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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2024-11-01
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| author | Eunju Shin Jong Do Seo Hee Sook Shim Hanah Kim Mina Hur Yeo-Min Yun Hee-Won Moon |
| author_facet | Eunju Shin Jong Do Seo Hee Sook Shim Hanah Kim Mina Hur Yeo-Min Yun Hee-Won Moon |
| author_sort | Eunju Shin |
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| description | <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. |
| format | Article |
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| institution | OA Journals |
| issn | 2075-4418 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | MDPI AG |
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| series | Diagnostics |
| spelling | doaj-art-31aea4d9c4e34626b1e4486453e313492025-08-20T02:07:59ZengMDPI AGDiagnostics2075-44182024-11-011422249010.3390/diagnostics14222490Clinical Comparison of OC-Sensor Pledia and Phadia 250 for Fecal Calprotectin TestingEunju Shin0Jong Do Seo1Hee Sook Shim2Hanah Kim3Mina Hur4Yeo-Min Yun5Hee-Won Moon6Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul 05030, Republic of KoreaDepartment of Laboratory Medicine, Konkuk University School of Medicine, Seoul 05030, Republic of KoreaDepartment of Laboratory Medicine, Konkuk University School of Medicine, Seoul 05030, Republic of KoreaDepartment of Laboratory Medicine, Konkuk University School of Medicine, Seoul 05030, Republic of KoreaDepartment of Laboratory Medicine, Konkuk University School of Medicine, Seoul 05030, Republic of KoreaDepartment of Laboratory Medicine, Konkuk University School of Medicine, Seoul 05030, Republic of KoreaDepartment of Laboratory Medicine, Konkuk University School of Medicine, Seoul 05030, Republic of Korea<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.https://www.mdpi.com/2075-4418/14/22/2490OC-SensorcalprotectinPhadia 250agreementperformanceinflammatory bowel disease |
| spellingShingle | Eunju Shin Jong Do Seo Hee Sook Shim Hanah Kim Mina Hur Yeo-Min Yun Hee-Won Moon Clinical Comparison of OC-Sensor Pledia and Phadia 250 for Fecal Calprotectin Testing Diagnostics OC-Sensor calprotectin Phadia 250 agreement performance inflammatory bowel disease |
| title | Clinical Comparison of OC-Sensor Pledia and Phadia 250 for Fecal Calprotectin Testing |
| title_full | Clinical Comparison of OC-Sensor Pledia and Phadia 250 for Fecal Calprotectin Testing |
| title_fullStr | Clinical Comparison of OC-Sensor Pledia and Phadia 250 for Fecal Calprotectin Testing |
| title_full_unstemmed | Clinical Comparison of OC-Sensor Pledia and Phadia 250 for Fecal Calprotectin Testing |
| title_short | Clinical Comparison of OC-Sensor Pledia and Phadia 250 for Fecal Calprotectin Testing |
| title_sort | clinical comparison of oc sensor pledia and phadia 250 for fecal calprotectin testing |
| topic | OC-Sensor calprotectin Phadia 250 agreement performance inflammatory bowel disease |
| url | https://www.mdpi.com/2075-4418/14/22/2490 |
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