Determination Of Total Serum Bilirubin Research Articles

Diagnostic Performance Analysis of the Point-of-Care Bilistick System in Identifying Severe Neonatal Hyperbilirubinemia by a Multi-Country Approach

ImportanceThe real prevalence and clinical burden of severe neonatal jaundice are undefined due to difficulties in measuring total serum bilirubin (TSB) outside secondary and tertiary clinical centers. ObjectiveTo assess the diagnostic performance of the point-of care Bilistick System (BS) in identifying neonatal jaundice patients requiring treatment. DesignBetween April 2015 and November 2016, 1911 neonates, were recruited to participate in the study. Blood samples were simultaneously collected for the TSB determination by BS and by hospital laboratory (Lab). Data were collected and sent to the Bilimetrix headquarter in Trieste where statistical analysis was performed. Newborns with neonatal jaundice were treated with phototherapy according to each center's guidelines. Setting17 hospitals from Nigeria, Egypt, Indonesia, and Viet Nam. Participants1911 newborns were included, of which 1458 (76·3%) fulfilled the inclusion criteria. ResultsTSB level measured by BS agreed (p < .0001) with the lab result in all four countries. The diagnostic performance of BS showed a positive predictive value (PPV) of 92·5% and a negative predictive value (NPV) of 92·8%. Conclusions and RelevanceBS is a reliable system to detect neonatal jaundice over a wide range of bilirubin levels. Since Bilistick is a point-of-care test, its use may provide appropriate and timely identification of jaundiced newborns requiring treatment.

Transcutaneous Bilirubin Assessment for Screening of Hyperbilirubinemia in Term and Near-Term Neonates with Jaundice, a Comparative Study

Introduction: Hyperbilirubinemia is a common condition in neonates. In this study, we aimed to investigate the association of total serum bilirubin (TSB) with sternum transcutaneous bilirubin (TcB) level obtained by KJ-8000 Transcutaneous bilirubin meter (KEJIAN medical apparatus). Methods: Eighty newborns were enrolled in the present prospective cross-sectional study. At first, blood sampling was performed for determination of TSB, and immediately after that, TcB levels were recorded at the sternum skin by KJ-8000 device. Data was analyzed by statistical software SPSS version 21.0. Results: The mean gestational age of the infants was 38.2±1.5 weeks. The mean level of TSB was 13.52±4 mg/dL, while the mean value of TcB was 13.71±3.53 mg/dL. Pearson correlation analysis showed a correlation coefficient of r=0.770 between sternum TcB recorded by KJ-8000 device and TSB. Conclusion: Given a strong correlation between TcB and TSB levels, it is advised the transcutaneous bilirubinometery be considered as the screening method in infant jaundice.

Use of Transcutaneous Bilirubin to Determine the Need for Phototherapy in Resource-Limited Settings

Background: Routine and timely determination of total serum bilirubin (TSB) remains a challenge in many resource-limited countries with substantial burden of severe neonatal hyperbilirubinemia. Limited evidence exists on the potential usefulness of transcutaneous bilirubin (TcB) to identify infants who may require phototherapy based on possible treatment criteria in such settings. Objective: To compare the number of infants requiring phototherapy across different TSB criteria and determine the predictive performance of TcB under each criterion. Methods: Infants with paired TcB and TSB measurements in a maternity hospital in Lagos, Nigeria, were assessed for phototherapy based on TSB criteria by the American Academy of Pediatrics (AAP), National Institute for Health and Clinical Excellence (NICE) UK, and World Health Organization (WHO), and an absolute threshold of ≥12 mg/dL. The predictive performance of TcB across treatment criteria was evaluated with receiver operating curve analysis. Results: A total of 1,011 infants with a mean TcB of 10.54 ± 3.19 (range: 2.7-19.9) mg/dL and TSB of 9.63 ± 2.61 (range: 0.3-19.5) mg/dL were assessed. Some 60 (5.9%) infants required phototherapy by 1 or more TSB criteria, with TSB ≥12 mg/dL identifying 55 (91.7%) and AAP 27 (45%) of these infants. All infants identified by the NICE and WHO criteria were equally detected by the AAP criterion. TcB showed negative predictive values of 99.0-99.9%, and positive predictive values of 7.7-15.5% across all criteria. Conclusions: The number of infants requiring phototherapy varies significantly across treatment criteria. TcB may be useful in identifying infants who do not require phototherapy, but may also identify a high proportion of false positives that is burdensome in resource-limited settings.

