Validity of BiliDx as a point-of-care bilirubin measurement device to diagnose and monitor neonatal jaundice at Muhimbili National Hospital, an observational study
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SUBMITTER: Clemence P
PROVIDER: S-EPMC10863160 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
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Project description:Newborns are at increased risk of jaundice, a condition in which excess bilirubin accumulates in blood. Left untreated, jaundice can lead to neurological impairment and death. Jaundice resulting from unconjugated hyperbilirubinemia is easily treated with exposure to blue light, and phototherapy systems have been developed for low-resource settings; however, there are no appropriate solutions to diagnose and monitor jaundice in these settings. To address this need we present BiliSpec, a low-cost reader and disposable lateral flow card designed to measure the concentration of total bilirubin from several drops of blood at the point of care. We evaluated the performance of BiliSpec, using blood from normal volunteers spiked with varying amounts of bilirubin; results measured using BiliSpec correlated well with a reference laboratory bilirubinometer (r = 0.996). We then performed a pilot clinical study using BiliSpec to measure total bilirubin in neonates at risk for jaundice at Queen Elizabeth Central Hospital in Blantyre, Malawi. Concentrations measured using BiliSpec correlated well with those measured using a laboratory reference standard in 94 patient samples ranging from 1.1 mg/dL to 23.0 mg/dL in concentration (r = 0.973). The mean difference between bilirubin levels measured with BiliSpec and the reference standard was 0.3 mg/dL (95[Formula: see text] CI: -1.7-2.2 mg/dL).
| S-EPMC5754796 | biostudies-literature
Project description:IntroductionNeonatal jaundice is a common cause of concern in immediate newborn period for parents as well as for the caregivers. Babies with visible jaundice are identified by the healthcare provider, and blood samples are sent for confirmation. Clinical expertise varies from person to person and may lead to sending excessive blood sampling. Obtaining blood bilirubin samples is a painful procedure; it predisposes the baby to infections and requires skilled health personnel. Moreover, laboratory tests are costly and time consuming, leading to unnecessary delays in commencing phototherapy and discharge from hospital. Transcutaneous bilirubinometer has been in use for a long time as screening tool in postnatal wards. With passage of time, its accuracy and validity have improved tremendously.MethodologyWe aim to implement a quality improvement initiative to reduce the number of blood bilirubin samples using transcutaneous bilirubin (TcBR) nomogram in full-term, low-risk babies who are born at our hospital and are admitted in postnatal ward after birth. Using preanalysis and postanalysis study design, this study will be performed in two phases of 6 months each. Data regarding total number of admissions in postnatal wards, demographics, serum bilirubin(TSBR) samplings and need for phototherapy will be recorded in both phases. TcBR will be done and recorded in postimplementation phase.Analysis and resultsComparisons between the two groups will be made. Primary outcome will be reduction in blood bilirubin samples for TSBR after the implementation of TcBr protocol. The proportion of infants having TSBR performed in both periods will be compared. Crude sampling cost of TSBR will be obtained from laboratory, and cost comparison between two phases will be done to look for difference.
| S-EPMC5862169 | biostudies-literature
Project description:Neonatal jaundice is an important cause of morbidity and mortality worldwide, and neonates born in low and middle-income countries bear a disproportionate burden. We previously developed a low-cost, point-of-care system to measure total serum bilirubin (TSB) in neonates. This device was effective at detecting and monitoring jaundice; however, the disposable strips were difficult to produce at scale. Here, we report a new lateral flow cassette design, called BiliDx, that was produced at scale using traditional manufacturing techniques. We evaluated the performance of BiliDx at sites in Nigeria and Malawi. The lateral flow strip consists of plasma separation membranes, nitrocellulose, and a plastic cassette. We evaluated the performance of the strips and reader at two hospitals located in Nigeria and Malawi compared to reference standard TSB. We also assessed performance for samples with high direct bilirubin (DB) and high hematocrit (HCT). We collected 1,144 samples from 758 neonates (TSB ranged from 0.2 to 45.9 mg/dL). The mean bias of BiliDx measurements in the validation set was +0.75 mg/dL, and 95% limits of agreement were -2.57 to 4.07 mg/dL. The mean bias and limits of agreement were comparable for samples with HCT < 60% and HCT ≥ 60%, and for samples with low and intermediate DB levels; the samples with high DB levels had wider 95% limits of agreement (-4.50 to +3.03 mg/dL). Error grid analysis shows that 96.9% of samples measured with BiliDx would have resulted in the same clinical decision as the reference standard. This performance is comparable to previous results that used a handmade two-dimensional strip. Additionally, error grid analysis shows that all 20 samples with high DB levels would have resulted in the same clinical decision as the reference standard. This evaluation supports the use of BiliDx lateral flow cassettes to provide accurate point-of-care measurements in low-resource settings.
