Accuracy and Reproducibility of BiliCare™ Transcutaneous Bilirubin Device.

Abstract

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.