Abstract
Introduction:
Screening for G6PD deficiency can inform disease management including malaria. Treatment with the antimalarial drugs primaquine and tafenoquine can be guided by point-of-care testing for G6PD deficiency.
Methods and findings:
Data from similar clinical studies evaluating the performance of the STANDARD G6PD Test (SD Biosensor, South Korea) conducted in Bangladesh, Brazil, Ethiopia, India, Thailand, the United Kingdom, and the United States were pooled. Test performance was assessed in a retrospective analysis on capillary and venous specimens. All study sites used spectrophotometry for reference G6PD testing, and either the HemoCue or complete blood count for reference hemoglobin measurement. The sensitivity of the STANDARD G6PD Test using the manufacturer thresholds for G6PD deficient and intermediate cases in capillary specimens from 4212 study participants was 100% (95% Confidence Interval (CI): 97.5%-100%) for G6PD deficient cases with <30% activity and 77% (95% CI 66.8%-85.4%) for females with intermediate activity between 30%-70%. Specificity was 98.1% (95% CI 97.6%-98.5%) and 92.8% (95% CI 91.6%-93.9%) for G6PD deficient individuals and intermediate females, respectively. Out of 20 G6PD intermediate females with false normal results, 12 had activity levels >60% on the reference assay. The negative predictive value for females with G6PD activity >60% was 99.6% (95% CI 99.1%-99.8%) on capillary specimens. Sensitivity among 396 P. vivax malaria cases was 100% (69.2%-100.0%) for both deficient and intermediate cases. Across the full dataset, 37% of those classified as G6PD deficient or intermediate resulted from true normal cases. Despite this, over 95% of cases would receive correct treatment with primaquine, over 87% of cases would receive correct treatment with tafenoquine, and no true G6PD deficient cases would be treated inappropriately based on the result of the STANDARD G6PD Test.
Conclusions:
The STANDARD G6PD Test enables safe access to drugs which are contraindicated for individuals with G6PD deficiency. Operational considerations will inform test uptake in specific settings.
| Original language | English |
|---|---|
| Article number | e0011652 |
| Pages (from-to) | e0011652 |
| Number of pages | 21 |
| Journal | PLoS Neglected Tropical Diseases |
| Volume | 17 |
| Issue number | 10 |
| DOIs | |
| Publication status | Published - 1 Oct 2023 |
Bibliographical note
Funding Information:The Brazil, Ethiopia, India, Thailand, UK, and US studies were funded by the United Kingdom’s Foreign, Commonwealth & Development Office (FCDO), grant number 204139 and, by the Bill & Melinda Gates Foundation [OPP1107113]. The FCDO and Bill & Melinda Gates Foundation awards to PATH support the availability of point-of-care tests for G6PD deficiency. GB, CSC, and FN work at the Shoklo Malaria Research Unit, part of the Mahidol Oxford University Research Unit supported by the Wellcome Trust Mahidol Major Overseas Programme–Thailand Unit (Grant Number 220211). For the purpose of Open Access, the authors have applied a CC BY public copyright license to any author accepted manuscript version arising from this submission RNP and the Bangladesh study were funded by the Wellcome Trust (Senior Fellowship in Clinical Science, 200909), BL is funded by the Australian Department of Foreign Affairs and Trade, RNP is funded by the Bill & Melinda Gates Foundation (OPP1054404 and OPP1164105). MVGL and WMM are funded by Brazilian CNPq. Under the grant conditions of the Gates Foundation, a Creative Commons Attribution 4.0 Generic License has been assigned to the Author Accepted Manuscript version that might arise from this submission. The findings and conclusions contained within are those of the authors and do not necessarily reflect the positions of FCDO or the Gates Foundation. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Publisher Copyright:
© 2023 Adissu et al.
