Transcutaneous bilirubin measurement: Comparison of Respironics BiliCheck and JM-103 in a normal newborn population

doi:10.1016/j.clinbiochem.2012.03.014

Clinical Biochemistry

Volume 45, Issue 9, June 2012, Pages 659-662

https://doi.org/10.1016/j.clinbiochem.2012.03.014 Get rights and content

Abstract

Objectives

To compare the accuracy of BiliCheck™ (Respironics, Marietta, GA) and Konica-Minolta Air Shield JM-103 (Drager Medical Inc, Telford, PA) to evaluate total serum bilirubin (TSB).

Methods

Prospective blinded study comparing two diagnostic devices in 630 neonates requiring TSB measurement.

Results

Linear regression analysis showed a good correlation between BiliCheck™ and TSB (r = 0.8212) as well as between JM-103 and TSB (r = 0.8686). BiliCheck shows a tendency to underestimate TSB. The mean difference in TSB–TcB was − 1.4 mg/dL for BC (− 4.7/+ 1.8 mg/dL) and 0.3 mg/dL for JM-103 (− 2.6/+ 3.2 mg/dL). ROC analysis for TSB ≥ 12 mg/dL showed area under the curve for BiliCheck™ significantly lower than those for JM-103 (p < 0.0001). JM-103 resulted less time expensive than BiliCheck.

Conclusions

In spite of similar diagnostic accuracy JM-103 could be preferred for some practical advantages, but its suitability in performing universal screening for severe hyperbilirubinemia deserves further investigations.

Highlights

► Our study includes 224 knee OA patients. ► We compare the differences in serum levels of MIF between knee OA patients and healthy controls. ► We determine the association of serum and SF levels of MIF with the radiographic severity of OA.

Introduction

Visual assessment of skin colour is routinely employed in all nurseries and by all neonatologists or neonatal nurses to evaluate or predict serum bilirubin level, but its accuracy is very poor [1].

The attempt to “measuring bilirubin through the skin” [2] has undergone a significant evolution and devices called transcutaneous bilirubinometers have been released overtime thanks to technological improvements. The BiliCheck™ (BC; Respironics, Marietta, GA, USA) and the Konica-Minolta Air Shield JM-103 (Drager Medical Inc, Telford, Pennsylvania) are the two devices actually in common use to predict serum bilirubin levels measuring the yellowness of the skin. Both devices analyse the light reflected by the skin with some difference in the wavelengths used, in the light generation and in the analysis of light reflected. Literature data seem to suggest the equivalence of these devices in predicting/evaluating serum bilirubin values, but their comparison on large study populations is lacking [3], [4].

The aim of this study is to compare BC and JM-103 accuracy in predicting TSB in clinical practice in a large population of healthy full-term and late preterm neonates.

Section snippets

Technical data

BiliCheck® (BC; Respironics Inc, Marietta, GA) is a device that analyses the light reflected from the newborn's skin with a multi-wavelength spectral reflectance technique (137 wavelengths in the range 380–785 nm, with resolution of 12 nm); determining optical densities respectively attributed to bilirubin and other skin pigments. BC provides a rapid and accurate measure of TSB, without the problems of older devices. BC needs a disposable clean tip (called BiliCal®) for every measurement and

Results

All parents gave informed consent and 630 babies were enrolled in the study. Table 1 shows the clinical population characteristics. The mean CV for BC and JM-103 was 7.1% ± 1.1% and 6.5% ± 1%, respectively. The relationship between transcutaneous and serum measurements for each device is reported in Table 2. We defined transcutaneous underestimation or overestimation for differences in TcB–TSB ≥ 0.5 mg/dL. BC overestimates TSB values in the 77.5% of measurements compared to 28.4% of JM-103 (p < 0.0001).

Discussion

Jaundice is a common clinical condition in neonates, and in the last years socio-economical issues and the short-hospital stay policies further pushed the clinicians to improve its management. Several systems have been developed, in order to predict hyperbilirubinemia, to avoid unnecessary blood samplings, and to save money without any risk for the babies. Transcutaneous bilirubinometers have faced these challenges, and BC nowadays should be considered the best available device for this aim [5]

References (14)

K. Rodriguez-Capote et al.
Clinical implication of the difference between transcutaneous bilirubinometry and total serum bilirubin for the classification of newborns at risk of hyperbilirubinemia
Clin Biochem
(2009)
W.D. Dupont et al.
PS power and sample size program available for free on the Internet
Controlled Clin Trials
(1997)
D. De Luca et al.
Using Bilicheck™ for preterm neonates in a sub-intensive unit: diagnostic usefulness and suitability
Early Hum Dev
(2007)
V.A. Moyer et al.
Accuracy of clinical judgement in neonatal jaundice
Arch Pediatr Adolesc Med
(2000)
V.K. Bhutani et al.
Measuring bilirubin through the skin?
Pediatrics
(2003)
M.J. Maisels et al.
Evaluation of a new transcutaneous bilirubinometer
Pediatrics
(2004)
S. Ip et al.
An evidence-based review of important issues concerning neonatal hyperbilirubinemia
Pediatrics
(2004)

There are more references available in the full text version of this article.