Development and validation of serum bilirubin nomogram to predict the absence of risk for severe hyperbilirubinaemia before discharge: a prospective, multicenter study

BackgroundEarly discharge of healthy late preterm and full term newborn infants has become common practice because of the current social and economic necessities. Severe jaundice, and even kernicterus, has developed in some term infants discharged early. This study was designed to elaborate a percentile-based hour specific total serum bilirubin (TSB) nomogram and to assess its ability to predict the absence of risk for subsequent non physiologic severe hyperbilirubinaemia before discharge.MethodsA percentile-based hour-specific nomogram for TSB values was performed using TSB data of 1708 healthy full term neonates. The nomogram's predictive ability was then prospectively assessed in five different first level neonatal units, using a single TSB value determined before discharge.ResultsThe 75 th percentile of hour specific TSB nomogram allows to predict newborn babies without significant hyperbilirubinemia only after the first 72 hours of life. In the first 48 hours of life the observation of false negative results did not permit a safe discharge from the hospital.ConclusionThe hour-specific TSB nomogram is able to predict all neonates without risk of non physiologic hyperbilirubinemia only after 48 to 72 hours of life. The combination of TSB determination and risk factors for hyperbilirubinemia could facilitate a safe discharge from the hospital and a targeted intervention and follow-up.

Estimation de la bilirubinémie par méthode transcutanée chez le nouveau-né prématuré

Transcutaneous bilirubinometry is an effective screening tool for neonatal jaundice in full-term babies. But its accuracy is not shown yet in preterm infants. Methodology We carried out a prospective study in a neonatal intensive care unit. The study included 47 preterm infants. From birth, a transcutaneous bilirubin measurement (BTc) using the BiliCheck ® was made on the forehead of each newborn every 8 h. Blood sampling for determination of total serum bilirubin (BS) was combined with BTc : 1) if value of BTc was higher than limits values for phototherapy; 2) on the second day of life and 3) 4 hours after cessation of phototherapy. Results Mean gestational age was 30 week and mean birth weight was 1419 g. We studied 151 pairs of BTc and BS. Mean values obtained by BTc and BS were respectively 160.6 ± 50 μmol/L and 190.6 ± 61.4 μmol/L. A significant correlation between BTc and BS was found. But the limits of agreement were very wide. The negative predictive value (NPV) of BTc was above 90% in each group of gestational age. Discussion The need for phototherapy cannot be determined by BTc in preterm infants. But the BTc is reliable when its value is under the limits for phototherapy. Conclusion With a very high incidence of neonatal jaundice (87%) in our cohort, a value of BTc under the limits for phototherapy has a good NPV in preterm infants.

Enhancement in sample preconcentration by the on-line incorporation of cloud point extraction to flow injection analysis inside the chemiluminescence cell and the determination of total serum bilirubin

The on-line incorporation of cloud point extraction (CPE) to flow injection analysis (FIA) was previously based on the use of a cotton-packed column to entrap the analyte-containing surfactant aggregates after salt-induced CPE, and then the preconcentrated analyte was eluted into a separate detection cell for subsequent chemiluminescence (CL) detection ( via the peroxyoxalate CL reaction). In the work, the on-line CPE/FIA technique was improved by the following: (1) sample preconcentration and CL detection were both carried out directly inside the collection column, thus avoiding the decrease in detection sensitivity due to sample dispersion and dilution, and (2) CL detection was performed through the reaction between nitrite and hydrogen peroxide, which is compatible with aqueous samples and should allow for chemical excitation to occur more efficiently inside the collection column. In addition to more effective sample preconcentration, the CL detection of the entrapped analytes directly inside the collection column, i.e., a unique heterogeneous microenvironment in which analyte-containing surfactant aggregates were embedded within the densely packed filtering material, may also contribute to the overall increase in CL intensity (e.g., a CL enhancement factor of ca. 1000) . Under optimum experimental conditions, the calibration curve was found to be linear for the CL detection of bilirubin (5 to 120 μg L −1), the limit of detection (S/N = 3) was 1.8 μg L −1, and the R.S.D. was ca. 2.6% ( n = 30) for 20 μg L −1 bilirubin. Good agreements were obtained for the determination of total bilirubin in certified reference human serum samples between the present approach and an established clinical method.

