Clinical Comparison of OC-Sensor Pledia and Phadia 250 for Fecal Calprotectin Testing
<b>Background:</b> The fecal calprotectin (f-Cal) test is a convenient method used for differentiating inflammatory bowel disease (IBD) from functional bowel disorders. The OC-Sensor Pledia (OC-FCa; Eiken Chemical Co., Tokyo, Japan) is a latex agglutination turbidimetric immunoassay used...
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| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2024-11-01
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| Series: | Diagnostics |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2075-4418/14/22/2490 |
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| Summary: | <b>Background:</b> The fecal calprotectin (f-Cal) test is a convenient method used for differentiating inflammatory bowel disease (IBD) from functional bowel disorders. The OC-Sensor Pledia (OC-FCa; Eiken Chemical Co., Tokyo, Japan) is a latex agglutination turbidimetric immunoassay used for f-Cal measurements. We evaluated the clinical performance of OC-FCa and compared the f-Cal levels between OC-FCa and Phadia 250 (Thermo Fisher Scientific, Freiburg, Germany). <b>Methods:</b> We collected 278 stool samples; of these, 158 were taken from patients with suspected IBD, and 120 were taken from healthy individuals. We analyzed the f-Cal distribution in each group and compared the clinical performance and agreement between OC-FCa and Phadia 250. <b>Results:</b> The f-Cal of patients with IBD was significantly different from that of patients without IBD for both OC-FCa and Phadia 250 (<i>p</i> < 0.0001 and <i>p</i> < 0.001, respectively). The concordance between OC-FCa and Phadia 250 was 82.3%, with moderate agreement (kappa = 0.644, 95% confidence interval = 0.525–0.763). OC-FCa and Phadia 250 showed a high correlation (r = 0.90); their diagnostic performance showed moderate accuracy (AUC = 0.873 and 0.866, respectively) and had no significant difference (<i>p</i> = 0.616). <b>Conclusions:</b> Both OC-FCa and Phadia 250 showed a high correlation and good clinical performance. F-Cal measured using OC-FCa was reliable for initial differentiation between patients with IBD and without IBD. Therefore, OC-FCa and Phadia 250 could be alternative devices for measuring f-Cal depending on the laboratory situation. |
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| ISSN: | 2075-4418 |