Sadhewa Arkasha, Satyagraha Ari Winasti, Alam Mohammad Shafiul, Adissu Wondimagegn, Anvikar Anup, Bancone Germana, Bharti Praveen K, Bhutani Vinod K, Das Santasabuj, Hamid Muzamil Mahdi Abdel, Hossain Mohammad Sharif, Nitika Nitika, Okech Bernard A, Panggalo Lydia Visita, Talukdar Arunansu, von Fricken Michael E, Wong Ronald J, Yilma Daniel, Price Ric N, Thriemer Kamala, Ley Benedikt
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.
PLoS Negl Trop Dis. 2025 Mar 25;19(3):e0012864. doi: 10.1371/journal.pntd.0012864. eCollection 2025 Mar.
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.
We undertook an individual level meta-analysis of the performance of commercially available quantitative point-of-care diagnostics (PoCs) 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 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]).
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. Accuracy of the SDB was higher in females at the 30% cut-off (OR: 3.49, p=0.002) and lower in malaria patients at the 70% cut-off (OR: 0.59, p = 0.005).
The SDB performed better than other 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.
葡萄糖-6-磷酸脱氢酶（G6PD）缺乏是使用8-氨基喹啉（8AQ）治疗后发生严重溶血的主要危险因素。世界卫生组织建议在基于8AQ的灭疟原虫治疗前进行G6PD检测。
我们对市售定量即时诊断（PoC）与参考分光光度法的性能进行了个体水平的荟萃分析。系统文献检索（PROSPERO：CRD42022330733）共识别出595篇文章，其中16篇（2.7%）符合预定义的纳入标准并纳入分析，另外还有4个数据集。总共分析了12,678对测量值，其中10,446对（82.4%）通过标准G6PD检测（SD生物传感器，韩国，[SDB]），2,042对（16.1%）通过CareStart G6PD生物传感器（AccessBio，美国，[CSA]），150对（1.2%）通过CareStart生物传感器（WellsBio，韩国[CSW]），40对（0.3%）通过FINDER（Baebies，美国，[FBA]）。
当测量G6PD活性低于正常水平的30%时，SDB在毛细血管血中的合并敏感性为0.82（95%置信区间[CI]：0.72 - 0.89），在静脉血样本中为0.93（95% CI：0.75 - 0.99）。测量G6PD活性低于70%时的相应值分别为0.93（95% CI：0.67 - 0.99）和0.89（95% CI：0.73 - 0.96）。对于所有血样和G6PD活性阈值，SDB的合并特异性均较高（>96%）。无论使用何种血样和阈值，CSA的敏感性均未超过62%，尽管在30%和70%阈值时特异性均较高（>88%）。CSW和FBA各仅纳入一项研究。CSW在30%和70%阈值（静脉血样本）时的敏感性分别为0.04（95% CI：0.01 - 0.14）和0.81（95% CI：0.71 - 0.89）。FBA在30%和70%阈值（静脉血样本）时的敏感性分别为1.00（95% CI：0.29 - 1.00）和0.75（95% CI：0.19 - 0.99）。CSW和FBA在两个阈值下的特异性均始终较高（>90%）。在30%的临界值时，SDB在女性中的准确性较高（OR：3.49，p = 0.002），在70%的临界值时，在疟疾患者中的准确性较低（OR：0.59，p = 0.005）。
SDB的性能优于其他即时诊断方法。与其他即时诊断方法相比，有更多关于SDB性能的证据，这使其在诊断G6PD缺乏症方面的实用性更具可信度。
