B-015 Neonatal Bilirubin Method Comparison on Three General Chemistry Platforms Using Pooled Neonatal Samples
Notice bibliographique
Résumé
Abstract Background Neonatal total bilirubin (NBIL) results are used to guide the medical need for phototherapy or exchange transfusion in babies. When sample analysis occurs across multiple vendors and instrument platforms, clinical result interpretation challenges can occur. This study evaluated the performance of NBIL methods across multiple general chemistry analyzers - Roche Cobas, Siemens Atellica, and Ortho Vitros - using pooled neonatal plasma samples. NBIL was measured as total bilirubin on Roche Cobas and Siemens Atellica, whereas on Ortho Vitros, it was measured as the sum of conjugated and unconjugated bilirubin fractions (Bc and Bu) using dry slide chemistry. Methods Residual neonatal plasma samples were collected at selected hospital laboratories in Alberta, Canada, and pooled. This was a process requiring meticulous effort due to the small volume typically available from each neonate. Pooled samples were divided into five sets and analyzed in duplicates at separate clinical laboratories using the NBIL method on the respective platform (two laboratories using Roche Cobas (8000 vs Pro), two laboratories using Ortho Vitros XT3400 BuBc slides (two slide generations) and one laboratory using Siemens Atellica. Results from each platform were compared to assess method performance and bias. Graphical and statistical analysis were completed, including Passing Bablok regression analysis. Total allowable difference used for the data analysis was ±20% or 6.84 umol/L. Results Method comparisons reveal up to 29% bias for neonatal bilirubin measurements between Roche Cobas and Siemens Atellica platforms, with an average bias of +27%. Ortho Vitros XT3400 showed an average bias of +11% compared to Roche Cobas. Among the three platforms studied, Siemens Atellica demonstrated the highest bias, while Roche Cobas consistently ran lower compared to the other platforms, with Vitros XT3400 positioned in between. Passing Bablok regression revealed the following relationships:Ortho Vitros (X) vs. Atellica (Y): y=1.12x-0.34Roche Cobas (X) vs. Atellica (Y): y=1.27x-0.26Ortho Vitros (X) vs. Roche Cobas (Y): y=0.86x+2.98 The average bias between two generation of slides installed on two Vitros analyzers was 0.3%, while the average difference between Cobas Pro and Cobas 8000 was 2.9%. Conclusions: Among the three vendor platform families studied, Siemens Atellica demonstrated the highest bias, while Roche Cobas was consistently lower compared to the other two platforms. These discrepancies underscore the critical need for mitigation strategies and assay performance assessment by the vendor to significantly reduce inter-platform bias, to better support patient care, minimize unnecessary or excessive patient management, and ensure consistent and reliable neonatal care. Given the significant variability observed between different vendor platforms for NBIL it is crucial for manufacturers to minimize within-platform inconsistencies. While inter-platform differences can pose challenges for clinical interpretation, reducing variability within a single manufacturer*s systems can help improve result reliability and standardization.
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Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,001 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,001 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,001 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».