ALPCO, a globally recognized provider of specialized diagnostic solutions, is pleased to announce the official launch of its Calprotectin Immunoturbidimetric Assay, recently cleared by the FDA under the 510(k) designation. This new addition significantly enhances ALPCO's suite of Gastrointestinal (GI) diagnostic solutions, catering to the in vitro diagnostic needs for inflammatory bowel disease (IBD) diagnosis, specifically Crohn’s disease (CD) and ulcerative colitis (UC). Additionally, the assay aids in distinguishing IBD from irritable bowel syndrome (IBS) when utilized alongside other clinical and laboratory findings.

With a clinical sensitivity of 90.5% and a clinical specificity of 93.4%, the Calprotectin Immunoturbidimetric Assay minimizes false positives. This feature allows healthcare professionals to efficiently prioritize patients for confirmatory colonoscopies, thereby reducing unnecessary procedures for those diagnosed with IBS.

This strategic addition further strengthens ALPCO's comprehensive GI solutions portfolio, making it an attractive option for hospitals and large reference labs seeking reliable, efficient, and high-throughput testing solutions. ALPCO's commitment to integrating automation with immunoassay expertise is exemplified in the development of the Calprotectin Immunoturbidimetric Assay. The early adoption of this innovative assay has been met with significant success in the realm of gastrointestinal diagnostics.

Source: alpco.com