Angela Carla Borrelli

D De Luca

ET Schmidt

Francesca Landolfo

Francesco Raimondi

G Bertini

J Panburana

Letizia Capasso

Maria Sellitto

MJ Maisels

Paola Milite

Rosalba Maffucci

S Sanpavat

SC Kazmierczak

Silvia Lama

T Karen

YM Qualter

BMC Pediatrics

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Raimondi et al. BMC Pediatrics 2012, 12:70http://www.biomedcentral.com/1471-2431/12/70RESEARCH ARTICLE Open AccessMeasuring transcutaneous bilirubin: acomparative analysis of three devices on amultiracial populationFrancesco Raimondi*, Silvia Lama, Francesca Landolfo, Maria Sellitto, Angela Carla Borrelli, Rosalba Maffucci,Paola Milite and Letizia CapassoAbstractBackground: Hyperbilirubinemia can lead to potentially irreversible bilirubin-induced neurotoxicity. Transcutaneousbilirubin (TcB) determination has become a valuable aid in non invasive screening of neonatal jaundice.The aim of this study is to compare the performance of three most widespread transcutaneous bilirubinometers ona multiracial population of term and late pre-term neonates.Methods: Bilirubin concentration was determined using traditional photometric determination andtranscutaneously with Bilicheck, BiliMed and JM-103, in random order.Total serum bilirubin (TSB) was determined over a wide concentration range (15,8–0,7 mg/dl) with a mean of 9,5mg/dl. Related TcB values using Bilicheck (TcB-BC), BiliMed (TcB-BM), and JM-103 (TcB-JM) are reported in Table 1.Results: A multiracial population of 289 neonates was enrolled with a gestational age ranging from 35 to 41 weeks;birth weight ranging from 1800to 4350 grams; hours of life ranging from 4 to 424. In the total study populationcorrelation analysis using Pearson coefficients showed good results for Bilicheck (r = 0.86) and JM-103 (r = 0.85) butpoor for BiliMed (r = 0,70). Similar results were found for the non-Caucasian neonates subgroup. Bilicheck andJM-103 had a greater area under the curve than BiliMed when TSB =14 mg/dl was chosen as a threshold valueboth for the total study population and the non-Caucasian subgroup.Conclusions: Bilicheck and JM-103, but not BiliMed, are equally reliable screening tools for hyperbilirubinemia inour multiracial neonatal population.BackgroundTranscutaneous bilirubin (TcB) determination has becomea valuable aid in avoiding significant neonatal hyperbiliru-binemia [1] and has significantly reduced the number ofheel stick blood samplings and their complications [2].Current technology analyses the light reflected by the skinand the subcutaneous tissue providing a useful alternativemeasurement for total serum bilirubin (TSB). Neonatalskin colour and thickness represents important variablesin TcB measurements. Different devices have beenindividually validated versus spectrophotometric or highpressure liquid chromatography determination of TSB,often on neonates with a single ethnic background [3].* Correspondence: raimondi@unina.itDivision of Neonatology, Department of Pediatrics, Università “Federico II”,Via Pansini 5, 80131, Napoli, Italy© 2012 Raimondi et al.; licensee BioMed CentCommons Attribution License (http://creativecreproduction in any medium, provided the orTo provide useful clinical information, we comparedthe performance of the three most widespread transcuta-neous bilirubinometers on a multiracial population ofterm and late pre-term neonates.MethodsInfants born at the well baby nursery of the University“Federico II” of Naples with gestational age over 35 weekswere enrolled between January and December 2009. Theinvestigation protocol was approved by the local ethicalcommittee and parental consent was obtained.Infants with Rh or ABO isoimmunisation, major con-genital malformations, haemoglobinopathies or evidenceof liver disease were excluded from the study.Infants with post-natal age from 4 to 75 hours were mea-sured TSB by an experienced