A novel point-of-care device for measuring glucose-6-phosphate dehydrogenase enzyme deficiency

Extreme hyperbilirubinemia can cause bilirubin neurotoxicity. Infants with glucose-6 phosphate dehydrogenase (G6PD) deficiency can develop hemolysis and thus are at high risk. We evaluated a device that quantitatively measures G6PD activity kinetically using digital microfluidics (DMF). Intraand inter-instrument and-day imprecision (CVs) were first assessed. G6PD activity in 86 samples was then measured and compared between DMF and 2 reference methods. Overall DMF reproducibility was 3.8% over 5 days by 2 operators on 2 instruments. Mean intraand inter-instrument variabilities were 3.6% and 3.9%, respectively (n = 28), with a user variability of 4.3%. Mean G6PD activity was 6.404.62 and 6.374.62 U/g hemoglobin for DMF and Reference Methods 1 (n = 46) and 12.15 +/- 3.86 and 11.48 +/- 1.55 for DMF and 2 (n = 40), respectively, and strongly correlated (r = 0.95 and 0.95) with mean biases of +0.04 +/- 2.90 and +0.67 +/- 1.55 for methods 1 and 2, respectively. The novel device could be used for early newborn G6PD screening. (c) 2020 The Author(s). Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)