| S-EPMC10409260 | biostudies-literature
Project description:Jaundice affects almost all neonates in their first days of life and is caused by the accumulation of bilirubin. Although the core biochemistry of bilirubin metabolism is well understood, it is not clear why some neonates experience more severe jaundice and require treatment with phototherapy. Here, we present the first genome-wide association study of neonatal jaundice to date in nearly 30,000 parent-offspring trios from Norway (cases ≈ 2000). The alternate allele of a common missense variant affecting the sequence of UGT1A4 reduces the susceptibility to jaundice five-fold, which replicated in separate cohorts of neonates of African American and European ancestries. eQTL colocalization analyses indicate that the association may be driven by regulation of UGT1A1 in the intestines, but not in the liver. Our results reveal marked differences in the genetic variants involved in neonatal jaundice compared to those regulating bilirubin levels in adults, suggesting distinct genetic mechanisms for the same biological pathways.
| S-EPMC11364559 | biostudies-literature
Project description:BackgroundMultiple systematic reviews and meta-analyses have examined the association between neonatal jaundice and autism spectrum disorder (ASD) risk, but their results have been inconsistent. This may be because the included observational studies could not adjust for all potential confounders. Mendelian randomization study can overcome this drawback and explore the causal relationship between the both.MethodsWe used the data of neonatal jaundice, direct bilirubin (DBIL), indirect bilirubin (IBIL), and ASD collected by genome-wide association study (GWAS) to evaluate the effects of neonatal jaundice, DBIL and IBIL on ASD by using a two-sample Mendelian randomized (MR). The inverse variance-weighted method (IVW) was the main method of MR analysis in this study. Weighted median method, MR-Egger regression and mendelian randomization pleiotropy residual sum and outlier (MR-PRESSO) test were used for sensitivity analysis.ResultsThere was no evidence of an effect of neonatal jaundice (OR, 1.002, 95% CI, 0.977-1.027), DBIL (OR, 0.970, 95% CI, 0.884-1.064) and IBIL (OR, 1.074, 95% CI, 0.882-1.308) on ASD risk by IVW test. In the weighted median method, MR-Egger regression and leave-one-out analysis, the results were robust and no heterogeneity or pleiotropy was observed.ConclusionsWe found that neonatal jaundice, DBIL and IBIL were not associated with ASD in this study. However, this paper did not explore the effect of severity and duration of jaundice on ASD in different ethnic populations, which may require further research.