resident (SL) as ordered bythe attending clinician unaware of the study purpose.ral Ltd. This is an Open Access article distributed under the terms of the Creativeommons.org/licenses/by/2.0), which permits unrestricted use, distribution, andiginal work is properly cited.Table 1 Basic characteristic and clinical variables ofinfants with hyperbilirubinemiaMean birthweight (gr) 3060range 1800-4350Gestational age (week range) 35-41Male sex 119Famale sex 170Ethnic groupCaucasians 253non-Caucasians 36Total measurement 343Mean TSB (mg/dl) 9.5range (15.8-0.7)Mean TcB Bilicheck (mg/dl) 9.8range (17.2-0.4)Mean TcB Minolta JM103 (mg/dl) 9.8range (18.8-0.1)Mean TcB Bilimed (mg/dl) 10.4range (17.5-2.9)Raimondi et al. BMC Pediatrics 2012, 12:70 Page 2 of 5http://www.biomedcentral.com/1471-2431/12/70Samples were obtained from heelsticks in capillary tubes,centrifuged at 3000 rpm for five minutes and then read bya direct spectrophotometer (GB13A, Bertocchi Elettrome-dicali, Cremona, Italy). Spectrophotometry was used as areference as it is the technique used in daily routine andhas better agreement with high pressure liquid chromatog-raphy (HPLC) than any other technique [4].Within 20 minutes before TSB determination, TcB wasmeasured on the infant’s forehead, protected from directsunlight and avoiding areas with hair, bruises, nevi orother skin anomalies.We used three well known transcutaneous bilirubin-ometers according to the manifacturer’s instructions.Bilicheck (SpectRX, Norcross, GA) was calibrated usinga Bilical before each measurement, calculated averagingfive readings. The device scans the whole spectrum ofvisible light and automatically subtracts the lightreflected by confounding factors like haemoglobin ormelanin. BiliMed (Medick, S.A. France) operates by tenlight emitting diodes that form a single beam when hit-ting the newborn skin. A silicon diode captures thereflected light and the internal software calculates thehighest intensity for every wavelength range. BiliMedwas used as recommended at 2 cm from the neonate’sforehead. JM-103 (Draeger Medical Systems, Inc.,Telford, PA) uses 2 wavelengths and a dual optical pathsystem; each measurement was calculated averaging fivereadings.All measurements were performed in the ambientmorning light of the nursery, in random order accordingto a computer generated randomization table.Data were analyzed using MedCalc software v.11(MedCalc Software, Mariakerke, Belgium). Linear regres-sion analysis, Pearson correlation coefficients, Bland-Altman plots and receiver operating curve (ROC) wereperformed.ResultsA total of 343 determinations obtained on 253 Caucasianand 36 West African infants were included in the study.The demographic characteristics are shown in Table 1.TSB was determined over a wide concentration range(15,8 – 0,7 mg/dl) with a mean of 9.5 mg/dl. RelatedTcB values using Bilicheck (TcB-BC), BiliMed (TcB-BM),and JM-103 (TcB-JM) are reported in Table 1. Figure 1Ashows the linear regression analysis for the three trans-cutaneous bilirubinometers on the whole study popula-tion. Pearson’s coefficients were almost equivalent forBiliCheck (0.86) and JM-103 (0.85) but substantiallylower for BiliMed (0.70). Extrapolating non-Caucasianinfants, correlation coefficients were 0.92 for JM-103,0.88 for BiliCheck and 0.74 for BiliMed (Figure 1B).Error plots for the three devices are shown in Figure 2.Bilicheck showed a lower trend to underestimate TSB;this was more evident for BiliMed which also was theleast accurate, while JM-103 had a tendency tooverestimate and a distribution of 98% of measurementsthat was intermediate between Bilicheck and BiliMed.Figure 3 reports ROC curves for the three transcutane-ous bilirubinometers when TSB> 14 mg/dl was used ascut-off, on the whole population (Figure 3A) and on thenon-Caucasian subgroup (Figure 3B). The areas underthe curve resulted 