Original Paper

Received: February 3, 2003

Biol Neonate 2004;85:21–25
Accepted: April 29, 2003
DOI: 10.1159/000074953 Published online: November 19, 2003

The Accuracy of Transcutaneous

Bilirubin Measurements in Neonates:
A Correlation Study
Shakuntala Nanjundaswamy Anna Petrova Rajeev Mehta
William Bernstein Thomas Hegyi
Department of Pediatrics, Division of Neonatology, University of Medicine and Dentistry of New Jersey,
Robert Wood Johnson Medical School, New Brunswick, N.J., USA

Key Words Introduction

Neonates W Transcutaneous bilirubin measurements W
Accuracy
Abstract
A prospective observational study was conducted on 212
neonates born between 24 and 42 weeks of gestation
who required blood sampling to determine total serum
bilirubin (TSB) in the first week of life, prior to photother-
apy. The transcutaneous bilirubin (TcB) measurements
were performed on the infant’s forehead using Bili-
Check™ within B30 min of a blood sample being drawn.
There was significant (r = 0.78) correlation between bili-
rubin levels obtained transcutaneously and those mea-
sured in the infant’s blood. The correlation was not
affected by birth weight and was dependent on the biliru-
bin levels. The negative nonsignificant correlation ap-
pears when TSB levels are greater than 11 mg/dl. Thus,
TcB measurements can accurately predict TSB values
lower than 11 mg/dl in a multiracial preterm and term
neonatal population.
Copyright © 2004 S. Karger AG, Basel
The early identification of neonates with high bilirubin
levels, when coupled with prompt medical intervention,
has an important implication for preventing kernicterus
[1, 2]. Previous studies have suggested that transcuta-
neous bilirubinometry (TcB) may be useful for screening
neonatal jaundice, could reduce unnecessary blood tests
and could also decrease complications related to severe
hyperbilirubinemia [3–6].
Over the past two decades, numerous attempts have
been made to develop a more precise transcutaneous
device and to investigate the accuracy of TcB measure-
ments in screening for neonatal jaundice [7–9]. The origi-
nal bilirubinometers demonstrated that the correlation
between transcutaneous and serum bilirubin measure-
ments was affected by skin pigmentation, gestational age
and birth weight, and was dependent on race/ethnicity
[10–13].
One of the latest commercially available TcB devices is
the BiliCheck™ (SpectRx Inc., Norcross, Ga., USA),
which allows for an unbiased measurement that is inde-
pendent of gestational age, birth weight and postnatal age
[14, 15]. It has been suggested that TcB measurements
with the BiliCheck could be used as a screening tool for
the healthy multiracial neonatal population [9, 15, 16].

© 2004 S. Karger AG, Basel Anna Petrova, MD, PhD, MPH

ABC 0006–3126/04/0851–0021$21.00/0 Department of Pediatrics, University of Medicine and Dentistry
141.213.236.110 - 9/15/2013 9:24:14 PM

Fax + 41 61 306 12 34 Robert Wood Johnson Medical School

Univ. of Michigan, Taubman Med.Lib.

