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Performance Evaluation of Open Channel Buhlmann Fecal Calprotectin Turbo Assay on Abbott Alinity C Analyzer
Kavithalakshmi Sataranatarajan1, Shishir Adhikari2, Ngoc Nguyen2
1Department of Pathology, University of Texas Southwestern Medical Center, Dallas, TX 75235, USA.
Insights
A new automated fecal calprotectin (fCAL) assay (AFCAL) shows excellent performance for diagnosing inflammatory bowel disease (IBD). This validated method improves efficiency and reduces costs in clinical laboratories.
Area of Science:
- Gastroenterology
- Clinical Chemistry
- Laboratory Medicine
Background:
- Inflammatory bowel disease (IBD) involves chronic gastrointestinal inflammation.
- Fecal calprotectin (fCAL) is a key noninvasive biomarker for IBD diagnosis and monitoring.
- Current fCAL testing relies on ELISA methods, prompting the need for automated solutions.
Purpose of the Study:
- To validate the performance of the Buhlmann fCAL turbo assay on the automated Abbott Alinity C analyzer (AFCAL).
- To assess the clinical utility and efficiency of AFCAL in a core laboratory setting.
Main Methods:
- Imprecision studies (5-day) evaluated assay variability.
- Reportable range determination was performed.
- Deming regression and Bland-Altman analysis compared AFCAL to predicate ELISA methods.
- Retrospective clinical performance was assessed in 62 IBD patients.
Main Results:
- Excellent imprecision: within-run 5.3%, between-day 2.5%.
- Reportable range: 30-20,000 µg/g.
- Strong correlation (r=0.99) and low bias (1.8%) with predicate ELISA.
- AFCAL implementation improved turnaround time, reduced costs, and increased clinician satisfaction.
Conclusions:
- The automated AFCAL assay is a reliable and efficient method for fecal calprotectin measurement.
- AFCAL offers significant advantages over traditional ELISA methods for IBD management.
- This validation supports the integration of AFCAL into routine clinical laboratory testing for IBD patients.
Abstract:
Inflammatory bowel disease (IBD) is characterized by chronic inflammation of the gastrointestinal (GI) tract. Fecal calprotectin (fCAL) is a noninvasive laboratory test used in the diagnosis and monitoring of IBDs such as Crohn's disease and ulcerative colitis. The fCAL send-out test that our facility has been offering so far uses an ELISA-based method. In the current study, we sought to validate the performance of a Buhlmann fCAL turbo assay in an automated Abbott Alinity C analyzer (AFCAL) in our core laboratory. Five-day imprecision studies showed good performance for both within-run (5.3%) and between-day (2.5%) measurements. The reportable range was verified as 30-20,000 µg/g. Deming regression and Bland-Altman analysis indicated a strong correlation of r = 0.99 with a low, acceptable bias of 1.8% for AFCAL relative to the predicate Buhlmann fCAL ELISA results. AFCAL's clinical performance was determined retrospectively in 62 patients with ICD codes for IBD. Overall, the implementation of AFCAL in our routine clinical testing has improved our turnaround time, reduced the cost per test, and significantly increased our clinician satisfaction.