0.95 for Bilicheck, 0.75 for Bilimedand 0.91 for JM-103 on the whole population; for thenon-Caucasian subgroup the areas under the curve were0.98 for Bilicheck, 0.75 for Bilimed and 0.94 for JM-103.DiscussionIn a comparative evaluation of the three most commontranscutaneous bilirubinometers we showed that Bilicheckand JM-103 but not BiliMed are reliable screening toolsfor moderate neonatal hyperbilirubinemia. The latter de-vice resulted inferior to Bilicheck in previous studies onCaucasian populations [5,6]. We found that on non-Caucasians BiliMed looses further ground to JM-103 andBilicheck, the two transcutaneous bilirubinometers withthe largest literature and broadest distribution. We alsoprovided the first direct comparison of Bilicheck andJM-103 on a multiracial population as previous authorsinvestigated these technologies on Asian or Caucasianinfants [7-9].In the present study, both JM-103 and Bilicheckresulted equally accurate screening tools over the rangeof concentrations tested, regardless of the skin pigmen-tation. JM-103, in particular, represents an improvementof a previous device. In the study of Robertson et al.0 5 10 15 20181614121086420TSBBiliCheck0 5 10 15 2018161412108642TSBBilimed0 5 10 15 2020151050TSBJM103r =  0.86p< 0.0001y = 0.8901 + 0.9326r =  0.70p< 0.0001y = 3.7747 + 0.6943 x r =  0.85p< 0.0001y = 0.5642 + 1.0084 x Figure 1 A. Pearson’s correlation coefficients for the whole population. B. Pearson’s correlation coefficients for African population.Raimondi et al. BMC Pediatrics 2012, 12:70 Page 3 of 5http://www.biomedcentral.com/1471-2431/12/70JM-102 was less accurate than Bilicheck and influencedby the skin color. In the present study, JM-103 had agood performance on dark skinned infants, required nodisposables to calibrate and was quicker to operate thanBilicheck.Looking at the Bland Altman plots, the threedevices had a tendency to overestimation on higherend of the tested concentration range. Although thismay be per se protective against the clinical damageof hyperbilirubinemia, one would expect that newertechnologies should be more accurate thereforeexpanding the concentration range where a TSB de-termination can be spared. We acknowledge a limita-tion of the study as we do not provide comparativedata on preterm infants. Previous studies have shownthat transcutaneous bilirubin evaluation can be use-ful on this population which is at increased risk ofclinical damage as early as 24 weeks of gestationalage [10]. It will be interesting to compare data onpreterm infants since, as in the present study on latepreterm and term infants, devices using differenttechnologies may have variable performances. Clini-cians need to be aware of these differences.ConclusionsIn our multiracial neonatal population Bilicheck and JM-103, but not BiliMed, are equally reliable screening toolsfor hyperbilirubinemia.0 5 10 15 206420-2-4-6-8AVERAGE of TSB and Bilimed(mg/dl)TSB - Bilimed(mg/dl)Mean-0,8-1.96 SD-5,3+1.96 SD3,60 5 10 15 2086420-2-4-6-8AVERAGE of TSB and JM103(mg/dl)TSB - JM103(mg/dl) Mean0,5-1.96 SD-3,1+1.96 SD4,10 5 10 15 206420-2-4-6-8AVERAGE of TSB and BiliCheck(mg/dl)TSB - BiliCheck(mg/dl) Mean-0,2-1.96 SD-3,4+1.96 SD2,90 5 10 15 206420-2-4-6-8AVERAGE of TSB and Bilimed(mg/dl)TSB - Bilimed(mg/dl) Mean-0,7-1.96 SD-6,0+1.96 SD4,70 5 10 15 20420-2-4-6-8AVERAGE of TSB and JM103(mg/dl)TSB - JM103(mg/dl)Mean-0,9-1.96 SD-5,2+1.96 SD3,30 5 10 15 206420-2-4-6AVERAGE of TSB and BiliCheck(mg/dl)TSB - BiliCheck(mg/dl)Mean-0,0-1.96 SD-3,8+1.96 SD3,8ABFigure 2 A and 2B. Bland Altman plot for the whole population and for African neonates respectively. These graphs show the meandifference between TSB and TcB for each transcutaneous bilirubinometer ± 1.96 SD that are index of imprecision of the instruments.A BiliCheckBilimedJM1030 20 40 60 80 100100806040200100-SpecificitySensitivityB BiliCheckBilimedJM1030 