A prospective clinical study to compare the clinical performance of the FINDER™ Instrument and the G6PD assay to an FDA cleared instrument/reagent combination in adult and neonate populations. Neonate and adult subjects will be recruited from 3 clinical sites. Neonate samples will be collected as heel prick unless an in dwelling line is already in place at which point a venous or arterial/umbilical sample will be collected. Adult samples will be collected as venous/arterial samples and finger stick samples. Samples will be tested at the point of care/near patient and in the clinical laboratory using the FINDER Instrument and G6PD assay on a digital microfluidic platform. Samples will also be sent to a third party CLIA laboratory for test using an FDA 510(k) cleared instrument/reagent combination for G6PD.
A prospective clinical study to compare the clinical performance of the FINDER™ Instrument and the G6PD assay to an FDA cleared instrument/reagent combination in adult and neonate populations.