Transcutaneous Bilirubinometer Research Articles

Machine Learning to Improve Accuracy of Transcutaneous Bilirubinometry

Plain Language SummaryNeonatal jaundice is a common condition that might occur in the first week of life. Severe high bilirubin levels can lead to long-term problems like cerebral palsy, hearing impairment, and developmental delay. Therefore, newborns are usually evaluated for jaundice every day during their first week. To accurately assess jaundice, we need to measure the total bilirubin in the blood. However, daily blood draws for bilirubin measurements can be uncomfortable and may cause anemia in newborns. Thus, transcutaneous bilirubinometry is devised. It is a device that measures bilirubin through the skin and is commonly used because it is non-invasive. However, transcutaneous bilirubinometry has some accuracy issues. In this study, we successfully improved the accuracy of bilirubin measurement by combining machine learning with transcutaneous bilirubinometry. Being used alone, the transcutaneous bilirubinometer had an error of 1.08 mg/dL. However, combining transcutaneous bilirubinometry with machine learning, the error decreased to 0.80 mg/dL, which is a 25% of improvement. Using this approach, unnecessary blood draws could be reduced by up to 78%. If we incorporate this algorithm into transcutaneous bilirubinometry, this novel method has the potential to improve prediction accuracy and reduce the burden on babies.

Development of a Non-Invasive Jaundice Meter Using Transcutaneous Bilirubinometry

Proposed work focuses on the use of transcutaneous bilirubinometers as a non-invasive method for estimating total serum bilirubin (TSB) levels in jaundiced individuals. By measuring the yellowness of the skin and analyzing the optical signals reflected from subcutaneous tissues, these bilirubinometers provide a reliable technique for assessing bilirubin levels without the need for invasive procedures. The correlation between cutaneous bilirubin and TSB is explored in detail, highlighting the importance of this relationship in the management of jaundice. Experimental results demonstrate a high correlation between cutaneous bilirubin measurements and TSB levels, further supporting the efficacy of transcutaneous bilirubinometry. The report also discusses the advantages of this method over traditional spectro-photometric techniques, emphasizing its potential as a reliable alternative for estimating TSB levels in Jaundice Patients. Our proposed valuable insights into the use of transcutaneous bilirubinometers and their role in improving the management of jaundice.

STrIP Score for Neonatal Jaundice: From Bench to Bedside

Background: Non-invasive assessment of neonatal hyperbilirubinemia is done clinically with the Kramer scale and transcutaneous bilirubinometer. Recently, the Stool color for Triage of Infants needing Phototherapy (STrIP) score was studied and found to be better than both of the above methods in predicting measured serum bilirubin. This study sheds light on the clinical utility of the STrIP score in making therapeutic decisions. Method: This was a prospective study done in a tertiary-level neonatal unit. Breastfed term babies with clinical jaundice were recruited. The Kramer scale and STrIP score were performed on them and compared with respect to the therapeutic decision of commencing phototherapy based on measured serum bilirubin. Results: One hundred and twenty-eight infants were studied. The Kramer scale correctly aided the therapeutic decision on phototherapy (either to start or not to start) in 47 (36.7%) and the STrIP score in 119 (93%) of our subjects ( p = .0001). In 81 (63.2%) of the subjects, the Kramer scale underestimated the need for phototherapy. In contrast, the STrIP score overestimated the need for phototherapy in 11 (9%). Conclusion: The STrIP score helps in making more accurate therapeutic decisions in neonatal hyperbilirubinemia compared to the Kramer scale alone with respect to commencing phototherapy.

A Novel Smartphone App for Self-Monitoring of Neonatal Jaundice Among Postpartum Mothers: Qualitative Research Study.

