ALPCO receives FDA 510(k) clearance for the Calprotectin Immunoturbidimetric Assay
SALEM, NH, June 15, 2023 - American Laboratory Products Company, Ltd. ("ALPCO"), a global provider of specialty diagnostic solutions, today announced recent FDA 510(k) clearance of its Calprotectin Immunoturbidimetric Assay.
The Calprotectin Immunoturbidimetric (IT) Assay is now IVDD and 510(k)-cleared for in vitro diagnostic use as an aid in the diagnosis of inflammatory bowel disease (IBD), specifically Crohn’s disease (CD) and ulcerative colitis (UC). It also aids in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other clinical and laboratory findings. The product will launch at the American Association for Clinical Chemistry (AACC) annual meeting in July 2023.
Developed in conjunction with Diazyme Laboratories, the Calprotectin Immunoturbidimetric Assay is compatible with most commercially available clinical chemistry analyzers. “This new Calprotectin assay is highly sensitive and robust with excellent precision and good concordance with colonoscopic results. In addition, the assay is fully automated and user friendly.” said Chong Yuan, Managing Director of Diazyme Laboratories, Inc. This allows lab directors to easily implement calprotectin testing in-house or switch from other methods. Doing so can increase throughput, improve turn-around time, and improve clinical specificity, or simply free up space on other analyzers.
The Calprotectin IT Assay boasts a clinical sensitivity of 90.5% with a clinical specificity of 93.4%. The low false positive rate allows clinicians to prioritize patients in greatest need when scheduling confirmational colonoscopies, thus reducing unnecessary procedures for IBS patients.
Erik Allen, Chief Executive Officer (CEO) of ALPCO-GeneProof said, "The Calprotectin Immunoturbidimetric Assay exemplifies our commitment to combine the advantages of automation with expertise in immunoassays to develop products that provide efficiency, reliability, and accuracy for our customers. With the new immunoturbidimetric assay, we’re able to deliver a high throughput test that is compatible with existing clinical chemistry analyzers while maintaining accurate differentiation between IBD and IBS."
ALPCO was founded in 1991 as an importer and distributor of immunoassay-based products for the North American life science markets. The company has since evolved into a leading producer of novel immunodiagnostic reagents for specialty testing laboratories. In 2022, ALPCO merged with GeneProof, a Czech Republic-based provider of specialty molecular diagnostic solutions. Founded in 2005, GeneProof offers a portfolio of more than 50 IVDD and 6 IVDR PCR test kits for infectious diseases and genetic mutations, as well as a suite of proprietary instrumentation for clinical laboratories of all sizes. For additional information, please visit www.alpco.com and www.geneproof.com.