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.

中文翻译：

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胆量（护理点设备）检测新生儿高胆红素血症的准确性。

摘要

介绍

新生儿黄疸的早期诊断和适当处理对于避免严重的高胆红素血症和脑损伤至关重要。一种低成本，微创的即时护理（PoC）工具，用于总胆红素（TB）估算，这对小时的所有胆红素值范围和所有设置都是有用的。

目的

为了评估Bilistick系统（一种PoC装置）的准确性，该系统可用于与通过分光光度法进行估算的TB测量相比较。

设计/方法

在这项横断面临床研究中，在需要结核病评估的婴儿中，同时从用于实验室胆红素评估的静脉血中收集了25 µl样品移液管中的血液样品。通过分光光度法在胆红素估计值的±2 mg / dl范围内，Bilistick估计TB的准确性是主要的结果。

结果

在入选的婴儿中，有198例婴儿符合研究分析条件，平均妊娠36±2.3周，平均出生体重2368±623 g。入组时的中位年龄为68.5小时（四分位间距：48-92）。通过分光光度法测得的结核病差异在±2 mg / dl之内，只有54.5％的婴儿在测量TB时，双盲法是准确的。两种方法之间的相关度中等（r  = 0.457； 95％CI：0.339–0.561，p值<0.001）。Bland–Altman分析显示平均差异为0.5 mg / dl（SD±4.4），一致极限在-8.2和+9.1 mg / dl之间。

结论

在通过分光光度法估算的TB的临床可接受的差值（±2 mg / dl）内，作为PoC装置的Billistick无法准确估算TB，需要进一步改进以使其更加准确。