Table 1-.

A comparative review of G6PD diagnostic tests

	Gold Standard	Fluorescent Spot Test	CareStart™ RDT	CareStart™ G6PD Biosensor	STANDARD™ G6PD by SD Biosensor	“Sample -to- readout”	BS-240
Method	Spectrophotometry	UV fluorescence visualization	Colorization chamber	Biosensor, test strip	Biosensor, test strip	Colorization, fabricated biosensor	Automated UV enzyme system
Volume	10μL	5μL	2μL	5μL	10μL	15μL	20μL
Blood	Venous	Venous	Whole	Whole	Venous or capillary	Whole	Hemolys ate venous blood
Time	5-10 min	10 min + air dry time	10 min	4 min	2 min	10 min + air dry time	2 min
Temperature	30°C	Room temperature	Variable	Room temperature	Variable	Room temperature	37°C
Intermediate Reading*	Yes	No	No	Yes	Yes	Yes	No
Measurement	Quantitative	Qualitative	Qualitative	Quantitative	Quantitative	Qualitative	Quantitative
Sensitivity #	Very High	Med-High	Med-High	High	High	Med-High	Med-High
Specificity #	Very High	Med-High	Med-High	High	High	Med-High	Med-High
Diagnostic Accuracy#	Very High	Low-Med	Medium	High	Very High	Med-High	Low-Med

^*Intermediate readout for the G6PD activity is important for diagnosis on mild/intermediate G6PD deficiency. This provides the scope for determining threshold of G6PD deficiency for safety of therapeutics in G6PD deficient populations.

^#The performance of individual methods of diagnosis of G6PD deficiency regarding sensitivity, specificity, and diagnostic accuracy is subjective and may not be compared quantitatively.