ArticleJournal of clinical laboratory analysis2024
Evaluation of a Diazo-Based Point-Of-Care Bilirubin Assay careSTART S1 Total Bilirubin Strip.
Article in Journal of clinical laboratory analysis, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed.
- The effectiveness of the diazo reaction in the determination of tip-end position after blind insertion of the nasoenteric tube by ICU nurses: A prospective comparative study.International journal of nursing sciences · 2026Article
- Assessing Diagnostic Accuracy of a Handheld Point-of-Care Device for Quantifying Neonatal Bilirubin Levels: The BEAT Jaundice @Home Study.Neonatology · 2026Article
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Authors and funding
5 authors.
Funding
Abstract
backgroundNeonatal jaundice (NNJ) affects a significant proportion of newborns globally, with an increased burden in low-resource settings. Effective health risk management of NNJ is hindered, particularly in resource-constrained environments, where early detection and treatment are challenging. The careSTART S1 Total Bilirubin Strip, a point-of-care testing (POCT) device based on a diazo-method, offers a potential solution by enabling onsite bilirubin measurement, thus, addressing the gap in early NNJ detection and management.
methodsThe current study evaluated the analytical performance of the careSTART S1 Total Bilirubin Strip for precision, linearity, method comparison, and lot-to-lot consistency following CLSI guidelines. For method comparison, 105 residual EDTA whole blood samples were analyzed with the careSTART S1 Total Bilirubin Strip and compared with reference measurements from the Roche Cobas c702 analyzer. Additionally, statistical analyses, including Passing-Bablok regression and Bland-Altman plots, were performed.
resultsThe careSTART S1 Total Bilirubin Strip showed allowable (<10%) within-laboratory imprecision of 2.5%-3.6% across all levels and demonstrated linearity over the range of 4.16-439.3 μmol/L. Method comparison revealed a constant negative bias with a mean bias -4.19 μmol/L. However, the 95% confidence interval (-7.10 to -1.28 μmol/L) of the bias is covered by the prespecified allowable bias of 8.3%, at medical decision point. Lot-to-lot variation ranged from 0.14%-6.49%, and was within the acceptable critical difference of 8.3%.
conclusionThe careSTART S1 Total Bilirubin Strip provided accurate and reliable bilirubin measurements that could contribute to neonatal care in settings lacking central laboratory facilities.
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Registered trials
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