Abstract
Background: Screening and monitoring serum bilirubin (SBR) in neonates is crucial to prevent neonatal hyperbilirubinemia (NH)-associated morbidity and mortality worldwide. A lack of resources is often a barrier for measuring SBR in developing countries. Reliable, cost-effective, easy to use point-of-care (POC) SBR tests are needed. This study aimed to evaluate the technical accuracy and usability of the Bilistick System (BS), a new bilirubin POC test, in a tropical setting. Methods: This was a mixed-methods study, including laboratory validation of the BS, direct observation of technical procedures as performed by the midwives and midwives' assessment of the device's easiness of use through focus group discussions (FGD) and a self-administered questionnaire. The study was conducted in a field clinic of the Shoklo Malaria Research Unit along the Thailand-Myanmar border between January and December 2017. Results: A total of 173 samples were tested at a median age of 4 days. BS generated an error message-providing no SBR readout-in 48.6% of the tests performed. For the tests that yielded a result, the correlation coefficient (95% CI) between BS and routine laboratory bilirubinometer SBR was 0.87 (0.77-0.93). The accuracy decreased with increasing haematocrit and at higher humidity (≥75%). Direct observation of the operators using the device and analysis of the focus group discussions and questionnaires indicated that the BS was considered easy to use and required limited training. Conclusions: This evaluation showed that the BS, in its current formulation, does not provide reliable results for measuring SBR in a tropical, low-resource setting but has acceptable usability features.
Highlights
Neonatal hyperbilirubinemia (NH), a common disorder worldwide, has a benign course if promptly managed
Three tests were excluded from analysis because the laboratory technicians were unavailable to supervise the procedure; four additional tests were excluded from further evaluation: three had insufficient amounts of blood to complete the Bilistick System (BS) test, and the reader stopped functioning during one test, yielding an incomplete test result
Delayed cord clamping is regularly practiced at the Shoklo Malaria Research Unit (SMRU) clinic according to WHO recommendations[28] resulting in newborns having a median HCT of 59% (IQR, 54-64) at 24 hours of life[29], a value similar to other settings worldwide[26,27,30]
Summary
Neonatal hyperbilirubinemia (NH), a common disorder worldwide, has a benign course if promptly managed. Serum bilirubin concentration is the gold standard reference for determining NH management[2,3,4,5], and it is done by laboratory-based colorimetric assay, which requires large blood volumes and a fully-equipped laboratory— often beyond the reach of clinics in low-resource settings. This study aimed to evaluate the technical accuracy and usability of the Bilistick System (BS), a new bilirubin POC test, in a tropical setting. Methods: This was a mixed-methods study, including laboratory validation of the BS, direct observation of technical procedures as performed by the midwives and midwives’ assessment of the device’s easiness of use through focus group discussions (FGD) and a self-administered questionnaire. Conclusions: This evaluation showed that the BS, in its current formulation, does not provide reliable results for measuring SBR in a tropical, low-resource setting but has acceptable usability features
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