# Evaluation of the Diagnostic Accuracy of the Quantitative Point‐of‐Care SD Biosensor Standard G6PD Test for Assessment of G6PD Deficiency in Infectious Diseases

## TL;DR

This study evaluates a new point-of-care test for G6PD deficiency, showing high accuracy and potential to improve safe malaria treatment in endemic regions.

## Contribution

The study introduces and validates a quantitative point-of-care G6PD test with hemoglobin normalization for use in low-resource settings.

## Key findings

- The test showed almost perfect agreement with reference methods (kappa = 0.82).
- Concordance rates were 95% for females, 97% for males, and 96% overall.
- The test enables accurate G6PD measurement in lower-tier clinical settings.

## Abstract

G6PD deficiency affects about 500 million people worldwide and is prevalent in many malaria‐endemic settings. People with G6PD deficiency are at risk of hemolysis when exposed to certain medications, including 8‐aminoquinoline drugs used to treat Plasmodium vivax malaria. Increasing access to testing for G6PD deficiency at or near the point of care is critical to expanding the safe treatment of
P. vivax
malaria. We aimed to evaluate the performance of a semiquantitative test for G6PD deficiency, the SD Biosensor Standard G6PD Test with the Brewer's method, in a reference site for the treatment of infectious diseases.

We evaluate the diagnostic accuracy performance of the SD Biosensor Standard G6PD Test in 125 individuals with infectious diseases and other illnesses.

We observed a trend of concordance between the G6PD status (Deficient or Normal), with low frequencies of discordances in the screenings. The strength of agreement between G6PD tests was classified as almost perfect in all participants (k = 0.82, 95% CI = 0.66, 0.97) and in sex subgroups: females (k = 0.83, 95% CI = 0.59, 1.00) and males (k = 0.81, 95% CI = 0.59, 1.00). The total concordance percentage (number of concordances/total) was 95% for females, 97% for males, and 96% overall.

The SD Biosensor STANDARD G6PD test is an innovative point‐of‐care solution. It offers quantitative measurement of glucose‐6‐phosphate dehydrogenase activity while normalizing for hemoglobin levels. This advancement enables its use in lower‐tier clinical and laboratory settings, expanding access to accurate G6PD testing.