Neonatal jaundice (NNJ) or hyperbilirubinemia is a ubiquitous condition in newborn infants. Currently, the transcutaneous bilirubinometer is used to screen for NNJ in health care facilities, where neonates need to be physically present (ie, a centralized model of care for NNJ screening). Mobile health (mHealth) apps present a low-cost, home-based, and noninvasive system that could facilitate self-monitoring of NNJ and could allow mothers the convenience of screening for NNJ remotely. However, end users' acceptability of such mHealth apps is of fundamental importance before the incorporation of such apps into clinical practice. The study aimed to explore the perception of postpartum mothers toward self-monitoring of NNJ using a novel mHealth app. Mothers attending video consultations for early postpartum care at 2 Singapore primary care clinics watched an instructional video for a hyperbilirubinemia-screening mHealth app (HSMA). An independent researcher used a semistructured topic guide to conduct in-depth interviews with 25 mothers, assessing their views on HSMAs. All interviews were audio recorded, transcribed verbatim, and checked for accuracy before data analysis. Two researchers independently analyzed the transcripts via thematic analysis. Data were managed using NVivo qualitative data management software. The identified themes were grouped under perceived usability and utility. Mothers valued the convenience and utility of HSMAs for remote monitoring of NNJ. They appreciated the objectivity the app readings provided compared to visual inspection. However, they perceived that the app's applicability would be restricted to severe jaundice, were concerned about its accuracy and restriction to the English language, and lacked confidence in using it. Nevertheless, they were willing to use it once its accuracy was proven and when they received adequate guidance from health care professionals. They also suggested including an action plan for the measured readings and clinical signs within the app. Mothers proposed pairing teleconsultations with HSMAs to boost their confidence and enhance adoption. Mothers were receptive to using HSMAs but had concerns. Multiple languages, proof of accuracy, and resources to guide users should be incorporated into the app in the next phase to increase its successful adoption. Complementing such apps with a teleconsultation service presents a plausible and pragmatic NNJ care delivery model in general practice.

Investigation of correlation study among transcutaneous and total serum bilirubin content in preterm neonates

Background. Neonatal jaundice is a commonly occurring problem in both full term and preterm neonates. It is one of the major causes for neonatal mortality and morbidity. Objective. To assess the correlation among transcutaneous bilirubinometer readings and Total serum bilirubin levels at different sites in early and late preterm neonates before and at the end of phototherapy. Method. An observational study was conducted in preterm neonates diagnosed with jaundice. The Transcutaneous Bilirubin (TCB) instrument, Drager JM105 is used to assess TCB and it was recorded on three sites and average of the three readings was noted. Prior to phototherapy, TCB was noted 30 min before TSB was sent. A photo-opaque patch was placed on the sternum and phototherapy was given. At the end of the phototherapy, TCB on the sternum was noted and then TSB was sent with a time gap of not more than 30 min. Results. In this study, out of 50 neonates 14 were early preterm and 36 were late preterm babies. It was found that there was a positive correlation between TCB and TSB in early preterm babies before phototherapy (p value=0.0019), but there was no correlation between TCB and TSB at the end of phototherapy. In late preterm babies there was no correlation between TCB and TSB both before phototherapy and at the end of phototherapy. Conclusion. In this study it was found that TCB has positive correlation with TSB and can be implemented for the screening of hyperbilirubinemia even in preterm neonates.

Assessment of the Performance of selected Special Care Newborn Units (SCANUs) in Bangladesh: A cross Sectional Study

