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Portable Point-of-Care Device for Dual Detection of Glucose-6-Phosphate Dehydrogenase Deficiency and Hemoglobin in
Rehab Osman Taha1, Napaporn Youngvises2, Runtikan Pochairach2
1Graduate Program in Bioclinical Sciences, Chulabhorn International College of Medicine, Thammasat University, Pathum Thani 12120, Thailand.
Insights
A new point-of-care device, MyG6PD, accurately measures Glucose-6-phosphate dehydrogenase (G6PD) deficiency. This tool enables rapid screening, crucial for preventing hemolytic reactions from certain medications in at-risk populations.
Area of Science:
- Biochemistry
- Clinical Diagnostics
- Point-of-Care Testing
Background:
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency is a prevalent genetic disorder with critical implications for drug safety and neonatal care.
- Accurate and timely G6PD deficiency diagnosis is essential to prevent severe hemolytic anemia triggered by oxidative stress.
- Existing diagnostic methods may lack the speed or accessibility required for immediate clinical decision-making.
Purpose of the Study:
- To evaluate the analytical performance of the MyG6PD device, a novel quantitative point-of-care tool.
- To assess the MyG6PD device's capability in measuring both hemoglobin concentration and G6PD enzyme activity.
- To determine the suitability of MyG6PD for G6PD deficiency screening in diverse clinical settings.
Main Methods:
- Analytical performance evaluation of the MyG6PD device.
- Benchmarking against established laboratory spectrophotometry and the STANDARD G6PD Analyzer™.
- Assessment of linearity, accuracy, and precision across various G6PD activity levels, including heterozygous females.
Main Results:
- MyG6PD demonstrated excellent linearity (R² ≥ 0.99), accuracy (bias < ±15%), and precision (CV < 15%).
- The device reliably detected G6PD activity across normal, intermediate, and deficient ranges.
- The MyG6PD device showed consistent performance, including for intermediate phenotypes characteristic of heterozygous females.
Conclusions:
- The MyG6PD device offers a reliable and accurate quantitative assessment of G6PD enzyme activity.
- Its point-of-care design, rapid results, and ease of use make it suitable for resource-limited settings.
- MyG6PD provides a clinically actionable solution for timely G6PD deficiency screening, enhancing patient safety and outcomes.
Abstract:
Glucose-6-phosphate dehydrogenase (G6PD) deficiency is a common enzymopathy with significant clinical implications, particularly in malaria-endemic regions and in the management of neonatal hyperbilirubinemia. Timely and accurate detection of G6PD deficiency is critical to prevent life-threatening hemolytic events following oxidative drug administration. This study evaluated the MyG6PD device, a quantitative point-of-care (PoC) tool, for the assessment of hemoglobin concentration and G6PD enzyme activity. Analytical performance was benchmarked against laboratory spectrophotometry and the STANDARD G6PD Analyzer™ (SD Biosensor; Suwon-si, Republic of Korea). MyG6PD demonstrated excellent linearity (R2 ≥ 0.99), accuracy (bias < ±15%), and precision (CV < 15%) across normal, intermediate, and deficient activity ranges, including heterozygous females with intermediate phenotypes. The device's compact, battery-operated design, rapid turnaround, and minimal training requirements support its use in decentralized and resource-limited settings. Furthermore, cost-effective consumables and robust detection of intermediate activity highlight its potential for large-scale deployment. Overall, MyG6PD provides a reliable, accessible, and clinically actionable solution for urgent G6PD deficiency screening, enabling safer administration of oxidative therapies and improving patient outcomes in high-risk populations.
