Now Available: 510(k) Cleared Fecal Calprotectin ELISA
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ALPCO received 510(k) clearance from the US FDA for its new fecal Calprotectin Chemiluminescence ELISA test.
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The ALPCO Calprotectin Chemiluminescence ELISA’s superior clinical accuracy will enable clinical laboratories to provide the most accurate results to gastroenterologists facing the challenges of differentiating IBD from IBS.
FOR IMMEDIATE RELEASE - Salem, NH, October 29, 2019 - ALPCO, a leading developer and manufacturer of life science test solutions to advance research and improve clinical outcomes, announced today that the US Food and Drug Administration (FDA) granted its Calprotectin Chemiluminescence ELISA 510(k) clearance. The ALPCO Calprotectin Chemiluminescence ELISA, the latest addition to ALPCO's STELLUX® product portfolio, has the highest clinical specificity of any FDA cleared calprotectin test.
This feature will enable clinical laboratories to provide the most accurate results to gastroenterologists facing the challenge of differentiating inflammatory bowel disease (IBD) from irritable bowel syndrome (IBS). Calprotectin is a well-established, non-invasive biomarker for identifying inflammation in the gastrointestinal tract associated with IBD. Testing for calprotectin levels in stool assists gastroenterologists with excluding IBS as a possible diagnosis for patients with symptoms shared by both IBS and IBD. “Although many of the calprotectin tests available have high clinical sensitivity, they fall short on clinical specificity and consequently have high false positive rates,” explained Sean Conley, ALPCO’s president. “This indicates that there are still many unnecessary colonoscopies ordered by gastroenterologists trying to exclude IBS as a diagnosis.”
ALPCO’s new Calprotectin Chemi ELISA exhibits a clinical specificity of 95.1% and provides the lowest false positive rate of any currently cleared calprotectin test without sacrificing clinical sensitivity. In addition, the ALPCO Chemi Calprotectin ELISA is capable of quantifying calprotectin levels between 7.9 – 6,000 µg/g from the primary dilution. This range is 1.7 – 25 times broader than the predicate devices on the market, and can ultimately reduce reruns along with lost time and money in the field. After testing ALPCO’s Calprotectin Chemi ELISA, Jack A. Maggiore, PhD, MT(ASCP) Assistant Director, Chemistry Laboratory and R&D at Doctor's Data, Inc. commented on his choice to switch to the assay, “The decision of Doctor’s Data to select the ALPCO chemiluminescence method for measuring fecal calprotectin was influenced by its analytical precision, sensitivity, reportable range, and clinical accuracy. As a recognized leader in microplate immunoassay testing, our laboratory team trusts the quality and reliability of ALPCO’s products.”
Many patients with IBD have symptoms similar to IBS which can cause a delay in receiving the correct diagnosis and care. “IBD and IBS are difficult enough for patients to live with,” said Bethany Bell, PhD, Director of Product Management at ALPCO. “We recognized the need for a calprotectin test that gives clinical labs and GIs the most accurate results to assist with the diagnosis. Ultimately, we developed the best assay to help patients enter the correct care pathway faster, in hopes of improving their lives.” To learn more about the Calprotectin Chemiluminescence ELISA’s clinical accuracy, download ALPCO’s white paper, The Importance of Clinical Specificity: A Review of FDA Cleared Fecal Calprotectin Tests.