ArticleMalaria journal2025
Evaluation of the Wondfo G6PD/Hb Test for glucose-6-phosphate dehydrogenase deficiency: preliminary performance, matrix equivalence, and usability.
Article in Malaria journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundCurrent treatment guidelines for radical cure of Plasmodium vivax malaria recommend the use of 8-aminoquinolines, which can result in life-threatening complications in people with glucose-6-phsophate dehydrogenase (G6PD) deficiency. Testing for this condition is recommended prior to administering such drugs. The Wondfo G6PD/Hb Test (Guangzhou Wondfo Biotech Co., Ltd., China) is a novel, quantitative point-of-care (POC) G6PD test that may help decentralize testing, expanding access to safe treatment options.
methodsTwo studies were conducted: a retrospective diagnostic accuracy study on frozen venous whole blood specimens and a prospective matrix equivalency study. First, 300 frozen specimens from Mae Sot, Thailand were tested from July-August 2022 using the Wondfo test in laboratory and simulated field conditions. Reference testing for G6PD and Hb (spectrophotometer [Pointe Scientific, USA] and HemoCue [HemoCue AB, Sweden], respectively) was completed in the laboratory. Usability was evaluated among 10 intended users. Next, 225 participants were enrolled into a prospective matrix equivalency study from March-May 2023 in Memphis, Tennessee, USA. The Wondfo test was conducted at the POC with fingerstick capillary blood, and Wondfo and HemoCue tests were completed on fresh venous (K
resultsThe Wondfo G6PD measurement showed strong correlation under both laboratory and field conditions (R
conclusionsThe Wondfo G6PD/Hb Test demonstrates good diagnostic performance using current manufacturer thresholds across various conditions and both venous and capillary specimens. Comparable performance in both specimen types supports matrix equivalence. Usability is acceptable for end users, though refinements were recommended.
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