Background: Government of Bangladesh initiated the Special Care Newborn Units (SCANU) in 2011 at selected district hospitals followed by its scale up in other districts with support from UNICEF and other partners. The objective of the study was to assess the performance of those SCANUs in Bangladesh. Methods: A cross-sectional study approach was applied for assessment of the performance of SCANU facilities compared to facilities without SCANU. Fifteen facilities with SCANUs and five facilities without SCANUs were selected from eight divisions of the country for the study. The selected SCANU and Non-SCANU facilities were of secondary level hospital with similar patient flow and workload. Quantitative data were collected from direct observation of the 20 facilities and interviews with 678 caregivers using a field-tested questionnaire. Caregivers were mothers of the infants (<59 days old) who were admitted and stayed for at least one day in those hospitals. Analysis was done using Stata version 15.1 and presented in tabular, graphical and numerical measures of central tendency and dispersion. Result: The results of the assessment found that 60% of SCANU facilities had KMC care services and 27% of SCANU facilities had rooming in services and special sick baby ward services but no such services was available in non-SCANU facilities. Equipment in the SCANUs such as resuscitation bag and mask, radiant warmers, phototherapy machines and to a large extent CPAP machines and Oxygen blenders were mostly available and functioning optimally. More than half of the SCANUs still need to have oxygen blenders, CPAP machines and transcutaneous bilirubinometers since they were not found/functional during the assessment. Majority of SCANU facilities 60%-80% reported no stock-outs of critical medications like dexamethasone, ceftriaxone and gentamicin which are critical for management of preterm and sick babies. A web-based online ‘Individual Case Tracking’ system has been developed for online reporting from all SCANUs by the Health Management Information System (HMIS) of the Directorate General of Health Services (DGHS). UNICEF was supporting its linkage to the district health information system (DHIS-2). There was a statistically significant difference between SCANUs and non-SCANUs with respect to the proportions of admissions. SCANUs are acting as referral destination for sick and small newborns as 41%-45% of the admitted newborns were either were born at home or in other facilities. Conclusion: The assessment findings will be helpful for country strategy for improving newborn care through expansion of SCANU expansion throughout the country

Performance of smartphone application to accurately quantify hyperbilirubinemia in neonates: a systematic review with meta-analysis.

Neonatal jaundice is a common clinical condition that can progress to severe hyperbilirubinemia if identification and intervention are delayed. In this study, we aimed to analyze the current evidence on the accurate performance of smartphone applications to quantify bilirubin levels. PubMed, Embase, Emcare, MEDLINE, the Cochrane Library, and Google Scholar were searched from inception until July 2022. Grey literature was searched on "OpenGrey" and "MedNar" databases. We included prospective and retrospective cohort studies that recruited infants with a gestation of ≥ 35weeks and reported paired total serum bilirubin (TSB) and smartphone app-based bilirubin (ABB) levels. We conducted the review using the guidelines of the Cochrane Collaboration Diagnostic Test Accuracy Working Group and reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses-diagnostic test accuracy (PRISMA-DTA) statement. The data were pooled using the random effects model. The outcome of interest was agreement between ABB and TSB measurements, provided as correlation coefficient, mean difference, and standard deviation. Certainty of evidence (COE) was assessed based on GRADE guidelines. Fourteen studies were included in the meta-analysis. The number of infants in individual studies ranged between 35 and 530. The pooled correlation coefficient (r) between ABB and TSB was 0.77 (95% CI 0.69 to 0.83; p < 0.01). Reported sensitivities for predicting a TSB of 250µmol/L in individual studies ranged between 75 and 100% and specificities ranged from 61 to 100%. Similarly, a sensitivity of 83 to 100% and a specificity of 19.5 to 76% were reported for predicting a TSB of 205μmol/L. Overall COE was considered moderate. Conclusion: Smartphone app-based bilirubin estimation showed a reasonable correlation to TSB levels. Well-designed studies are required to determine its utility as a screening tool for various TSB cut-off levels. What is Known: • Neonatal jaundice is a common clinical condition.Timely screening and intervention are necessary to prevent neurological morbidities • Transcutaneous bilirubinometer is a widely used non-invasive screening device but is mostly available in hospital settings and has cost limitations.Researchers have recently explored the utility of smartphone applications to estimate bilirubin levels in neonates. What is New: • This is the first systematic review and meta-analysis conducted to assess the performance of smartphone applications to detect neonatal hyperbilirubinemia. • Bilirubin estimates of newborn infants obtained through smartphone applications had a reasonable correlation with serum bilirubin levels.

