Introduction: Treatment with 8-aminoquinolines can result in severe hemolysis in Plasmodium (P.) vivax patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. A point-of-care test for G6PD deficiency may play a big role in providing access to safe radical cure of P. vivax in India. The aim of this study was to assess the sensitivity and specificity of the novel point-of-care STANDARD™ G6PD Test (SD Biosensor, Republic of Korea) for the detection of normal, intermediate, and deficient populations in Eastern India when used by trained health care workers.
Methods: 1,012 consented participants were recruited through the Outpatient Department of Medical College and Hospital, Kolkata, and the malaria community clinic. The STANDARD G6PD Test was evaluated on both capillary and venous blood specimens for performance against the reference spectrophotometric assay. The G6PD reference assay was conducted at the National Institute of Cholera and Enteric Diseases (NICED), Kolkata. Specimens were stored at 4°C until tested at NICED within 48 hours of collection.
Results: The sensitivity and specificity of the STANDARD G6PD Test was 100% (95% CI [86.8–100]) and 97.6% (95% CI [96.3–98.5]) respectively for deficient males and females with < 30% G6PD activity, using either venous or capillary samples. The sensitivity and specificity of the test for intermediate females using a 70% activity threshold was 62.5% (95% CI [35.4–85.8]) and 94.1% (95% CI [90.8–98.0]) respectively, using either venous or capillary samples. The majority of intermediate cases had a G6PD activity of greater than 60%.
Conclusion: This study demonstrated that the STANDARD G6PD Test supports P. vivax case management with 8-aminoquinolines. It met the acceptance criteria for diagnosing G6PD deficiency for individuals with ≤ 30% G6PD activity across all study participants for both venous and capillary specimens.