Diagnostics 2024, 14(16), 1744; https://doi.org/10.3390/diagnostics14161744 (registering DOI) - 11 Aug 2024
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
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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.
Full article
(This article belongs to the Special Issue Diagnosis and Management of Gastrointestinal Inflammation)
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Figure 1
Figure 1
<p>Flow chart of the fecal sample processing adopted from vendor kit insert.</p> Full article ">Figure 2
<p>Scatter plot of the linearity study.</p> Full article ">Figure 3
<p>Comparison of AFCAL results to the predicate Buhlmann fCAL ELISA results shown in (<b>A</b>). Bias and percent Bias between the AFCAL and Buhlmann ELISA are shown in (<b>B</b>,<b>C</b>).</p> Full article ">Figure 4
<p>fCAL data comparison between ELISA and AFCAL assay. (<b>A</b>) Percentage of patients tested for ICD codes of Crohn’s disease, ulcerative colitis, and other digestive disorders. (<b>B</b>) Percentage of matched and unmatched fCAL values when comparing the fCAL values of the same patients in ELISA versus turbidimetry.</p> Full article ">Figure 5
<p>Data analysis of patient demographics and AFCAL results. (<b>A</b>) Percentage of male and female patients. (<b>B</b>) Age groups of patients tested for fCAL. (<b>C</b>) Percentage of patients tested for ICD codes for Crohn’s disease, ulcerative colitis, and other digestive disorders. (<b>D</b>) fCAL levels measured using Abbott Alinity C analyzer and percentage of patients in the normal, borderline, and abnormal fCAL level groups.</p> Full article ">
<p>Flow chart of the fecal sample processing adopted from vendor kit insert.</p> Full article ">Figure 2
<p>Scatter plot of the linearity study.</p> Full article ">Figure 3
<p>Comparison of AFCAL results to the predicate Buhlmann fCAL ELISA results shown in (<b>A</b>). Bias and percent Bias between the AFCAL and Buhlmann ELISA are shown in (<b>B</b>,<b>C</b>).</p> Full article ">Figure 4
<p>fCAL data comparison between ELISA and AFCAL assay. (<b>A</b>) Percentage of patients tested for ICD codes of Crohn’s disease, ulcerative colitis, and other digestive disorders. (<b>B</b>) Percentage of matched and unmatched fCAL values when comparing the fCAL values of the same patients in ELISA versus turbidimetry.</p> Full article ">Figure 5
<p>Data analysis of patient demographics and AFCAL results. (<b>A</b>) Percentage of male and female patients. (<b>B</b>) Age groups of patients tested for fCAL. (<b>C</b>) Percentage of patients tested for ICD codes for Crohn’s disease, ulcerative colitis, and other digestive disorders. (<b>D</b>) fCAL levels measured using Abbott Alinity C analyzer and percentage of patients in the normal, borderline, and abnormal fCAL level groups.</p> Full article ">
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