Cited by (35)

Diagnosis of neonatal hyperbilirubinemia using CNN model along with color card techniques
2023, Biomedical Signal Processing and Control
In the first few days of life, neonatal jaundice is the situation that causes yellow discoloration on the skin of the baby. The severity level of the disease is determined by using a bilirubin meter. It may lead to poor performance due to a lack of severity level identification. The severity level should be resolved by using some techniques or methodology. Therefore, the proposed system is in the method of developing feature fusion techniques and CNN-based severity level detection to enhance the diagnosis of the disease. In this work, first, data are grouped as jaundiced babies and healthy babies. Consider the babies among 24 and 48 hr after birth. It is performed to remove the small hairs and noises from the baby's skin. Fourth, the Feature Fusion Framework to extract and select highly informative features. It includes feature extraction, feature fusion, and feature selection respectively. Feature extraction is carried out by a novel method of Structural Color Grey Coherent Feature (SCGCF) Extraction, feature fusion by a concatenation operation, and feature selection by the enhanced method of Salp Swarm Optimization. Sixth, the CNN model was trained along with color-card techniques to identify their severity level. The performance evaluation of the model provides class 1 and class 2 sensitivity of 0.99 and 0.98, specificity of 0.98 and 0.98, the accuracy of the 0.98 and 0.98, MCC of 0.97 and 0.96, and f-measure of 0.98 and 0.98 respectively.
Non-invasive detection of total bilirubin based on multi-wavelength PPG signal
2023, Computer Methods and Programs in Biomedicine
Abnormal bilirubin metabolism can result in various liver function disorders. Current clinical practice for bilirubin level detection involves invasive blood collection from patients, which is time-consuming, painful, and poses infection risks. Thus, there is a pressing need for non-invasive bilirubin detection methods. This study aims to develop a non-invasive total serum bilirubin(TSB) detection method in humans based on multi-wavelength photoplethysmography (PPG) signals.
The experimental instrument includes a light source and a spectrometer. PPG signals are collected from the subjects' fingers, and the samples are selected based on the PPG deviation degree screening method. The absorption spectrum of blood is extracted from the PPG signal using dynamic spectroscopy. Finally, locally developed software calculates the total bilirubin value. The instrument is modeled and validated according to the clinical-biochemical test values.
The results of the prediction set (correlation coefficient is 0.91, RSMEP is 2.32 umol/L, average absolute error percentage is 9.3%) show that our method has a strong correlation with the detection results of clinical-biochemical analysis instruments. The Bland-Altman test showed that the device deviated from the data detected by biochemical methods in the clinic with a mean deviation of about 0.12 umol/L and a 95% confidence interval between -2.95 umol/L and 2.7 umol/L.
This study's non-invasive bilirubin detection method has high accuracy, which can meet the needs of continuous non-invasive total bilirubin detection in clinical practice.
Newborn jaundice determination by reflectance spectroscopy using multiple polynomial regression, neural network, and support vector regression
2019, Biomedical Signal Processing and Control
Citation Excerpt :
The use of transcutaneous bilirubinometers is recommended in clinical practice guidelines on the management of jaundice [3]. Examples of transcutaneous bilirubinometers currently available in the market are BiliChek (BC; Respironics, Marietta, GA, USA) and the Draeger JM-103 (Draeger Medical Inc., Telford, Pennsylvania) [5]. A research study found that TcB measurements correlate well with TSB levels, with correlation coefficients between 0.77 and 0.97 [6].
Diffuse reflectance spectroscopy is a non-destructive method to obtain biochemical and physiological information by investigating the optical properties of skin. Transcutaneous bilirubin (TcB) measurement utilizes reflectance spectroscopy to determine the jaundice level in newborns. Although TcB measurement has some advantages over total serum bilirubin (TSB) measurement such as being non-invasive, noninfectious, painless, and instantaneous, the existing TcB devices cannot yet replace TSB devices due to the inaccuracy of measurements. In this paper, we propose the use of reflectance spectroscopy in conjunction with regression tools such as multiple polynomial regression (MPR), artificial neural network (ANN), and support vector regression (SVR) to predict the jaundice level. The proposed methods were tested on TcB measurement data obtained from 314 babies. TcB measurements were collected by two devices: a commercially available product, Draeger JM-103, and a prototype device on which we can implement the proposed algorithms. The results are encouraging towards increasing the clinical usage of transcutaneous bilirubinometers as all the three methods accurately predict the jaundice level with a correlation value between 0.932 and 0.943. The proposed use of ANN improves the non-invasive transcutaneous approach, with results converging to more accurate invasive serum bilirubin measurements by blood sampling.
