Diagnostic systems company Inova Diagnostics announced on Wednesday that it has passed the US Food and Drug Administration's (FDA) clearance for the QUANTA Flash Calprotectin that aids in the diagnosis of inflammatory bowel disease (IBD) and helps differentiate IBD from irritable bowel syndrome (IBS).
The company said the QUANTA Flash Calprotectin is one of the 29 US FDA cleared assays available on BIO-FLASH and can be run simultaneously with other QUANTA Flash assays.
According to the company, the accurate detection of calprotectin levels can provide essential information for practitioners who are treating patients with gastrointestinal disorders in order to provide appropriate care and avoid unnecessary procedures that lead to increased health care costs.
In addition, the QUANTA Flash Calprotectin provides precise quantification, with an analytical measurement range of up to 3500 mg/kg as well as improve patient care, while helping to reduce costs, added the company.
QUANTA Flash Calprotectin is a chemiluminescence immunoassay performed on BIO-FLASH for the detection of fecal calprotectin in human stool samples. BIO-FLASH is a random access chemiluminescent instrument for the autoimmune laboratory, delivers results in as little as 30 minutes and offers a wide analytical measuring range and precise quantification for greater confidence in results, concluded the company.
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