Large scale validation of a new non-invasive and non-contact bilirubinometer in neonates with risk factors

Abstract

The study was aimed to evaluate the performance of a newly developed non-invasive and noncontact bilirubin measurement device (AJo-neo) as an alternative to the conventional invasive biochemical method of total serum bilirubin (TSB) estimation in preterm and term neonates suffering from hyperbilirubinemia associated with risk factors, and/or undergoing phototherapy. The safety and efficacy of the device were assessed in 1968 neonates with gestational ages ranging from 28 to 41 weeks and suffering from incidences of hyperbilirubinemia. Linear regression analysis showed a good correlation between AJO-Neo and the conventional method of TSB (Pearson's coefficient, r = 0.79). The small bias (0.27 mg/dL) and limits of agreements (− 3.44 to 3.99 mg/dL) were within the range of clinical acceptance. The device was also precise in the measurement of bilirubin levels in all subgroups of the study. The receiver operator curve (ROC), that takes account of both sensitivity and specificity of a device showed high efficacy of the device (area under the curve, AUC = 0.83) in the detection of bilirubin. While monitoring the bilirubin level during phototherapy, the device indicated promising results showing good agreement with TSB. Specificities and sensitivities of the device indicated a much higher accuracy in neonates with associated risk factors for hyperbilirubinemia. Hence, the newly developed device (AJO-Neo) is reliable in measuring bilirubin level in preterm, and term neonates irrespective of gestational or postnatal age, sex, risk factors, feeding behavior or skin color. Neonatal jaundice or Icterus neonatorum affects more than 60% of the term and 80% of preterm newborns in the first week of life 1-3 due to excessive production of bilirubin, and the inability of the newly developed liver to excrete it 4. Although benign at low concentrations, persistently elevated levels of bilirubin can cause severe neurotoxicity termed as kernicterus, which may lead to significant morbidity and mortality 5,6. Thus, proper monitoring of the bilirubin level in newborns is mandatory as per the guideline of American Academy of Pediatrics (AAP) to ensure appropriate management 7. The contemporary method of detection of serum bilirubin

Comparing the accuracy of NEORUBIN NEO-2020 jaundice meter, Dräger JM103 jaundice meter and conventional blood testing for estimating total serum bilirubin in infants with jaundice in Malaysia

“…The high accuracy of the device in measuring bilirubin levels in infants with jaundice symptoms were regardless of gestational or postnatal age, sex, Asian ethnicity, and feeding behavior. These results were also in line with other high-performing transcutaneous bilirubinometers as demonstrated in other studies [9,10].…”

“…There are concerns that skin color may affect the accuracy of a non-invasive jaundice meter (TcB) in predicting bilirubin levels [9][10][11][12][13]. One study involving the jaundice meter JM 103 showed that the TcB was underestimating the TSB for infants with light or medium skin color while overestimating the TSB for the darker skin infants [13].…”

Non-invasive estimation of hemoglobin, bilirubin and oxygen saturation of neonates simultaneously using whole optical spectrum analysis at point of care

“…Analysis of the data was done using descriptive statistical analysis, simple linear regression analysis, and the Bland & Altman method [52][53][54][55] . For the correlation between the values obtained from the device and the gold standard, linear regression and Bland Altman was used.…”

“…This in turn, causes improper management particularly to the diseased population that tend to get their Hb and blood saturation values over estimated. The SAMIRA device is based on such spectroscopy based approach where the information is collected from the vascular bed underneath the nail plate 55 . Thus, we hypothesize that SAMIRA will be able to overcome the limitations of the conventional trans cutaneous devices for the simultaneous measurement of three blood parameters from a single optical spectrum.…”

Biosensors and biomarkers for determining gestational diabetes mellitus and jaundice in children

“…Different sensing methods and biomarkers have been utilized to watch the glucose level, and researchers are still experimenting toward an efficient jaundice and glucose identification methods. [16][17][18][19][20][21][22][23] This review discusses about the recent development of biosensor in glucose monitoring and jaundice identification, which are mandatory during the pregnancy period and helpful for healthy pregnancy.…”