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.

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

“…BiliSpec calibration cards are housed inside the reader. The calibration process was performed daily during the trials . There was substantial variation in the reference methods used, and these included blood gas and chemistry analyzers.…”

“…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).…”

“…Two studies evaluated the performance of BiliSpec (3rd Stone Design), a POC test for total bilirubin quantification in 50 μL of whole blood. 35,37 BiliSpec, now called BiliDx, consists of a handheld reader and lateral flow card. The lateral flow card separates the blood and plasma (using a fiber plasma separation membrane) and stabilizes the sample so that the bilirubin concentration remains constant over time.…”

“…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.…”

“…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. 39 Studies were published between 2012 and 2022.…”