Comparative Study of Elevated CA19-9 Levels in Non-Gastrointestinal Tumors Patients: Evaluation of Different Immunoassay Methods and Analysis of Potential Interfering Factors
<b>Objectives</b>: CA19-9 elevation in non-gastrointestinal tumor patients may be influenced by various non-tumor factors, which poses challenges for clinical diagnosis. This study aims to assess the consistency between initial elevated CA19-9 levels detected by the ARCHITECT/Alinity i s...
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2025-06-01
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| author | Yangyang Liu Wenxuan Li Shaoxi Tang Ruihao Wu Yumin Wang Fanggui Shao |
| author_facet | Yangyang Liu Wenxuan Li Shaoxi Tang Ruihao Wu Yumin Wang Fanggui Shao |
| author_sort | Yangyang Liu |
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| description | <b>Objectives</b>: CA19-9 elevation in non-gastrointestinal tumor patients may be influenced by various non-tumor factors, which poses challenges for clinical diagnosis. This study aims to assess the consistency between initial elevated CA19-9 levels detected by the ARCHITECT/Alinity i system (Abbott Diagnostics) and subsequent retesting using the Elecsys CA19-9 assay (Roche Diagnostics) in 5372 non-gastrointestinal tumor patients, and to explore potential factors contributing to CA19-9 non-specific elevation. <b>Methods</b>: Bland-Altman and Passing-Bablok analyses were used to assess the agreement between the two assays. Nonparametric Spearman and Pearson’s chi-square tests were used to assess the correlation between CA19-9 and different clinical comorbidities/antigen concentration strata and to compare the categorization by age/disease, respectively. <b>Results</b>: Bland–Altman and Passing–Bablok regression analyses revealed that the CA19-9 test results from Abbott and Roche platforms show significant systematic bias and weak correlation, making the two methods not directly interchangeable. After excluding common confounders, the study focused on heterophilic antibodies (HAs) as target. Blood samples were treated with a commercial blocking agent demonstrated alignment with baseline Elecsys CA19-9 results but differed significantly from initial ARCHITECT/Alinity i measurements. Furthermore, non-specific CA19-9 elevation was also associated with comorbidities such as diabetes mellitus, pulmonary infections, breast nodules, uterine leiomyoma, and its incidence increased with age. <b>Conclusions</b>: The study highlights the need to consider potential interferences and underlying disorders when results conflict with clinical diagnoses. Method-specific validation and comprehensive clinical correlation are crucial for accurate interpretation of CA19-9 levels to prevent misdiagnosis and ensure appropriate patient management. |
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| spelling | doaj-art-baafb6c5943e4caa8adfe09f180d34772025-08-20T03:26:25ZengMDPI AGBiomedicines2227-90592025-06-01136138610.3390/biomedicines13061386Comparative Study of Elevated CA19-9 Levels in Non-Gastrointestinal Tumors Patients: Evaluation of Different Immunoassay Methods and Analysis of Potential Interfering FactorsYangyang Liu0Wenxuan Li1Shaoxi Tang2Ruihao Wu3Yumin Wang4Fanggui Shao5Central Laboratory, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou 325000, ChinaDepartment of Laboratory Medicine, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou 325000, ChinaDepartment of Laboratory Medicine, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou 325000, ChinaDepartment of Laboratory Medicine, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou 325000, ChinaDepartment of Laboratory Medicine, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou 325000, ChinaDepartment of Laboratory Medicine, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou 325000, China<b>Objectives</b>: CA19-9 elevation in non-gastrointestinal tumor patients may be influenced by various non-tumor factors, which poses challenges for clinical diagnosis. This study aims to assess the consistency between initial elevated CA19-9 levels detected by the ARCHITECT/Alinity i system (Abbott Diagnostics) and subsequent retesting using the Elecsys CA19-9 assay (Roche Diagnostics) in 5372 non-gastrointestinal tumor patients, and to explore potential factors contributing to CA19-9 non-specific elevation. <b>Methods</b>: Bland-Altman and Passing-Bablok analyses were used to assess the agreement between the two assays. Nonparametric Spearman and Pearson’s chi-square tests were used to assess the correlation between CA19-9 and different clinical comorbidities/antigen concentration strata and to compare the categorization by age/disease, respectively. <b>Results</b>: Bland–Altman and Passing–Bablok regression analyses revealed that the CA19-9 test results from Abbott and Roche platforms show significant systematic bias and weak correlation, making the two methods not directly interchangeable. After excluding common confounders, the study focused on heterophilic antibodies (HAs) as target. Blood samples were treated with a commercial blocking agent demonstrated alignment with baseline Elecsys CA19-9 results but differed significantly from initial ARCHITECT/Alinity i measurements. Furthermore, non-specific CA19-9 elevation was also associated with comorbidities such as diabetes mellitus, pulmonary infections, breast nodules, uterine leiomyoma, and its incidence increased with age. <b>Conclusions</b>: The study highlights the need to consider potential interferences and underlying disorders when results conflict with clinical diagnoses. Method-specific validation and comprehensive clinical correlation are crucial for accurate interpretation of CA19-9 levels to prevent misdiagnosis and ensure appropriate patient management.https://www.mdpi.com/2227-9059/13/6/1386CA19-9non-gastrointestinal tumorsheterophilic antibodyconcordance analysis |
| spellingShingle | Yangyang Liu Wenxuan Li Shaoxi Tang Ruihao Wu Yumin Wang Fanggui Shao Comparative Study of Elevated CA19-9 Levels in Non-Gastrointestinal Tumors Patients: Evaluation of Different Immunoassay Methods and Analysis of Potential Interfering Factors Biomedicines CA19-9 non-gastrointestinal tumors heterophilic antibody concordance analysis |
| title | Comparative Study of Elevated CA19-9 Levels in Non-Gastrointestinal Tumors Patients: Evaluation of Different Immunoassay Methods and Analysis of Potential Interfering Factors |
| title_full | Comparative Study of Elevated CA19-9 Levels in Non-Gastrointestinal Tumors Patients: Evaluation of Different Immunoassay Methods and Analysis of Potential Interfering Factors |
| title_fullStr | Comparative Study of Elevated CA19-9 Levels in Non-Gastrointestinal Tumors Patients: Evaluation of Different Immunoassay Methods and Analysis of Potential Interfering Factors |
| title_full_unstemmed | Comparative Study of Elevated CA19-9 Levels in Non-Gastrointestinal Tumors Patients: Evaluation of Different Immunoassay Methods and Analysis of Potential Interfering Factors |
| title_short | Comparative Study of Elevated CA19-9 Levels in Non-Gastrointestinal Tumors Patients: Evaluation of Different Immunoassay Methods and Analysis of Potential Interfering Factors |
| title_sort | comparative study of elevated ca19 9 levels in non gastrointestinal tumors patients evaluation of different immunoassay methods and analysis of potential interfering factors |
| topic | CA19-9 non-gastrointestinal tumors heterophilic antibody concordance analysis |
| url | https://www.mdpi.com/2227-9059/13/6/1386 |
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