IMMUNOCROMATOGRAPHIC TEST FOR THE QUICK QUANTITATIVE DETERMINATION OF FECAL CALPROTECTIN
CalFast XT is a non-invasive test developed by Eurospital that allows the identification of subjects with symptoms related to chronic inflammatory bowel disease (IBD), including ulcerative colitis, Crohn's disease and the so-called “indeterminate colitis”, in less than 20 minutes. CalFast XT determines the level of calprotectin present in the feces with a rapid, accurate and quantitative analysis.
Until today, to evaluate the inflammatory state of the intestinal mucosa it was necessary to resort to invasive tests (colonoscopy and subsequent histological examination). Recently, the use of non-invasive markers has found more and more credit: among these, one of the most reliable and safe is the determination of fecal concentration of calprotectin, an antimicrobial protein present in neutrophils that, in the presence of inflammatory bowel processes, is released into the intestinal lumen and therefore can be detected in feces. The diagnostic principle of CalFast XT is based on the quantitative determination of calprotectin in the stool: in patients with Chronic Inflammatory Bowel Diseases (IBD), the level of calprotectin is in fact generally very high. In subjects with Irritable Bowel Syndrome (IBS), the level of calprotectin is instead much lower than that found in patients with the active disease, sometimes higher than the reference value but, in any case, always higher than that found in healthy subjects.
Samples with a calprotectin concentration above 70 mg/kg should be considered positive for the test. In healthy adults the average value of Calprotectin is 25 mg/kg. A positive result of CalFast XT is an indication of intestinal inflammation and allows to safely select patients that need to undergo further diagnostic tests.
|< 70 mg/kg of feces||Negative|
|70 - 100 mg/kg of feces||Gray area, it is recommended to repeat the test|
|> 100 mg/kg of feces||Positive|
The performance of CalFast XT, its easy execution and the non-invasiveness of the immunochromatographic method allow to extend the usage of the test from early diagnosis to the screening of patients for the identification, for example, of inflammatory causes of chronic diarrhea. In addition, CalFast XT can be also used for the follow up of chronic inflammatory bowel diseases (IBD), diverticulosis and as well for monitoring of drug therapies. Even though there is often an improvement in the clinical status of the patient and also a decrease of the inflammation index, the inflammatory state of the intestinal mucosa may remain high, this being the main reason for the relapses often occurring in these pathologies. The longer the time between the clinical remission and the eventual relapse of the disease, the better the prognosis of the course of the disease. Until recently, the histological remission of the disease, i.e. the complete functional recovery of the mucosa, could only be verified by invasive methods. Recently it has been shown that in patients suffering from ulcerative colitis (UC), a negative calprotectin value is an indication of not only clinical but also histological remission.
The availability of a non-invasive method such as CalFast XT has led to a notable progress not only in the diagnosis of intestinal inflammation, but also in the monitoring and in the optimization of medical therapies. Monitoring the clinical course of the patient with CalFast XT helps preventing possible relapses and allows to eventually adapt the therapeutic strategy.
The values of sensitivity and specificity of CalFast XT are superimposable to those reported in the literature for Calprest.
The first phase consists in collecting the stool sample: a process made extremely easy thanks to the new and exclusive diagnostic medical device developed by Eurospital: EasyCal.
The device, CE-marked, contains the amount of extraction solution necessary to perform the test. Once extracted, the sample is diluted and dispensed on the diagnostic device. A dedicated reader provides the concentration of calprotectin detected in the sample in just 20 minutes.
In the event of a positive result, it is advisable to perform the Calprest NG (ELISA) test to gain more information on the inflammation of the intestinal tract.
|CalFast XT - Configuration||CalFast XT - Codes|
|20 test cards||CalFast XT - cod. 9191XT|
|20 EasyCal ready to use devices for sample collection and extraction||CalFast Reader - cod. 9190|
|Dilution buffer ready to use||CalFast Bar Code Reader - cod. 9189|
|CalFast Reader supplied separately||CalFast Printer - cod. 9188|