KRAMERS RULE AS A SCREENING TEST TO ASSESS NEONATAL HYPERBILIRUBINEMIA

Background: neonatal jaundice is a frequently encountered condition in the postnatal ward. If not treated properly, it can lead to permanent neurological sequelae. The gold standard investigation for diagnosis is total serum bilirubin (TSB)level. Transcutaneous bilirubinometers and visual assessment of cephalo-caudal progression of yellowish discoloration of neonatal skin by Kramers rule are commonly used non-invasive methods to predict jaundice. If correctly applied, these methods can help in minimising the number of blood samples to be drawn for TSB testing. Aims/Objectives:1. To assess the reliability of Kramers rule in predicting TSB in healthy neonates admitted in postnatal ward. 2. To assess theusefulness of Kramers rule in deciding which neonates require testing of TSB levels. Methods: This is a cross sectional study conducted on 100 healthy neonates admitted in the post-natal ward of a tertiary care hospital. Data was collected in pre-designed case record sheets. Sensitivity and specificity of Kramers rule in correct prediction of serum bilirubin was identified by using true and false outcomes. Results:The mean age at which neonates were examined was at 72 hours of life. 41% of the neonates were male and 59% were female.79% of the total babies were born via normal vaginal delivery and 21% via caesarean section.The sensitivity of Kramers rule in predicting serum bilirubin levels was 83.33% with a specificity of 54.55% (P value 0.015). Conclusion: Kramers rule is a fairly reliable method for predicting serum bilirubin levels and can help in avoiding unnecessary blood testing in neonates, especially in resource limited settings where such facilities might not be available.

Intérêt de la bilirubinémie en néonatalogie : recommandations pour une utilisation coordonnée par le LBM de la biologie délocalisée et des tests rapides d’orientation diagnostique

In pediatrics, accurate measurement of total serum bilirubin (TSB) is of major importance for reliable diagnosis and appropriate management of neonatal jaundice. However, several studies evidenced poor comparability of results obtained with the different available methods either in central lab or in POCT, on serum, capillary blood or transcutaneous. This situation is partly due to the lack of Reference Materials, especially for high bilirubin concentrations but also on poor communication between central lab and neonatology unit. To progress on these issues, we have compiled some data from CNRHP to propose guidelines for choice, use and management of POCT devices and to help clinical laboratories to achieve a better answer to clinical needs with specific local constraints. The results from several CNRHP studies are presented: traceability to International System of Units, inter-laboratories comparability, POCT vs central labs comparisons with POCT CO-oximeter or photometer, integration of transcutaneous bilirubinometer. We propose, based on an analysis of devices advantages and issues, guidelines to help labs either to improve neonates monitoring in their local context; we distinguished the choices inside laboratory for a better harmonization of results compared to published thresholds and outside lab contexts, to organize a coordinated chain with POCT devices, with capillary and/or transcutaneous approaches.

A Comparative Study between Transcutaneous Bilirubinometry and Total Serum Bilirubin Measurement in Jaundiced Newborns

Background: Drawing blood to measure total serum bilirubin is painful &amp; time consuming. Transcutaneous bilirubinometer working by multiwavelength spectral reflectance from the skin surface on forehead or upper sternum is a quick &amp; painless technique. Objectives: to compare the effectiveness of transcutaneous (over the upper sternum and forehead) and serum bilirubin measurement of neonate with jaundice. Subjects and Methods: This is a cross sectional prospective study. It enrolled 175 jaundiced neonates &amp; excluded those exposed to phototherapy. It was conducted at Child Central Teaching Hospital in Baghdad, Iraq from the 1st of August to the 30th of October 2018. Transcutaneous bilirubin measurement on forehead and upper sternum was done by JM 103 Minolta Air shields bilirubinometer. Total serum bilirubin was measured by APEL BR 501 BILIRUBIN METER. Data entered &amp; analyzed using SPSS 20 computer software. Means, frequencies, cutoff values, sensitivity &amp; specificity were calculated. Results: The mean age, gestational age &amp; birth weight were (6.3±4.3 days), (36.9±2.1 weeks) and (2.7±0.6 Kg) respectively. Mean total serum bilirubin, transcutaneous chest &amp; forehead bilirubin levels were 12.6±4.2 mg/dl, 11.8±3.8 mg/dl &amp; 11.2±3.9 mg/dl respectively. Mean total serum bilirubin was significantly higher than transcutaneous chest and forehead bilirubin. Cutoff values of transcutaneous chest &amp; forehead bilirubin levels were [(9 mg/dl) with sensitivity (95.4%) &amp; specificity (86.4%)] and [(8.2 mg/dl) with sensitivity (94.7%) &amp; specificity (86.4%)] respectively. Conclusions: Transcutaneous bilirubin measurements on chest and forehead have an acceptable validity in predicting hyperbilirubinemia with less accuracy on forehead.