20 40 60 80 100100806040200100-SpecificitySensitivityBiliCheck Bilimed JM 103 AUC 0.95                0.75                     0.9295% CI 0.92-0.97 0.7-0.79 0.88-0.95 Difference between areasBiliCheck/Bilimed 0.197 p = 0.001 BiliCheck/JM 103  0.028 p = 0.511 Bilimed/JM 103  0.169 p = 0.007 Figure 3 ROC curves when TSB> 14 mg/dl was the outcome of choice for the three transcutaneous bilirubinometer (A: wholepopulation; B: African neonates). AUC and difference between areas are reported for whole population.Raimondi et al. BMC Pediatrics 2012, 12:70 Page 4 of 5http://www.biomedcentral.com/1471-2431/12/70Raimondi et al. BMC Pediatrics 2012, 12:70 Page 5 of 5http://www.biomedcentral.com/1471-2431/12/70Competing interestsThe authors have no competing financial interest in relation to the workdescribed. no external financial support was provided for the study.Authors’ contributionsFR conceived the study and participated in its design and coordination; SLoperated the bilirubinometers; FL, MS, ACB assisted with data collection andstatistics; RM, PM, LC drafted the manuscript. All authors read and approvedthe final manuscrpit.Received: 7 May 2011 Accepted: 1 March 2012Published: 14 June 2012References1. Maisels MJ: Historical perspectives: transcutaneous bilirubinometry.NeoReviews 2006, 7:e217–e225.2. Maisels MJ, Kring E: Transcutaneous bilirubinometry decreases the needfor serum bilirubin measurements and saves money. Pediatrics 1997,99:599–601.3. Bertini G, Pratesi S, Cosenza E, Dani C: Transcutaneous bilirubinmeasurement: evaluation of Bilitest. Neonatology 2008, 93:101–105.4. Kazmierczak SC, Robertson AF, Catrou PG, Briley KP, Kreamer BL, Gourley GR:Direct spectrophotometry method for measurement of bilirubin innewborns: comparison with HPLC and an automated diazo method. ClinChem 2002, 48:1096–1097.5. De Luca D, Zecca E, Corsello M, Tiberi E, Semeraro C, Romagnoli C: Attemptto improve transcutaneous bilirubinometry: a double-blind study ofMedick BiliMed versus Respironics BiliCheck. Arch Dis Child Fetal NeonatalEd 2008, 93(2):F135–F139.6. Karen T, Bucher HU, Fauchere JC: Comparison of a new transcutaneousbilirubinometer (BilimedW) with serum bilirubin measurements inpreterm and full-term infants. BMC Pediatr 2009, 9:70.7. Sanpavat S, Nuchprayoon I: Comparison of two transcutaneousbilirubinometers - Minolta AirShields Jaundice Meter JM103 and SpectrxBilicheck - in Thai neonates. Southeast Asian J Trop Med Public Health 2005,36(6):1533–1537.8. Qualter YM, Allen NM, Corcoran JD, O’Donovan DJ: Transcutaneousbilirubin - comparing the accuracy of BiliChekW and JM 103W in aregional postnatal unit. J Matern Fetal Neonatal Med 2011, 24(2):267–270.9. Panburana J, Boonkasidach S, Rearkyai S: Accuracy of transcutaneousbilirubinometry compare to total serum bilirubin measurement. J MedAssoc Thai 2010, 93(Suppl 2):S81–S86.10. Schmidt ET, Wheeler CA, Jackson GL, Engle WD: Evaluation oftranscutaneous bilirubinometry in preterm neonates. J Perinatol 2009,29:564–569.doi:10.1186/1471-2431-12-70Cite this article as: Raimondi et al.: Measuring transcutaneous bilirubin:a comparative analysis of three devices on a multiracial population.BMC Pediatrics 2012 12:70.Submit your next manuscript to BioMed Centraland take full advantage of: • Convenient online submission• Thorough peer review• No space constraints or color ﬁgure charges• Immediate publication on acceptance• Inclusion in PubMed, CAS, Scopus and Google Scholar• Research which is freely available for redistributionSubmit your manuscript at www.biomedcentral.com/submit

Measuring transcutaneous bilirubin: a comparative analysis of three devices on a multiracial population

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Measuring transcutaneous bilirubin: a comparative analysis of three devices on a multiracial population

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