Source and size of included datasets.

BackgroundGlucose-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.MethodsWe 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]).FindingsThe pooled sensitivities of the SDB when measuring G6PD activity 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).ConclusionsThe 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.背景：葡萄糖-6-磷酸脱氢酶（glucose-6-phosphate dehydrogenase, G6PD）缺乏症是接受8-氨基喹啉（8-aminoquinolines, 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，在实施以8AQ为基础的疟原虫休眠体杀灭治疗前，应先开展G6PD检测。 方法：本研究采用个体层面的荟萃分析，对比评估市售定量床旁诊断试剂（point-of-care diagnostics, PoCs）与参考方法分光光度法的检测性能。通过系统文献检索（PROSPERO注册号：CRD42022330733）共检索到595篇文献，其中16篇（占比2.7%）符合预先设定的纳入标准，被纳入本次分析，额外纳入4个数据集。本研究共分析12678对配对检测数据：其中10446对（82.4%）来自STANDARD G6PD检测试剂盒（SD Biosensor，韩国，简称SDB），2042对（16.1%）来自CareStart G6PD生物传感器（AccessBio，美国，简称CSA），150对（1.2%）来自CareStart生物传感器（WellsBio，韩国，简称CSW），40对（0.3%）来自FINDER检测试剂盒（Baebies，美国，简称FBA）。 结果：在针对所有血液样本及G6PD活性临界值（cutoff）的检测中，SDB的合并灵敏度最高可达96%（原文此处存在信息缺失）。无论采用何种血液样本类型或临界值，CSA的灵敏度均未超过62%，但其在30%和70%两个临界值下的特异性均维持在较高水平（>88%）。本次分析仅纳入了1项针对CSW的研究和1项针对FBA的研究。在静脉血样本中，CSW在30%和70%临界值下的灵敏度分别为0.04（95%置信区间：0.01~0.14）和0.81（95%置信区间：0.71~0.89）；FBA在对应临界值下的灵敏度分别为1.00（95%置信区间：0.29~1.00）和0.75（95%置信区间：0.19~0.99）。CSW和FBA在两个临界值下的特异性均持续高于90%。SDB的检测准确性在30%临界值下对女性群体更高（优势比OR=3.49，P=0.002），而在70%临界值下对疟疾患者更低（OR=0.59，P=0.005）。 结论：SDB的检测性能优于其余同类床旁诊断试剂。相较于其他PoCs，现有针对SDB检测性能的研究证据更为充分，使其在G6PD缺乏症诊断中的应用价值更具可信度。