Authors
Ruth Namazzi, Robert O Opoka, Charles Ssuuna, Michael J Goings, Kathryn McElhinney, Dibyadyuti Datta, Russell E Ware, Chandy C John, Andrea L Conroy
Published in
BMC research notes. Jun 19, 2026. Epub Jun 19, 2026.
Abstract
To evaluate the performance of the point-of-care i-STAT device for creatinine measurement in Ugandan children with sickle cell anemia (SCA), and to determine the clinical impact of hydroxyurea-associated assay interference.
This secondary analysis was nested within a randomized clinical trial involving 248 Ugandan children with SCA. The mean age at enrollment was 32 months, and 115/248 (46.2%) initiated hydroxyurea during 12 months of follow-up as part of routine clinical care. At enrollment, creatinine values measured by i-STAT and reference laboratory testing were clinically comparable. At follow-up, children receiving hydroxyurea had significantly higher creatinine values measured by i-STAT than by reference laboratory testing (mean difference + 0.19 mg/dL; p = 0.006), with several i-STAT results falling within the clinically abnormal range. No such discrepancy was observed among children not receiving hydroxyurea. In a subset of samples, serum hydroxyurea concentrations measured by high-performance liquid chromatography accounted for 73% of the variability in i-STAT creatinine values. These findings demonstrate clinically meaningful interference of hydroxyurea with enzymatic point-of-care creatinine testing, which may result in misclassification of kidney function and inappropriate clinical decision-making in children with SCA receiving hydroxyurea.
gov identifier: NCT03528434 (date registered: May 7th, 2018).
PMID:
42321870
Bibliographic data and abstract were imported from PubMed on 20 Jun 2026.
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