Global and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Australia.
Central Department of Microbiology, Tribhuvan University, Kirtipur, Kathmandu, Nepal.
PLoS One. 2024 Jan 19;19(1):e0296708. doi: 10.1371/journal.pone.0296708. eCollection 2024.
In remote communities, diagnosis of G6PD deficiency is challenging. We assessed the impact of modified test procedures and delayed testing for the point-of-care diagnostic STANDARD G6PD (SDBiosensor, RoK), and evaluated recommended cut-offs. We tested capillary blood from fingerpricks (Standard Method) and a microtainer (BD, USA; Method 1), venous blood from a vacutainer (BD, USA; Method 2), varied sample application methods (Methods 3), and used micropipettes rather than the test's single-use pipette (Method 4). Repeatability was assessed by comparing median differences between paired measurements. All methods were tested 20 times under laboratory conditions on three volunteers. The Standard Method and the method with best repeatability were tested in Indonesia and Nepal. In Indonesia 60 participants were tested in duplicate by both methods, in Nepal 120 participants were tested in duplicate by either method. The adjusted male median (AMM) of the Biosensor Standard Method readings was defined as 100% activity. In Indonesia, the difference between paired readings of the Standard and modified methods was compared to assess the impact of delayed testing. In the pilot study repeatability didn't differ significantly (p = 0.381); Method 3 showed lowest variability. One Nepalese participant had <30% activity, one Indonesian and 10 Nepalese participants had intermediate activity (≥30% to <70% activity). Repeatability didn't differ significantly in Indonesia (Standard: 0.2U/gHb [IQR: 0.1-0.4]; Method 3: 0.3U/gHb [IQR: 0.1-0.5]; p = 0.425) or Nepal (Standard: 0.4U/gHb [IQR: 0.2-0.6]; Method 3: 0.3U/gHb [IQR: 0.1-0.6]; p = 0.330). Median G6PD measurements by Method 3 were 0.4U/gHb (IQR: -0.2 to 0.7, p = 0.005) higher after a 5-hour delay compared to the Standard Method. The definition of 100% activity by the Standard Method matched the manufacturer-recommended cut-off for 70% activity. We couldn't improve repeatability. Delays of up to 5 hours didn't result in a clinically relevant difference in measured G6PD activity. The manufacturer's recommended cut-off for intermediate deficiency is conservative.
在偏远社区，诊断 G6PD 缺乏症具有挑战性。我们评估了修改后的检测程序和即时诊断 STANDARD G6PD（SDBiosensor，韩国）的延迟检测对其的影响，并评估了推荐的截止值。我们分别使用指尖的毛细血管血（标准方法）和微采血管（BD，美国；方法 1）、真空采血管（BD，美国；方法 2）进行静脉血检测，还分别使用了不同的样本施加方法（方法 3 和 4），并使用了微量移液器而非检测的一次性移液管（方法 4）。重复性通过比较两次配对测量的中位数差异来评估。所有方法在实验室条件下对 3 名志愿者进行了 20 次测试。在印度尼西亚和尼泊尔，分别对标准方法和重复性最佳的方法进行了测试。在印度尼西亚，60 名参与者分别通过两种方法进行了两次重复检测，在尼泊尔，120 名参与者分别通过两种方法中的任意一种进行了两次重复检测。根据 Biosensor 标准方法读数的调整男性中位数（AMM）将定义为 100%活性。在印度尼西亚，比较了标准方法和改良方法的配对读数之间的差异，以评估延迟检测的影响。在试点研究中，重复性差异无统计学意义（p=0.381）；方法 3 显示出最低的变异性。一位尼泊尔参与者的活性<30%，一位印度尼西亚参与者和 10 位尼泊尔参与者的活性为中间值（≥30%至<70%）。在印度尼西亚，重复性差异无统计学意义（标准方法：0.2U/gHb [IQR：0.1-0.4]；方法 3：0.3U/gHb [IQR：0.1-0.5]；p=0.425）或尼泊尔（标准方法：0.4U/gHb [IQR：0.2-0.6]；方法 3：0.3U/gHb [IQR：0.1-0.6]；p=0.330）。与标准方法相比，方法 3 在 5 小时延迟后测量的 G6PD 活性中位数高 0.4U/gHb（IQR：-0.2 至 0.7，p=0.005）。标准方法中 100%活性的定义与制造商推荐的 70%活性的截止值相匹配。我们无法提高重复性。长达 5 小时的延迟不会导致测量的 G6PD 活性出现临床相关差异。制造商推荐的中间缺陷的截止值较为保守。
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