E-Mail karger@karger.ch Accessible online at: 1 Robert Wood Johnson Place, New Brunswick, NJ 08901 (USA)
www.karger.com www.karger.com/bon Tel. +1 732 235 7036, Fax +1 732 235 7075, E-Mail petroran@umdnj.edu
Downloaded by:
However, the accuracy of TcB measurements has been
questioned in some recent studies [17–19]. It is possible
that variation in the neonatal population and the different
laboratory techniques utilized for the measurement of
serum bilirubin could be a likely explanation [20, 21].
To resolve some of these issues, we embarked on a cor-
relation study in an attempt to evaluate the accuracy of
the BiliCheck measurements in neonates with different
birth weight, race/ethnic background and serum bilirubin
values.
Patients and Methods
This prospective observational study was conducted at Saint Pe-
ter’s University Hospital in the Regular Nursery and the Neonatal
Intensive Care Unit, Department of Pediatrics, Division of Neona-
tology, and was approved by the Saint Peter’s University Hospital
Committee for the Protection of Human Subjects in Research.
The BiliCheck (SpectRx Inc.) is a noninvasive, handheld device
that utilizes an optical method to assess the ‘yellowness’ of skin. It
was standardized to the industry gold standard high-performing liq-
uid chromatography (HPLC) utilized for total serum bilirubin (TSB)
measurements. As compared to the other transcutaneous devices
such as Minolta, BiliCheck evaluates jaundice by using multiple
wavelength analysis of reflectance data [9, 22]. Skin chromogens do
not interfere with the BiliCheck result because it uses the whole spec-
trum of visible light. The subtraction of the aforementioned compo-
nents (dermal maturity, hemoglobin and melanin) is used to quantify
total bilirubin, which is proportional to the concentration of bilirubin
in the subcutaneous capillary beds and tissue [23].
The TcB measurements were performed on the infant’s forehead
on an area of skin without visible bruising, within B30 min of a
blood sample being drawn for serum bilirubin. The device was cali-
brated before each measurement as per the manufacturer’s instruc-
tions to ensure the accuracy of the TcB. After testing three devices for
interdevice variability (less than 0.2 md/dl), the same BiliCheck unit
was used for all the measurements, and TcB measurements were
made by the same operator to avoid interoperator imprecision. The
light source in the unit was triggered for five measurements which
were automatically averaged to provide a TcB value. The total proce-
dure for the TcB measurement took between 10 and 15 s. Because of
the possible influence of light on the correlation between TSB and
TcB measurements [24], all TcB measurements were done with the
same room illumination. TSB was measured by the AEROSER® Sys-
tem, a direct spectrophotometric assay from Abbott Laboratories, in
the chemistry laboratory at Saint Peter’s University Hospital. Direct
spectrophotometry for the measurement of bilirubin in sera from
newborns is a simple and rapid method that requires a small volume
of blood [25].
A sample of 212 neonates born between 24 and 42 weeks of gesta-
tion who required blood sampling to determine TSB in the first week
of life was included in the study. Infants who had previously been
exposed to phototherapy and/or exchange transfused were excluded
from the study population.
Statistical analysis was performed using ‘STATISTICA’ software.
Continuous data are presented as mean B standard deviation. The
22 Biol Neonate 2004;85:21–25
standard racial/ethnic categories as a combination of the basic (black
and white) and Hispanic or Latino were used. American Indians or
Alaskans and Native Asian or Pacific Islanders were classified as
belonging to the ‘other’ racial/ethnic group. Because of evidence of the
possible influence of birth weight and bilirubin levels on the correla-
tion between TSB and TcB measurements, data were stratified by birth
weight categories: less than 1,500 g, 1,500–2,000 g and more than
2,000 g, and also by bilirubin levels: ^10, 10.1–15 and 615 mg/dl.
Descriptive statistics, correlation analysis, ¯2 test, analysis of
variance and multiple regressions were performed to characterize
data and determine differences in correlation between TSB and TcB
measurements by birth weight, race/ethnicity and observed TSB cat-
egories. Paired TSB/TcB comparisons were made to calculate the
proportion of accurately paired measurements, which were defined
as not more than B1.5 mg/dl according to the BiliCheck manufactur-
er’s reference [26]. p values ! 0.05 were considered statistically signif-
icant.
Results
A total of 212 paired TSB/TcB measurements were
performed in infants between 1–7 days old (mean 2.5 B
1.6 days). Most of the infants had a birth weight greater
than 2,000 g (165 out of 212, 77.8%; p ! 0.001); 26 neo-
nates (12.3%) were less than 1,500 g, and 21 infants
(9.9%) were between 1,500 and 2,000 g. Out of the 212
infants included in the data analyses, 50% (106) were
white, 16.0% (34) were black, 11.8% (25) were Hispanic
and 22.2% (47) were of other racial or ethnic origin. In our
study, the ‘other’ group was mostly (n = 42, 89.4%; p !
0.001) represented by Native Asians. The proportion of
infants of a different birth weight and different age in each
race/ethnic group was similar (¯2 = 3.2, p = 0.106, and ¯2 =
1.97, p = 0.218, respectively). Most of the paired TSB/
TcB measurements in each race/ethnic group were per-
formed in the first 2 days of life: white: n = 94 (88.7%);
black: n = 28 (82.4%); Hispanic: n = 21 (84%); and other:
n = 40 (85.1%). TSB levels of 152 infants (71.7%) were
equal to or less than 10 mg/dl, in 51 infants (24.1%) they
were between 10.1 and 14.9 mg/dl, and in 9 neonates
(4.2%) they were equal to or greater than 15 mg/dl.
The results of our study showed that out of the 212
paired TSB/TcB bilirubin measurements, only 90 (43.4%)
were within the B1.5 mg/dl range. Out of these 90, most
of the paired TSB/TcB measurements (n = 61, 67.8%) had
a difference that showed overestimation of TSB in the
range of less than 1.5 mg/dl. Overestimation of TSB in the
range outside 1.5 mg/dl was observed in 111 TSB/TcB
paired comparisons (52.4%). In 11 neonates (5.2%), TcB
underestimated TSB levels by more than 1.5 mg/dl.
Overall, there was significant (r = 0.78, p ! 0.0001)
correlation between bilirubin levels obtained transcuta-
Nanjundaswamy/Petrova/Mehta/Bernstein/
Hegyi
141.213.236.110 - 9/15/2013 9:24:14 PM
Univ. of Michigan, Taubman Med.Lib.
Downloaded by:
Table 1. Correlation coefficients between TSB and TcB measurements in association with birth weight, race and serum bilirubin levels

