Accre 8 emerging point of care CLIA system for vitamin B12 assessment compared with three established assays
Abstract Accurate Vitamin B12 (Vit B12) quantification is essential for diagnosing deficiencies linked to neurological and hematological disorders. The Accre 8 Point-of-Care (POC) Chemiluminescent Immunoassay (CLIA) system offers a compact design, rapid single-step operation, and minimal calibration...
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Nature Portfolio
2025-04-01
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| Online Access: | https://doi.org/10.1038/s41598-025-97503-4 |
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| author | Farah M. Trad Tasneem AlHamad Nadin Younes Shaden Abunasser Salma Younes Parveen B. Nizamuddin Dayana El Chaar Israa M. Salameh Nader I. Al-dewik Wanida Laiwattanapaisal Pattramon Aungbamnet Pollanat Loungjinda Palanee Ammaranond Meng Li Laith J. Abu-Raddad Gheyath K. Nasrallah |
| author_facet | Farah M. Trad Tasneem AlHamad Nadin Younes Shaden Abunasser Salma Younes Parveen B. Nizamuddin Dayana El Chaar Israa M. Salameh Nader I. Al-dewik Wanida Laiwattanapaisal Pattramon Aungbamnet Pollanat Loungjinda Palanee Ammaranond Meng Li Laith J. Abu-Raddad Gheyath K. Nasrallah |
| author_sort | Farah M. Trad |
| collection | DOAJ |
| description | Abstract Accurate Vitamin B12 (Vit B12) quantification is essential for diagnosing deficiencies linked to neurological and hematological disorders. The Accre 8 Point-of-Care (POC) Chemiluminescent Immunoassay (CLIA) system offers a compact design, rapid single-step operation, and minimal calibration requirements. This study evaluates Accre 8’s performance against established CLIA immunoassays (Abbott and Roche) and LC-MS/MS, the gold standard for Vit B12 quantification. A total of 297 serum samples, spanning deficient to sufficient Vit B12 levels, were analyzed. Accre 8 demonstrated a strong correlation with LC-MS/MS (r = 0.94, p < 0.001), with median Vit B12 levels closely aligning with LC-MS/MS (256.0 pmol/L). Accre 8 exhibited high sensitivity (96.9%) and specificity (86.7%), with Cohen’s Kappa agreement (0.76). Bland-Altman analysis showed a mean bias of - 18.5%, while Passing-Bablok regression indicated proportional bias at higher concentrations (slope = 1.44). ROC analysis confirmed excellent diagnostic accuracy (AUC = 0.98). Accre 8’s strong diagnostic performance, minimal calibration needs, and low sample volume requirements position it as a practical alternative to conventional CLIA systems for Vit B12 assessment, particularly in clinical and resource-limited settings. These findings support its potential integration into routine diagnostic workflows for Vit B12 deficiency screening and monitoring. |
| format | Article |
| id | doaj-art-778838e051bf49d6b4bf16b2d6c95f10 |
| institution | OA Journals |
| issn | 2045-2322 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | Nature Portfolio |
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| series | Scientific Reports |
| spelling | doaj-art-778838e051bf49d6b4bf16b2d6c95f102025-08-20T02:17:47ZengNature PortfolioScientific Reports2045-23222025-04-0115111310.1038/s41598-025-97503-4Accre 8 emerging point of care CLIA system for vitamin B12 assessment compared with three established assaysFarah M. Trad0Tasneem AlHamad1Nadin Younes2Shaden Abunasser3Salma Younes4Parveen B. Nizamuddin5Dayana El Chaar6Israa M. Salameh7Nader I. Al-dewik8Wanida Laiwattanapaisal9Pattramon Aungbamnet10Pollanat Loungjinda11Palanee Ammaranond12Meng Li13Laith J. Abu-Raddad14Gheyath K. Nasrallah15Biomedical Research Center, QU Health, Qatar UniversityBiomedical Sciences Department, College of Health Sciences, QU Health, Qatar UniversityBiomedical Research Center, QU Health, Qatar UniversityBiomedical Research Center, QU Health, Qatar UniversityBiomedical Research