The accuracy of transcutaneous bilirubinometer measurements to identify the hyperbilirubinemia in outpatient newborn population
2018, Clinical Biochemistry
Citation Excerpt :
It has been denoted that new research is needed to evaluate the performance of different transcutaneous bilirubinometer to predict serum bilirubin. Moreover, in a study comparing the accuracy of BiliCheck and Konica-Minolta Air Shield JM-103 bilirubinometer in determining bilirubin values in newborn infants, Romagnoli et al. [12] have found that the agreement between TcB and TSB results differs to manufacturers of transcutaneous bilirubinometers. In this context, to the best of our knowledge, this is the first study to evaluate the accuracy of JH20-1C jaundice detector device for predict serum bilirubin in outpatient population.
To assess the ability of transcutaneous bilirubinometer for prediction total serum bilirubin levels in newborn infants after hospital discharge.
Newborn infants requiring total serum bilirubin (TSB) level measurement during an outpatient follow-up visit were included into the study. Transcutaneous bilirubin (TcB) measurement was carried out using JH20-1C (Ningbo David, China) transcutaneous jaundice detector and total serum bilirubin was simultaneously determined by direct spectrophotometry. The agreement between paired TSB and TcB measurements were assessed by Bland-Altman plot and Deming regression analysis. Predictive indices were also identified in different TcB cut-off values for TSB levels of 222, 256 and 291 μmol/L.
A total of 271 paired TcB and TSB measurements were obtained from 218 newborn infants. 40.2% had an age of above 7 days at measurement time. The mean difference (95% CI) between TcB and TSB values was −1.7 (−5.4 to 2.1) μmol/L. For TSB levels of at least 256 and 291 μmol/L, a TcB cut-off of 222 μmol/L shows sensitivity of 90.6% and 100%, respectively. It was also determined that 39.4% of TSB measurements could be avoided when using TcB cut-off value of 222 μmol/L.
The measurement of TcB with JH20-1C seems to be a reliable screening method for hyperbilirubinemia in the outpatient population when used a TcB cut-off of 222 μmol/L. The use of transcutaneous bilirubinometer could reduce the number of invasive blood sampling for the determination serum bilirubin.
Transcutaneous bilirubinometry
2014, Seminars in Perinatology
Citation Excerpt :
Similar findings were reported by Raimondi et al.44; in this study, both the BiliChek™ and JM-103™ performed similarly and were superior to BiliMed™. Romagnoli et al.88,89 have performed the most recent and largest comparisons of the JM-103™ with the BiliChek™ (Fig. 5). Performance of the two devices was similar, although the authors noted that the JM-103™ may have some practical advantages such as more timely results and no need for disposable materials.
Although the modern era of transcutaneous bilirubin monitoring (TcB) began only about 35 years ago, this screening tool is now widely used in newborn nurseries and outpatient clinics, offices, and emergency departments to obtain a rapid and non-invasive estimate of the degree of hyperbilirubinemia. TcB devices have become more sophisticated, and major breakthroughs include the following: (a) ability to report a bilirubin value rather than an index value, (b) enhanced correction for chromophores other than bilirubin, and (c) technologic improvements including interface with electronic medical records. Good agreement with laboratory bilirubin measurement has been demonstrated, and the ability of TcB screening to predict and decrease the incidence of subsequent hyperbilirubinemia has been well-documented. To date, it has not been shown that this screening results in improved long-term outcomes.
Validity of BiliDx as a point-of-care bilirubin measurement device to diagnose and monitor neonatal jaundice at Muhimbili National Hospital, an observational study
2024, BMC Pediatrics

View all citing articles on Scopus

View full text

Transcutaneous bilirubin measurement: Comparison of Respironics BiliCheck and JM-103 in a normal newborn population

Abstract

Objectives

Methods

Results

Conclusions

Highlights

Introduction

Section snippets

Technical data

Results

Discussion

Clin Biochem

Controlled Clin Trials

Early Hum Dev

Accuracy of clinical judgement in neonatal jaundice

Arch Pediatr Adolesc Med

Measuring bilirubin through the skin?

Pediatrics

Evaluation of a new transcutaneous bilirubinometer

Pediatrics

An evidence-based review of important issues concerning neonatal hyperbilirubinemia

Pediatrics