Point-of-care device to diagnose and monitor neonatal jaundice in low-resource settings.

Newborns are at increased risk of jaundice, a condition in which excess bilirubin accumulates in blood. Left untreated, jaundice can lead to neurological impairment and death. Jaundice resulting from unconjugated hyperbilirubinemia is easily treated with exposure to blue light, and phototherapy systems have been developed for low-resource settings; however, there are no appropriate solutions to diagnose and monitor jaundice in these settings. To address this need we present BiliSpec, a low-cost reader and disposable lateral flow card designed to measure the concentration of total bilirubin from several drops of blood at the point of care. We evaluated the performance of BiliSpec, using blood from normal volunteers spiked with varying amounts of bilirubin; results measured using BiliSpec correlated well with a reference laboratory bilirubinometer (r = 0.996). We then performed a pilot clinical study using BiliSpec to measure total bilirubin in neonates at risk for jaundice at Queen Elizabeth Central Hospital in Blantyre, Malawi. Concentrations measured using BiliSpec correlated well with those measured using a laboratory reference standard in 94 patient samples ranging from 1.1 mg/dL to 23.0 mg/dL in concentration (r = 0.973). The mean difference between bilirubin levels measured with BiliSpec and the reference standard was 0.3 mg/dL (95[Formula: see text] CI: -1.7-2.2 mg/dL).

Drop-to-drop variation in the cellular components of fingerprick blood: implications for point-of-care diagnostic development.

OBJECTIVES: Blood obtained via fingerprick is commonly used in point-of-care assays, but few studies have assessed variability in parameters obtained from successive drops of fingerprick blood, which may cause problems for clinical decision making and for assessing accuracy of point-of-care tests. METHODS: We used a hematology analyzer to analyze the hemoglobin concentration, total WBC count, three-part WBC differential, and platelet count in six successive drops of blood collected from one fingerprick from each of 11 donors, and we used a hemoglobinometer to measure the hemoglobin concentration of 10 drops of fingerprick blood from each of 7 donors. RESULTS: The average percent coefficient of variation (CV) for successive drops of fingerprick blood was higher by up to 3.4 times for hemoglobin, 5.7 times for WBC count, 3 times for lymphocyte count, 7.7 times for granulocyte count, and 4 times for platelets than in venous controls measured using a hematology analyzer. The average percent CV for fingerprick blood was up to 5 times higher for hemoglobin than venous blood measured using a point-of-care hemoglobinometer. Fluctuations in blood parameters with increasing volume of fingerprick blood are within instrument variability for volumes equal to or greater than 60 to 100 µL. CONCLUSIONS: These data suggest caution when using measurements from a single drop of fingerprick blood.