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    The aim of this study was to evaluate the analytical performance of a new transcutaneous bilirubin (TcB) device - BiliCareTM (Gerium Medical, Yavne, Israel). The neonatal TcB measurements were compared between BiliCareTM and the existing BiliChekTM systems (n = 40). TcB measured by BiliCareTM were also compared with total serum bilirubin (TSB) using a Roche Cobas702 chemistry analyzer (n = 31) and whole blood bilirubin using a Radiometer ABL 835 (n = 11). Reproducibility was assessed by repeating TcB measurements with 2 BiliCareTM devices on a normal neonate, two with borderline jaundice, and one with overt jaundice 10 to 20 times respectively within 30 minutes. Compared with BiliChekTM, BiliCareTM demonstrated an average bias of -35.9 µmol/L (-20.6%) (Bili-CareTM = 0.6724 BiliChekTM +20.984, r = 0.8414). BiliCareTM had a better agreement with Cobas702 (BiliCareTM = 0.8356 Cobas702 +31.884, r = 0.8576, average bias 8.0 µmol/L (5.3%)). Similarly, BiliCareTM had a -12.7 µmol/L (-7.2%) average bias compared with ABL835 (BiliCareTM = 0.6166 ABL835 +54.464, r = 0.8287). At TcB 94.5, 155.2, 182.7, and 269.3 µmol/l levels, BiliCareTM had demonstrated imprecision as 8.9%, 9.8%, 5.4%, and 6.9% respectively. The new BiliCareTM correlates with total serum bilirubin as measured on laboratory chemistry analyzer Cobas702 and is acceptable for neonatal transcutaneous bilirubin testing.

    Citation

    Yu Chen, Susan Lake, Kate Scott. Accuracy and Reproducibility of BiliCare™ Transcutaneous Bilirubin Device. Clinical laboratory. 2023 Sep 01;69(9)

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    PMID: 37702683

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