Significant hyperbilirubinemia among well neonates due for discharge at Kawempe-Mulago Hospital, prevalence, factors associated, and accuracy of transcutaneous bilirubinometry for screening.

Neonates in low resource settings with a lack of pre-discharge screening and early intervention are at risk for complications associated with significant hyperbilirubinemia (SHB). To determine the prevalence, factors associated and performance of transcutaneous bilirubin (TCB) in identifying well neonates with SHB. Over a one month period 235 well neonates 24 to 72 hours of age due for discharge at Kamempe-Mulago Hospital were enrolled in this study. Visual inspection using Kramer rule, transcutaneous bilirubin over the sternum using Draeger JM103 bilirubinometer, and serum bilirubin were determined. Neonates with SHB (total serum bilirubin warranting treatment) were referred for treatment. Relevant data were analyzed. A P-value of <0.05 was considered significant at 95% confidence interval. Thirty two (13.6%) of the neonates had SHB and three (1.3%) had levels above exchange transfusion threshold. Significant hyperbilirubinemia was independently associated with CRP ≥ 10mg/l (AOR 3.96, CI 1.23-12.73, p 0.021), ABO discordance (AOR 3.67, CI 1.28-10.49, p 0.015), jaundice in a previous sibling (AOR 3.565, CI 1.10-11.51, p 0.034) and time of first feed > 1 hour (AOR 2.74, CI 1.10-6.90, p 0.007). The sensitivity, specificity, positive and negative predictive values of TCB were 96.5%, 84.6%, 47.5% and 99.4% respectively compared to 31.2%, 98.5%, 76.9% and 90% respectively for visual assessment (Kramer grading). A significant number of well neonates have SHB. Transcutaneous bilirubinometry is a suitable screening tool in this setting. Early initiation of feeding should be promoted. The cause for high CRP among well neonates with SHB needs to be studied further.

Evaluation of a Point-of-Care Test for Bilirubin in Malawi.

BiliSpec is a low-cost spectrophotometric reader and disposable paper-based strip to quantify total serum bilirubin from several blood drops. This study was a prospective evaluation of BiliSpec in 2 neonatal wards in Malawi compared with a reference standard bilirubinometer over a large range of bilirubin and hematocrit levels. The accuracy of BiliSpec and a transcutaneous bilirubinometer were compared with the reference standard of spectrophotometry for 475 blood samples collected from 375 subjects across a range of total serum bilirubin concentrations from 0.0 to 33.7 mg/dL. The development of error grids to assess the clinical effects of measurement differences is reported. BiliSpec was found to have a mean bias of -0.48 mg/dL and 95% limits of agreement of -5.09 mg/dL to +4.12 mg/dL. Results show 90.7% of BiliSpec measurements would have resulted in the same clinical decision as the reference standard, whereas 55.0% of transcutaneous bilirubin measurements would have resulted in the same clinical decision as the reference standard. This evaluation supports use of BiliSpec to provide accurate, low-cost, point-of-care bilirubin measurements in low-resource hospitals. Future work is needed to evaluate BiliSpec among a larger number of users.