Center, QU Health, Qatar UniversityBiomedical Research Center, QU Health, Qatar UniversityFaculty of Medicine, Department of Nutritional Sciences, University of TorontoBiomedical Research Center, QU Health, Qatar UniversityDepartment of Research, Women’s Wellness and Research Center, Hamad Medical CorporationDepartment of Clinical Chemistry, Faculty of Allied Health Sciences, Chulalongkorn UniversityMedical Technology Unit, Health Sciences Service Center, Faculty of Allied Health Sciences, Chulalongkorn UniversityMedical Technology Unit, Health Sciences Service Center, Faculty of Allied Health Sciences, Chulalongkorn UniversityDepartment of transfusion medicine and clinical microbiology, Faculty of Allied Health Sciences, Chulalongkorn UniversityGuangzhou Wondfo Biotech Co., LtdWeill Cornell Medical College – Qatar, Cornell UniversityBiomedical Research Center, QU Health, Qatar UniversityAbstract Accurate Vitamin B12 (Vit B12) quantification is essential for diagnosing deficiencies linked to neurological and hematological disorders. The Accre 8 Point-of-Care (POC) Chemiluminescent Immunoassay (CLIA) system offers a compact design, rapid single-step operation, and minimal calibration requirements. This study evaluates Accre 8’s performance against established CLIA immunoassays (Abbott and Roche) and LC-MS/MS, the gold standard for Vit B12 quantification. A total of 297 serum samples, spanning deficient to sufficient Vit B12 levels, were analyzed. Accre 8 demonstrated a strong correlation with LC-MS/MS (r = 0.94, p < 0.001), with median Vit B12 levels closely aligning with LC-MS/MS (256.0 pmol/L). Accre 8 exhibited high sensitivity (96.9%) and specificity (86.7%), with Cohen’s Kappa agreement (0.76). Bland-Altman analysis showed a mean bias of - 18.5%, while Passing-Bablok regression indicated proportional bias at higher concentrations (slope = 1.44). ROC analysis confirmed excellent diagnostic accuracy (AUC = 0.98). Accre 8’s strong diagnostic performance, minimal calibration needs, and low sample volume requirements position it as a practical alternative to conventional CLIA systems for Vit B12 assessment, particularly in clinical and resource-limited settings. These findings support its potential integration into routine diagnostic workflows for Vit B12 deficiency screening and monitoring.https://doi.org/10.1038/s41598-025-97503-4Vitamin B12DeficiencyImmunoassayAccre 8CLIAPoint-of-Care |
| spellingShingle | Farah M. Trad Tasneem AlHamad Nadin Younes Shaden Abunasser Salma Younes Parveen B. Nizamuddin Dayana El Chaar Israa M. Salameh Nader I. Al-dewik Wanida Laiwattanapaisal Pattramon Aungbamnet Pollanat Loungjinda Palanee Ammaranond Meng Li Laith J. Abu-Raddad Gheyath K. Nasrallah Accre 8 emerging point of care CLIA system for vitamin B12 assessment compared with three established assays Scientific Reports Vitamin B12 Deficiency Immunoassay Accre 8 CLIA Point-of-Care |
| title | Accre 8 emerging point of care CLIA system for vitamin B12 assessment compared with three established assays |
| title_full | Accre 8 emerging point of care CLIA system for vitamin B12 assessment compared with three established assays |
| title_fullStr | Accre 8 emerging point of care CLIA system for vitamin B12 assessment compared with three established assays |
| title_full_unstemmed | Accre 8 emerging point of care CLIA system for vitamin B12 assessment compared with three established assays |
| title_short | Accre 8 emerging point of care CLIA system for vitamin B12 assessment compared with three established assays |
| title_sort | accre 8 emerging point of care clia system for vitamin b12 assessment compared with three established assays |
| topic | Vitamin B12 Deficiency Immunoassay Accre 8 CLIA Point-of-Care |
| url | https://doi.org/10.1038/s41598-025-97503-4 |
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