Transcutaneous bilirubinometry with the Bilicheck® in very premature newborns

Objectives: To investigate the potential advantages of use of the Bilicheck® in the very preterm population, with special emphasis on the effect of possible adverse skin conditions on the accuracy of the measurements. In addition we estimated the potential for safe reduction of the number of blood samples taken for serum bilirubin determinations by introduction of the Bilicheck® into the neonatal intensive-care unit (NICU). Methods: Total serum bilirubin (TSB) and transcutaneous bilirubin (TcB) were determined in very preterm newborns (gestational age < 30 weeks). To assess the agreement between TSB and TcB values, Bland-Altman plots were analyzed. Accuracy and (intra-device) imprecision were determined by statistical analysis. A screening model was developed to estimate the potential for safe reduction of the number of blood samples taken for TSB determination. Results: Correlations between TcB and TSB values varied between 0.86 and 0.88 and all were statistically significant. Bland-Altman plots and statistical analysis showed that the agreement between TcB and TSB measurements was largest for the group with good skin conditions, as expected. The Bilicheck® device had an acceptable level of intra-device imprecision (2.29 ± 13.51 μmol/l). Applying the screening model to our entire study population, 35 of the 93 TSB measurements (38%) could have been saved. Conclusions: The Bilicheck® is a screening device with the potential to reliably indicate hyperbilirubinemia in very preterm infants. Caution is required when skin measurements are performed in the presence of peripheral edema and/or a poor peripheral circulation. Its application in the NICU environment has the potential to reduce the number of blood samples by 40%.

Transcutaneous bilirubin measurement: a multicenter evaluation of a new device.

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. 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. 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 = -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 micromol/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 micromol/L) and 14 mg/dL (240 micromol/L) for BCF and TSB also produced similar sensitivity/specificity (90%/87% for the BC and 87%/83% for TSB). 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.

Early Meconium Evacuation: Effect on Neonatal Hyperbilirubinemia

Delayed passage of meconium may increase enterohepatic circulation of bilirubin, which appears to be an important contributor to neonatal jaundice. To evaluate the effect of early meconium evacuation on neonatal hyperbilirubinemia, between January 1993 and December 1993, 265 healthy neonates were studied and randomly divided into two groups. Group 1 consisted of 130 neonates who received glycerin enema (1 mL of glycerin mixed with 1 mL of warmed normal saline) within 30 minutes after birth and the same procedure was repeated at 12 hours of age. Group 2 consisted of 135 neonates receiving no glycerin enema throughout their hospital stay. Determination of total serum bilirubin using capillary samples was performed daily for 7 days. Our data showed that 12 neonates (15.4%) in group 1 and 18 neonates (13.3%) in group 2 had serum bilirubin level 15 mg/dL or higher and received phototherapy. We conclude that early evacuation of meconium by using glycerin enema within 30 minutes after birth and 12 hours after birth in order to reduce enterohepatic circulation of bilirubin has no effect on lowering peak serum bilirubin levels or on serum bilirubin concentrations in the first 7 days of life.

Clinical value of serum bilirubin subfractionation by high-performance liquid chromatography and conventional methods in patients with primary biliary cirrhosis

The clinical value of serum bilirubin subfractionation, using high-performance liquid chromatography (HPLC), was studied in 26 patients with primary biliary cirrhosis (PBC) from whom 59 serum samples were obtained. Total bilirubin (TB) levels were determined by alkaline methanolysis and HPLC (TBHPLC) as well as by the conventional diazo method (TB diazo). The correlation between TBHPLC and TBdiazo was significant (P less than 0.001) but bilirubin concentrations measured by HPLC amounted to only about 30% of those by diazo method. This difference is probably caused by tightly albumin-bound bilirubin, so called 'delta bilirubin' or 'bilirubin-albumin', which is measured by the diazo but not by the HPLC method. Bilirubin conjugates were present in 16 sera of 26 patients; 14 of these had normal total bilirubin levels. There was an excellent correlation between bilirubin conjugates (BcHPLC) and TB diazo (P less than 0.001). In all conjugate-containing samples, mono- and diconjugates were present in about equal proportions. Our results suggest that the biochemical methods of choice in the follow-up of patients with primary biliary cirrhosis are determination of total serum bilirubin by conventional diazo technique and determination of serum alkaline phosphatase activity. Both are simple methods which correlate well with liver histology. For the detection of patients with liver disease, such as asymptomatic PBC, the more elaborate HPLC technique has the distinct advantage of being a reliable method to detect bilirubin conjugates at normal total bilirubin levels. However, one should realize that with the presently used HPLC method only free conjugates are measured whereas covalently bound 'bilirubin-albumin' may represent up to 70% of all bilirubin species in cholestatic serum. Both free conjugates and 'bilirubin-albumin' start to appear in serum at total bilirubin levels as low as 5 mumol/l. The presence of bilirubin conjugates and 'bilirubin-albumin' in serum suggests liver disease. Reliable methods to quantify 'bilirubin-albumin' are needed.

