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Firmino F. Rubaltelli, MD*; Glenn R.
Gourley , MD ;Norbert Loskamp, MDS; Neena Modi,MB,ChB,MD,FRCP;
Matthias Roth-Kleiner ,MD ;Alfred Sender, MD#; and Paul Vert, MD**
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ABSTRACT
Objectives. The early discharge of neonates from hospitals makes
transcutaneous measurement of total bilirubin concentration a useful
tool to monitor neonatal jaundice. The objectives of this study were
to determine whether 1) transcutaneous bilirubin (TcB) measurement,
as performed using BiliCheck(BC), correlates with total serum
bilirubin (TSB) levels, measured with standard laboratory methods
and with high-pressure liquid chromatography (HPLC-B); 2) infant
race, gestational age, postnatal age, or body weight interferes with
the measurement of TcB levels in newborn infants; 3) the variability
of the TcB measurement is comparable to the variability of TSB
measurements; and 4) TcB measurements obtained from the forehead
(BCF) and sternum (BCS) generate comparable results.
study Design. Newborn infants who
were <28 days and> 30 weeks' gestational age and who underwent tests
for TSB as part of their normal care in 6 different European
hospitals were studied. A total of 210 infants were enrolled in the
study, 35 at each site. Near simultaneous (within +_ 30 minutes)
blood collection for TSB and BCF and BCS measurements were
performed. TSB levels were determined by the serum bilirubin method
in use at each site, and all HPLC-B determinations were made at the
same, independent laboratory.
Results. The study group consisted
of 140 white, 31 Asian, 14 Hispanic, 9 African, and another 16
newborns of different race. The correlation confficient (r) between
BCF and HPLC-B was 0.890 (95% confidence interval= 0.858-0.915). BCF
and BCS generated similar results (r value= 0.890 for BCF and 0.881
for BCS), even if BCS slightly overestimated (mean error = -0.04
mg/dL) and BCF slightly underestimated (mean error= 0.96 mg/dL) in
comparison with HPLC-B. Analysis of covariance demonstrated that BC
accuracy was independent of race, birth weight, gestational age ,
and postnatal age of the newborn. Receiver operathing characteristic
curves were evaluated for BCF and TSB, each compared with HPLC-B.
with the use of a cutoff point for HPLC-B of 13 mg/dL (222
m
mol/L) and a cutoff of 11 mg/dL on the BCF and TSB, similar
sensitivity/specificity (93%/73% for BCF, 95%/76% for TSB) were
observed. The use of a cutoff point for HPLC-B of 17 mg/dL(290
m
mol/L) and 14 mg/dL(240
m
mol/L) for BCF and TSB also produced similar
sensitivity/specificity (90%/87% for the Bc and 87%/83% for TSB).
Conclusions. Because the
correlation coefficient for HPLC-B and BCF is very similar to that
found for HPLC-B and laboratory TSB,BC could be used not only as a
screening device but also as a reliable substitute of TSB
determination. At higher levels of TSB,in which phototherapy and/or
exchange transfusion might be considered , BC performed slightly
better than the laboratory . The accuracy and precision of the TcB
measurement in this study was observed to be comparable to the
standard of care laboratory test. Pediatrics
2001;107:1264-1271;jaundice, newborn, bilirubin, Kernicterus,
transutaneous bilirubin measurement, laboratory bilirubin
determination.
ABBREVIATIONS. TSB, total serum bilirubin;BC BiliCheck;TcB ,
transutaneous bilirubin; HPLC-B, high-pressure liquid chromatography
bilirubin;BCF, BiliChek forehead;BCS,BiliCheck sternum;SD,standard
deviation; ROC, receiver operating characteristic;CI, 95%confidence
inteval.
PEDIATRICS Vol. 107
No. 6 June 2001 |
