Accuracy of Bilistick (a Point-of-Care Device) to Detect Neonatal Hyperbilirubinemia

Kamineni, Bhargavi; Tanniru, Anusha; Vardhelli, Venkateshwarlu; Sharma, Deepak; Pawale, Dinesh; Kulkarni, Dattatray; Muppidi, Pranitha Reddy; Deshabhotla, Saikiran; Murki, Srinivas

doi:10.1093/tropej/fmaa026

Cited by 10 publications

(18 citation statements)

References 18 publications

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“…Unfortunately, in these cases, no error message appears. In line with our findings, Kamineni and colleagues [24] recently called to further improve the accuracy of the Bilistick ® . Differences in the comparisons of TCB and Bilistick ® System with TSB are not surprising because we compared complete different methodologies.…”

Section: Discussionsupporting

confidence: 87%

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

et al. 2021

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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.

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Section: Discussionsupporting

confidence: 87%

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

et al. 2021

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“…After removing duplicates, titles and abstracts were screened for 879 records. Twenty-four records were selected for full-text assessment, of which 10 were included in qualitative and quantitative analyses 12,[31][32][33][34][35][36][37][38][39] (Figure 1).…”

Section: Resultsmentioning

confidence: 99%

“…Table 1 lists the study characteristics of the 10 included studies (representing 3122 neonates), of which 9 used a crosssectional design 12,[31][32][33][34][35][36][37][38] and 1 a prospective cohort design 39 ; guidelines for phototherapy [40][41][42] used by some studies are also presented. Five studies were performed in Southeast Asia, 12,[31][32][33][34] 3 in Africa, [35][36][37] Africa and Southeast Asia.…”

Section: Study Characteristicsmentioning

confidence: 99%

Diagnostic Accuracy of Portable, Handheld Point-of-Care Tests vs Laboratory-Based Bilirubin Quantification in Neonates

et al. 2023

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ImportanceQuantification of bilirubin in blood is essential for early diagnosis and timely treatment of neonatal hyperbilirubinemia. Handheld point-of-care (POC) devices may overcome the current issues with conventional laboratory-based bilirubin (LBB) quantification.ObjectiveTo systematically evaluate the reported diagnostic accuracy of POC devices compared with LBB quantification.Data SourcesA systematic literature search was conducted in 6 electronic databases (Ovid MEDLINE, Embase, Web of Science Core Collection, Cochrane Central Register of Controlled Trials, CINAHL, and Google Scholar) up to December 5, 2022.Study SelectionStudies were included in this systematic review and meta-analysis if they had a prospective cohort, retrospective cohort, or cross-sectional design and reported on the comparison between POC device(s) and LBB quantification in neonates aged 0 to 28 days. Point-of-care devices needed the following characteristics: portable, handheld, and able to provide a result within 30 minutes. This study was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-analyses reporting guideline.Data Extraction and SynthesisData extraction was performed by 2 independent reviewers into a prespecified, customized form. Risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies 2 tool. Meta-analysis was performed of multiple Bland-Altman studies using the Tipton and Shuster method for the main outcome.Main Outcomes and MeasuresThe main outcome was mean difference and limits of agreement in bilirubin levels between POC device and LBB quantification. Secondary outcomes were (1) turnaround time (TAT), (2) blood volumes, and (3) percentage of failed quantifications.ResultsTen studies met the inclusion criteria (9 cross-sectional studies and 1 prospective cohort study), representing 3122 neonates. Three studies were considered to have a high risk of bias. The Bilistick was evaluated as the index test in 8 studies and the BiliSpec in 2. A total of 3122 paired measurements showed a pooled mean difference in total bilirubin levels of −14 μmol/L, with pooled 95% CBs of −106 to 78 μmol/L. For the Bilistick, the pooled mean difference was −17 μmol/L (95% CBs, −114 to 80 μmol/L). Point-of-care devices were faster in returning results compared with LBB quantification, whereas blood volume needed was less. The Bilistick was more likely to have a failed quantification compared with LBB.Conclusions and RelevanceDespite the advantages that handheld POC devices offer, these findings suggest that the imprecision for measurement of neonatal bilirubin needs improvement to tailor neonatal jaundice management.

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“…24 In 2020, Kamineni and colleagues called to further improve the accuracy of the Bilistick. 25 Despite of these observations, the reliability and clinical use of the Bilistick® System 1.0 for measuring TSB was considered to be appropriate in other studies performed under similar weather conditions. 22,26,27 POC diagnosis of hyperbilirubinemia has also been claimed by Tabatabaee and colleagues who reported fast and reproducible TSB measurements in whole blood with a recently developed smartphone-based bilirubin assay kit using photoluminescent bacterial cellulose nanopaper.…”

Section: Diagnostic Methods-invasive Total Serum Bilirubin Measurements Multiparameter Instrumentsmentioning

confidence: 99%

Diagnostic methods for neonatal hyperbilirubinemia: benefits, limitations, requirements, and novel developments

et al. 2021

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Invasive bilirubin measurements remain the gold standard for the diagnosis and treatment of infants with severe neonatal hyperbilirubinemia. The present paper describes different methods currently available to assess hyperbilirubinemia in newborn infants. Novel point-of-care bilirubin measurement methods, such as the BiliSpec and the Bilistick, would benefit many newborn infants, especially in low-income and middle-income countries where the access to costly multi-analyzer in vitro diagnostic instruments is limited. Total serum bilirubin test results should be accurate within permissible limits of measurement uncertainty to be fit for clinical purposes. This implies correct implementation of internationally endorsed reference measurement systems as well as participation in external quality assessment programs. Novel analytic methods may, apart from bilirubin, include the determination of bilirubin photoisomers and bilirubin oxidation products in blood and even in other biological matrices.

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Accuracy of Bilistick (a Point-of-Care Device) to Detect Neonatal Hyperbilirubinemia

Cited by 10 publications

References 18 publications

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

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

Diagnostic Accuracy of Portable, Handheld Point-of-Care Tests vs Laboratory-Based Bilirubin Quantification in Neonates

Diagnostic methods for neonatal hyperbilirubinemia: benefits, limitations, requirements, and novel developments

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