Glucose Administration and Heme Catabolism After Caloric Restriction

Heme catabolism was monitored through the determination of total serum bilirubin and endogenous production of carbon monoxide in 6 healthy males before and after administration of 100 g of glucose orally and intravenously, respectively. To facilitate comparison, hyperbilirubinemia was induced through a 36-hr period of subtotal caloric restriction before the study. A decrease in production of carbon monoxide was seen after glucose given orally as well as intravenously, whereas total serum bilirubin decreased significantly only after glucose orally. It is suggested that oral as well as intravenous glucose administration temporarily inhibits heme catabolism, at least when given after a period of caloric restriction. In addition, oral glucose might have--probably via a gut-related factor--a facilitating effect on liver uptake of bilirubin.

Improved stable diazonium salt procedure for determination of total serum bilirubin

Improved stable diazonium salt procedure for determination of total serum bilirubin

A rapid micro diazo technique for measuring total bilirubin

A diazo method for the determination of total serum bilirubin is described. This procedure used standardized techniques and pre-packaged reagents. The new method was compared with the routine method used in the clinical laboratory. The results were quite comparable and there were several obvious advantages to the new method.

A new simple and rapid method for the determination of total serum bilirubin

A simple method for total bilirubin determination in serum is described. It is based on bilirubin coupling with a stable diazonium salt (Fast red RC) at a defined pH. Procedure: 0.2 ml of serum and 100 mg of test reagent are allowed to react for 15 min and then diluted with 2.5 ml of the diluting solution; the result is measured spectrophotometrically at λ = 573 nm. The reaction conditions and the results of a comparison with two classical methods are given. The method can be applied either as a quantitative one, or as a semiquantitative modification.

A New Colorimetric Method for the Determination of Total Serum Bilirubin

A New Colorimetric Method for the Determination of Total Serum Bilirubin

A NEW COLORIMETRIC METHOD FOR THE DETERMINATION OF TOTAL SERUM BILIRUBIN.

Journal Article A New Colorimetric Method for the Determination of Total Serum Bilirubin Get access Patrick V. Ferro, B.S., Patrick V. Ferro, B.S. Department of Chemistry, Dade Reagents, Inc., Miami, Florida Mr. Ferro is Chief Chemist, and Miss Ham is Medical Technologist. Search for other works by this author on: Oxford Academic Google Scholar Anna Bell Ham, M.T. (ASCP) Anna Bell Ham, M.T. (ASCP) Department of Chemistry, Dade Reagents, Inc., Miami, Florida Search for other works by this author on: Oxford Academic Google Scholar American Journal of Clinical Pathology, Volume 40, Issue 2_ts, August 1963, Pages 209–215, https://doi.org/10.1093/ajcp/40.2_ts.209 Published: 01 August 1963 Article history Received: 17 December 1962 Accepted: 22 April 1963 Published: 01 August 1963

Direct Spectrophotometry of Total Serum Bilirubin in the Newborn

Abstract A simple, rapid direct spectrophotometric method for the determination of total serum bilirubin on a micro basis, with a 1:21 dilution of serum in phosphate buffer, is presented for use with the Junior Coleman spectrophotometer. The formula, mg./100 ml. bilirubin = 50 A455 - 119 A575, is applied, where A represents the absorbancy at the wave length specified. The method for obtaining this or a similar equation is presented. The spectrophotometric method, when applied to sera obtained from newborns, gives apparently reliable results in the presence or absence of hemolysis. An evaluation of the method and its limitations is presented.