Arkasha Sadhewa is a PhD student at the Menzies School of Health Research, supervised by Dr. Benedikt Ley (Menzies), Dr.sc.hum Ari Satyagraha (Eijkman), Assoc. Prof. Kamala Thriemer (Menzies), and Prof. Ric Price (Menzies). Her PhD project focuses on G6PD deficiency (G6PDd) diagnostics for the safe deployment of vivax radical cure. It involves collating G6PDd prevalence data in Indonesia, assessing and improving the operational characteristics of G6PDd quantitative point of care diagnostics, and assessing the intra-individual variability in G6PD activity. Her presentation abstract is below:
“Performance of Quantitative Point-of-Care Tests to measure G6PD activity: An Individual Participant Data Meta-Analysis”
Arkasha Sadhewa1, Ari W. Satyagraha2, Wondimagegn Adissu3,4, Mohammad Shafiul Alam5, Anup Anvikar6, Germana Bancone7,8, Praveen K. Bharti6, Vinod K. Bhutani9, Santasabuj Das10, Muzamil Mahdi Abdel Hamid11, Mohammad Sharif Hossain5, Nitika6, Bernard A. Okech12, Lydia V. Panggalo13, Ric N. Price1,8,14, Arunansu Talukdar15, Michael E. von Fricken16,17, Ronald J. Wong9, Daniel Yilma4,18, Kamala Thriemer1, Benedikt Ley1,19
Abstract
Background: Glucose-6-phosphate dehydrogenase (G6PD) deficiency is the main risk factor for severe haemolysis following treatment with 8-aminoquinolines (8AQ). The World Health Organization recommends G6PD testing prior to 8AQ-based hypnozoitocidal treatment.
Methods: We undertook an individual level meta-analysis of the performance of commercially available quantitative point-of-care diagnostics (PoC) compared with reference spectrophotometry. A systematic literature search (PROSPERO: CRD42022330733) identified 595 articles of which 16 (2.7%) fulfilled pre-defined inclusion criteria and were included in the analysis, plus an additional 4 unpublished datasets. In total there were 12,678 paired measurements analyzed, 10,446 (82.4%) by STANDARD G6PD Test (SD Biosensor, RoK, [SDB]), 2,042 (16.1%) by CareStart G6PD Biosensor (AccessBio, USA, [CSA]), 150 (1.2%) by CareStart Biosensor (WellsBio, RoK [CSW]), and 40 (0.3%) by FINDER (Baebies, USA, [FBA]).
Findings: The pooled sensitivities of the SDB when measuring G6PD activity <30% of normal were 0.82 (95% confidence interval [CI]: 0.72-0.89) for capillary and 0.93 (95% CI: 0.75-0.99) for venous blood samples. The corresponding values for measuring <70% G6PD activity were 0.93 (95% CI: 0.67-0.99) and 0.89 (95% CI: 0.73-0.96), respectively. The pooled specificity of the SDB was high (>96%) for all blood samples and G6PD activity thresholds. Irrespective of the blood samples and thresholds applied, sensitivity of the CSA did not exceed 62%, although specificity remained high at both 30% and 70% thresholds (>88%). Only one study each for CSW and FBA was included. Sensitivities of the CSW were 0.04 (95% CI: 0.01-0.14) and 0.81 (95% CI: 0.71-0.89) at the 30% and 70% thresholds, respectively (venous blood samples). Sensitivities of the FBA were 1.00 (95% CI: 0.29-1.00) and 0.75 (95% CI: 0.19-0.99) at the 30% and 70% thresholds (venous blood samples). Specificities of the CSW and FBA were consistently high (>90%) at both thresholds. Sensitivity analyses found that participants’ sex impacted test accuracy of SDB (odds ratio [OR]: 3.12 and 0.77 at the 30% and 70% thresholds, respectively) and CSA (OR: 0.61 at the 70% threshold).
Conclusions: The SDB performed significantly better than other tested PoCs. More evidence was available for the performance of the SDB compared to other PoCs, giving higher confidence in its utility in diagnosing G6PD deficiency.
Author Affiliations
- Menzies School of Health Research and Charles Darwin University, Global and Tropical Health Division, Darwin, Australia
- Eijkman Research Center for Molecular Biology, National Research and Innovation Agency, Cibinong, Indonesia
- School of Medical Laboratory Sciences, Jimma University, Jimma, Ethiopia
- Clinical Trial Unit, Jimma University, Jimma, Ethiopia
- International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh
- ICMR-National Institute of Malaria Research, New Delhi, India
- Shoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Thailand
- Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom
- Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine, Stanford, CA, USA
- National Institute of Cholera and Enteric Diseases, Kolkata, India
- Institute of Endemic Diseases, University of Khartoum, Khartoum, Sudan
- Department of Preventive Medicine & Biostatistics, Uniformed Services University of the Health Sciences, F. Edward Hébert School of Medicine, Bethesda, MD, USA
- EXEINS Health Initiative, Jakarta, Indonesia
- Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
- Kolkata Medical College Hospital, India
- One Health Center of Excellence, Emerging Pathogens Institute, University of Florida, Gainesville, FL, USA
- Department of Environmental & Global Health, University of Florida, Gainesville, FL, USA
- Department of Internal Medicine, Jimma University, Jimma, Ethiopia
- Menzies School of Health Research and Charles Darwin University, Division of Education, Darwin, Australia
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