This innovative assay showcases a clinical sensitivity of 90.5% and a clinical specificity of 93.4%
The Calprotectin IT Assay is a strategic addition to ALPCO's comprehensive GI solutions menu. (Credit: Testalize.me on Unsplash)
American Laboratory Products Company, a global provider of specialty diagnostic solutions, proudly announces the commercial launch of its FDA 510(k) cleared Calprotectin Immunoturbidimetric Assay, enhancing its suite of Gastrointestinal (GI) diagnostic solutions.
In July 2023, ALPCO unveiled the Calprotectin Immunoturbidimetric Assay at the American Association for Clinical Chemistry (now ADLM) annual meeting.
This assay, cleared for in vitro diagnostic use, aids in diagnosing inflammatory bowel disease (IBD) – specifically Crohn’s disease (CD) and ulcerative colitis (UC), while also assisting in differentiating IBD from irritable bowel syndrome (IBS) when used alongside other clinical and laboratory findings.
This innovative assay showcases a clinical sensitivity of 90.5% and a clinical specificity of 93.4%. Its low false-positive rate enables clinicians to effectively prioritize patients for confirmational colonoscopies, thereby minimizing unnecessary procedures for IBS patients.
A Pivotal Addition to ALPCO’s GI Solutions Suite
The Calprotectin IT Assay is a strategic addition to ALPCO’s comprehensive GI solutions menu, offering an appealing option particularly for hospitals and large reference labs seeking reliable, efficient, and high throughput testing solutions.
ALPCO has always been dedicated to blending the benefits of automation with expertise in immunoassays, a commitment that is exemplified in the Calprotectin Immunoturbidimetric Assay.
Erik Allen, CEO of ALPCO-GeneProof, expressed, “We’re thrilled to deliver a high-throughput test that is compatible with existing clinical chemistry analyzers while preserving accurate differentiation between IBD and IBS, embodying our unwavering commitment to providing efficiency, reliability, and accuracy for our customers.”
A Resounding Early Adoption
The early adoption of the new calprotectin assay has been met with overwhelming success. Dr. Amy Peace Brewer, Chief Scientific Officer and Senior Laboratory Director at Genova Diagnostics, remarks on the assay’s performance, “[ALPCO’s] new calprotectin assay is very impressive. We were able to validate and get the assay into production in a very short time frame. The assay hasn’t let us down and performs in a robust and reliable way. The very quick run times accommodate large batches with ease and efficiency.”
Source: Company Press Release