Transcutaneous Bilirubinometers Saves Dollars and Lives

Many newborns with ABO incompatibility hyperbilirubinemia do not have their condition detected within the first 24 hours of life. Transcutaneous bilirubinometers (TCBs) are fast, cost-efficient, noninvasive methods to screen and monitor for pathological jaundice at regular intervals. By introducing and standardizing TCB screening at 12 and 24 hours of life, my organization has identified cases of severe pathological jaundice, initiated treatment earlier, and decreased NICU transfers by 60%. Timely intervention can save lives and prevent complications from kernicterus while reducing hospitals costs.

Challenges and recommendations to improve implementation of phototherapy among neonates in Malawian hospitals

BackgroundSevere neonatal jaundice can result in long term morbidities and mortality when left untreated. Phototherapy is the main-stay intervention for treating moderate jaundice and for prevention of the development of severe jaundice. However, in resource-limited health care settings, phototherapy has been inconsistently used. The objective of this study is to evaluate barriers and facilitators for phototherapy to treat neonatal jaundice at Malawian hospitals.MethodsWe conducted a convergent mixed-method study comprised of a facility assessment and qualitative interviews with healthcare workers and caregivers in southern Malawi. The facility assessment was conducted at three secondary-level hospitals in rural districts. In-depth interviews following a semi-structured topic guide were conducted at a district hospital and a tertiary-level hospital. Interviews were thematically analysed in NVivo 12 software (QSR International, Melbourne, Australia).ResultsThe facility assessment found critical gaps in initiating and monitoring phototherapy in all facilities. Based on a total of 31 interviews, participants identified key challenges in diagnosing neonatal jaundice, counselling caregivers, and availability of infrastructure. Participants emphasized the need for transcutaneous bilirubinometers to guide treatment decisions. Caregivers were sometimes fearful of potential harmful effects of phototherapy, which required adequate explanation to mothers and family members in non-medical language. Task shifting and engaging peer support for caregivers with concerns about phototherapy was recommended.ConclusionImplementation of a therapeutic intervention is limited if accurate diagnostic tests are unavailable. The scale up of therapeutic interventions, such as phototherapy for neonatal jaundice, requires careful holistic attention to infrastructural needs, supportive services such as laboratory integration as well as trained human resources.

Gestational Age-Specific Nomogram of Transcutaneous Bilirubin in First 120 h of Life for Term and Late Preterm Indian Neonates

To create a nomogram based on transcutaneous bilirubin values (TCB) in first week of life for term and late preterm (>34 weeks) neonates. Prospective longitudinal study. Four tertiary-care teaching hospitals (one each in eastern and southern India, two in northern India) between February 2019 and March 2020. A total of 2492 term and late preterm (>34 weeks) neonates. Bilirubin was measured by transcutaneous bilirubinometer (Drager JM-105, Germany) in all neonates in pre-specified times of the day, 12 hourly every day since birth till discharge between 48 and 72 h, and data were recorded in epochs of 6 hourly intervals. Post-discharge, all neonates were called for review in next 48 h. Primary-TCB in first week of life. Secondary-factors having significant association with significant hyperbilirubinaemia requiring phototherapy. Total of 2492 neonates (males 1303 and female 1189), with a total of 14162 TCB recordings were analysed and mean hourly bilirubin (TCB) at hourly intervals till 120 h and then daily bilirubin values on Days 6 and 7 were tabulated. We have constructed hour-specific bilirubin nomogram with percentiles as per gestational age in term and near-term Indian neonates till 120 h of life. Amongst the known risk factors, delayed cord clamping, primipara and breastfeeding jaundice had significant association for hyperbilirubinaemia needing phototherapy. We have created gestation-specific nomogram of TCB levels in 6 hourly intervals for the first 120 postnatal hours, obtained from a large predominantly breast fed healthy, term and near-term Indian neonates.

Development of a mobile phone camera-based transcutaneous bilirubinometer for low-resource settings.

