Evaluation of the Kejian KJ‐8000 bilirubinometer in an Australian setting

Abstract

To evaluate the accuracy of the Kejian 8000 (KJ-8000) transcutaneous bilirubinometer in infants of differing ethnicity and gestational age. This was a prospective study of infants in the Newborn Care Unit at Gold Coast University Hospital. Transcutaneous bilirubin (TcB) and serum bilirubin (SBR) results were compared using linear regression and a Bland-Altman plot. Predicted indices were calculated to assess the KJ-8000 as a screening tool using local jaundice management guidelines. A total of 416 paired samples were collected from 201 infants. There was a strong correlation between TcB and SBR with a Pearson correlation coefficient of 0.8 (<0.00001). The bias was -5.9 μmol/L (95% confidence interval: -101, 89). The bias was not evenly spread, with the KJ-8000 tending to underestimate at higher SBR levels. Infants <32 weeks' gestation had a poor correlation of 0.48. Non-Caucasian infants were more likely to have TcB overestimation, and measurements were less precise. As a screening tool using local guidelines, the KJ-8000 had a sensitivity, specificity, positive predictive value and negative predictive value of 83, 53, 20 and 96%, respectively, and is predicted to avoid blood tests in 48% of infants screened. In this study, the correlation and agreement of TcB measurements using the KJ-8000 were not as good as has been reported with other more studied devices but may still have value as a screening tool. The poor correlation in preterm infants suggests that use should be restricted to term infants. The overall results of this study are affected by an underrepresentation of term infants, and so, further clinical assessment of this device should be undertaken before it can be recommended for widespread use.