Summary:
QuidelOrtho and BÜHLMANN Laboratories have partnered to launch the fCAL turbo and fPELA turbo fecal biomarker assays on VITROS Systems, enhancing rapid, non-invasive diagnostics for inflammatory bowel disease and pancreatic insufficiency.

Takeaways:

  • The assays deliver results in under 10 minutes with wide reportable ranges and 90-day stability on the analyzer.
  • Integration with CALEX® Cap technology simplifies stool sample preparation and supports safe, efficient testing workflows.
  • This collaboration promotes personalized, cost-effective healthcare by reducing reliance on invasive procedures and improving gastrointestinal and pancreatic diagnostics.

QuidelOrtho Corporation and BÜHLMANN Laboratories AG have announced the availability of the BÜHLMANN fCAL turbo and fPELA turbo assays on QuidelOrtho’s VITROS Systems as an MPA. Both particle-enhanced turbidimetric immunoassays, the fCAL turbo assay for fecal calprotectin measurement aids in the diagnosis of inflammatory bowel disease (IBD) and its differentiation from irritable bowel syndrome, and the fPELA turbo assay for fecal pancreatic elastase aids in the determination of pancreatic insufficiency.

This collaboration addresses key healthcare trends, including the rise of non-invasive diagnostic tools, the demand for cost-effective healthcare solutions, and the growing focus on gastrointestinal and pancreatic health and its systemic impact. The fCAL and fPELA turbo assays exemplify innovation in diagnostics technology, supporting the shift toward tailored medicine and preventive healthcare.

Tests Available in and Outside the US

The fCAL and fPELA turbo assays are both now available for use on QuidelOrtho’s VITROS Systems (fCAL turbo and fPELA turbo assays – U.S. and Outside U.S.: VITROS XT 7600 and 5600 Integrated System, as well as VITROS 4600 Chemistry Systems.

Key features include:

  • Rapid results in less than 10 minutes
  • Wide reportable ranges
  • 90-day on-analyzer stability
  • Compatibility with VITROS Automation Solutions
  • Simplified sample extraction and preparation with CALEX® Cap technology

“The integration of BÜHLMANN’s fCAL and fPELA turbo assays with our VITROS Systems represents a significant advancement in IBD and pancreatic insufficiency diagnoses,” says Jonathan Siegrist, PhD, executive vice president of Research & Development & chief technology officer at QuidelOrtho. “This collaboration allows laboratories to provide fast results to aid in the diagnosis and management of IBD and pancreatic issues. With features like the long calibration interval and the ability to use the CALEX Cap–prepared stool samples directly, we’re offering a solution that combines clinical accuracy with operational efficiency, ultimately improving patient care.”

These assays contribute to better management of gastrointestinal health, reducing the need for invasive procedures and lowering long-term healthcare costs.

Fecal Assays Simplify Sample Extraction and Preparation

Both assays utilize BÜHLMANN’s innovative CALEX Cap technology, which simplifies sample extraction and preparation while facilitating safe handling, all seamlessly integrated onto a single VITROS System.

“We are thrilled to collaborate with QuidelOrtho to expand the delivery of an efficient, automated solution for fecal biomarker testing,” says Christian Eberle, chief executive officer at BÜHLMANN Laboratories AG. “Our assays, combined with the CALEX Cap stool preparation device, optimize stool extraction efficiency to help maximize stability and yield, resulting in robust fecal calprotectin and pancreatic elastase test results. This collaboration between QuidelOrtho and BÜHLMANN Laboratories AG meets evolving patient and provider needs in the era of personalized medicine and preventive healthcare, offering innovative solutions that align with the industry’s focus on non-invasive, cost-effective, and patient-centric diagnostic tools.”

The fCAL and fPELA turbo assays’ integration with VITROS Systems offers laboratories an efficient workflow for a wide variety of sample collection methods, enhancing flexibility in sample handling and processing.

*CALEX, fCAL and fPELA are trademarks of BÜHLMANN Laboratories AG and VITROS and MicroTip are trademarks of QuidelOrtho.

Featured Image: VITROS MPA fCAL/fPELA Turbo Assays. Image: QuidelOrtho/BÜHLMANN Laboratories