PEDIATRICS Vol. 107 No. 6 June 2001, pp. 1264-1271
Transcutaneous Bilirubin Measurement: A Multicenter Evaluation of a New Device
Received Apr 3, 2000; accepted Sep 18, 2000.
,
,
From the * Department of Critical Care Medicine and Surgery,
Section of Neonatology, Careggi University Hospital, University of
Florence Medical School, Florence, Italy; 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
races. The correlation coefficient (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 = 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.
Department of Pediatrics
and Waisman Center, University of Wisconsin School of Medicine,
Madison, Wisconsin; § Evangelisches Waldkrankenhaus Spandau, Der
Humboldt Universität Zu Berlin, Berlin, Germany;
Imperial
College School of Medicine, Hammersmith Hospital, London, England;
¶ University Hospital Zürich, Zürich, Switzerland; # Centre
d'Hemobiologie Périnatale, Hôpital Saint Antoine, Paris,
France; and ** Maternite Regionale A. Pinard, Nancy, France.
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 operating 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 µmol/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 µmol/L) and 14 mg/dL (240 µmol/L) for BCF and TSB also produced similar sensitivity/specificity (90%/87% for the BC and 87%/83% for TSB).
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