| S-EPMC10133461 | biostudies-literature
Project description:BackgroundTrauma-induced coagulopathy (TIC) is a common feature after severe trauma. Detection of TIC is based upon classic coagulation tests including international normalized ratio (INR) value. Point-of-care (POC) devices have been developed to rapidly measure INR at the bedside on whole blood. The aim of the study was to test the precision of the Coagucheck® XS Pro device for INR measurement at hospital admission after severe trauma.MethodsWe conducted a prospective observational study in a French level I trauma center. From January 2015 to May 2016, 98 patients with a suspicion of a post-traumatic acute hemorrhage had POC-INR measurement on whole blood concomitantly to classic laboratory INR determination (lab-INR) on plasma at hospital admission. The agreement between the two methods in sorting three predefined categories of INR (normal coagulation, moderate TIC and severe TIC) was evaluated using the Cohen's kappa test with a quadratic weighting. The correlation between POC-INR and lab-INR was measured using the Pearson's coefficient. We also performed a Bland and Altman analysis.ResultsThe agreement between the lab-INR and the POC-INR was moderate (Kappa = 0.45 [95% CI 0.36-0.50]) and the correlation between the two measurements was also weak (Pearson's coefficient = 0.44 [95% CI 0.27-0.59]). Using a Bland and Altman analysis, the mean difference (bias) for INR was 0.22 [95% CI 0.02-0.42], and the standard deviation (precision) of the difference was 1.01.Discussion/conclusionPOC Coagucheck® XS Pro device is not reliable to measure bedside INR. Its moderate agreement with lab-INR weakens the usefulness of such device after severe trauma.Trial registrationNCT02869737 . Registered 9 August 2016.
| S-EPMC5480161 | biostudies-literature
Project description:BackgroundLeading authorities in North America recommend universal screening via total serum bilirubin (TSB) measurement or transcutaneous bilirubinometry (TcB) for kernicterus prevention. We assessed costs associated with these 2 screening methods in hospital and in urban and rural community settings.MethodsOur tertiary care centre in Saskatoon, with about 5600 births per year, serves the local population of 300 000; in addition, 30% of patients are referred from outside the local community and surrounding area. We obtained health administrative data for two 6-month periods: before (June 1 to Nov. 30, 2015 [TSB program]) and after (June 1 to Nov. 30, 2016 [TcB-TSB program]) implementation of universal screening with TcB. Data on nurses' time and mileage were collected to assess the mean time for screening and sample transportation. We performed a cost-minimization analysis.ResultsThe observed requirement for TSB blood draws decreased by 71.4% after implementation of TcB (1383.2/1000 live births to 397.8/1000 live births), whereas the overall number of screens increased from 1383.2 to 2758.6/1000 live births. The mean time per screen decreased from 12.52 (95% confidence interval [CI] 10.44-14.59) minutes with TSB to 2.94 (95% CI 2.55-3.33) minutes with TcB (p < 0.001). The estimated cost per TcB screen in hospital and community (urban and rural) settings was $3.54 and $3.76, respectively, and the estimated cost per TSB screen in hospital and in urban and rural community settings was $15.82, $50.21 and $65.03, respectively. The estimated overall 6-month savings with the TcB-TSB hospital and community programs were $19 760 and $6417, respectively.InterpretationThe TcB-TSB program reduced nurses' time to screen and provided immediate results at the point of care. Transcutaneous bilirubinometry reduced the requirement for painful heel pokes while improving access to screening and decreasing the overall program cost.
