Accuracy of Bilistick (a Point-of-Care Device) to Detect Neonatal Hyperbilirubinemia. (20th May 2020)

• Record Type: Journal Article
• Authors: Kamineni, Bhargavi; Tanniru, Anusha; Vardhelli, Venkateshwarlu; Sharma, Deepak; Pawale, Dinesh; Kulkarni, Dattatray; Muppidi, Pranitha Reddy; Deshabhotla, Saikiran; Murki, Srinivas
• Is Part Of: Journal of tropical pediatrics. Volume 66:Number 6(2020:Dec.)
• Page Start: 630
• Page End: 636
• Publication Date: 2020-05-20
• Subjects: neonatal jaundice -- bilirubin -- Bilistick -- hyperbilirubinemia -- point-of-care device; Pediatrics -- Periodicals; Tropical medicine -- Periodicals; Pediatrics -- Periodicals; Tropical Medicine -- Periodicals; Environmental Health -- Periodicals; Infant; Child; 618.929883
• DOI: 10.1093/tropej/fmaa026
• Languages: English
• ISSNs: 0142-6338

Abstract

Abstract: Introduction: Early diagnosis and appropriate management of neonatal jaundice is crucial in avoiding severe hyperbilirubinemia and brain injury. A low-cost, minimally invasive, point-of-care (PoC) tool for total bilirubin (TB) estimation which can be useful across all ranges of bilirubin values and all settings is the need of the hour. Objective: To assess the accuracy of Bilistick system, a PoC device, for measurement of TB in comparison with estimation by spectrophotometry. Design/methods: In this cross-sectional clinical study, in infants who required TB estimation, blood samples in 25-µl sample transfer pipettes were collected at the same time from venous blood obtained for laboratory bilirubin estimation. The accuracy of Bilistick in estimating TB within ±2 mg/dl of bilirubin estimation by spectrophotometry was the primary outcome. Results: Among the enrolled infants, 198 infants were eligible for study analysis with the mean gestation of 36 ± 2.3 weeks and the mean birth weight of 2368 ± 623 g. The median age at enrollment was 68.5 h (interquartile range: 48–92). Bilistick was accurate only in 54.5% infants in measuring TB within ±2 mg/dl difference of TB measured by spectrophotometry. There was a moderate degree of correlation between the two methods ( r = 0.457; 95% CI: 0.339–0.561, p value < 0.001). Bland–Altman analysis showed a mean difference of 0.5 mg/dl (SD ± 4.4) with limits of agreement between −8.2 and +9.1 mg/dl. Conclusion: Bilistick as a PoC device is not accurate to estimate TB within the clinically acceptable difference (±2 mg/dl) of TB estimation by spectrophotometry and needs further improvement to make it more accurate.