Newborns in high-income countries are routinely screened for neonatal jaundice using transcutaneous bilirubinometery (TcB). In low-and middle-income countries, TcB is not widely used due to a lack of availability; however, mobile-phone approaches for TcB could help expand screening opportunities. We developed a mobile phone-based approach for TcB and validated the method with a 37 patient multi-ethnic pilot study. We include a custom-designed snap-on adapter that is used to create a spatially resolved diffuse reflectance detection configuration with the illumination provided by the mobile-phone LED flash. Monte-Carlo models of reflectance from neonatal skin were used to guide the design of an adapter for filtered red-green-blue (RGB) mobile-phone camera reflectance measurements. We extracted measures of reflectance from multiple optimized spatial-offset regions-of-interest (ROIs) and a linear model was developed and cross-validated. This resulted in a correlation between total serum bilirubin and mobile-phone TcB estimated bilirubin with a R2= 0.42 and Bland-Altman limits of agreement of +6.4 mg/dL to -7.0 mg/dL. These results indicate that a mobile phone with a modified adapter can be utilized to measure neonatal bilirubin values, thus creating a novel tool for neonatal jaundice screening in low-resource settings.

Evaluation of a new transcutaneous bilirubinometer in newborn infants

To avoid brain damage in newborn infants, effective tools for prevention of excessive neonatal hyperbilirubinemia are needed. The objective of this study was to evaluate a new transcutaneous bilirubinometer (JAISY). For this purpose, 930 bilirubin measurements were performed in 141 newborn infants born near-term or at term (gestational age 35–41 weeks; postnatal age 1–6 days; 71 boys; including 29 infants with darker skin) and compared to those of a previously validated instrument (JM105). In each infant, the mean of three repeated measurements in the forehead was calculated for each instrument, followed by a similar measurement on the chest. The bilirubin values varied between 0 and 320 µmol/l (0–18.8 mg/dl). There was a high degree of agreement with significant correlations between bilirubin values measured with the two devices on the forehead (Pearson’s r = 0.94, p < 0.001) and the chest (r = 0.94, p < 0.001). The correlations remained after stratifying the data by gestational age, postnatal age and skin color. The coefficient of variation for repeated bilirubin measurements was 8.8% for JAISY and 8.0% for JM105 (p = 0.79). In conclusion, JAISY provides accurate and reproducible information on low to moderately high bilirubin levels in newborn infants born near-term or at term.

Development and evaluation of a novel method “bilirubin color card” for screening of treatable jaundice in neonates: prospective comparative diagnostic study

Background Various methods of screening or diagnosis of severe hyperbilirubinemia like transcutaneous bilirubinometer and laboratory testing havemethodological or practical limitations. In this perspective, we designed and evaluated an invasive but simple screening Color Card method in rapid assessment of various levels of bilirubin categories. Objective This prospective comparative diagnostic study objectives were to create “Color Card” initially by yellow color shades that fall into 4 bilirubin categories, i.e. TSB up to 7 mg/dl, 7.1 to 12 mg/dl, 12.1 to 18 mg/dl and >18 mg/dl from the samples analyzed by diazo method, and to study its sensitivity and specificity for the diagnosis of moderate or severe hyperbilirubinemia in comparison to total serum bilirubin (TSB) by diazo method. Results Out of total 188 samples obtained, 134 were unique patients. The specificity, negative predictive value and accuracy of the color card for the observations made by observer 1 comparing with lab TSB were >95% for clinically important categories of <7 mg/dl and >18 mg/dl. The overall accuracy of color card in measuring various TSB ranges varied from 75% to 96.8%. The agreement between two observers was 85.6% (Cohen’s kappa co-efficient: 0.61, p-value: .0001) overall and was 92.3%, 86%, 84%, 81.2% for each of the four bilirubin categories in ascending order. Conclusion Bilirubin color card has good accuracy and may be very useful in the low resource settings, especially in the first referral units and community settings, where laboratory TSB estimation is not available easily. However, it requires centrifugation and easier methods of centrifugation will make this method simpler.

