), obtained using PLT.
Elphick and Kapur concluded that: the newer FE-1 is a simpler test to perform and more accurately predicts the response to pancreatic enzyme supplementation in patients with chronic, unexplained diarrhoea with a clinical insufficiency than the traditional uPLR. This is of significant relevance in the clinical setting (click here for more information).
The high sensitivity and high specificity of the Faecal Pancreatic Elastase Test has made it the non-invasive ‘test of choice’ for measuring pancreatic exocrine function. It is included in recommendations by both the British Society of Gastroenterology (reference 2) (click here for more information)and the Cystic Fibrosis Trust (reference 3) (clickhere for more information).
Ivor Smith, Managing Director of ScheBo Biotech UK Ltd, says: No doubt most doctors, pharmacists and labs that have been using PLT will now switch to our Faecal Pancreatic Elastase Test. I’m sure they will be impressed by its ease of use.
Last year, we enhanced the test even further by the introduction of a new POD-Streptavidin-antibody complex, which has made it even faster and easier – without any loss of reliability or accuracy. The total incubation time was reduced by 55% - from 145 minutes to just 65 minutes. More details here.
He continues: I’m convinced that we have the most accurate and practical non-invasive test for pancreatic exocrine insufficiency on the market.
Because our test uses monoclonal antibodies specific for human pancreatic elastase, any patients already using enzyme replacement therapy can keep taking their capsules during the test. This also makes it ideal for monitoring patients for declining pancreatic function.
More information about the Faecal Pancreatic Elastase Test can be obtained by contacting ScheBo Biotech UK Limited on: 01256 477259, by email to: i.smith@schebo.co.uk or by visiting here.
References:
1. Elphick DA, Kapur K (2005). Comparing the Urinary Pancreolauryl Ratio and Faecal Elastase-1 as Indicators of Pancreatic Insufficiency in Clinical Practice. Pancreatology 5:196-200.
2. Thomas, PD et al (2003). Guidelines for the investigation of chronic diarrhoea, 2nd Edition. Gut 52: (Suppl V), v1-v15 Click here for more information.
3. Littlewood, JE et al (2001). Standards for the Clinical Care of Children and Adults with Cystic Fibrosis in the UK. The CF Trust’s Clinical Standards and Accreditation Group.