RApid immunochRomAtogRAphic test foR glucose-6-phosphAte dehydRogenAse deficiency

An individual’s glucose-6-phosphate dehydrogenase (G6PD) activity level should be known prior to prescribing certain drugs, such as primaquine, for malaria prevention or treatment of malaria, due to the risk of hemolytic anemia when such drugs are used in those with G6PD deficiency. Current screening methods for G6PD deficiency are impractical for use in rural areas where malaria is endemic because of the need for large equipment or highly trained personnel. The NOW G6PD immunochromatographic test (ICT) is a rapid screening device for G6PD deficiency appropriate for use in malaria endemic areas. G6PD deficient and G6PD normal subjects enrolled at Boston Medical Center completed a demographic survey and provided 2 tubes of blood. Blood preserved in both EDTA and heparin from each subject was analyzed using the NOW G6PD test. Analysis of heparinized blood was performed using the Trinity Biotech quantitative determination of G-6-PDH. Results from the two methods were compared using 4.0 U G6PD/g Hb (as measured by the standard Trinity Biotech assay) as the cut off for G6PD deficiency. Between June 2007 and February 2008, blood from 50 G6PD deficient and 196 control subjects was analyzed. The average G6PD activity of the deficient samples was 1.7 ± 1.6 U/g Hb; the average G6PD activity for the control samples was 8.1 ± 1.7 U/g Hb. After lysed blood was applied to the NOW G6PD test device, results were read for the heparinized samples after 5 minutes and after 7 minutes for the EDTA samples. The sensitivity, specificity, positive and negative predictive values of the NOW G6PD test using heparinized whole blood were 0.98, 0.98, 0.72 and 1.00. The sensitivity, specificity, positive and negative predictive values of the test using EDTA whole blood were 0.98, 0.97, 0.63, and1.00. In summary, the NOW G6PD rapid ICT is a sensitive screen for G6PD deficiency that requires minimal training and equipment, and allows for rapid diagnosis of G6PD deficiency.