Correlation between Transcutaneous Bilirubinemia and Blood Bilirubinemia in Screening Term Newborn for Neonatal Jaundice at the Essos Hospital Centre (EHC), Yaound&amp;#233;, Cameroon

Background: Early and non-invasive diagnosis of neonatal hyperbilirubinemia remains critical in dark skinned babies of low resource settings. Objective: To assess correlation/agreement between transcutaneous bilirubin (Tcb) and serum bilirubin (Tsb) values in full term neonates with jaundice. Methodology: An analytical cross-sectional study was conducted at the neonatology unit of the Essos Hospital Centre (EHC) from January to June 2019. All full-term neonates aged 0 to 7 days with suspected jaundice who did not receive phototherapy were eligible for the study. The enrolled neonates in the study were assessed clinically, then with the MBJ20 transcutaneous bilirubinometer (TcB). The MBJ20 transcutaneous bilirubinometer highest measurement over the forehead and the sternum were compared to TsB. Data were entered and then analysed with the CsPro7.2 and R (version 3.6.0) software. Correlation was captured by Bland & Alman plots and Concordance Correlation Coefficient (CCC) estimates. The Pearson correlation coefficient and Student test for paired data were used for descriptions purposes, and the significance level was 5%. Results: We recruited 88 neonates. The sex ratio of the babies included was 1.25 favouring males. Median Post-natal age was 3 days with 62% aged 72 hours or more. The mean TcB corresponding to the maximum average between frontal and sternal measurement was 153 mg/dl ± 48 and the average Tsb was 123.80 mg/dl ± 50.48. A good linear correlation was found between TcB and total serum bilirubin level r = 0.86 [0.80; 0.91]. Positive correlation was noted between both (forehead and sternum) TcB measurements sites, namely r = 0.78 and r = 0.86. The Bland & Altman plot measured the bias at -29.68 mg/l (confidence interval at 95%, 21.14 - 80.50). The CCC estimate was 0.2 varying from -0.22 to 0.76 according to TcB measurement threshold and post-natal age. The ROC area under the curve value for a threshold Conclusion: A good linear correlation was found despite a poor agreement between TcB and Tsb. TcB method systematically overestimated the value of TsB.

Diagnostic Properties of a Portable Point-of-Care Method to Measure Bilirubin and a Transcutaneous Bilirubinometer

Background: Recently, the Bilistick®, a point-of-care instrument to measure bilirubin levels, has been developed. It is fast and cheaper than transcutaneous bilirubin (TCB)-measuring devices, but data on diagnostic properties are scarce. Objective: This study aimed to compare the performance of the Bilistick® (BM-BS 1.0 – FW version 2.0.1) and the JM-105 bilirubinometer for measuring bilirubin. Method: This is a prospective study in infants born after ≥32 weeks’ gestation, and/or a birth weight of ≥1,500 g, and a postnatal age ≤14 days in Surabaya, Indonesia. Bilirubin was measured with the Bilistick® System (BM-BS 1.0 – FW version 2.0.1), transcutaneously (TCB) with the JM-105 bilirubinometer, and in serum (TSB) with a routine laboratory technique. Mean differences and 95% limits of agreement (LOA) and correlations were calculated. Result: We enrolled 149 neonates and 126 had paired measurements of Bilistick® bilirubin, TCB, and TSB. Bilistick® failed in 16 (10.7%) infants. Mean Bilistick® bilirubin-TSB difference was −11 µmol/L (95% LOA: −101 to 79 µmol/L) and r = 0.738 (p < 0.001). Mean TCB-TSB difference was 26 μmol/L (95% LOA: −33 to 88) and r = 0.785 (p < 0.001). The sensitivity, specificity, PPV, and NPV for Bilistick® bilirubin for a TSB above treatment thresholds were 0.74, 0.84, 0.67, and 0.88, respectively, and for TCB 0.92, 0.64, 0.54, and 0.95, respectively. Conclusion: The Bilistick® System (BM-BS 1.0 – FW version 2.0.1) underestimates TSB, whereas TCB overestimates TSB in jaundiced Indonesian infants. Further improvement of Bilistick®’s diagnostic accuracy with less false-negative readings is essential to increase its use.