Global and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Australia.
Eijkman Institute for Molecular Biology, Jakarta, Indonesia.
PLoS Negl Trop Dis. 2022 Feb 17;16(2):e0010174. doi: 10.1371/journal.pntd.0010174. eCollection 2022 Feb.
The introduction of novel short course treatment regimens for the radical cure of Plasmodium vivax requires reliable point-of-care diagnosis that can identify glucose-6-phosphate dehydrogenase (G6PD) deficient individuals. While deficient males can be identified using a qualitative diagnostic test, the genetic make-up of females requires a quantitative measurement. SD Biosensor (Republic of Korea) has developed a handheld quantitative G6PD diagnostic (STANDARD G6PD test), that has approximately 90% accuracy in field studies for identifying individuals with intermediate or severe deficiency. The device can only be considered for routine care if precision of the assay is high.
Commercial lyophilised controls (ACS Analytics, USA) with high, intermediate, and low G6PD activities were assessed 20 times on 10 Biosensor devices and compared to spectrophotometry (Pointe Scientific, USA). Each device was then dispatched to one of 10 different laboratories with a standard set of the controls. Each control was tested 40 times at each laboratory by a single user and compared to spectrophotometry results. When tested at one site, the mean coefficient of variation (CV) was 0.111, 0.172 and 0.260 for high, intermediate, and low controls across all devices respectively; combined G6PD Biosensor readings correlated well with spectrophotometry (rs = 0.859, p<0.001). When tested in different laboratories, correlation was lower (rs = 0.604, p<0.001) and G6PD activity determined by Biosensor for the low and intermediate controls overlapped. The use of lyophilised human blood samples rather than fresh blood may have affected these findings. Biosensor G6PD readings between sites did not differ significantly (p = 0.436), whereas spectrophotometry readings differed markedly between sites (p<0.001).
Repeatability and inter-laboratory reproducibility of the Biosensor were good; though the device did not reliably discriminate between intermediate and low G6PD activities of the lyophilized specimens. Clinical studies are now required to assess the devices performance in practice.
新型短期疗程治疗方案的引入，需要可靠的即时诊断，以识别葡萄糖-6-磷酸脱氢酶（G6PD）缺乏个体。虽然可以使用定性诊断测试来识别缺乏的男性，但女性的基因构成需要定量测量。SD Biosensor（韩国）开发了一种手持式定量 G6PD 诊断（STANDARD G6PD test），在现场研究中，该测试在识别中重度缺乏个体方面的准确率约为 90%。只有在该检测方法具有高精度的情况下，该设备才能被认为是常规护理的选择。
用高、中、低 G6PD 活性的商业冻干对照品（ACS Analytics，美国）在 10 个 Biosensor 设备上评估 20 次，并与分光光度法（Pointe Scientific，美国）进行比较。然后，每个设备被分发给 10 个不同实验室中的一个，每个实验室都有一套标准对照品。每个对照品由一名用户在每个实验室测试 40 次，并与分光光度法结果进行比较。在一个地点进行测试时，所有设备的高、中、低对照品的平均变异系数（CV）分别为 0.111、0.172 和 0.260；Biosensor 联合 G6PD 读数与分光光度法相关性良好（rs = 0.859，p<0.001）。在不同实验室进行测试时，相关性较低（rs = 0.604，p<0.001），Biosensor 确定的低、中对照品的 G6PD 活性重叠。使用冻干人血样本而不是新鲜血液可能会影响这些发现。不同地点之间的 Biosensor G6PD 读数没有显著差异（p = 0.436），而分光光度法读数在不同地点之间差异显著（p<0.001）。
Biosensor 的重复性和实验室间再现性良好；尽管该设备不能可靠地区分冻干标本的中重度 G6PD 活性。现在需要进行临床研究来评估该设备在实际中的性能。