| S-EPMC6182126 | biostudies-literature
Project description:BackgroundRecent advancements in wearable technology have enabled easy measurement of daily activities, potentially applicable in rehabilitation practice for various purposes such as maintaining and increasing patients' activity levels. In this study, we aimed to examine the validity of trunk acceleration measurement using a chest monitor embedded in a smart clothing system ('hitoe' system), an emerging wearable system, in assessing the physical activity in an experimental setting with healthy subjects (Study 1) and in a clinical setting with post-stroke patients (Study 2).MethodsStudy 1 involved the participation of 14 healthy individuals. The trunk acceleration, heart rate (HR), and oxygen consumption were simultaneously measured during treadmill testing with a Bruce protocol. Trunk acceleration and HR were measured using the "hitoe" system, a smart clothing system with embedded chest sensors. Expiratory gas analysis was performed to measure oxygen consumption. Three parameters, moving average (MA), moving standard deviation (MSD), and moving root mean square (RMS), were calculated from the norm of the trunk acceleration. The relationships between these accelerometer-based parameters and oxygen consumption-based physical activity intensity measured with the percent VO2 reserve (%VO2R) were examined. In Study 2, 48 h of simultaneous measurement of trunk acceleration and heart rate-based physical activity intensity in terms of percent heart rate reserve (%HRR) was conducted with the "hitoe" system in 136 post-stroke patients.ResultsThe values of MA, MSD, RMS, and %VO2R were significantly different between levels 1, 2, 3, and 4 in the Bruce protocol (P < 0.01). The average coefficients of determination for individual regression for %VO2R versus MA, %VO2R versus MSD, and %VO2R versus RMS were 0.89 ± 0.05, 0.96 ± 0.03, and 0.91 ± 0.05, respectively. Among the parameters examined, MSD showed the best correlation with %VO2R, indicating high validity of the parameter for assessing physical activity intensity. The 48-h measurement of MSD and %HRR in post-stroke patients showed significant within-individual correlation (P < 0.05) in 131 out of 136 patients (correlation coefficient: 0.60 ± 0.16).ConclusionsThe results support the validity of the MSD calculated from the trunk acceleration measured with a smart clothing system in assessing the physical activity intensity.Trial registrationUMIN000034967. Registered 21 November 2018 (retrospectively registered).
| S-EPMC9185863 | biostudies-literature
Project description:For many patients with sickle cell disease (SCD), jaundice is a significant clinical disease manifestation that impacts on patient well-being. We report a case of a patient with SCD and chronic jaundice treated with voxelotor (GBT440), a novel small molecule hemoglobin oxygen affinity modulator and potential disease-modifying therapy for SCD. The case patient is a 27-year-old Black male with a long history of SCD with clinical jaundice and scleral icterus. After starting voxelotor, the patient reported that his jaundice cleared within one week, and that he felt much better with more energy, and was relieved after his eyes cleared. Voxelotor reduced bilirubin and unconjugated bilirubin (by up to 76%), and hemoglobin improved from 9.9 g/dL at baseline to 11.1 g/dL at 90 days. Jaundice impacts many adults with SCD, significantly impacting self-image. Voxelotor treatment reduced bilirubin levels and improved jaundice, resulting in an improved sense of well-being in our case patient.
| S-EPMC6036983 | biostudies-literature
Project description:ObjectiveTo evaluate the role of bilirubin UDP-glucuronosyltransferase family 1, polypeptide A1 (UGT1A1) gene variations on prolonged unconjugated hyperbilirubinemia associated with breast milk feeding (breast milk jaundice [BMJ]).Study designUGT1A1 gene allelic variation was analyzed in 170 Japanese infants with BMJ with polymerase chain reaction-direct sequencing, and their genotypes compared with serum bilirubin concentrations. In 62 of 170 infants, serum bilirubin concentration was followed after 4 months of life. Genotypes were examined in 55 infants without BMJ.ResultsOf 170 infants with BMJ, 88 (51.8%) were homozygous UGT1A1*6. Serum bilirubin concentrations (21.8 ± 3.65 mg/dL) were significantly greater than in infants with other genotypes (P < .0001). The Gilbert UGT1A1*28 allele was not detected in infants with BMJ, except in an infant who was compound heterozygous with UGT1A1*6. At 4 months of age, serum bilirubin concentration improved to >1 mg/dL, except in 2 infants who were homozygous UGT1A1*7. Homozygous UGT1A1*6 was not detected in the control group.ConclusionOne-half of the infants with BMJ were homozygous UGT1A1*6 and exhibited a serum bilirubin concentration significantly greater than other genotypes. This finding indicates that UGT1A1*6 is a major cause of BMJ in infants in East Asia. Previous finding have demonstrated that 5β-pregnane-3α,20β-diol present in breast milk inhibits p.G71R-UGT1A1 bilirubin glucuronidation activity. Thus, prolonged unconjugated hyperbilirubinemia may develop in infants with UGT1A1*6 who are fed breast milk.
| S-EPMC4123958 | biostudies-literature