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Point-of-care device to diagnose and monitor neonatal jaundice in low-resource settings.

ABSTRACT: 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).

SUBMITTER: Keahey PA

PROVIDER: S-EPMC5754796 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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Point-of-care device to diagnose and monitor neonatal jaundice in low-resource settings.

Keahey Pelham A PA Simeral Mathieu L ML Schroder Kristofer J KJ Bond Meaghan M MM Mtenthaonnga Prince J PJ Miros Robert H RH Dube Queen Q Richards-Kortum Rebecca R RR

Proceedings of the National Academy of Sciences of the United States of America 20171204 51

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 ...[more]

PMID: 29203650

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Project description:BackgroundNeonatal jaundice is a condition caused by elevated levels of bilirubin in the bloodstream. Laboratory determination of serum bilirubin concentration by total serum bilirubin (TSB) test is still considered as gold standard for clinical guidance and practice. In developed countries, diagnosis of neonatal jaundice is shifting towards point-of-care medical devices. BiliDx is a device developed to allow a fast, blood-based determination of bilirubin levels at the point of care. This study aimed to determine the accuracy of the BiliDx device relative to a standard laboratory total serum bilirubin to diagnose and monitor jaundice among neonates admitted at Muhimbili National Hospital (MNH).Material and methodologyThis was a prospective hospital-based observational study conducted at the Neonatal Ward - MNH, Dar-es-Salaam, Tanzania from November 2022 to January 2023. A total of 180 neonates admitted at the neonatal ward with jaundice and whose parents consented were enrolled in the study. Blood samples were collected; 2 ml of venous blood into the vacutainer bottle for standard laboratory measurement of total serum bilirubin (TSB) and 25µL blood collected into a transfer pipette tube and applied to BiliDx. STATA version 15.1 was used for data analysis.ResultsOut of 180 neonates, 39.4% (71/180) had birth weight between 1500 - 2499.9 g, approximately 2/3rd (120/180) were preterm, 92/180 (51.1%) were males and 100/180 (55.6%) were undergoing phototherapy treatment the moment sample taken. The mean bilirubin concentration was 92 mmol/l for BiliDx and 118 mmol/l for standard laboratory TSB. The minimum and maximum values obtained with BiliDx were, 3.4 and 427.5 mmol/l respectively, compared with 10.7 and 382.1 mmol/l using standard laboratory TSB. A linear relationship and correlation coefficient of 0.8408 (p = 0.000) between BiliDx and standard laboratory TSB was found. The regression analysis showed the presence of constant error [coefficient of BiliDx/slope = 0.91, 95% CI (0.82-0.99), p = 0.000] and random error exclusively [coefficient of constant/y-intercept = 48.52, 95%CI (37.70-59.34), p = 0.000]. The Bland-Altman plot showed an acceptable mean difference of 39.1mmol/l, limits of agreement of -48.3mmol/l to 126.4mmol/l, and 179 points (179/180 = 99.4%) lying inside the limits of agreement.ConclusionThe results support the use of BiliDx for rapid and accurate testing of elevated levels of bilirubin in the bloodstream among neonates since 99.4% of the differences between BiliDx and standard laboratory TSB lie between the lines of agreement.

Project description:IntroductionCurrent guidelines by WHO for cervical cancer screening in low- and middle-income countries involves visual inspection with acetic acid (VIA) of the cervix, followed by treatment during the same visit or a subsequent visit with cryotherapy if a suspicious lesion is found. Implementation of these guidelines is hampered by a lack of: trained health workers, reliable technology, and access to screening facilities. A low cost ultra-portable Point of Care Tampon based digital colposcope (POCkeT Colposcope) for use at the community level setting, which has the unique form factor of a tampon, can be inserted into the vagina to capture images of the cervix, which are on par with that of a state of the art colposcope, at a fraction of the cost. A repository of images to be compiled that can be used to empower front line workers to become more effective through virtual dynamic training. By task shifting to the community setting, this technology could potentially provide significantly greater cervical screening access to where the most vulnerable women live. The POCkeT Colposcope's concentric LED ring provides comparable white and green field illumination at a fraction of the electrical power required in commercial colposcopes. Evaluation with standard optical imaging targets to assess the POCkeT Colposcope against the state of the art digital colposcope and other VIAM technologies.ResultsOur POCkeT Colposcope has comparable resolving power, color reproduction accuracy, minimal lens distortion, and illumination when compared to commercially available colposcopes. In vitro and pilot in vivo imaging results are promising with our POCkeT Colposcope capturing comparable quality images to commercial systems.ConclusionThe POCkeT Colposcope is capable of capturing images suitable for cervical lesion analysis. Our portable low cost system could potentially increase access to cervical cancer screening in limited resource settings through task shifting to community health workers.

Project description:Hypothermia occurs frequently among clinically unstable neonates who are not suitable to place in skin-to-skin care. This study aims to explore the existing evidence on the effectiveness, usability, and affordability of neonatal warming devices when skin-to-skin care is not feasible in low-resource settings. To explore existing data, we searched for (1) systematic reviews as well as randomised and quasi-randomised controlled trials comparing the effectiveness of radiant warmers, conductive warmers, or incubators among neonates, (2) neonatal thermal care guidelines for the use of warming devices in low-resource settings and (3) technical specification and resource requirement of warming devices which are available in the market and certified medical device by the US Food and Drug Administration or with a CE marking. Seven studies met the inclusion criteria, two were systematic reviews comparing radiant warmers vs. incubators and heated water-filled mattresses vs. incubators, and five were randomised controlled trials comparing conductive thermal mattresses with phase-change materials vs. radiant warmers and low-cost cardboard incubator vs. standard incubator. There was no significant difference in effectiveness between devices except radiant warmers caused a statistically significant increase in insensible water loss. Seven guidelines covering the use of neonatal warming devices show no consensus about the choice of warming methods for clinically unstable neonates. The main warming devices currently available and intended for low-resource settings are radiant warmers, incubators, and conductive warmers with advantages and limitations in terms of characteristics and resource requirements. Some devices require consumables which need to be considered when making a purchase decision. As effectiveness is comparable between devices, specific requirements according to patients' characteristics, technical specification, and context suitability must play a primary role in the selection and purchasing decision of warming devices. In the delivery room, a radiant warmer allows fast access during a short period and will benefit numerous neonates. In the neonatal unit, warming mattresses are low-cost, effective, and low-electricity consumption devices. Finally, incubators are required for very premature infants to control insensible water losses, mainly during the first one to two weeks of life, mostly in referral centres.

Dataset Information

Point-of-care device to diagnose and monitor neonatal jaundice in low-resource settings.

Publications

Point-of-care device to diagnose and monitor neonatal jaundice in low-resource settings.

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