Birth weight, g Race/ethnicity TSB levels, mg/dl

! 1,500 1,501–2,000 1 2,000 white black Hispanic other ^10 10.1–14.9 615
(n = 26) (n = 21) (n = 165) (n = 106) (n = 34) (n = 25) (n = 47) (n = 152) (n = 51) (n = 9)

0.88** 0.86** 0.73** 0.84** 0.65* 0.75** 0.85** 0.72** 0.54** –0.30

* p ! 0.001, ** p ! 0.0001.

neously and those measured in the infant’s blood (fig. 1).

The correlation plot shows that with increasing serum bil-
irubin levels, the majority of points fall above the 95%
confidence interval of the correlation coefficient.
The correlation coefficients for TSB and TcB measure-
ments were estimated in association with the infants’
birth weight, race and serum bilirubin levels (table 1).
As is shown in table 1, the correlation coefficient for
TSB and TcB measurements in infants with a birth weight
greater than 2,000 g was slightly lower (r = 0.73) than in
infants in the low (1,500–2,000 g) or very low (!1,500 g)
birth weight categories (p = 0.054). Also, the correlation
between TSB and TcB measurements among black neo-
nates (r = 0.65) was lower than among white (r = 0.84) and
other race/ethnic groups (r = 0.85, p ! 0.05). The data
showed significant variation of TSB values in race/ethnic
categories (¯2 = 17.8, p ! 0.01). Of the 9 infants with TSB
equal to or greater than 15 mg/dl, 5 infants (55.6%) were
Fig. 1. Correlation between TSB and TcB measurements (paired
black, 3 (33.3%) were white and 1 (11.1%) belonged to the comparison in 212 infants).
other race/ethnic group. Stratification of our data by the
TSB values shows significant correlation between TSB
and TcB levels in infants with TSB less than 10 mg/dl (r =
0.72, p ! 0.0001) and also for infants with TSB between
10.1 and 14.9 mg/dl (r = 0.54, p ! 0.0001). However, at public health concerns regarding the frequency of severe
TSB levels equal to or greater than 15 mg/dl, there was hyperbilirubinemia and kernicterus [15, 27]. However,
negative correlation between TSB and TcB (r = –0.30, p 1 there is controversy regarding the reliability of TcB for the
0.05). The negative nonsignificant correlation appeared assessment of neonatal jaundice [14, 15, 17, 18, 28]. In
when TSB levels were more than 11 mg/dl: 11–12 mg/dl: our study, we addressed as many factors as possible in
n = 18 (r = –0.29); 12–13 mg/dl: n = 8 (r = –0.65); 13–14 order to avoid the interaction of factors that may affect
mg/dl: n = 6 (r = –0.46); and more than 14 mg/dl: n = 12 the prediction of TSB using TcB measurements [17, 29].
(r = –0.18). The difference in skin thickness was indirectly negated by
including preterm infants in the study. Although the skin
color was not quantified, approximately 50% non-white
Discussion infants were studied in an attempt to address this issue.
The TcB was measured before phototherapy, to preclude
Evaluating the accuracy of noninvasive TcB measure- its influence on the reliability of TcB measurements [18].
ments for the assessment of neonatal jaundice has an Not all of the BiliCheck evaluation studies have addressed
important implication in clinical practice because of the the above factors [14, 15, 18]. Moreover, in these studies,

