B-015 Neonatal Bilirubin Method Comparison on Three General Chemistry Platforms Using Pooled Neonatal Samples
Bibliographic record
Abstract
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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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".