Page 110 - 16Neonatal Jaundice_compressed

Recognition

Evidence summary – Minolta JM-103
The EL II evidence on diagnostic accuracy of the Minolta JM-103 shows variation in term babies.
The correlation coefficients between the transcutaneous bilirubin readings and serum bilirubin
levels ranged from a moderate positive 0.77 to a significantly positive 0.93. While three studies
found evidence of underestimation of serum bilirubin by the device in term babies, the fourth
study indicated overestimation that was much higher in babies with dark skin tones compared
with those with light skin tones. The AROC was 0.87 but the summary ROC curve did not show
a curvilinear pattern, indicating heterogeneity in the study results. The pooled sensitivity and
specificity were 85% and 80%, respectively, with strong evidence of statistical heterogeneity for
both results.
In preterm babies the correlation was positive, with values of 0.79 in one study and ranging
from 0.82 to 0.92 in the second study. The JM-103 consistently underestimated bilirubin levels
by a mean of 19 ± 32 micromol/litre.

GDG translation from evidence – Minolta JM-103
Forehead or sternum measurement of transcutaneous bilirubin using the Minolta JM-103 is more
accurate than visual assessment for the recognition of jaundice in term babies.
The evidence from two good-quality studies showed a positive correlation between the JM-103
and serum bilirubin estimations. The GDG was concerned that the JM-103 consistently
underestimated serum bilirubin by up to 50 micromol/litre.
Results from one study (EL II) showed that the reliability of the JM-103 was lower when used on
babies with dark skin tones when compared with those with light skin tones.
Recommendations

See the end of Section 5.2.
Description of included studies – BiliChek

Seven studies 44;45;77-81 have been included in this section – three 77-79 with EL Ib, two 44;80 with EL II
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and two 45;81 with EL III. The study population comprised term babies in one study, term and
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preterm babies in five studies, 44;45;77;80;81 and preterm babies only in one study. One study
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included African babies. It was not possible to combine the studies in a meta-analysis as there
were different study populations, different threshold values of transcutaneous bilirubin for
calculating diagnostic accuracy, and different levels of laboratory serum bilirubin used as the
reference standard. Hence these studies have been described in a narrative manner.
Review findings – BiliChek

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The first study is a multicentre European study conducted in six hospitals across five countries
– the UK, France, Germany, Italy and Switzerland. A total of 210 term and preterm babies (35
from each centre) who underwent serum bilirubin measurements as part of normal care at these
hospitals were recruited as the sample population. White babies made up 66% of the sample
population and about 20% had a gestational age of 36 weeks or less. A single transcutaneous
bilirubin measurement was made from the forehead and sternum of each baby using BiliChek
30 minutes before or after blood was drawn. The laboratory estimation of serum bilirubin in
each of the participating centres was done using the laboratory’s routine equipment. A portion
of the blood sample was also sent to a central laboratory for bilirubin assay using HPLC-B
without disclosure of the hospital laboratory results. There was a significant correlation between
the forehead and sternum transcutaneous bilirubin measurements and laboratory serum
bilirubin levels (r = 0.87 and 0.85, respectively; P < 0.001 for both). The correlation between
the laboratory serum bilirubin and HPLC-B levels was also statistically significant (r = 0.93;
P < 0.001).

The difference between the mean serum bilirubin values and the mean transcutaneous bilirubin
measurements was not statistically significant at either the forehead (MD = 2.4 micromol/litre,
95% CI −2.4 to 7.1 micromol/litre) or the sternum (MD = −14.8 micromol/litre, 95% CI −19.9
to 9.5 micromol/litre). An AROC curve was plotted to calculate the diagnostic accuracy of

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