Accuracy of Transcutaneous Bilirubin Biol Neonate 2004;85:21–25 23

Measurements
141.213.236.110 - 9/15/2013 9:24:14 PM
Univ. of Michigan, Taubman Med.Lib.
Downloaded by:
regression analysis was predominantly used to determine
the correlation between TSB and TcB measurements
despite the different correlation plots obtained by regres-
sion and correlation analysis [28].
As in previous studies in this field, significant correla-
tion was found between TSB and TcB measurements
using the BiliCheck device [14, 15, 17, 18]. Nevertheless,
the magnitude of correlation was different. Bhutani et al.
[15] used the BiliCheck device to screen term and near-
term multiracial infants whose TSB values (measured by
HPLC) were in a range similar to ours (measured by the
AEROSER® System, direct spectrophotometric assay)
and reported a higher correlation (r = 0.91) as compared
to our results (r = 0.78). In a recent multicenter study,
Rubatelli et al. [14], using the HPLC methodology for
TSB measurements in a multiracial neonatal population
greater than 30 weeks’ gestational age, also obtained a
higher correlation (r = 0.89). We believe that a reason for
the discrepancy in the correlation between TSB and TcB
is the different methodology utilized for the serum biliru-
bin measurements, since there is a discrepancy in TSB
measured by HPLC, direct spectrophotometry and other
methods [25]. The BiliCheck device has been standard-
ized with the gold standard [15] for TSB measurements,
the HPLC technique, which is labor-intensive and not
practical for routine use [25]. Therefore, using methodol-
ogy other than the HPLC technique for a TSB/TcB corre-
lation study will always affect the correlation coefficient.
Our findings are in agreement with results in other
publications [14, 15] that race/ethnicity and birth weight
do not notably affect the correlation between TSB and
TcB measurements. Increasing TSB levels affected the
accuracy of TcB measurements. This has been previously
mentioned by some studies [17, 28]. Beck et al. [28]
showed that the BiliCheck is not reliable for TSB levels
greater than 11 mg/dl because of underestimation of TSB.
A recent publication by Engle et al. [17] reported the ten-
dency of TcB to underestimate TSB, particularly in those
neonates with relatively high bilirubin values (greater
than 15 mg/dl). However, the correlation coefficient for
TSB/TcB in neonates with TSB levels greater than 15 mg/
dl was not reported. They concluded that the weaker cor-
relation between TSB and TcB in the Hispanic population
was the result of a significantly higher proportion of TSB
values equal to or greater than 15 mg/dl in the Hispanics
(31%) as compared to non-Hispanics (9%). We made the
same conclusion regarding the lower correlation coeffi-
cient between TSB and TcB in black neonates as com-
pared to white infants and those from the other race/eth-
nic group.
Therefore, the magnitude of correlation between TSB
and TcB measurements is very much reliant on serum bil-
irubin values. Underestimation of TSB by TcB measure-
ments when TSB levels are more than 11 mg/dl may have
the same clinical implication as overestimation of TSB
when TSB is less than or equal to 10 mg/dl. Because of the
clinical significance of TSB levels lower than 11 mg/dl in
the management of low- and very-low-birth weight neo-
nates [30], TcB measurements can be an objective, rapid
and noninvasive screening technique to identify preterm
neonates requiring phototherapy. However, TcB is unreli-
able at levels of bilirubin that require clinical decision
making for term neonates.

