Evaluation of a Point-of-Care Test for Bilirubin in Malawi

Abstract

Objectives: BiliSpec is a low-cost spectrophotometric reader and disposable paper-based strip to quantify total serum bilirubin from several blood drops. This study was a prospective evaluation of BiliSpec in 2 neonatal wards in Malawi compared with a reference standard bilirubinometer over a large range of bilirubin and hematocrit levels.

Methods: The accuracy of BiliSpec and a transcutaneous bilirubinometer were compared with the reference standard of spectrophotometry for 475 blood samples collected from 375 subjects across a range of total serum bilirubin concentrations from 0.0 to 33.7 mg/dL. The development of error grids to assess the clinical effects of measurement differences is reported.

Results: BiliSpec was found to have a mean bias of -0.48 mg/dL and 95% limits of agreement of -5.09 mg/dL to +4.12 mg/dL. Results show 90.7% of BiliSpec measurements would have resulted in the same clinical decision as the reference standard, whereas 55.0% of transcutaneous bilirubin measurements would have resulted in the same clinical decision as the reference standard.

Conclusions: This evaluation supports use of BiliSpec to provide accurate, low-cost, point-of-care bilirubin measurements in low-resource hospitals. Future work is needed to evaluate BiliSpec among a larger number of users.

Trial registration: ClinicalTrials.gov NCT03866213.