Genova Diagnostics is the sole licensee for the distribution and sales of Calprotectin PhiCal ELISA tests within the United States.
Calprotectin is a highly-sensitive clinical biomarker for GI-specific inflammation. The United States Food and Drug Administration (FDA) has cleared this non-invasive ELISA test kit to differentiate Inflammatory Bowel Disease (IBD) from Irritable Bowel Syndrome (IBS) as well as identifying other types of intestinal inflammation.* The results are quantitative and offer reliable information to aid clinicans in deciding if a patient needs referral for colonoscopy, treatment options for IBS or supportive care.
Calprotectin is a valuable clinical marker for inflammation. Calprotectin belongs to a group of calcium-binding neutrophil-derived proteins. Calprotectin makes up 60% of the cytosolic proteins within the neutrophil.1 It is very resistant to bacterial degradation in the gut and is stable in stool for up to one week at room temperature.2,3 Calprotectin is the noninvasive "test of choice" for quantifying the degree of GI inflammation and differentiating Irritable Bowel Syndrome (IBS) from Inflammatory Bowel Disease (IBD).
The evaluation of patients presenting with symptoms suggestive of irritable bowel syndrome (IBS) has traditionally been done by first excluding, via endoscopy or colonoscopy, more ominous diagnoses, such as inflammatory bowel disease (IBD) or gastrointestinal malignancies (the diagnosis of exclusion approach).
As it is non-invasive, evaluating fecal calprotectin levels can be beneficial for clinicians who want to easily determine the severity of a patients gastrointestinal discomfort by easily differentiating IBS from IBD.
*On select profiles that measure calprotectin, a modified version of the FDA-cleared kit is used to improve operational efficiency; one or more of its performance characteristics were determined by Genova Diagnostics in a manner consistent with CLIA requirements.