References

1 Sarici SU, Yurdakok M, Serdar MA, Oran O,
Erdem G, Tekinalp G, Yigit S: An early (sixth-
hour) serum bilirubin measurement is useful in
predicting the development of significant hy-
perbilirubinemia and severe ABO hemolytic
disease in a selective high-risk population of
newborns with ABO incompatibility. Pediat-
rics 2002;109:e53.
2 Stevenson DK, Fanaroff AA, Maisels MJ,
Young BW, Wong RJ, Vreman HJ, MacMahon
JR, Yeung CY, Seidman DS, Gale R, Oh W,
Bhutani VK, Johnson LH, Kaplan M, Ham-
merman C: Prediction of hyperbilirubinemia
in near-term and term infants. J Perinatol
2001;21(suppl):S63–S72, discussion S83–S87.
3 Strange M, Cassady G: Neonatal transcuta-
neous bilibinometry. Clin Perinatol 1985;12:
51–62.
4 Schumacher RE, Thornberry JM, Gutcher GR:
Transcutaneous bilirubinometry: A compari-
son of old and new methods. Pediatrics 1985;
76:10–14.
5 Linder N, Regev A, Gazit G, Carplus M, Man-
delberg A, Tamir I, Reichman B: Noninvasive
determination of neonatal hyperbilirubinemia:
Standardization for variation in skin color. Am
J Perinatol 1994;3:223–225.
6 Maisels MJ, Kring IA, Kirk JM: Transcuta-
neous bilirubinometry decreases the need for
serum bilirubin measurements and saves mon-
ey. Pediatrics 1997;99:599–601.
7 Hegyi T, Hiatt MI, Indyk L: Transcutaneous
bilirubinometry. 1. Correlations in term in-
fants. J Pediatr 1981;98:454–457.
8 Hegyi T, Hiatt MI, Gertner I, Indyk L: Trans-
cutaneous bilirubinometry. The cephalocaudal
progression of dermal icterus. Am J Dis Child
1981;135:547–549.
9 Ho C: Using a spectral reflectance technique to
measure transcutaneous bilirubin in neonates:
A new device. Issues Emerg Health Technol
2002;33:1–4.
10 Lin YJ, Ju SN, Lin CH: The clinical applica-
tion of transcutaneous bilirubinometry in full
term Chinese infants. Acta Paediatr Scand
1993;34:69–76.
11 Tayaba R, Gribetz D, Gribetz I, Holzman IR:
Noninvasive estimation of serum bilirubin. Pe-
diatrics 1998;102:E28.
12 Schumacher RE: Noninvasive measurements
of bilirubin in the newborn. Clin Perinatol
1990;17:417–435.

