BÜHLMANN Laboratories AG Launches New fPELA® turbo Automated, Random Access Pancreatic Elastase Test
BÜHLMANN fPELA® turbo (FDA Exempt. For in vitro Diagnostic Use) is an in vitro diagnostic assay intended for the quantitation of pancreatic elastase in human stool, is now commercially available in the US.
Amherst, NH, June 24, 2020 --(PR.com)-- BÜHLMANN Laboratories AG is proud to announce the launch of its BÜHLMANN fPELA® turbo. This turbidimetric assay is a test for the quantitative determination of pancreatic elastase in human fecal extracts and is intended to be run on clinical chemistry analyzers. Fecal pancreatic elastase is a well-established biomarker to detect pancreatic exocrine insufficiency (PEI) in patients suffering from conditions such as chronic pancreatitis and cystic fibrosis. The concentration of pancreatic elastase levels in feces reflects the level of pancreatic output and correlates with the output of other pancreatic enzymes such as lipase, amylase, and trypsin.
Just like the FDA 510(k) cleared, BÜHLMANN fCAL® turbo, the fPELA® turbo test is a particle enhanced turbidimetric immunoassay (PETIA) assay developed to be run directly with stool extracts derived from the CALEX® Cap extraction device. This device is pre-filled with unique extraction buffer designed for fecal extraction of pancreatic elastase and calprotectin, allowing for quantification of both analytes at the same time. This synergy further streamlines the workload for fecal testing in the modern automated laboratory. Both turbo assays can be applied economically in low/mid volume laboratories as well as in very high volume reference labs due its quality performance and high capacity. Testing turnaround time can be reduced significantly not only compared to the existing ELISA methods but also to any other automated, random access pancreatic elastase and calprotectin assays.
“We are very excited to launch yet another robust, high quality assay to assist physicians in evaluating gastroenterology patients in a timely manner, providing results within 10 minutes,” CEO of BUHLMANN Diagnostics Corp., Doug Olson commented. “This assay not only has high correlation to the manual gold standard reference method, but also is specific to human enzymatic isoforms. The BÜHLMANN fPELA® turbo is a great addition to our gastroenterology assay portfolio, offering speed, quality and flexibility to pancreatic elastase testing.”
Visit www.buhlmannlabs.com to learn more about this assay, and overall performance.
About BÜHLMANN Calprotectin Product Line
The calprotectin portfolio consists of the FDA 510(k) cleared BÜHLMANN fCAL® ELISA, the FDA 510(k) cleared automated BÜHLMANN fCAL® turbo (in combination with CALEX® Cap fecal extraction device) for testing on most clinical chemistry analyzers, Quantum Blue® fCAL rapid test (RUO in the US), and IBDoc®, the first and only Health Canada Licensed home-testing application for fecal calprotectin in IBD patients (IBDoc® not available for sale in the US).
Visit https://calprotectinassays.com to learn more about the BÜHLMANN fCAL assay line.
About BÜHLMANN Laboratories AG
Founded in 1976, BÜHLMANN Laboratories AG has continued to focus on growing a product portfolio of in vitro diagnostics and research markets. BÜHLMANN is known for outstanding product quality, providing excellent after-sales services, and delivering remarkable scientific innovations. BÜHLMANN offers the broadest range of calprotectin products as well as a selection of unique, high-quality assays such as the BÜHLMANN Flow CAST® product group for Basophil Activation Testing, the BÜHLMANN GanglioCombi™ products for Neuroimmunology, and a variety of Melatonin Assays.
About BUHLMANN Diagnostics Corp. (BDC)
BUHLMANN Diagnostics Corp. (BDC) is the North American affiliate of BÜHLMANN Laboratories AG, the worldwide provider of ELISA kits, RIA kits, lateral flow and flow cytometry assays. Located in Southern New Hampshire, BDC has a highly experienced team who represent a breadth of experience in serving both clinical and basic science research laboratories.
Contact Information
BUHLMANN Diagnostics Corp
Collin Shaw
844-300-9799
www.buhlmannlabs.com
info@buhlmannlabs.com
Just like the FDA 510(k) cleared, BÜHLMANN fCAL® turbo, the fPELA® turbo test is a particle enhanced turbidimetric immunoassay (PETIA) assay developed to be run directly with stool extracts derived from the CALEX® Cap extraction device. This device is pre-filled with unique extraction buffer designed for fecal extraction of pancreatic elastase and calprotectin, allowing for quantification of both analytes at the same time. This synergy further streamlines the workload for fecal testing in the modern automated laboratory. Both turbo assays can be applied economically in low/mid volume laboratories as well as in very high volume reference labs due its quality performance and high capacity. Testing turnaround time can be reduced significantly not only compared to the existing ELISA methods but also to any other automated, random access pancreatic elastase and calprotectin assays.
“We are very excited to launch yet another robust, high quality assay to assist physicians in evaluating gastroenterology patients in a timely manner, providing results within 10 minutes,” CEO of BUHLMANN Diagnostics Corp., Doug Olson commented. “This assay not only has high correlation to the manual gold standard reference method, but also is specific to human enzymatic isoforms. The BÜHLMANN fPELA® turbo is a great addition to our gastroenterology assay portfolio, offering speed, quality and flexibility to pancreatic elastase testing.”
Visit www.buhlmannlabs.com to learn more about this assay, and overall performance.
About BÜHLMANN Calprotectin Product Line
The calprotectin portfolio consists of the FDA 510(k) cleared BÜHLMANN fCAL® ELISA, the FDA 510(k) cleared automated BÜHLMANN fCAL® turbo (in combination with CALEX® Cap fecal extraction device) for testing on most clinical chemistry analyzers, Quantum Blue® fCAL rapid test (RUO in the US), and IBDoc®, the first and only Health Canada Licensed home-testing application for fecal calprotectin in IBD patients (IBDoc® not available for sale in the US).
Visit https://calprotectinassays.com to learn more about the BÜHLMANN fCAL assay line.
About BÜHLMANN Laboratories AG
Founded in 1976, BÜHLMANN Laboratories AG has continued to focus on growing a product portfolio of in vitro diagnostics and research markets. BÜHLMANN is known for outstanding product quality, providing excellent after-sales services, and delivering remarkable scientific innovations. BÜHLMANN offers the broadest range of calprotectin products as well as a selection of unique, high-quality assays such as the BÜHLMANN Flow CAST® product group for Basophil Activation Testing, the BÜHLMANN GanglioCombi™ products for Neuroimmunology, and a variety of Melatonin Assays.
About BUHLMANN Diagnostics Corp. (BDC)
BUHLMANN Diagnostics Corp. (BDC) is the North American affiliate of BÜHLMANN Laboratories AG, the worldwide provider of ELISA kits, RIA kits, lateral flow and flow cytometry assays. Located in Southern New Hampshire, BDC has a highly experienced team who represent a breadth of experience in serving both clinical and basic science research laboratories.
Contact Information
BUHLMANN Diagnostics Corp
Collin Shaw
844-300-9799
www.buhlmannlabs.com
info@buhlmannlabs.com
Contact
BUHLMANN Diagnostics Corp
Collin Shaw
844-300-9799
www.buhlmannlabs.com
info@buhlmannlabs.com
Collin Shaw
844-300-9799
www.buhlmannlabs.com
info@buhlmannlabs.com
Contact
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