A-393 Evaluating Discrepancies in Transcutaneous Bilirubin Measurements: The Impact of Skin Tone and Device Precision on Neonatal Jaundice Screening
Notice bibliographique
Résumé
Abstract Background Dräger Jaundice Meter JM-105 is a transcutaneous bilirubin (TcB) meter utilized to screen neonates for jaundice in Saskatoon, Saskatchewan Canada. Elevated TcB readings are followed up with core laboratory testing of total serum bilirubin (TSB), and patients with high TSB levels undergo further evaluation with bilirubin fractionation to determine appropriate management. Failure to accurately identify and treat neonatal jaundice can lead to severe complications, including kernicterus. One important limitation of TcB meters is their lack of traditional quality assurance components, including quality control and proficiency testing materials. Concerns have been raised regarding discrepancies between TcB meter readings and core laboratory bilirubin results, as these inconsistencies may lead to unnecessary blood draws in patients with falsely elevated TcB levels or, more critically, missed diagnoses in patients with falsely low TcB readings. This study aims to identify possible sources of these discrepancies. Methods Between 2023 and 2025, TcB measurements were taken from 235 neonates as part of the post-calibration workup of a fleet of Dräger Jaundice JM-105 meters during routine screening. Five replicates were taken per patient, and the average reading was calculated and compared to time-matched TSB levels, which were measured using the Roche Cobas® c502 (Bilirbin Total Gen. 3). Concordance was assessed by how many TcB-TSB pairs exceeded a total allowable error (TEa) of 15-20% for TSB. The precision of replicate readings was also assessed and compared against manufacturer’s specifications, which state that readings should be within 50 µmol/L. Neonates were classified as having light, medium, or dark skin tone using color swatches. For each meter, ten consecutive electronic light checks were performed daily for five days, and the percent coefficient of variance was calculated. An acceptance goal of 10% was set for light checks based on consultation with other laboratories using the Dräger Jaundice JM-105 meters. Results Of the matched TcB-TSB pairs, 28.1% (66/235) exceeded a TEa of 15%, 16.6% (41/235) exceeded 20%, and 6.3% (15/235) surpassed 30%. Skin tone was found to influence TcB accuracy, with 90.0% (9/10) of patients with darker skin exhibiting TcB overreads. Overreads were also observed in 15.0% (16/107) of light-skinned and 20.3% (22/108) of medium-skinned neonates beyond the 15% TEa threshold. Falsely low TcB readings were identified in 7.5% (8/107) of light-skinned neonates and 3.7% of medium-skinned neonates; no falsely low readings were observed in dark-skinned neonates. Overall, 6% (14/235) of replicate readings exceeded the manufacturer’s specification, with some variations exceeding 100 µmol/L. Additionally, 38% of electronic light checks failed to meet the laboratory*s precision goal of 10%. Conclusion At least some of the discrepant TcB readings can be attributed to the skin tone of the patient. However, imprecise readings, whether due to user technique or device limitations, cannot be ruled out. These issues highlight the critical need for continuous quality assurance measures and the development of validated QC materials to enhance the reliability of TcB measurements. Addressing these challenges is crucial for improving the accuracy of neonatal jaundice screening and ensuring better patient outcomes.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
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 | 0,002 | 0,003 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 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 ».