Modification of the Pointe Scientific Automated Glucose-6-Phosphate Dehydrogenase (G6PD) Assay for High-Throughput Use in the Clinical Laboratory

Herein we report a modified Pointe Scientific method for Glucose-6-Phosphate Dehydrogenase (G6PD) testing which eliminates time-consuming and labor intensive pre-analytical steps previously required. Pre-lyse and on-board lyse Pointe Scientific methods were compared to the on-board lyse Trinity Biotech method using Abbott Architect c8000 analyzers integrated into an a3600 track system. In order to streamline the implementation of this method involving both G6PD and hemoglobin analysis, we sought to capitalize on the Instrument Manager (IM) middleware and the a3600 Abbott track system for high-throughput analysis using the Abbott Architect c8000 platform. IM rules were developed to route the whole blood specimen to the wait area of the Input Output Module (IOM) while the initial result is determined. When the initial result is intermediate or deficient, the G6PD activity per gram of hemoglobin (U/g Hgb) is determined by rerouting the specimen to the analyzer as an automated reflex test. The data associated with method comparison, precision, carryover and linearity studies completed per regulatory guidelines indicate the assay parameters reported herein are available for the immediate implementation of fully-automated G6PD testing. A viable method that includes on-board lysing and reflex testing has been implemented allowing for high-throughput G6PD testing in a clinical laboratory. Given market research yielded limited vendors with Food and Drug Administration (FDA)-cleared G6PD assays, the automation of the Pointe Scientific method will allow Department of Defense (DOD) laboratories to rapidly screen service members in order to ascertain the tolerability of a Primaquine dosing regimen