A-357 Direct establishment of pediatric reference intervals for 16 electrolytes and metabolites on the Roche cobas® pro integrated system in the CALIPER cohort of healthy children
Bibliographic record
Abstract
Abstract Background Since 2008, the the Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) has pursued the objective to establish comprehensive and accurate pediatric reference intervals for assays performed on major analytical platforms used by clinical laboratories. To date, reference intervals that have been established for >200 laboratory biomarkers using specimens from healthy children recruited from the community, and are freely accessible in CALIPER’s online database which is continually updated to augment precision pediatric healthcare. In the current study, pediatric reference intervals for 16 electrolyte and metabolites were directly established on the Roche cobas pro® system. Methods Prior to beginning reference interval studies, analytical performance verification was conducted for each assay including assessment of within and between-day imprecision, linearity across the analytical measuring range, and accuracy. Within and between day imprecision were evaluated using 10 runs within the same day and 20 runs over 20 days for two levels of quality controls, respectively. Imprecision was determined through calculation of coefficients of variation for each level of quality control. Linearity was assessed using commercial linearity materials from Maine Standards (ME, USA). Accuracy was assessed via patient comparisons (n=40). Subsequently, 60 CALIPER samples (30 males, 30 females) were initially analyzed from the following age groups: 0-1, 1-5, 6-10, 11-14, and 15-18 years. For biomarkers that were found to change more dynamically, additional samples were further analyzed in order to establish statitiscally robust partitions. Statistical analysis and partitioning using R software were carried out as per previous CALIPER studies. Results All 16 assays demonstrated analytical performance specifications including imprecision and linearity consistent with manufacturer’s claims. Patient comparisons were acceptable demonstrating biases within IQMH (Institute for Quality Management in Healthcare) allowable limits. New pediatric reference intervals were established for 16 electrolytes and metabolites: sodium, potassium, chloride, calcium, phosphorus, magnesium, iron, glucose, lactate, total CO2, ß-hydroxybutyrate, creatinine, urea, uric acid, total and direct bilirubin. The pattern of changes with age and sex for each analyte changed was consistent with previous CALIPER data on other platforms. With the exception of sodium, potassium, magnesium, and glucose, age and/or sex partitions were required. During the neonatal period, several analytes showed significantly different values, highlighting the need for additional samples from this age group to be analyzed. Conclusions This study is the first to establish pediatric reference intervals for several common biochemical markers on the Roche cobas pro® system using the direct method in the CALIPER cohort. Additionally, reference intervals for potassium, sodium, chloride, magnesium, glucose, lactate, and total CO2 on the Roche platform were previously unavailable on any Roche platform from CALIPER. As the newer Roche system becomes more widely adopted in clinical laboratories, these findings will help ensure the availability of the most accurate pediatric reference intervals.
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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 | 0.002 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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".