24 Biol Neonate 2004;85:21–25 Nanjundaswamy/Petrova/Mehta/Bernstein/

Hegyi
141.213.236.110 - 9/15/2013 9:24:14 PM
Univ. of Michigan, Taubman Med.Lib.
Downloaded by:
13 Bilgen H, Ince Z, Ozek E, Bekiroglu N, Ors R:
Transcutaneous measurement of hyperbiliru-
binemia: Comparison of the Minolta jaundice
meter and the Ingram icterometer. Ann Trop
Paediatr 1998;18:325–328.
14 Rubatelli FF, Gourley GR, Loskamp N, Modi
N, Roth-Kleiner M, Sender A, Vert P: Transcu-
taneous bilirubin measurement: A multicenter
evaluation of a new device. Pediatrics 2001;
107:1264–1271.
15 Bhutani VK, Gourley GR, Adler S, Kreamer B,
Dalin C, Johnson LH: Non-invasive measure-
ment of total serum bilirubin in a multiracial
predischarge newborn population to assess the
risk of severe hyperbilirubinemia. Pediatrics
2000;106:1–9.
16 Robertson A, Kazmierczak S, Vos P: Improved
transcutaneous bilirubinometry: Comparision
of SpectR(X) BiliCheck and Minolta Jaundice
Meter JM-102 for estimating serum bilirubin
in a normal newborn population. J Perinatol
2002;22:12–14.
17 Engle WD, Jackson GL, Sendelbach D, Man-
ning D, Frawley WH: Assessment of a transcu-
taneous device in the evaluation of neonatal
hyperbilirubinemia in a primarily Hispanic
population. Pediatrics 2002;110:61–67.
Accuracy of Transcutaneous Bilirubin
Measurements
18 Knupfer M, Pulzer F, Braun L, Heilmann A,
Robel-Tilling E, Vogtmann C: Transcutaneous
bilirubinometry in preterm infants. Acta Pae-
diatr 2001;90:899–903.
19 Konstantinou D, Klonou M, Klaydianou M,
Moiras P: Non-invasive measurement of total
bilirubin by multi-wavelength spectral reflec-
tance using Bilicheck, in pre-term and term
infants; in: Clinical Perspectives in Transcuta-
neous Bilirubin Measurement: A Compendium
of Studies on the BiliCheck™ Non-Invasive
Bilirubin Analyzer. Norcross, SpectRx, 1999,
p 7.
20 Schumacher RE: Transcutaneous bilirubinom-
etry and diagnostic tests: ‘The right job for the
tool’. Pediatrics 2002;110:61–67.
21 Hegyi T: Transcutaneous bilirubinometry in
the newborn infant: State of art. J Clin Monit
1986;2:53–59.
22 Yamanouchi I, Yamauchi Y, Igarashi I: Trans-
cutaneous bilirubinometry: Preliminary stud-
ies of noninvasive transcutaneous bilirubin
meter in the Okayama National Hospital. Pedi-
atrics 1980;65:195–202.
23 Onks D, Silverman L, Robertson A: Effect of
melanin, oxyhemoglobin and bilirubin on
transcutaneous bilirubinometry. Acta Paediatr
1993;82:19–21.
24 Yamauchi Y, Yamanouchi I: Factors affecting
transcutaneous bilirubin measurement: Effect
of daylight. Acta Paediatr Jpn 1991;33:658–
662.
Biol Neonate 2004;85:21–25
25 Kazmierczak SC, Robertson AF, Catrou PG,
Briley KP, Kreamer BL, Gourley GR: Direct
spectrophotometric method for measurement
of bilirubin in newborns: Comparison with
HPLC and an Automated Diazo Method. Clin
Chem 2002;48:1096–1097.
26 BiliCheck™ Clinical Indications for Use. User
Instruction Manual. Norcross, SpectRx, 1997.
27 Newman TB, Klebanoff MA: Neonatal hyper-
bilirubinemia and long-term outcome: Another
look at the collaborative perinatal project. Pe-
diatrics 1993;92:651–657.
28 Beck M, Schlebusch H, Kau N: Transcuta-
neous bilirubin measurement in mature new-
born; in: Clinical Perspectives in Transcuta-
neous Bilirubin Measurement: A Compendium
of Studies on the BiliCheck™ Non-Invasive
Bilirubin Analyzer. Norcoss, SpectRx, 1999,
p 5.
29 Amit Y, Jabbour S, Arad ID: Effect of skinfold
thickness on transcutaneous bilirubin measure-
ments. Biol Neonate 1993;63:209–214.
30 Maisels MJ: Jaundice; in Avery GB, Fletcher
MA, MacDonald M (eds): Neonatal Patho-
physiology and Management of the Newborn.
Philadelphia, JB Lippincott, 1994, pp 688–
689.
25
141.213.236.110 - 9/15/2013 9:24:14 PM
Univ. of Michigan, Taubman Med.Lib.
Downloaded by: